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HomeMy WebLinkAboutBOH MEETING PACKET 12_01_2025Board of Heatth Hittard Boskey, M.D Mary Craig Chartes T. Hotway Laurance Venezia DVM Eric Weston Assistant Hoatth Director Barry Lewis Town ofYarmouth Board of Heatth 1 146 Route 28, South Yarmouth, MA 02664 (5O8)39&2231 BOARD OF HEALTH MEETING AGENDA December 1, 2025 at 5:00 PM This meeting wilt be conducted in person at the date, time and tocation identified above. This moans that at least a quorum of the members of the pubtic body witt afiend the meeting in person and members ol the pubtic are welcome to attend in person as wetl. As a counesy onty, access to the meeting is atso being provided via remote means in accordance with applicebte law. Ptease note thatwhite an option for remote attendance and/or participation is being provided as a counesy to the pubtic, the meeting/hearing witl not be suspended or terminated if technotogicat probtems interrupt the virtual broadcast or atfect remote attendance or participation, unloss othorwise required by taw. Msmbers of the pubtic with panicutar interest in any specific item on this agenda, which includes an appticant and its representatives, shoutd make ptans for in-person vs. virtual attendance accordingly. Members of the pubLic who wish to attend the meeting may do so in the toLLowing manner: Phone: 1-253-215-8782 ot 1-312-626-6799 and enter the meeting lD (871 1 526 3955) To request to speak: Press *9 and waitto be recognized, Zoom Webinar: Join the meeting hosted in Zoom by usingthe fotLowing tink https://lso2web.zoom.us/j/871 1 5263955 The meetlngwitt be broadcast [ive, in realtime, via a live stream on Yarmouth's YouTube Channet tocated atthe toltowing link: hftps://www.youtube.com/channeUUCgQl QFZevmoqW5Mz2PnWKpA/ It is rocommended that phone participants access materiats in advance ofthe meeting PLease note that forany item tisted betowthe Board of Heatth maytake officialaction includingvotes. 1 . Cat[ to order 2. Dectaration of a Quorum3. Pubtic comment The open meetlng law discourages publlc bod,es from discussing toprc s not listed on the agenda. fhe public should thetatorc not expect the Board to respord to guestlors or statements made during the Public Commant pottion of the meetin+ 4. Smoke Detector Awareness & Education - Yarmouth Fire Department 5. Variance- 97 Hetmsman Drive, Yarmouth Port, MA6. Nicotine Free Generation - Discussion 7. Kratom - Discussion 8. Review & Approve Minutes a. November 3, 2025b. December 18,2023 9. New/Otd Business 10. Ad.iournment fi 6l"-P.-tLJ ;J. I'Ll Ci-bfi-xer\: --uLr lrl a,.r fri\l 7tii ?sxLr rn J-..S1 TOWN OF YARMOUTH HEALTH DEPARTMEN VARIANCE/PUBLIC HEARING APPLICATION n/ 2 D (U2q .894 €pr N NEW CONSTRUCTION/ALTERATIONS/ADDITIONS tr SEPTIC SYSTEM FAILURES N VOLI.]NTARY IJPGRADE N VARIANCE (SEPTIC) XVARIANCE (OT N TOXIC/HAZARDOUS MATERIALS LOCATED IN A ZONE Il: tl YES trNO owNrn's NaN{Ei\grt 0L a C, I !/,A.+ cs aQ i ffi-,gtL \LOl'# RLSREETFACILITY ST MAP # OWNER'S PHONE#c_ )d >t4lt ao 54 ionfic,r qf CEMAII- \c'tntl .l OWNER'S MAILTIIG ADDRESSla nr< J APPLICANT/PREPARER'S COMPANY PHONE # EMAIL MAILIN(i ADDRESS -S Rrstnrunar n coMMERCIAL n EDUCATIoNAL tr MIXEDUsE TYPE OF FACILITY SCRIBE IACII,ITY (lF RIQUIRTD.PLEASE ATTACH A SE () ORE SPACtr R{TE SHT]ET) TYPE OF SYSTEM PROPOSED (CHECK ALL THAT APPLY) t] PT]MPED SYSTEM t] GRAVITY SYSTEM tr PRESSI]RE DOSED N TIGHT TANK D CONVENTIONAL TITLE 5! VASYSTEM D OTHER DESCRIBE I]XISTING & PROPOSED SYSTEM COMPONENTS (lr M()RE sP.rcE Is REQUIRTD. PLfASf, AT1 ACH A SDPAR{'I E S}IEET) DESIGN FLOW PER 3IO CIIIR 15.203 (IN CALLONS/DAY) EXISTING PROPOShD DESIGN FLOW OF SYSl'EM TOTAL DESIGN FLOW OF FACILITY (llj IIORE l l{AN ONE SYSI-EM ON SUBIL.'I fl) PROPt,R'lY) DIlSIGN ENGINEER/SANITARIAN (DESIGN ENGINEER IS REQUIRID TO ATTEND HEARING AS REPRESENT SIGNA tURr, l-]-10"i 1 '- : r L4r-zN| / (APPLTCANT/OWN}n ndpnpsENrarrVr I PHONE # ,oru t tlobs )^ )+-'I I 310 CMR: DEPARTME..NT oF ENVIRONMENTAL PROTECTION 15.222: continued (7) The building sewer shallbe laid on a continuous Srade and as nearly as possible in a straight line in accordance wrth accepled tngineering praclice. (8) Manholes, with metal fiames and covers at grade, sweeping bends, or a cleanout accessible at thc surface of the ground, shall be provided at the junction of two or morc sewers. at all changes in direction or a change in grade ofthe sewers, altd at intervals no greater than 100 feet. All gravity sewer manholes shall have an open charuel depth equal to or greater than the diameter ofthe inlet sewer and the change ofdirection in each manhole shall not exceed 90'. (Change ofdirection is the interior angle between the new direction of flow and the projected extension ofthe original direction of flow.) (9) The building sewer shall b€ vented through the vent stack or main vent ofthe brilding served by it. No trap shall be installed in the building sewer ot building drain. (10) All building sewers shall be constntcted in accordance with the State Plunbing Code, 248 CMR 2.00. ( I) Scptic lanks shall havc thc lollo\\ ing capacitics: (a) f'or a siDglc lamily drvcllurg unit $' ith a design flow of less than I .000 gallons pcr day. a rninimum cffcctive liquid capacit) ol l01)9'o of thc rlesign flou or a nrrnlmunr hldraulic tlctention flo* of ,l8 hours. *hichercr is grealer. shall Lrc rcquired In no casc shall the cf'fectivc liquid capacitv ofthe tank as nreasured belo\\ the outlct invcrl.lcvationbe lcss than 1.500 gallons. lb) Whcn designed to ser\e facililies othcr tharr a single ianrily dwe)ling unit or rvhcncler thc calculatcd dcsign flo\\ is 1.000 gnllons pcr day or elcatar, a t\4 o companmcnt tank or 1\\o tar is in series are rcquircd. Thc d.sigrr ol tlrc tanks shall be in accordancc \\ith 3l0 CMR 15 221 for multiplc compartmcnt lanks and I l0 CN{R 15.215 ibr tanks in series. At a rrrinimum. the total. cornbined c'ffcctivc liquid capacity olboth tanks in scrics or ofthe mlrhiplc compartmcnt lank shall not bc less than 1,500 Ballons.(c) When a domestic garbage grinder is propos€d or installed, the minimum liquid capacity of the septic tank shall be 200% of the design flow with a mhimum tank size of 1,500 gallons and a two compartment tank or two tanks in series shall be required which meet the design criteria specified in 310 CMR 15.223( I )(b). Domestic garbage ginders are prohibited in facilities which include an elevated septic tank constructed in accordance with 310 CMR 15.213 (construction in V-zones). (2) The liquid depth ofthe tank, measued from the outlet tee invert to the tank bottom, shall be a minimum offour feel. A tank with a minimum depth olthree feet below the outlet tee invert maybe permitted only for upgrade ofexisting nonconforming or failed systems, pursuant to 3 l0 CMR l5.405 (local upgrade approvals), where installation ofa tanl( with a four foot liquid depth is not feasible and shall be pumped on an annual basis with the results submitted to the Approving Authority. (3) Tanks which are rectangular in crcss-section shall have a minimum inside length to width ratio ofno less than 1.5 to l. Round tanks may be allowed. The inside len$h ofall tanks. measured from the inlet tee to the outlel tee. shall be a minimum ofsix feet. The inside uidrh of the tank shall be a minimum of three feet. t-arger length to width ratios are preferred. (4) Venical cylindrical tanks shall have a minimum diameter offivc feet. (5) Horizontal cylindrical tanks shall have a minimum length ofsix feet and a minimum rvidth at the liquid sudace ofthree feet. I5.224: Multiplc Compartment Tanks Tanks with multiple compartments shall be required as specified in 310 CMR 15.223(t) When multiple compaftment tanks are used the following shall be rcquircd: 15.223: Septic Tanks ./. 4 gu lo a- fi^te 1,17 /YgO. ,*uj7/ry41 t/o a477<.a SEPT I C SYSTEM FLOW ESIIUATE SEPTIC TANX cAt/DAy r 2 DAyS USE GALLON SEPTI SOIL A PTIO U BEpRoors AT .//O GAL/DAY,/BEDRooM -.jij{lrGAL/DAy TH-2 .cfr#4{ DES IGN 2 Z f1,4. f-€.r Ez-\ {4 --1-z '12-. ,/,'Zo'/4\--J )_- '.l/ 1.r-l )g- .,J <'- zl ci z'x F1 dlcl -F>.r - (4 G^L C TANK /€X, ir'o7- Y)t <. ><7 tg 3/ ,1Y J&-c Srxtt l/ 7* --l-'tj_€ t--t -- l,r€ ! trct:_,tD 1l st BbT DE AREA: ZY rO}T AREA:-,>t3 XZx o-*) KO 1 <7, SEP T IC SYSTEM SECT ION .-/ cl L, -.!'U.,riLl t L 7,6 V, q llrrJ*'rm a GAL D.BOX 3'g.ti1tSEPTIC TANK (p5g e'fl.€. ID, ffi 4t,& <+1 +tlt/5 ,,<. * TH.I -'z e-e 6\ .4../48?/ SYSTEM t-of+ga \ - I c Jo o)lc c, =.- C =o q,lEo.} =.o C Jo O)lc C) =.E c fo o)fc o.tf t 1( HHS Public Access Author manuscript Int J Dntg Policy. Author manuscript; available in PMC 2021 February l3 Published in final edited form as: lnt J Drug Policy.20l9 August ; 70 '10-77 . doi:10.10164.dru9po.2019.05.003 Kratom policy: The challenge of balancing therapeutic potential with public safety Walter C. Prozialecka,', Bonnie A. Averyb, Edward W. Boyef, Oliver Grundmannd, Jack E. Henningfielde, Andrew C. Kruegelf, Lance R. McMahons, Christopher R. McCurdyd, Marc T. Swoggef . Charles A. Veltrii, Darshan SinghJ aDepartment of Pharmacology, Midwestern University, 555 31st Street, Downers Grove, lL 60515, USA bDepartment of Pharmaceutics, College of Pharmacy, University of Florida, Gainesville, FL 32610, USA cDepartment of Emergency Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 021 15, USA dDepartment of Medicinal Chemistry, College of Pharmacy, University of Florida, Gainesville, FL 32610, USA .Research, Health Policy and Abuse, Liability, Pinney Associates And Department of Psychiatry and Behavioral Sciences, The Johns Hopkins University School of Medicine, 4800 Montgomery Lane, Suite 400, Bethesda, MD 20814, USA rDepartment of Chemistry, Columbia University, 3000 Broadway, New York, NY 10027, USA sDepartment of Pharmacodynamics, college of Pharmacy, University of Florida, Gainesville, FL 32610, USA hDepartment of Psychiatry, University of Rochester Medical Center, 300 Crittenden Blvd., Rochester, NY 14682, USA iDepartment of Pharmaceutical Sciences, Midwestern University, 19555 N.59th Avenue, Glendale, AZ 85308, USA icentre for Drug Research, Universiti Sains Malaysia, Minden, Malaysia Abstract This is an op€n access article under the CC BY-NC-ND licens€ (http: /ereltrv,r.onmroN ors ir(.ns.s:UY,NC-\D I 0 ).'Correspondins aulhor- wprozi@midwcstcm.cdu (WC. Prozialeck). Authors' roles in writing manuscript Drs. Walter Prozialeck and Darshe Singh conceived th€ manuscript and wrole the first dmft. All ofthe authors provided significant input into the writing and editing of the manuscript- AII authoN have .pproved the 6nal version of the manuscript. Authors' conflicl of interesl stat€m€nt Drs. Prozialeck. Avcry, Mccurdy, McMahon, Grundmann and singh havc no potcntial conflicrs of intcrcst to disclosc. Dr Edward Boyer is a Fulbright Scholar sludying the efccrs ofkarom. Dr. Andrew Kruegel has served as a non-compei$ated consultant to the American Kratom Association and is a co-invenror on several katom-related patent applications filed by Columbia University. D. Jack E. HenninSfield provides consulting suppo( tfuough Pinney Associares. on rhe developmenl of abuse porenrial assessmenrs and reSulation ol new mediches and formulatiotrr for the treatment ofpaiD, addiclioL epilepsy. and other central nervous system disordeB. He has also sewed as a consultant for the Amencan Kratom Assocrarion (see more ar s$r prlrnerasJo.rrr.\ !onr). c =o 0)fcao =.! c =o 0)5Coor.! Clo o)fc o =.! C fo 0)lC o =.! Pase 2 Kratorn (MitragJala speciosa) is a tree-like plant indigenous to South€ast Asia. Its leaves, and the teas brewed from them have long been used by peoplc in that region to stave olf fatigue and to manage pain and opioid withdrawal. Evidence suggcsts kratom is being increasingly used by people in the United States and Europc lor the self-managcmcnt ofopioid withdrawal and treatment ofpain. Rccent studies have confirmed that kratom and its chemical constituents have potentiatly useful pharmacological actions. However, there havc also been incrcasing numbers of reports ofadverse effects resulting ftom use of katom products. In August 2016, the US Drug Enforcement Administntion announced plans to classiry kratom and its mitragynine constituents as Schedule I Controlled Substances, a movc that triggercd a massive response from pro-kratom advocates. The debate regarding the risks, and benefits and safety of katom continues to intensiry. Kratom proponents tout kratom as a safer and less addictive altemative to opioids for the management ofpain and opioid addiction. The anti-katom faction argues that kratom, itself, is a dangerous and addictive drug that ought to bc banned. Given thc widespread use ofkratom and the extensive media attention it is receiving. it is impoflant for physicians. scientists and policy makers to be knowledgeable about thc subject. Thc purpose ofthis comnrenlary is to update readers about recent developments and controversics in this rapidly evolving area- All ofthc authors are engaged in various aspccts of katom rcsearch and it is our intention to provide a fair and balanced overview that can form the basis for informcd dccisions on kmtom policy. Our conclusions fiom these analyses are: (a) User reports and rcsults ofpreclinical studies in animals strongly suggest that katom and its main constituent alkaloid, mitragl.ninc may have useful activity in alleviatiug pain and managing symptoms ofopioid withdrawal, even though well-controlled clinical trials have yet to be done. (b) Even though kratom lacks many ofthe toxicities ofclassic opioids, there are legitimate concems about the safety and lack ofquality control of purported "kratom" products that are being sold in the US. (c) Thc issues rcgarding the safety and cllcacy of kmtom and its mitragymine constituent can only bc rcsolved by additional research. Classification ofthe Mitragyna alkaloids as Schedule I controlled substances would substantially impede this importanl research on kratom. lntroduction and background Kratom (also known as ketum in Malaysia) is a tree-likc plant (Mitragyna speciosa, Kotth. Havil) native to T'bailand, Malaysia. lndonesia and other regions ofSouthcast Asia. When the plant's lcaves are ingested in the form ofteas or other extracts/decoctions, kratom leaves produce complex, dose-dependent stimulant and analEesic eflects. For generations, indigenous people in Southeast Asia have used katom to treat common health maladies (e.g. diarrhea, hypertension, cough, fever, etc.), enhance work performance, combat fatigue, alleviate pain, and manage opioid dependence (hereafter referred to as opioid use disorder (OUD)) (Adkins, Boyel & McCurdy, 201 1; Cinosi et a1.,2015; Jansen & Prast, 1988; Vicknasingam, Narayanan, Beng, & Mansor, 2010). This suggests that raditional use of katom has therapeutic potential, or at least that it is used by people seeking improved health and well-being- In considering the uses of kratom, in this commcntary we distinguish Int ! Drug Policy. /rlt\hd manuscript: availablc in PMC 2021 Fehruary 13 Keywords Kratom; Ketum; Mitragynine; Opioid use disorder (OUD); Pain management; Drug policy C l'o o)f,C o E c Jo o)JClno =.'13 E =o 0) =c o =.! C J o)lc ol.! Pasr l traditional use from "therapeutic use", which in the United States (US) and many countries is defined by whether a substanc€ or product has been officially approved by a regulatory authority such as the US Food and Drug Administration (FDA), gpically with reliancc upon randomized controlled clinical trials for new drugs. We recognize that kratom has not yet met standards for therapeutic use claims and has not been approved in the US for "therapeutic use", despite the widespread and growing use of katom as a self-treatme[t for a number ofdisorders, including pain, OUD, and depression or anxiety (Grundmann, 2017) Rather, it is curently marketed and regulated in the US as a food and/or dietary ingedient that is not subject to thc same strict regulations that are used for approval of new drugs. Since kiatom has not been apptoved for therapeutic use in the U.S, it cannor legally be advertised as a remedy for any medical condition. Despite its long history oftraditional use in Southeast Asia, kratom has only recently received significant aftention as a plant-based temedy in thc West. The emergence of katom as a product of interest in the West, and particularly in the US, is evident fiom the results of several recent suryeys, analyses of oflline user reports, and reviews of the scientific litcrature (Prozialcck, 2016, Adkins et al.. 201 l; Grundmann, 2017; Kruegel & Grundmann' 2018; Pain News Network,20t8; Prozialeck, Jivan, & Andurkar,2012; Smith & Lawson, 2017; Swogger & Walsh, 2018; Swogger et al., 2015). Results ofthose analyses yield clear evidence that a large number ofindividuals in North America and Europe are using katom products for the self-management ofa number ofmedical conditions, including pain, OUD, anxiety, and depression (Grundmann, 2017). In the US, for example, current estimates from the American Kratom Association suggest that more than I million individuals in the USA may be using kratom (American Kratom Association, 2018a), although incidence ofuse has not been rigorously studied. At the same time, some unscrupulous marketers are promoting kratom as an opioidJike "legal high" (Babu, McCurdy, & Boyer, 2008; G ffin, Daniels, & Gardner, 2016: Rech, Donahey, Cappiello Dziedzic, Oh, & Greenhalgh, 2015; Schmidt, Sharma, Schifano, & Fcinmana, 201 I ). Thc unregulatcd sale of kntom via the intemet and deceitful marketing practices may have prompted some individuals to use katom as a recreational drug. This poorly regulated market, wide distribution, and reported risks of toxicity associated with katom use, are all likely to have encouraged regulatory agencies to suggest the removal ofthis product fiom the market. ln the West, a wide variety of kmtom products-including raw leaves, capsules, tablets, and concentrated cxtracts-are available either from Intemet-based suppliers or specialty stores commonly known as "head shops", "vaping shops" or "smoke shops". (Adkins et al., 201 I ; Boodman, 2016; Kroll, 2016; Prozialeck et al., 2012), unlike in traditional setlings where kratom is usually sold as freshly-brewed teas and decoctions (Singh, Narayanan, & Mcknasingam, 2016). The growth of kratom usc in the West parallels increasing concerns about the safety and abuse potential of katom. The emerging coltroversies regarding katom were highlighted in August of 2016, when the US Drug Enforcement Administration (DEA) announced plans to place the main active constitucnt of katom, mitragynine, and a stnrcturally related compound, 7-hydroxymitragynine, in Schedule I ofthe Controlled Substances Act (CSA), using its emergency scheduling authority (DEA,20l6b). This action would have restricted the use ofkratom in the US and made it extremely dilfcult for researchers to investigale the medicinal potential of katom (Prozialeck, 2016). The DEA's lnt J Drug Policy. A\thot manuscript: available in PMC 2021 February tj E l-o q) fc of.ro c =o o) =Caof-E C fo (I)lE o ! Page 4 proposed action sparked an unprecedented public debate and protesr, with thousands of kratom users filing comments in thc Federal Register supporting the uset'ulness of katom for the self-featment ofchronic pain or OUD without major abuse potential (DEA, 2016a). In response to the intensc public outcry the DEA withdrew its notice of intent to schedule kratom and has placed thc final dccision on indefinite hold pending an 8-factor ana:ysis by the US !'DA (DEA, 2016b,2016c; Icoll,20l6; Prozialeck, 2016). As ofthis writing, kratom remains lcgal throughout most ofthe US, although a few states. including Alabama, Arkansas, lndiana, Vermont, and Wisconsin, havc banned it. On Octobcr 17,201'7,the US Department of Health and Human Services asserted in a new letter to the DEA that mitragynine and 7-hydoxynitragynine should be classified as Schedule I controlled substance, a move that would severely restrict kratom use in the United States (Swetlitz, 2018). The details and timeframe tbr such a policy have yet to be worked out. With regard to intemational regulatory agencies, neither kratom. nor any ofits alkaloids, are currently listed in the 1961 and l97l Schedules of the United Nations Drug Conventions, although kratom has been criminalized in Thailand. Malaysia, Myanmar, and Australia, as well as several European nations. Notably, officials in Thailand have tfuice considered endilg their katom ban since 2000, citing no known cases ofoverdose, death, or violence following at least 100 years oftraditional use- Kratom-based drugs are curently classified as New Psychoactive Substances (NPS) by the United Nations Office on Drugs and Crime (UNODC), but do not appear on the agency's list ofemerging drug threats (UNDOC, 2019). The European Union has taken a position that there is no approved use of kmtom or its alkaloids in modem medicine (EMCDDA,20l5). The legal uncertainty surrounding kratom appears to arise from two opposing nanatives. The first is that kratom has potcntial therapeutic value as a substitutc for classical opioids (e.g. morphinc. oxycodone, heroin, etc.), providing safer pain management and a novel way for people who have OUD to wean themselves from the morc dangerous opioids (Grundmann, Browa, Henningfield, Swogger, & Walsh.20l8; Henningfield, l'ant, & Wang,2018; Ward, Rosenbaum, Hcmon, McCurdy, & Boyer, 201 I ). Thc sccond narrative is that kratom is a dangerous and addictive opioid, and thcrcfore. should be classificd in Schedule I ofthe US CSA (Gauvin & Zimmermann, 2018; HHS,201{t). Given the widespread use ofkratom and the extensive media attention it is receiving, physicians, scientists, and policy makers must be kno\trledgeable about the science of l(Iatom. The purpose ofthis commentary is to proyide an update about recent dsvelopments and controvercies in this rapidly evolving area from the perspective ofscientists who are actively engagcd in various aspects ofkratom research. In this commentary, we will address several key issues related to the opioid-like effects ofkratom, uncertainties about its toxicities and addictive potential, as well as questions about its efficacy in the treahnent of pain and OUD. Int I Drug Policy. A$h$ manuscripl: availablc in PMC 2021 Fcbnrary 1l c fo o)fcao_-.! c :to 0) =C(,o =. C fo o)lcao:.! c fo A)fc o =.! E:to !) =cao:. Prozialeck el al In describing their rationale for scheduling kratom (DEA,20l6b), the DEA emphasized that the mitragynine-type indole alkaloids can interact with opioid receptors and produce some opioidlike effects (Adkins et al., 201l; Kruegel & Grundmann, 2018; Matsumoto et al., 2006; Thongpradichote et al., t998). In 2018, thc FDA went further by publishing the rcsults ofits own molecular modeling study suggcsting that there were more than 20 substances in kratom that could theoretically intemct with opioid rcceptors (FDA, 2018c). A major shon-coming ofthese molecular modeling studies is that the molecules were never tested to determine if they did, in fact, have opioid agonist activity in living cells or organisms (Grundmann et al., 2018). In considering the active compounds in kmtom, it is important to note that the most well-documented pharmacological effects ofkratom. namely analgesic activity and attenuation ofopioid withdrawal symptorns, can bc explained largely by the actions ofmitragynine, thc primary alkaloid and also the most sludied (Krucgel & Grundmam, 2018; Takayama ct al., 2002). Other alkaloids arc either devoid ofknown pharmacological activity and/or, like 7-hydroxymitagynine, are present at such low levels as to not be considered factors in kratom effects or toxicity (Adkins et al., 201 l; Kruegel & Grundmann, 2018; Takayama et al., 2002; Takayama, 2004). It is also important to note that mitragynine has other pharmacological actions that remain understudied. For example, in preclinical studies, mitragynine has been found to modulate central serotonergic and adrenergic transmission (Matsumoto et al., 1996) and inhibit prostaglandin production (Utar, Majid, Adenan, Jamil, & Lan, 201 I ). Furthermore, mitBgynine has becn shown to interact direcdy with other CNS drug targets, rendering it distinct from classical opioids (Boyer, Babu, Adkins, McCurdy, & Halpem,2008; Kruegel & Crundmann. 2018). [t is also important to note that the functional activity ofmitragynine at these targets may vary from agonist to antagonist, but this is yet to be determined. Most ofthe scientific evidence on kratom's opioid-like activity is derived fiom findings in csll and animal studies, where mitragynine has been found to bind to and activate opioid receptors, and induce opioid receptor-dependent analgesic effects (Adkins et al., 201 I j Boyer et al., 2008; Kruegel & Grundmann, 2018; Prozialeck et al., 2012; Stolt et al., 2014; Yusoff et a1.,2016). While no well-controlled trials ofkratom in humans have been conducted, anecdotal reports and largel carefully conducted surveys have shown that people have used kratom to successfully treal pain and OUD effects (Grundmann, 2017; Swogger & Walsh, 2018), consistcnt with actions at opioid receptors. In addition, anecdotal reports and commentaries indicate that some cflects ofkratom in humans, such as mild euphoria, may resemble those ofopioid agonist drugs (Singh, Muller, Vicknasingam, & Mansor,20l5, 2016; Vicknasingam et al., 2010), but there is also strong evidence indicating thar kratom's eflects are distinct from those ofclassical opioids (Henningfield et al., 2018; Singh, Muller, & Vickmsingam,20l4,20l5,20l6; Mcknasingam er a1.,2010). For example, at low to moderate doses, kratom has mild stimulant properties, unlike the sedating efects often exhibited by opioids. In addition, katom does not seem ro produce an intense high or euphoria at t,?ical doses (Cinosi et al., 2015; Erowid, 2016; Prozialeck et al., 2012; speciosa.org, 2016; Wisdom, 2016). The most signilicant difference from opioids is that, Pagc 5 htt t DnE Polt.y. L\thot manL'scripti availablc rn PMC 202 t lrcbruary t l Should mitragynine and/or other kratom constituents be classified as opioids? c fo OJfc o =.! E fo 0)lC @o =.E c =o 0)lclt)ol.! c Jo 0)f,tr @ot. Page 6 even at very high doses. kmtom is much less likely to depress respiration (to a fatal degree) than classical opioids (Singh, Narayanan et aI..2018.2016: Varadi et al.,2016). Further, at the molecular leyel, mitragyninc has a chemical structure that is quite diflerent from classical opioids such as morphine, which are mostly derived lrom the alkaloids ofthe opium poppy (Adkins et al., 201 I : Kruegel & Crundmann, 2018; Prozialeck el a1..201,2: Takayama,2004). Recent studies indicate that even though mitragynine acts on opioid recaptors, its over-all molecular actions arc quitc different from those ofclassical opioids (Henningfield et a1.,2018; Prozialeck et a1.,2012). tn two recent studies, Varadi et al. (2016) and Kruegel et al. (2016) demonstrated that mitragyninc and sevcral rclated compounds act as G protein-biased agodsts at the mu-opioid receptor (MOR). ln other words, although they actiyated G protein-mediated signaling pathways, much like classical opioids, they did not activate the g-arrestin-2 signaling pathway. which has been implicated as a mediator of some opioid-induced side effects, including respiratory depression (Raehal & Bohn,20l4; Schmid et aI.,2017). Accordingly, the avoidance ofp-anestin-2 activation may in part explain the apparent respiratory safety ofkratom, despite other opioid-like effects. These studies also showed mitragynine to be a partial agonist at MOR, as compared to most classical opioids, which are full agonists. Partial activity is also expected to attenuate the severity ofside ellects. For example, buprenorphine, a partial agonist at MOR, cxhibits a dose ceiling for respiratory depression (Dahan et aI.,2005). lmportanrly, the improved side effect profile of mitragyrine and related compounds has also been supported by preliminary animal studies. An early study with mitragynine demonstrated attenuated respiratory depression and constipation for this compound compared to the classical opioid morphine in several animal species (Macko, Weisbach, & Douglas, 1972). Further, the Varadi study (Varadi et al., 201 6) dcmonstrated in mice that a mitragyninc-dcrived compound, mitragynine pseudoindoxyl, induced marked analgesic effects, but with attenuated respiratory depression, slower developmcnt oftolerancc, and lower rewarding effects than morphine. Accordingly, both the natural compounds in katom (e.9. mitragynine) and synthetic derivatires thereofmay represent a new class ofopioid- acting drugs with an improved window between therapeutic elfccts and negative side effects. As a result of its ability to interact with opioid receptors, mitragynine is often referred to as an "opioid". On the other hand, a large volume ofevidence indicates that mitragynine produces physiological. biochemical and behavioral effects that differ from those ofclassical opioids. Even though some effects ofmitragyninc may involve partial activation ofMOR, mitragynin€ is abl€ to interact v/ith many other receptors that classical opioids do not bind (Boyer et al., 2008). In light ofthis evidence. mitagynine and its analogs can best be described as "atypical opioids" (Raffa. Pergolizzi. Taylor, Ossipov. & Group, 2018), and may actually represent a uniquc class ofdrugs. ls kratom effective for the management of pain and/or OUD? OUD continues to be a growing problem in the US. and the federal govemment has begun to addrcss the challenge (Frieden & Houry, 2016; Harris' 2016; Nelson, Juurlink, & Penone, 2015; NIDA, 2018b). Among actiqns taken by the federal govemment' the most significant has been thc devclopment ofncw guidelines by the Centers for Diseas€ lntID g Policy. A\tthot manuscripl: availablc in PM( 2021 fcbruary l3 C 5 :E o =._o Cl'o q)lCao::.E c =o 0)fC o =.! C f,- o)fc o::.! Control and Prevention (CDC) for the prescribing ofopioids, tbr non-cancer pain (Dowell, Haegerich, & Chou,20l6). In this environment, physicians are discouraged from prescribing opioids. especially for long-term usage, a strategy that has compelled patients with chronic pain conditioDs to seek altcmatives to prescription opioid analgesics (Anson, 2016; Pain News Network, 20 [ 8; Smith & Lawson, 2017; Swogger et al., 2015). ln addition, many patielts receiving opioids for chronic pain seck altomatives that have fewer side effects and lower addiction potential than opioids (Anson, 2016; Pain News Network, 2018; Smith & Lawson, 2017; Swogger et al., 2015). Many individuals in the West have tumed to katom in the be lief that it may provide an effective and safe altemative to prescription or illicit opioids, a view voiced by peers on psychoactive substance websites such as l.:rorr rd rrlg (Erowid, 2016), Sage\\ isdom.org (Wisdom,20l6), speciosa.org (2016) and Ilcddit.conr r'kratol (Reddit,20l8). Howeveq kratom has not been eyaluated in thc t,?es ofmulti-center, controlled clinical trials that are required by regulatory authorities, such as the US FDA, to conclude that a drug is safe and ellective for thc tcatment of OUD or other indications. Nonetheless, katom has a long history of such use that is widely accepted in the general population in Southeast Asia, where it is commonly used as an affordable substitute for sheet heroin or other opioids (Vicknasingam et al., 2010). For example, a study conducted in northem Malaysia used convenience sampling to identiry and survey 136 kratom users (99% male) in areas where heatry katom use was reported (vicknasingam et al., 2010). Results indicated that 90% ofthe subjects were using kratom as a substitute for illicit opioids and 8470 reported that kratom helped to reduce their dependence on opioids and severity of withdrawal symptoms. Another Malaysian survey (Singh et aI.,2015) used snowball sampling to enroll 293 adult males. most ofwhom were manual laborers who had used katom for at least six months. Fifty perccnt indicated that they had used kratom to climinate addictions to illicit substances, including opioids and cannabis, and/or to relieve withdrawal symploms. Such use has increasingly been reported in the US through intemet suweys of katom users (Grundmann, 2017; Grundmanr et aI..2018: Smith & Lawsoo,20l7), and in more than 23,000 comments to the DEA and FDA (DEA,20l6a; Henningfield et a1.,2018). Thus, even though we do not makc the claim that kratom should be viewed as a medically proven effective and safe therapy for OUD, we believe it is wananted to take seriously the extensive user reports and analyical surveillance indicating that many people are self-managing their OUD using katom. Such information may be considered a form of Real-World Evidence that is taken seriously by users and many scientists and should not be ignored by the FDA which has stated that "Real world data (RWD) and real world evidence (RWE) are playing an increasing role in health care decisions" and is used to make "regulatory" decisions. The situation is analogous with respect to the management ofpain, where kmtom has not been approved as an analgesic medicine, but reliefofpain is among the more commonly rcported uscs (Grundmann, 2017; Henningfield et a1.,2018; Pain News Network,20l8; Swogger et al., 2015). Caution is wananted in comparing results from these studies, as doing so requires accounting for potendal cultual, demographic, and prcduct-related moderators ofeffects and bias introduced due to research methodology. Nonethelcss, the results of observational studies of kratom users in the US converge with case reports and descriptions oftraditional katom use in Southeast Asia to suggest that kratom does have utility as a Int I Dtug Polict. Anthcl manuscripr; avaitablc in pMC 2021 Fcbruary Il c 5o 0) =c(,o_-.E c:ro q)lcoo =-E C =o 0) =C o =.! c Jo =l\) =cao Page I substitute for potentially more dangerous classical opioids in treating pain and OUD and should be studicd in well-controlled clinical trials for such indications (Henningfield et al., 2018). [t is also worth noting that thc extensive anecdotal reports ofanalgesic afiiviry in humans are consistent with the partial agonisl activity ol'mitragynine at MOR and findings in animal models ofpain. where mitragynine and kmtom extracts cxhibit analgesic activity. With respect to the use of katom for self-management ofOUD, the statements by the US National Institute on Drug Abuse (NIDA) and the FDA are quite distinct. The FDA's position is that kratom usc can cause deleterious health risks and that katom users should tum to approved ffeatments (FDA, 2018c), despite the reality that many such usen have comment€d to the DEA and FDA that such aeatments were not available or acceptable, whereas katom was accessible and helpful. In contrast. without discouraging or encouraging kratom usc. NIDA simply states the facts on its wcbsite that kratom ( l) is used by people to self-manage withdrawal and OUD and (2) that katom has not been demonstrated to be safe and effectivc for pain treatment, in contrast to available opioid medications (NIDA, 2018b). The many positive user comrnents on l:ro$ rti org (Erowid, 2016), Sag.-Wisdorr.org (Wisdom,2016), Reddit.c(,r1r./rrkretoor (Reddil,2018) and Speciosu org (speciosa.org, 2016) comprise an extensive collection ofanecdotal data documenting klatom use. Scientific analyses ofsuch user reports clearly indicate that the therapeutic potential of kratom is too large to be ignored (Swogger et al., 2015). The 23,000+ comments submitted to the federal register in response to the DEA's proposed scheduling action also provide a vast collection of anecdotal data suggesting profound therapeutic benefits for kratom (DEA, 2016a). Another piece ofevidence suggesting that kratom may havc significant therapeutic potential is that US patents have been issued for companies and individuals who are interested in devcloping kratom-based drugs (Hcyworth, 1964; Takayama, Kitajima, Matsumoto, & Horie,2008). Togethcr, these observations provide evidence that katom may have poteltially useful therapeutic effects, and that well-controlled clinical trials are urgently needed to evaluate the safety and efficacy of katom and its principal alkaloid mitragynine. Many katom advocates have claimed that kratom is a safe and effective altemative to opioids for the treatment of OUD (Erowid, 2016; Singh et al., 2016; Toce, Chai, Bums, & Boyer, 2018). [n this context, kratom is analogous to agents such as methadone and buprenorphine, which are widely used as replacement therapies in the treatment ofOUD despite the fact that the treatment agents themselvcs may have significant potential for abuse (Eibl. Morin-Taus, & Marsh.20l6l HHS,20l6: Toce et a|.,2018). Kratom (or compounds derived therefrom) may, in fact, have even greater therapeutic potential, especially in light ofevidence suggcsting that it lacks the severe overdose risk ofclassical opioid drugs, including methadone (Singh ct al., 2014. 20 t 5; Singh ct al., 2016; Toce et al., 2018). ln fact, more than 3,000 methadone-related fatalities were reported in the US in 2017 (NIDA, 2018a), suggesting that existing FDA-approved therapics for OUD have significant safcty shortcomings that might be addressed in part by altemative kratom-based therapies' IDt J Drug Poticy. Authot manuscriptr availabl€ in PM('2021 lcbruarv l3 c J o)lcao:f-c C o q)lCao =. c Jo O) =C o =.]C C Jo q)fCao =.'(, Page 9 How serious are the abuse and addiction potentials of kratom? Regular use of kmtom, particularly at higher doses, can lead to tolerance and dependence (Galbis-Reig, 2016; Singh et a1.,2014; Swogger & Walsh,20l8; Yusoffet al.,2016). However, available human reports suggest that abstinencc from kratom is typically associated with milder symptomatology than abstinence from classical opioids (Erowid, 2016; Singh, Narayanan et al., 2018, 2014; Singh et al., 2016). At the same time, although these reports indicate that the effects of katom can, in some ways, resemble those of opioids, many individuals rcport that the subjective effccts ofkratom are quite different from those ofopioids. As noted previously, low to moderate doses of katom t€nd to be somewhat stimulating, mther than sedatiflg, and do not produce the "high" or strong euphoric effects associated with opioids, although some users have reponed intoxication and euphoria afler using higher doses (Erowid, 2016; Singh et al., 2016i speciosa.org, 2016; Swogger et al., 2015; Wisdom,20l6). This distinct spectrum ofeffects, including attenuated euphoria and abuse potential, is supported by fwo recent preclinical studies, which found that mitragynine is not self-administored by rats (Henrby, Mclntosh, Lcon, Cutler, & McCurdy,20l8; Yue, Kopajtic, & Katz, 2018). Further, even at high doses, kratom does not appear to severely depress respiration as do classical opioids (Singh et al., 2014, 2016). Thus, even though katom has some potential for abuse and dependence, several investigators have concluded that katom has both less abuse liability and much lower risk of fatal overdose than traditional opioids and that the potential benefits of kratom in the treatment ofouD may outweigh these risks (Henningfield et al., 2018; Singh et al., 2014, 2015; Singh et al., 2016; Swogger ct al., 2015). This does rlot mean that kratom is not som€times used by people to get high and/or intoxicated because such use has been documented (Swogger et al., 2015). Such findings were also considered by Henningfield et al. (201E), who concluded that the oyerall assessmcnt ofkratom did not warrant it being listed as a controlled substance. They noted that many substances, including over-the-counter drugs (for cough and cold symptoms) and dietary ingredients, are also sometimes misused and abused for the purposes ofcausing intoxication and to get high, yet overall, seem appropriately left unscheduled. Are kratom products safe? In recent years, kratom use has been associated with increasing reports ofadverse health effects, including death in rare cases (Anwar, Law, & Schier,2016; Forrester,20l3; Ulb cht et a1.,2013; Wamer, Kaufman, & Grundmann,20l6). These increases in adverse events were cited as a major mtionale for the DEA's proposal to ban kratom (DEA, 2016b). However, there is no concrete evidence to prove that kratom was the main culprit in all 44 total fatalities reported worldwide by the FDA as of 2018 (FDA, 2018c). At Iow to moderate doses of5 g of raw leaves or less, the adverse effects vary markedly &om one individual to another, but generally appear to be mild (Anwar et al., 2016; prozialeck et al., 2012; Singh et al., 2014, 2016). The most common adyerse effects are auiety, irritability, nausea and vomiting (Anwar et al., 20t6; prozialeck et al., 2012; Singh et al., 2014; Swogger et al., 2015). More troubling have been occasional reports of more serious toxicities, often associated with high dose usage or usage ofconcentrated extracts in the west. somc ofthe reported adyelse ellects include tachycardia, liver damage, and seizures (Doman, Wong, & Kian,20l5; Kapp, Maurer, Auwartet Winkelmann, & Hermanns-Clausen, 201 l; Lu et Int J Drug Policy. A\ttiot manuscript; avaitable in pM(j 2021 Fcbruary tl C fo 0) =c o =.! c:to o)fCll)ol.! c fo o)f,c o =.! c Jo 0)fcaof. Page l0 al.,20l4i Nelsen, Lapoint, Hodgman, & Aldous,2010i Pantano et a1.,2016). In addition, several deaths have been attributed to the use of"kratom" products (Anwar et al., 2016; DEA,20l6b: FDA.20l8c: cershman ct a1..2019; Karinen, Fosen, Rogde, & Vindenes, 2014; MclntJre, Trochta, Stolberg, & Campman,2015: Neerman. Frost, & Deking,20l3; Wamer et al., 20161 Wing, 2018), although in many such cases causality was not clearly linked given that little is known about lethal dose levels of katom in humans (Gershman et al., 2019; Wing, 2018). Further, in some cascs, sevcrc adverse events may stem from the use of adulterated "kratom" prcducts contaminated with other substances (including potent synthetic opioids) or where the content ofthe principal alkaloids mitragynine and 7-hydroxymitragynine is enriched compared to natural leafmaterial (Kronstrand, Roman, Thelander, & Eriksson, 201 l; Lydecker et al., 2016). In contrast, when used in its traditional context, pure kratom leafis unlikely to produce serious adverse effects in the vast majority ofuse$ (Trakulsrichai et al., 2013). ln fact, thcre have been no reported deaths attributed to kratom in Southeast Asia whcn used in the traditional setting as unadulterated. pure kmtom leaf. While the foregoing summary indicates why the FDA's and DEA's concems about the safety of kratom are reasonable, several factors require consideration in evaluating whether the FDA's and DEA's proposed bans are justified. Filst are the rclative statistics. ln announcing their decision to ban kratom, the DEA emphasized that between January 20[0 and December 2015 there had been 600 calls to poison control centers regarding adve$e reactions to kmtom products (DEA, 2016b). More recently, the FDA has rcported ,14 total deaths associated with use of katom products worldwide (FDA, 2018c). While these might seem on their face to be alarming numbers, they are actually rather small compared to the 49,000+ opioid overdose deathstn20lT tlonc (NIDA, 2018a). ln addition, the extent to which kratom playcd a role in the available lethal case reports is uncertain. In the majority of these cas€ reports associating kratom with lethal outcomes, patients haye had confounding health conditions, have been using othcr drugs along with katom, or both (Galbis-Reig, 2016; Gershman et al., 2019: Prozialeck et al., 2012; Singh et al.. 2015, 2016; Wing, 2018). Moreover, in the absence ofevidence for a defined mechanism by which katom would Iead to death (e.g. rcspiratory depression), these anecdotal reports involve considerable speculation and do little to establish a scientific backing for the proposition that kratom is potentially deadly. One ofthe major problems in evaluating the potential uscs and safety ofan herbal agent such as kratom is the lack ofunderstanding ofhow mitragyninc and other substances irr kratom may intemct with each other. prescription medications, drugs ofabuse, or even herbal supplements (Prozialeck et al.,2012r Ulbricht et a1.,2013). Recent findings show that kntom and its alkaloids are direct inhibitors and/or transcriptional inducers ofa number of cl.tochrome P450 enzymes and P-glycoprotein, suggcsting a significant potential for katom to cause complex herb-drug interactions that requirc further study (Hanapi, Ismail, & Mansor, 2013; Kong et al.. 201 l; Lim et al., 2013; M atda et al.,2014' 2011'1. These issues are compounded by a lack ofregulations and standardization related to the production and sale of "krutom" products. Further, an increasing body ofevidence supports the h)?othesis that many unscrupulous purveyors of"kratom" are adulterating their products with potentially toxic drugs (Chittakam, Penjamras, & Keawpradub, 2012; Griffrn et al', IntJ Drug Policy. Anthot manuscript; available in PMC 2021 Fcbruary ll c Jo o):lCaof.E C fo 0) =C o =.! C lo O)-cao =.E cJ q)lEao E Page I I 2016; Lydecker et a1.,2016; Scott, Yeakel, & Logan,20l4). Probably the most notorious example ofsuch adulteration involved a product known as "Krypton", which was touted as a very potent form of katom. lt was sold mainly in Europe and was found to be a factor in at least 9 deaths (Kronstrand et a1.,2011;Nelsen et a1.,2010). Detailed forensic analyses, however, revealed that Krypton was adulteratcd with large amounts ofthe synthetic opioid Adesmethyltamadol, which has potent opioid and neuromodulator activity (Kronstm[d et al., 20l l). Even though mitragynine was also detected in the products, it was not determined how the two subslances may have interacted to cause death. ln another study, several purported kratom products wete found to contain 7-hydroxymitragynine (a more potent opioid alkaloid) at concentrations significantly higher than those found in plain leaf products (Lydecker et al., 2016). The source of the high levels of 7-hydroxyminagynine reported in that study remains unclear More recently, the FDA has raised concems about the contamination of kratom products with Salmonella (FDA, 2018a) and toxic metals (FDA, 2018b). These reports ofcontamination ofsome kratom products highlight the need for quality control policies in the production and sale of kratom. Without standardization, use ofgood manufacturing practices, and strict quality control measures by manufacturcrs and distributers, individuals who ingest "katom" products cannot be sure what they are taking. This problem suggests that systematic and cautious regulation of katom products is likely to improve their safety. Such rcgulation and standardization is cenainly needed, but it is unclear how such quality control progams can be developed and administered. One possible approach mighl be to use mical concentmtions ofmitragynine and 7-hydroxymitragynine found in kntom leafas ceilings for alkaloid content ofall products. It would also be essential that the products be tested to show that they have not been fortified or contaminated with other substances. particularly opioid derivatives. The American Kratom Association has recently announced plans to address many ofthese issues by adopting a set of"Good Manufacturing" standards for the katom industry (American Kratom Association, 2018b). Despite the quality cont ol issues with katom products in the Wcst, a largc numbcr ofscientists havc statcd that in its traditionally used form (kratom leafdecoction or powdered leaf form), katom appears to be relatively benign, especially in comparison to classical opioids such as hydrocodone, oxycodone, or heroin (Singh et al., 2015, 2016; Trakulsrichai et al., 2013). In writing these conlments, we wish to emphasize that we, too, have concems about the safety ofso-called "k.atom" products. Moreover, since kratom contains pharmacologically active compounds (which it clearly does), it ccrtainly has potential toxiciti€s. Nevertheless, the scientific litcrature supports the conclusion that, in pure herbal form and in moderate doses of lcss than 5 g, purc leafkratom appears far less dangerous than classical opioids. Rccent kratom studies from Southeast Asia show that Iong-term kratom use does not appear to alter hematological and biochemical parameters (Singh, Mullcr ct al., 2018) or intcrfcre with uscrs' abilities to function in society (Singh et al., 2015). So far, no serious health incidents associated with katom use have been reported among regular users in traditional settings. Int J Drug Policy. A]ulhot manuscript;availablc in PM(l202, Fcbruary 13 C Jo o) =cao =.! C =o A)fC of,.! c fo fCao ! C fo =qaol.E Summary PaSe 12 and perspective Kratom is widely used in thc West and Southeast Asia as a relativcly safe herbal supplement (traditional medicine) for the self-treatment ofmcdical disorders, including pain and OUD. Extensive reports from kratom uscrs, considcred alongside limitcd basic science and clinical research studies, suggest that kmtom and its constituent compounds (especially mitragynine) may in fact have beneficial pharmacological and therapeutic propeflies. Unfortunately, no well-conkolled clinical trials haye becn performcd to date to dctermine the true risks and benefits of katom use in humans. The high monetary costs of such clinical trials greatly complicate this issue, given that sufficient intellectual property protection to justiry the large capital investments necessary for formal drug approval is often challenging to obtain for natural products like kratom. In response to the growing concems about safety and abuse/ addiction potential. it appears that the DEA is planning to classify kratom, mitragynine, and 7-hydroxymitragynine as Schedule I confolled substances, despite the preponderance ofpreclinical and anecdotal human evidence indicating that kratom is Iess harmful than prescription opioid analgesics or illicit opioids. We believe that actions by the FDA and DEA to classify mitragyninc as a Schedule I controlled substance could have several unintended consequences. First, such a classification would likely foster a significant "black market" for kratom products. Many thousands of individuals in the US have been using kratom as a means ofavoiding use of more dangerous classical opioids and are terrified of losing what they vielv as a life-line to sobriety (Anson, 2016; DEA,20l6c; FDA,20l8c; Henningfield et al.,2018). It is reasonable to conclude that under Schedule I restrictions. a subsct ofkratom users would tum to or retum to prescription or illicit opioids. resulting in an increase in unintended negative public health consequences, including higher incidence ofOUD, incarceration, and overdose death. A second potential problem is that a move ofkratom or its cons(ituents to Schedule I will make it much more difficult for researchers lo conduct necessary research exploring katom's medicinal potential (Chen, 2016). In this regard, thc legal milicu surrounding katom is comparable to what has happcned with "medical marijuana" and psychedelic-assisted therapies, where federal policies, including classification as a Schedule I substancc, havc impeded hypothesis{riven research investigations (Belouin & Henningfield, 2018; Stith & Vigil,2016). Many institutions and govemment agencies are reluctant to fund research on Schedule I substances because such work involves infrastructure and resources that many institutions lack (Belouin & Henningfield, 2018). Even in the absence ofcumbersome controllcd substance rcgulation, many practical issues complicate research on herbal products such as kratom. For cxample, what type of katom products (extracts or leafmaterials) should bc evaluated? How would products be "standardized" for activity? Sincc kralom contains a mixture ofactive compounds, this would be ar exfiemely complex problem to rqsolvc. One solution might involve focusing on specific chemical constituents, such as mitragyninc. However, in studying single molecular entities, researchers might miss important contributions ofother active constituents in kratom. This would require additional studies on the interactions of mixtures ofcompounds from kratom. Another major challenge is presented by the conelation ofhuman consumption practices with laboratory animal models. Clcarly, more scientific IntJ Drug Policy. A]lhor manuscript; availablc in PM( 2021 I'cbruary 13 c =o q)fC o =.c C =o o)f,E@ot- c Jo o)f,c o =.! c J 0lJCao E References Page Il research is needed to address these issues, which would be much more challenging under Schedule I regulatory policies. While this manuscript was under review. one of our co-authors, Dr. Bonnie Avcry pass€d away after a courageous balrl€ with canccr. Dr. Avcry $as a leader in kralom rcsearch, an outstandrng colleague and a wondcrful person- wc hercby dcdicatc the paper to Dr. Avcry. Shc will be missed. bul not forgolten. Adkins JE, Boyer EW & McCurdy CR (201l). Mitragyna speciosa, a psychoactive tlee ftom Southcast Asia with opioid activity. Cunent Topics in Medicinal Chemistry, I l(9), I 165 I I75 doi:BSP/CTMCE-Pub/-00019-l l-l [pii]. [PubMed: 21050173] American Kratom Association (2018a). Retrieved fiom hltf ,,*rv*.aurcricrnlralitor.otg. American Kmtom Association (2018b). American Kratom Association announces good maaufacturing practice (GMP) standars ior vendors. Retrieved iiomhttp5:./r ww w. prncu r \\ ir!. col, ilr'ws-rt lcas csr nm c ricil n-k rir I urll-:r 1\oc rJl ro n- irnnounccs-tLood-nr.rnulrcruflDglnLratlcr-gnrp-srllrJarrl'-tbrrcrdrrrs-]lr();5ll5lhtrnl. Anson P (2016). K.atom users say Ban will lead to more drug abuse. 2016, Retrieved fromPain NetworkNewshrlp:/;!!\{!\.litirncNsnrl\rork.org,\l(r'l!'s2{}L69,l1lkra()nr-uscrs-sat-bau-will-laad- tl>nl,n!-dnlr-Jbus!. Anwar M, Law R, & Schier J (2016). Notes from the Field: Kralom (Mitragyna speciosa) exposures reported to poison centers - United States,20l0-2015- MMWR Morbidity and Mortality Weekly Report, 65(29), 748-749. I0. 15585/mmwrmm6529a4. [Pr$Med: 27 466822) lnt I Dn,s Policy. L\lthot manu$ripI; alailable in PMC 2021 I:cbruary I3 Acknowledgement Kratom/ketum has been traditionally used in Southeast Asia for at least the last century for its medicinal properties. This traditional use of unadulterated, natural kratom lsafhas not resulted in large-scale abuse and toxicity. Further, significant evidence ofthe bcnefits of kratom gleaoed from this traditional use certainly warrants fi[ther study. We conclude that well-designed, controlled human clinical trials are needed to more thoroughly investigate thc therapeutic and addictivc potentialof katom; to establish safety and toxicology limits; and also, to evaluate pharmacological responses among various populations who might consume kratom. The effects of kratom in the general population are poorly described, while data on special populations, such as children, elderly, pregnant females and the developing fetus, and patients with confounding health conditions, are essentially non-existent. Finally, almost nothing is known about how kratom might intoract with other drugs or he6al agents that subiects may be using. Unfonunately, future control as a Schedule I substance would erect substantial barriers to this necessary research. Furthermore, the source offtrnding for such work is unclear, given the limited commercial oppoltunity provided by unpatentablq natural products. One possible approach to begin flrnding rcsearch might be for katom trade organizations and./or vendors to prcvide research grants to members ofthe scientific cornmunity. Also, kalom provides avenues for entrepreneurial-driven research, much like what is now happening in the burgeoning marijuana industry. Despite these significant challenges, clinical trials into the safety and efficacy of kratom and mitragynine can and should be done. It is our sincere hope, as katom researchers, that this commentary will facilitate an informed discussion about katom and lbster thc necessary research to resolve thc scientific and regulatory issues pr€sented here. Page 14 Babu KM, McCurdy CR. & Boyer EW (2008). Opioid receptors and legal highs: Salvia divinorum and Kratom. Clinical Toxicology (Philadelphia. Pa.). 46(2\,146 152 doi1789497982 lpiil; 10. 1 080/I 5563650'7 01241795. Belouin SJ, & Henningfield JE (2018). Psychcdelics: whcre we are now' why we got here. what we must do. Neuropharmacology. 10. l0l6/j.neuropharm.20l8.02.0l8. Boodman E (2016). Lawmakers urge DEA to reconsider' hasty'ban ofopioid-like kratom 2016, RetrievedfromSTAThltp\'w\\\strrnc\r'\.conl2lll6.{)921kra(nfi-ban-d!-r-congrc\\. Boyer EW, Babu KM, Adkins JE, Mccurdy CR, & Halpem JH (2008). Self-treatmeot ofopioid wirhdrawalusing kratom (Mifagynia speciosa korth). Addiction, 103(6), lM8-1050 doi:ADD2209 lpiil; l0.l I I l/j. 1360{443.2008.02209.x. [PubMed: 184E2427] Chen A (2016). Kratom drug ban may cripple promising painkiller research. Scientific Afieican.9l27 /2016, Retrieved liom htlf\:' \\ \! \\' !!icntilicamcrican.r{,rr'rfliclcrkralonr-drug- tran-rnar-criflrlc-promising-painkillcr-rescar'cht. Chittrakarn S. Penjamras B & Keawpradub N (2012). Quantitative analysis ofmitragynine, codeine, caffeine, chlorpheniramine and phenylephrine in a kratom (Mitragyna speciosa Korth.) cocktail using high-performance liquid chromatography. Forensic Science Intemational, 217(l -3), 8l-86 doi:S0379-0738(l l)00502-0 [pii]:10.1016/j.forsciint.20l 1.10.027. [PubMed: 22018854] Cinosi E, Martinotti G, Simonato R Singh D, Dcmetrovics Z, Roman-Urrestamzu A, ---Corszz O (2015). Following "the roots" ofIc-atom (Mitragyna speciosa): The evolution ofan enhancer from a ffaditional use to increase work and productivity in Southeast Asia to a recreational psychoactive drug in westem countries. BioMed Research lntcmational, 2015, 968786. 10.I 155/2015/968786. IPubMed: 26640804] Dahan A, Yassen A, Bijl H, Romberg R, Saaon E, Tcppema L, ... DanhofM (2005). Comparison ofthe respiratory ellects ofintmvenous buprenorphine and fentanyl in humans and rats. British Joumal of Anaesthesia, 94(6), 825 834. 10.1093/bja,taeil45. [PubMed: 15833777] DEA (2016a). Docket folder summary/schedules ofcontrolled substances: Temporary placement ofmitragynine and 7-hydroxymitragyninc into schedule I. Retricved from hrt|s:/,' u u \.r tqulalions.r0r.do( l.r7l) DI:,\-2016-001i. DEA (2016b). Schedules ofconaolled substances: Tcmporary placement ofmitragynine and 7-hydroxymitragynine into schedule I- Noles: Document number: 2016-20803. 2016. Retrieved fromFederal Registerhlms:,.r\\1\\\lcdcrrir.gistcr.gor,rii(unrLrnls20la),{18.1i,2016-:()l0irsch.dulos-o1- conlrollcd-sul-"tlnrc"-rcnrl\)l'0n-pliru.nr('f1i)l-rrilra!!nnrc-lrnd-l-h\dft)\.yn1i(r.r!\rinc-rnro DEA (2016c). Withdrawal ofnotice ofintont to temporarily place mitragynine and 7-hy&oxymitagynine into schedule l. 2016, Retrieved fiomlederal Register hflps' wwrv.deadiver sion Lrsrlol.g(r',1'c(l r.g\rrlrlL'si20l fr lillrl l l)(nr. Dorman C, Wong M, & Kian A (2015). Cholestatic hepatitis from prolonged kmtom use: A case .eport. Hepatofogy, 61(3 ). 108& 1087. 10.1002Aep.27612. [PubMed: 25418457] Dowell D, Haegerich TM, & Chou R (2016). CDC guideline for prescribing opioids for chronic pain - United States, 2016. MMWR Recommendarions and Repofts,65(l), l-49. http\:. doi.org, 1(). I 55351lnur\rr.11650 l. l. Eibl JK, Morin-Taus KA. & Mush DC (2016). Too much or never enough: A response to heatment ofopioid disorders in Canada: Looking at the' other epidemic'. Substance Abuse Treatment. Prevention, and Policy, I I ( 1), 33. l0.l 186/sll0l l -016-0076-2 10.I l86Al30l 1-016-0076-2 [pii]. EMCDDA (2015). Kratorn (Mitragyna speciosa) drug profile- Retrieved fiom hup:r: \rw\r'.cnrcdda cnropx cu,nublicltions drugjrrol jlcs. krrbnr. Erowid (2016). Ic-atom. 9/30/2016, Retrieved frofiErowid htp\:r,cr(Nid.orlrllanls,'kratom/ kratoln.shrrnl. FDA (2018a). FDA investigated multistate outbreak ofsalmonella infcctions lnked to products reportcd to containyJatorl], [Press release&elrieved fromhtlp\. u\\\\ Iila.go\ lbod , c(allsoolblcakserrrcucncics oulbralrk,'tlcnr.597265.hlnt. FDA (2018b). Statement by FDA commisioner scott goftlieb, M.D., On risk of heavy metals, including nickel and lead, found in some kratom products /Press releas4 Retrieved fiom htll)sr'l *rru fd;r gor \crrsl;rents,'Nerr:r'rxrrI Prc\s,\l)lr,)ulrUcrn. 1s,ucln.6267j3.htrD. E =o 0)fcao =.-o C =o =Cao:.! c:,o q):C o =.-o c fo 0) =Caol.E Int J Drug Policy. A,nthot manuscript;available in PMC 2021 Fcbruary 13 PROHIBITING THE MANUFACTURING, SALE AND DISTRIBUTION OF KRATOM A. Statement of Purpose and Authority: Whereas, Kratom, a tree-like plant indigenous to Southeast Asia, produces stimulant and sedative effects when orally ingested in tablet, capsule, or extract form. Kratom leaves can be chewed or dried and ingested as a tea. Use of Kratom can lead to psychotic symptoms, and psychological and physiological dependence because it contains mitragynine and 7-hydroxymitragynine, two major psychoactive ingredientsl. Whereas, Kratom is not regulated by the State of Massachusetts or the federal government Whereas, the Massachusetts Supreme ludicial Court has held that "[t]he riSht to engage in business must yield to the paramount right of government to protect public health by any rational means."2 Therefore, in furtherance of its mission to protect, promote and preserve the health and well-being of its residents, and pursuant to the authority granted to the Dracut Board of Health pursuant to G. L. c. 111, S3L, the Board of Health enacts this Regulation Restricting the Sale and Distribution of Kratom. B. Definitions: For the purposes ofthis regulation, the following words shall have the following meanings: Board:The Dracut Board of Health Business Aaent: An individual who has been designated by the owner or operator of any business to be the manager or otherwise in charge of said establishment Compliance Check: An enforcement activity where a person is sent into an establishment to attempt to purchase a restricted or prohibited product. Kratom: Refers to the leaves or an herbal extract from the leaves or the other parts of an evergreen tree in the Rubioceoe family native to Southeast Asia called Mitrogyno Specioso, that contains as its primary compounds, mitragynine and 7-hydroxymitragynine, which produces stimulant-like effects in low dosages and opioid-like effects in high dosages, and it may be marketed in different forms, including but not limited to smokeable products, tea, capsules, and as an additive to soft drinks or other products. 1 DRUG ENFORCEMENT ADMlN., GET SMART ABOUT DRUGS, available at http:l/www.eetsmartaboutd ruas. gov (last visited February 13, 2023). 2 Druzik v. Bd. Of Health of Haverhill, 324 Mass. t29, t3g l7g4gl Med., 239 Mass. 424, 428 (1921)). 1 citins Lawrence v. Bd. Of Res istration in REGULATION OF THE DRACUT BOARD OF HEATTH Person: Any individual, firm, partnership, association, corporation, company, or organization of any kind, including, but not limited to an owner, operator, manager, proprietor, or person in charge of any establishment, business or retail store. C. Sale of Kratom Products: 1. No person shall manufacture, distribute, sell, or offer for sale Kratom i!_q!Jg!!LDIqt as defined herein, or any Kratom derived products, or any products containing Kratom as an additive in the Town of Dracut D. Violations: 1. Any person or entity charged with violating this regulation shall receive a notice of violation from the Dracut Board of Health or its designated agent(s). 2. lt shall be the responsibility ofthe establishment owner and/or his or her manager or business agent to ensure compliance with this regulation. The violator shall receive: It, ln the case of a first violation within a 35-month period, a fine of one thousand dollars (S1000.00), ln the case of a second violation within 36 months from the first violation, a fine of two thousand dollars (52000.00), and a suspension of any permit issued by the Board, including but not limited to a permit to sell tobacco products, for seven (7) consecutive business days. ln the case of three or more violations within a 36-month period, a fine of five thousand dollars (55000.00) and a revocation of any permit issued by the Board, including but not limited to a permit to sell tobacco products. 3. Every day that a violation exists shall be deemed a separate offense. lf multiple violations occur stemming from the same inspection or compliance check, they shall be treated as separate violations. 4. Failure to pay a fine issued pursuant to this regulation within 21 days of its date of receipt by the violator shall constitute a separate and subsequent violation of this regulation subject to the penalties set forth at paragraph 2 of this section. Payment of a fine is not required while an appeal is pending. 5. Any person who receives notice of a violation of this regulation may request and appeal hearing before the Board. The request must be made in writing, signed by the violator or the violato/s attorney, filed with, and received by the Dracut Health Department within ten (10) business days of the date the notice of violation was received by the violator. 6. Any resident who desires to register a complaint pursuant to this regulation may do so by contacting the Dracut Health Department. 7. Before suspending or revoking any permit issued by the Dracut Board of Health, including a permit to Selltobacco products, the Board shall provide notice ofthe intent to suspend or revoke such permit, which notice shall contain the reasons therefor and shall establish a 2 time and date for a hearing, to be held no earlier than ten (10) business days from the date of receipt of the notice. The permit holder or their designee shall have the opportunity to be heard and shall be notified of the Board's decision and the reasons therefor in writing. lf after hearing, the Board finds that a violation of this regulation occurred, the Board shall suspend or revoke the subject permit. Such suspension or revocation shall not be carried out sooner than ten (10) business days of the date of receipt of the Board's decision. For purposes of such suspensions or revocations, the Board shall carry them out unless it receives an order of stay or injunction from the appropriate court before the date the suspension or revocation is set to go into effect. Upon suspension or revocation of a permit, all products subject to that permit must be removed from the retail establishment. Failure to remove such products shall constitute a separate violation of this regulation. Multiple permit suspension may not be served concurrently. 8. Failure to comply with the terms of a permit suspension imposed pursuant to this regulation may subject the permit holder to additional fines, as provided in paragraph 2 of this section, and suspension of all Board-issued permits for thirty (30) consecutive business days. E- Enforcement: Enforcement of this regulation shall be carried out by the Dracut Board of Health or its designated agent(s). F. Severability: lf any provision of this regulation is found to violate State or Federal preemption laws or is declared invalid or unenforceable, all other provisions shall not be affected thereby but shall be in full force and effect. This provision shall not apply if section C (1) of this regulation is found to violate State or Federal preemption laws or is declared invalid or un-enforceable. G. Effective Date: This regulation shall take effect on April 1, 2025 (Signature on file) Dr. Louis Rousseau, Chairman (Signature on file) Cynthia Campbell R.N., Vice-Chairman (Signature on File) 3 Tom Bomil, Clerk REGUTATION OF THE DRACUT BOARD OF HEALTH PROHIBITING THE MANUFACTURING, SAIE AND DISTRIBUTION OF KRATOM A, Statement of Purpose and Authority: Whereas, Kratom, a tree-like plant indigenous to southeast Asia, produces stimulant and sedative effects when orally ingested in tablet, capsule, or extract form. Kratom leaves can be chewed or dried and ingested as a tea. Use of Kratom can lead to psychotic symptoms, and psychological and physiological dependence because it contains mitragynine and 7-hydroxymitragynine, two major psychoactive ingredientsl. Whereas, Kratom is not regulated by the State of Massachusetts or the federal government Whereas, the Massachusetts supreme ludicial Court has held that "[t]he right to engage in business must yield to the paramount right of government to protect public health by any rational means."2 Therefore, in furtherance of its mission to protect, promote and preserve the health and well-being of its residents, and pursuant to the authority granted to the Dracut Board of Health pursuant to G. L. c. 111, 931, the Board of Health enacts this Regulation Restricting the Sale and Distribution of Kratom. B. Definitions: For the purposes of this regulation, the following words shall have the following meanings Board: The Dracut Board of Health Business Asent; An individual who has been designated by the owner or operator of any business to be the manager or otherwise in charge of said establishment Compliance Check: An enforcement activity where a person is sent into an establishment to attempt to purchase a restricted or prohibited product. Kratom: Refers to the leaves or an herbal extract from the leaves or the other parts of an evergreen tree in the Rubloceoe family native to Southeast Asia called Mitrogyno Specioso, that contains as its primary compounds, mitragynine and 7-hydroxymitragynine, which produces stimulantlike effects in low dosages and opioid-like effects in high dosages, and it may be marketed in different forms, including but not limited to smokeable products, tea, capsules, and as an additive to soft drinks or other products. 1 DRUG ENFORCEMENT ADMIN,, GET SMART ABOUT DRUGS, AVAiIAbIE At htt smartaboutdru OV (last visited February 13, 2023)s 2 Druzik v. Bd. Of Health of Haverhill 324 Mass. 129, 139 (1949) ( 1 Med.. 239 Mass. 424, 428 (1921)) citing Lawrence v. Bd. Of Reeistration in Person: Any individual, firm, partnership, association, corporation, company, or organization of any kind, including, but not limited to an owner, operator, manager, proprietor, or person in charge of any establishment, business or retail store. C. Sale of Kratom Products: 1. No person shall manufacture, distribute, sell,or offer for sale Kratom in any of its forms, as defined herein, or any Kratom derived products,or any products containing Kratom as an additive in the Town of Dracut D. Violations: 1.. Any person or entity charged with violating this regulation shall receive a notice of violation from the Dracut Board of Health or its designated agent(s). 2. lt shall be the responsibility of the establishment owner and/or his or her manager or business agent to ensure compliance with this regulation. The violator shall receive: t ln the case of a first violation within a 36-month period, a fine of one thousand dollars ($1000.00), ln the case of a second violation within 36 months from the first violation, a fine of two thousand dollars (52000.00), and a suspension of any permit issued by the Board, including but not limited to a permit to sell tobacco products, for seven (7) consecutive business days. ln the case of three or more violations within a 36-month period, a fine of five thousand dollars (S5000.00) and a revocation of any permit issued by the Board, including but not limited to a permit to sell tobacco products. 3. Every day that a violation exists shall be deemed a separate offense. lf multiple violations occur stemming from the same inspection or compliance check, they shall be treated as separate violations. 4. Failure to pay a fine issued pursuant to this regulation within 21 days of its date of receipt by the violator shall constitute a separate and subsequent violation of this regulation subject to the penalties set forth at paragraph 2 of this section. Payment of a fine is not required while an appeal is pending. 5. Any person who receives notice of a violation of this regulation may request and appeal hearing before the Board. The request must be made in writing, signed by the violator or the violator's attorney, filed with, and received by the Dracut Health Department within ten (10) business days of the date the notice of violation was received by the violator. 6. Any resident who desires to register a complaint pursuant to this regulation may do so by contacting the Dracut Health Department. Before suspending or revoking any permit issued by the Dracut Board of Health, including a permit to sell tobacco products, the Board shall provide notice of the intent to suspend or revoke such permit, which notice shall contain the reasons therefor and shall establish a 7 2 time and date for a hearing, to be held no earlier than ten (10) business days from the date of receipt of the notice. The permit holder or their designee shall have the opportunity to be heard and shall be notified of the Board's decision and the reasons therefor in writing. If after hearing, the Board finds that a violation of this regulation occurred, the Board shall suspend or revoke the subject permit. Such suspension or revocation shall not be carried out sooner than ten (10) business days ofthe date of receipt ofthe Board's decision. For purposes of such suspensions or revocations, the Board shall carry them out unless it receives an order of stay or injunction from the appropriate court before the date the suspension or revocatlon is set to go into effect. Upon suspension or revocation of a permit, all products subject to that permit must be removed from the retail establishment. Failure to remove such products shall constitute a separate violation of this regulation. Multiple permit suspension may not be served concurrently. 8. Failure to comply with the terms of a permit suspension imposed pursuant to this regulation may sub.iect the permit holder to additional fines, as provided in paragraph 2 of this section, and suspension of all Board-issued permits for thirty (30) consecutive business days. E. Enforcement: Enforcement of this regulation shall be carried out by the Dracut Board of Health or its designated agent(s). F. severability: lf any provision of this regulation is found to violate state or Federal preemption laws or is declared invalid or unenforceable, all other provisions shall not be affected thereby but shall be in full force and effect. This provision shall not apply if section C (1) of this regulation is found to violate state or Federal preemption laws or is declared invalid or un-enforceable. G. Effective Date: This regulation shall take effect on ril L 2 (Signature on file) Dr. Louis Rousseau, Chairman (Signature on file) cynthia campbell R.N., Vice-Chairman (Signature on File) Tom Bomil, Clerk CITY OF MARLBOROUGH BOARD OF HEALTH REGULATION R.ESTRIC TING THE MANUFACTURING SECTION 1. Purpose & Scope 2. Authority 3. Definitions 4, Distribution of Kratom Products 5, Enforcement and Penalties 6. Severability 7. Effective Date l. Purpose & Scooe The purpose of this regulation is to protect the health ofthe residents and general public in the City of Marlborough. Whereas Kratom, a tree-like plant indigenous to Southeast Asia, produccs stimulant and sedative effects when orally ingested in tablet, capsule, or extract form. Kratom leaves can be chewed or dried and ingested as tea. Use ofKratom can lead to psychotic symptoms, and psychological and physiological dependence because it contains mitragynine and 7- hydroxymitragyninc, two major psychoactivc ingredients.r Whereas Kratom is not regulated by the federal government or in Massachusetts. 2. Authoriw Whereas, the Massachusetts Supreme Judicial Court has held that "the right to engage in business must yield to the paramount right of govemment to protect public health by any rational means."'z Therefore, in furtherance of its mission to protect, promote, and preserve the health and well- being of its residents, this regulation is promulgated under the authority granted to the Marlborough Board of Health pursuant to Massachusetts General Laws Chapter l1l, Section 3 I that "boards of health may make reasonable health regulations," the Board ol Health enacts this Regulation Restricting the Manufacturing, Salc, and Distribution of Kratom. I ONUG ENNORCEMENT ADMIN., GET SMART ABOUT DRUGS, AVAiIAbIC At hftp://wr.\,w.getsmartaboutdrugs.gov (last visited February 13, 2023). 2 Dmzik v Bd. of Ileallh ol Haverhill 324 Mass. 129, 139 (1949) ( 239 Mass. 424, 428 ( 1 921 \\ citine Lawrence v. Bd. ofResistation in Med.. , SALE.AND DISTRIBUTION OF KRATO}I 1 3. Definitions Board fH th: The Marlborou gh Board of Health and its designated board ofhealth agents. Board of Health Agent: The Director ofPublic Health and any city employee designated by the board ofhealth, which may include board ofhealth and hcalth dcpartment staff, and code enforcement officers. Business Agent: An individual who has been designated by the owner or operator of any business to manage or oversee the establishment. Kratom: Refers to the leaves or an herbal extract from the leaves or other parts ofan evergreen tree in the Rubiaceae famlly, Mitag,,na speciosa, that contains mitragynine and 7-hydroxymitragynine. These compounds produce stimulantlike effects in low dosages and opioidJike effects in high dosages. Person: Any individual, firm, partnership, association, corporation, company, or organization ofany kind, including, but not limited to an owner, operator, manager, proprietor, or person in charge of any establishment, business, cultivation property, or retail store. 4. Distribution of Kratom Products (A) No person shall manufacture, distribute, sell, or offer for sale Kratom in any of its forms, as defined herein, or any Kratom-derivcd products, or any products containing Kratom as an additive in the City of Marlborough. 5. Enforcement and Penalties (A) Any person or entity charged with violating this regulation shall receive a notice of violation from the Board of Health or Board of Health Agent. (B) lt shall be the responsibility ofany cstablishmcnt owncr and/or the establishment owner's manager or business agent to ensurc compliancc with this regulation. The owner or manager ofany establishmcnt in which Kratom is manufactured, distributed, sold, or oflered for sale by any person in lawful conkol ofthe establishment, shall be responsible for the violation whether, or not, they authorized or were aware that the violation was taking place. (C) In the case ofa violation, the violator shall receive: ( I ) In the case of a first violation, a fine of one thousand dollars ($ 1000.00). (2) ln the case ofa second violation within 36 months ofa previous violation, a fine of two thousand dollars ($2000.00), and a suspension ofany permit issued by thc Board, including but not limited to a Tobacco Products Sales Permit, for scven (7) consecutive business days. (3) In the case ofthree or more violations within a 36-month period, a fine offive thousand dollars ($5000.00), and a suspension ofany permit issued by the 2 (D) (E) (F) (G) (H) Board, including but not limited to a Tobacco Products Sales Permit, for thirty (30) consecutive business days. In accordance with applicable law, the Board of Health may modify, suspend, or rescind any license or permit to conduct a business issued by the Board ofany person or entity who is found in violation of this regulation by manufacturing, distributing, selling, or offenng tbr sale Kratom or Kratom products on the premises that is the subject of the license or pcrmit. The authority to inspect establishments for compliance and to enforce this regulation shall be held by the Marlborough Board of Health and its agent(s). Any person may rcgister a complaint pursuant to this rcgulation to initiate an investigation and enforcement with the Marlborough Board of Health and its agent(s) Volations of this regulation may be enforced by thc non-criminal method of disposition as provided in M.G.L. c. 40, $ 2lD and as enabled pursuant to the Marlborough enabling ordinance. Each day a violalion exists shall be deemed to be a separate offense. (t)A person who reccivcs notice ofa violation of this regulation can request a hearing before the Board of Health. This request must be made in writing and filed within seven (7) days after the date the violation was served or actually received. 6. Severabili8 Ifany paragraph or provision of this Regulation is found to be invalid or unenforceable, against public policy or unconstitutional, it shalI not affect the legality ofany remaining paragraphs or provisions and shall continue in full force and effect. Signed this day October 7, 2025. Board of Health: By the Marlborough h.-14*7T---7- ldames Griffin. Chairman 3 n, MD. Vice-Chair 7. Effective Date This Regulation shall take effect for the City of Marlborough on the lst day of December 2025. CITY OF MARLBOROUGH BOARD OF HEALTH REGULATION RESTRICTING THE MANUFACTURING, SECTION l. Purpose & Scope 2. Authority 3. Delinitions 4. Distribution of Kratom Products 5. Enforcement and Penalties 6. Severability 7. Effective Date 1. Purpose & Scooe The purpose of this regulation is to protect the health ofthe residents and general public in the City of Marlborough. Whereas Kratom, a tree-like plant indigenous to Southeast Asia, produces stimulant and sedative effects when orally ingested in tablet, capsule, or extract form. Kratom leaves can be chewed or dried and ingested as tea. Use of Kratom can lead to psychotic symptoms, and psychological and physiological dependence because it contains mitragynine and 7- hydroxymitragyninc, two major psychoactivc ingrcdients.r Whereas Kratom is not regulated by the federal govemment or in Massachusetts. 2. Authoritv Whereas, the Massachusetts Supreme Judicial Court has held that "the right to engage in business must yield to the paramount right ofgovernment to protect public health by any rational means." ? Therefore, in furtherance of its mission to protect, promote, and preserve the health and well- being of its residents, this regulation is promulgated under the authority granted to the Marlborough Board of Health pursuant to Massachusetts General Laws Chapter I I l, Section 3l that "boards ofhealth may make reasonable health regulations," the Board of Health enacts this Regulation Restricting the Manufacturing, Sale, and Distribution of Kratom. I ONUG ENFORCEMENT ADMIN., GET SMART ABOUT DRUGS, AVAiIAbIE AI http://www.getsmartaboutdrugs.gov (last visited February 13, 2023). 2 Druzrkr-Bd-pIllcqlthpl tlcyqhill, 32,1Mass. 129, 139 (1949) 239 Mass. 424, 428 (1921)) 1 !Ltrng La Rtl of Reeistration in Med SALE. AND DISTRIBUTION OF KRATOM Business Agent: An individual who has been designated by the owner or operator of any business to manage or oversee the establishment. Kratom: Refers to the leaves or an herbal extract from the leaves or other parts ofan evergreen tree in the Rubiaceae family, Mitrag;na speciosa, that contains mitragynine and 7-hydroxymitragyninc. These compounds producc stimulant-like effects in low dosages and opioidJike effects in high dosages. Person: Any individual, firm, partnership, association, corporation, company, or organization ofany kind. including. but not limited to an owner. operator. manager. propnetor. or person in charge of any establishment, business, cultivation property, or retail store. 4. Distribution of Kratom Products (A) No person shall manufacture, distribute, sell, or offer for sale Kratom in any of its forms, as defined herein, or any Kratom-derived products, or any products containing Kratom as an additive in the City of Marlborough. 5. Enforcement and Penalties (A) Any person or entity charged with violating this regulation shall receive a notice of violation from the Board of Health or Board of Health Agent. (B) lt shall be the responsibility ofany establishment owner and/or the establishment owner's manager or business agent to ensure compliance with this regulation. The owner or manager ofany establishment in which Kratom is manufactured, distributed, sold, or offered for sale by any person in lawful control ofthe establishment, shall be responsible for the violation whether, or not, they authorized or were aware that the violation was taking place. (C) In the case ofa violation, the violator shall receive: (l) In the case ofa first violation, a fine ofone thousand dollars (S1000.00) (2) In the case ofa second violation within 36 months of a previous violation, a fine of two thousand dollars ($2000.00), and a suspension ofany permit issued by the Board, including but not limitcd to a Tobacco Products Sales Permit, for seven (7) consecutive business days. (3) ln the case ofthree or morc violations within a 36-month period, a fine offive thousand dollars ($5000.00), and a suspension ofany permit issued by the 2 3. Definitions Board of Health: The Marlborough Board of Health and its designated board ofhealth agents. Board of Health Agent: The Director of Public Health and any city employee designated by the board ofhealth, which may include board ofhcalth and health department staff, and code enforcement officers. Board, including but not limited to a Tobacco Products Sales Permit, for thirty 130) consecutive business days. (D)In accordance with applicable law, the Board of Health may modifu, suspend, or rescind any license or permit to conduct a business issued by the Board ofany person or entity who is found in violation ofthis regulation by manufacturing, distributing, selling, or offering for sale Kratom or Kratom products on the premises that is the subject ofthe license or permit. (E)The authority to inspect establishments for compliance and to enforce this regulation shall be held by the Marlborough Board of Health and its agent(s). (F) Any person may register a complaint pursuant to this regulation to initiate an investigation and enforcemenl with the Marlborough Board of Health and its agent(s) (G) Violations of this regulation may be enforced by the non-criminal method of disposition as provided in M.G.L. c. 40, $ 21D and as enabled pursuant to the Marlborough enabling ordinance. (H) Each day a violation exists shall be deemed to be a separate offense. 0) A person who receivcs notice ofa violation of this rcgulation can request a hearing before the Board of Health. This request must be made in writing and filed within seven (7) days after the date the violation was served or actually received. 6. Severabili$ Ifany paragraph or provision of this Regulation is found to be invalid or unenforceable, against public policy or unconstitutional, it shall not affect the legality ofany remaining paragraphs or provisions and shall continue in full force and effect. Signed this day October 7, 2025. Board of Health: By the Marlborough ames Griffin. Chairman 3 p . MD. Vice-Charr 7. Effectivc Date This Regulation shall take effect for the City of Marlborough on the fq! day of ])qDgI 2025. Advertise in the lndie. Reach more readers from Eastham to Provincetown. (iet the word oul Place an atl. Let us bringyou the paper. Your subscription supports real community journalism. Reacl lor:al. Subscril nor,rl!f HOME STORIES SHORTCUTS INDIE'S LJP SHOP ABOUT DONATE q CHOICE DRUGS The Kratom Conundrum Comes to Outer Cape Cod Health oflicials scrutinize a substance saidto ofler addiction - or its cure BY JACK STYLER . OCT 29, 2025 PRoVINCETOWN - Often locked in a glass case next to the rack of erectile dysfunction pills and in front of a wall of shining lottery tickets, kratom, an opiate{ike substance made from tree leaves native to Southeast Asia, has quietly found a niche on convenience-store counters across the country. Kratom is here on the Outer Cape, too. 3 pages left I Sign tn I subscribe The Gulf Station in Provincetown sells products advertised as both kratom and 7-OH. (Photo by Jack Style0 But for a growing number of people, kratom, which can be sold as shotiike drinks, pills, or powde5 has become a major pull - for some as an addictive, dangerous drug and for others as an alternative product for pain management or energy enhancement. In recent months, regulators at the federal, state, and local levels have been taking a harder Iook at kratom and its synthetic derivative, 7-Hydroxymitragynine (7-OH), which "produces respiratory depression, physical dependence, and withdrawal symptoms characteristic of classical opiates," according to a report released in lune by the U.S. Food and Drug Administration. Eliza Morrison, the director of harm reduction services at the AIDS Support Group of Cape Cod (ASGCC), told the Independent that she has heard "quite a bit" about both kratom and 7-OH from ) pages lcft I Sign In Subscribe I L t 1 " liAL{3lOs ADVANCEDI(RAIIOH ALT 'I r$I$$o'fIIlf f,riirrrilgrrstfru I PtAlrrtAs{sE.qI/EAt EXIBI.r\\ \, -r- L t , ( -,4 --fus{:=''-. -- - ------------- I I-4I I 5r's"'-" Iooking for help to stop using it. The other is people who say they are experimenting with it as a Foteniial alternative to the use of opiates or even alcohol. Either way, Morrison said that most users coming to ASGCC reported some adverse effects of taking kratom, including nausea, vomiting, heart palpitations, and seizures. They've told her that kratom can be extremely hard to stop using once they've started taking it regularly. The director of substance use disorder and outreach programs at the Duffy Health Center in Hyannis, Daniel Rodrigues, said that he has started to hear about kratom use as well. Rodrigues runs a recovery-based program for adolescents in Falmouth and Dennis and said one recently admitted adolescent in a group of 11 reported that kratom was her primary substance of choice. Rodrigues also said that his family support counselors have reported that families of other adolescents have become more anxious about the ubiquity of kratom in recent weeks. Kratom Versus 7-OH Kratom comes from a subtropical tree called Mitrogyno speciosa indigenous to Southeast Asia, where people used its leaves to treat pain, enhance work, and act as a social lubrlcant for centuries, according to a leading kratom researcher at the University of Florida, Chris McCurdy, who appeared on the health and science podcast "Huberman Lab" in fuly to discuss the substance. 3 pages left I Sign In I Subscribe "We're also hearing about a lot of young people who are using it," said Morrison, who added that kratom is not detected by drug tests. The leaves ofthe kratom tree are used to produce the substances being ottored forwellness and lor highs. (Photo by Thor Porre/CC 3.0) Though the kratom tree is in the coffee family, the chemical compounds present in kratom have both stimulant and opiate-like properties. Users say that, in low doses, kratom can have an energizing effect similar to caffeine. But at higher doses, kratom consumers are more likely to experience sedative effects and a euphoric "high" feeling, according to McCurdy. Estimates of the number of kratom users in the U.S. vary widely, but McCurdy said on the podcast that according to manufacturers' sales figures, well over 20 million Americans are daily kratom users. The type of kratom experience those 20 million people are having will depend on whether they are taking kratom in something like its natural form or from companies selling its synthetic derivative, 7-OH. Orrin Hatch's Pain Relief C.M. "Mac" Haddow, the senior fellow on public policy at the American Kratom Association, told thelnilepenilentthat the U.S. kratom industrywas hijackedin2023 by sawy entrepreneurs who increased the level of 7-OH to make it a "chemically manipulated full-blown opiate." I pagcs left I Sign In I Subscribe J € I ftt I ! I Haddow said that the association, which advocates for kratom education and the right to use it, ivants-the government to ban the sale of 7-OH products. "They're appealing to the drug seekers, and they're creating addictionsi' said Haddow. "They're creating serious adverse events from a product that should not be on the market." Haddow said that he's been a daily kratom user since being introduced to the substance in 2015 by former U.S. Sen. Orrin Hatch, who told him he'd been taking kratom for years for chronic pain. Haddow, who ran Sen. Hatch's first Senate campaign in 1976 and worked as the chief of staff in the U.S. Dept. of Health and Human Services during the Reagan administration, told the lndependent that he, too, uses kratom to manage chronic pain, as do thousands of Americans' But Can It Kill You? The U.S. Drug Enforcement Administration had announced that it would make kratom's active compounds a Schedule 1 drug - that is, one with no accepted medical use and a high potential for abuse - in September 2016. Following a public outcry and pushback from the American Kratom Association, scientists, and lawmakers, who argued that a ban would curtail research, the agency decided not to proceed, according to an investigation by the TampaBay Times. Haddow, however, told the Times that its death toll figures were "grossly overstated" and said that underlying medical conditions or mixing other substances may have been the main factor in those fatalities. In )une, the FDA recommended to the DEA that 7-OH products be scheduled as controlled substances. Haddow told the Independent that he had expected 7-OH products to be scheduled and removed from the market in the next month or two, but because of the government shutdown, the timeline for federal regulation moving forward is unclear. The Cumberland Farms convenience stores in Provincetown, Wellfleet, and Eastham all carry kratom in shot-like containers, but until a couple of months ago, Cumberland Farms had also sold "Mr. Mx" products, according to fuina Brown, the store manager in Provincetown. According to the company's website, "Mr. Mx" sells "precision-formulated" 7-OH tablets to "maximize your t pages lcit Sigrr ln i Srrhsr'ribt. The Times found that there had been over 2,000 kratom-related overdose deaths in 40 states and Washington, D.C. between 2021 and the time it published its investigation in December 2023. Brown said that before the corporate office told her to stop ordering the "Mr. Mx" products, a small group of customers would regularly come in and spend hundreds of doUars on the proaucts: Now, Brown said, the kratom bottles that they currently sell, which are not advertised as 7-OH, are a "waste of space." "We need these back," said Brown, speaking of the "Mr. Mx" products. "Or we are just going to discontinue everything." Cumberland Farms' parent company, EG Group, did not respond to a request for comment about its decision to stop selling 7-OH products in time for this issue's deadline. All Outer Cape convenience store clerks at retailers that sell kratom interviewed by the lndepenilentfor this story said that they require customers to be at least 21 years old to purchase the product. There is no federal age restriction on kratom purchases, and in Massachusetts there is no minimum legal age to purchase kratom. State and Local Regulation As the federal bureaucracy remains in gridlock, the Massachusetts legislature and some local boards of health have taken action to limit the sale of kratom or at least of 7-OH. During its Oct. 22 meeting, the Bourne Board of Health heard from more than 20 speakers, some ofwhom called in from other states, to advocate for or against a proposal to ban kratom sales in the town. Many ofthe speakers told the board that kratom had given them new life after struggling with chronic pain or opioid use disorder. But five mothers, each of whom said she had lost a child to a kratom-related overdose, also called in, sometimes speaking through tears, to urge the board to ban the substance outright. That board voted unanimously to ban kratom sales, making it the first Cape Cod town to do so. Several other Massachusetts municipalities have also outlawed the sale of kratom, including Lowell, Canton, Belchertown, Chelmsford, Marlborough, and Dracut. Six states and the District of Columbia have passed statewide kratom bans, including Rhode Island and Vermont. Before his death earlier this year, state Sen. Edward l. Kennedy introduced a bill in Massachusetts that would ban the sale of kratom statewide. It has been referred to the joint committee on public health, on which Sen. fulian Cyr of Provincetown serves as vice chair. Cyr told the Independentthathe would be taking a look at the bill, and the committee has until the first Wednesdav in December to take action - unless the deadline is extended. :i p.rgts lL:ft I sign In I suhscrihe Advertise in the lndie. Reach more readers from Eastham to Provincetown. ' w0rd out t an ad. Let us brint you the paper. Your subscription supports real community journalism. Read local- Subscribr now! HOME STORIES SHORTCUTS INDIE'S LJP SHOP ABOUT DONATE q CHOICE DRU GS The Kratom Conundrum Comes to Outer Cape Cod Health officials scrutinize a substance said to ofler adiliction - or its cure BY JACK STYLER . OCT 29, 2025 PROVINCETOWN - Often locked in a glass case next to the rack of erectile dysfunction pills and in front of a wall of shining lottery tickets, kratom, an opiate-like substance made from tree leaves native to Southeast Asia, has quietly found a niche on convenience-store counters across the country. Kratom is here on the Outer Cape, too. 3 pages left I Sign ln I subscribe --1 The Gulf Station in Provincetown sells products advsrtised as both kratom and 7-oH. (Photo bY Jack Styler) But for a growing number of people, kratom, which can be sold as shot-like drinks, pills, or powder, has become a major pull - for some as an addictive, dangerous drug and for others as an alternative product for pain management or energy enhancement. In recent months, regulators at the federal, state, and local levels have been taking a harder look at kratom and its synthetic derivative, 7-Hydroxymitraglmine (7-OH), which "produces respiratory depression, physical dependence, and withdrawal symptoms characteristic of classical opiates," according to a report released in June by the U.S. Food and Drug Administration. Eliza Morrison, the director of harm reduction services at the AIDS Support Group of Cape Cod (ASGCC), told the Inilependent that she has heard "quite a bit" about both kratom and 7-OH from t pages left I sign In Suhscribe L, \ Aotx*ceo l(R'rox A LKA Lo' Ds 't.$toRorltIIlRAG'rliiE rArrfrs .1 BA5EO EorArlcrll rxrslcl 'Fl \I t t L., .n*t^,I 4 Ij ! I A"F 7- t :rNAL Iooking for help to stop using it. The other is people who say they are experimenting with it as a potential alternative to the use of opiates or even alcohol. Either way, Morrison said that most users coming to ASGCC reported some adverse effects of taking kratom, including nausea, vomiting, heart palpitations, and seizures. They've told her that kratom can be extremely hard to stop using once they've started taking it regularly. "We're also hearing about a lot of young people who are using it," said Morrison, who added that kratom is not detected by drug tests. The director of substance use disorder and outreach programs at the Duffu Health Center in Hyannis, Daniel Rodrigues, said that he has started to hear about kratom use as well. Rodrigues runs a recovery-based program for adolescents in Falmouth and Dennis and said one recently admitted adolescent in a group of 1l reported that kratom was her primary substance of choice. Rodrigues also said that his family support counselors have reported that families of other adolescents have become more anxious about the ubiquity of kratom in recent weeks. Kratom Versus 7-OH Kratom comes from a subtropical tree called Mitragyno specioso indigenous to Southeast Asia, where people used its leaves to treat pain, enhance work, and act as a social lubricant for centuries, according to a leading kratom researcher at the University of Florida, Chris McCurdy, who appeared on the health and science podcast "Huberman Lab" in July to discuss the substance. }pageslcft lsignln I Subscribe The leaves ofthe kratom tree are used to produce the substances being offered forwellness and lor highs. (Photo byThor Porre/CC 3.0) Though the kratom tree is in the coffee family, the chemical compounds present in kratom have both stimulant and opiate-like properties. Users say that, in low doses, kratom can have an energizing effect similar to caffeine. But at higher doses, kratom consumers are more likely to experience sedative effects and a euphoric "high" feeling, according to McCurdy. Estimates of the number of kratom users in the U.S. vary widely, but Mccurdy said on the podcast that according to manufacturers' sales figures, well over 20 million Americans are daily kratom users. The type of kratom experience those 20 million people are having will depend on whether they are taking kratom in something like its natural form or from companies selling its synthetic derivative, 7-OH. Orrin Hatch's Pain Relief C.M. "Mac" Haddow, the senior fellow on public policy at the American Kratom Association, told the Indepenilent that the U.S. kratom industry was hijacked in 2023 by sawy entrepreneurs who increased the level of 7-OH to make it a "chemically manipulated full-blown opiate." ) pagos lcft I sign In I subscribe I '-/N I I I Haddow said that the association, which advocates for kratom education and the right to use it,' wan-ts the government to ban the sale of 7-OH products. "They're appealing to the drug seekers, and they're creating addictionsi' said Haddow. "They're creating serious adverse events from a product that should not be on the market." Haddow said that he's been a daily kratom user since being introduced to the substance in 2015 by former U.S. Sen. Orrin Hatch, who told him he d been taking kratom for years for chronic pain. Haddow, who ran Sen. Hatch's first Senate campaign in 1976 and worked as the chief of staff in the U.S. Dept. of Health and Human Services during the Reagan administration, told the Independent that he, too, uses kratom to manage chronic pain, as do thousands of Americans. But Can It Kill You? The U.S. Drug Enforcement Administration had announced that it would make kratom's active compounds a Schedule 1 drug - that is, one with no accepted medical use and a high potential for abuse - in September 2016. Following a public outcry and pushback from the American Kratom Association, scientists, and lawmakers, who argued that a ban would curtail research, the agency decided not to proceed, according to an investigation by the TampaBay Times' The Times found that there had been over 2,000 kratom-related overdose deaths in 40 states and washington, D.C. betvveen 2021 and the time it published its investigation in December 2023. Haddow, however, told the Times that its death toll figures were "grossly overstated" and said that underlying medical conditions or mixing other substances may have been the main factor in those fatalities. In June, the FDA recommended to the DEA that 7-OH products be scheduled as controlled substances. Haddow told the lnilependentthat he had expected 7-OH products to be scheduled and removed from the market in the next month or two, but because of the government shutdown, the timeline for federal regulation moving forward is unclear. The Cumberland Farms convenience stores in Provincetown, Wellfleet, and Eastham all carry kratom in shot-like containers, but until a couple of months ago, Cumberland Farms had also sold "Mr. Mx" products, according to Arina Brown, the store manager in Provincetown. According to the company's website, "Mr. Mx" sells "precision-formulated" T-OH tablets to "maximize your :i pagt,s lciL ] Sigrr ln I Subslribl "We need these backi' said Brown, speaking of the "Mr. Mx" products. "Or we are just going to discontinue everything." Cumberland Farms' parent company, EG Group, did not respond to a request for comment about its decision to stop selling 7-OH products in time for this issue's deadline. All Outer Cape convenience store clerks at retailers that sell kratom interviewed by the lnilepenilent for this story said that they require customers to be at least 21 years old to purchase the product. There is no federal age restriction on kratom purchases, and in Massachusetts there is no minimum legal age to purchase kratom. State and Local Regulation As the federal bureaucracy remains in gridlock, the Massachusetts legislature and some local boards of health have taken action to limit the sale of kratom or at least of 7-OH. During its Oct. 22 meeting, the Bourne Board of Health heard from more than 20 speakers, some ofwhom called in from other states, to advocate for or against a proposal to ban kratom sales in the town. Many of the speakers told the board that kratom had given them new life after struggling with chronic pain or opioid use disorder. But five mothers, each of whom said she had Iost a child to a kratom-related overdose, also called in, sometimes speaking through tears, to urge the board to ban the substance outright. That board voted unanimously to ban kratom sales, making it the first Cape Cod town to do so. Several other Massachusetts municipalities have also outlawed the sale of kratom, including Lowell, Canton, Belchertown, Chelmsford, Marlborough, and Dracut. Six states and the District of Columbia have passed statewide kratom bans, including Rhode Island and Vermont. Before his death earlier this yea! state Sen. Edward f. Kennedy introduced a bill in Massachusetts that would ban the sale of kratom statewide. It has been referred to the joint committee on public health, on which Sen. Iulian Cyr of Provincetown serves as vice chair. Cyr told the Independentthathe would be taking a look at the bill, and the committee has until the first Wednesday in December to take action - unless the deadline is extended. I pagps lcft I Sign In I Subscribc Brown said that before the corporate office told her to stop ordering the "Mr. Mx" products, a small group of customers would regulad come in and spend hundreds of dollars on the prodrfcts. Now, Brown said, the kratom bottles that they currently sell, which are not advertised as 7-OH, are a "waste of space." Town of Dover, MA Board of Health Regulations Chapter 220 Smoking; Sale of Tobacco and Nicotine Delivery Products Proposed amenclmenls lo Section 220-2 Findings; purpose: There exists conclusivc cvidencc that tobacco smoke causes canccr, respiratory diseascs, various cardiac problems, allerges, and irritations to the eyes. nose and throat ofboth the smokerand nonsmoker exposed to secondhand smoke. Evidence further demonstrates that nicotine, present in tobacco, is extremely addictive. Almost 90% of all smokers begin smoking before the age 18, and every day an estimated additional 3,000 minors begin smoking in thc United States. Thcre is an urgcnt health nced to reduce easy access by youths to tobacco and nicotine products through strict enfbrcement of the state law prohibiting sales to minors, MGL c. 210, $ 6, and additional measures. Therefore, these regulations are adopted pursuant to MGL c. I I l, $ 3 l, as reasonable health regulations designed to protect and improve the healh of the residents of the Town of Dover. Proposed amendments to Section 220-6 Retail sale of tobacco products.. B. No person, firm, corporation, establishment, or agency shall sell tobacco, nicotine, or e-cigarette products to anyone born on or after January l, 2005, Current D. All clerks selling tobacco products or nicotine delivery products shall verify by means of government- issued photogaphrc identification containing the bearer's date ol birth that no person purchasing the tobacco or nicoline contairung products is yormger than 2 I years ofage. No such verification is required fbr any pcrson over thc age of 26. No clcrk shall sell tobacco products or nicotine dclivery products to a person under 2l years of age who has a note from an adult requesting such sale. Proposed D. All clerks selling tobacco products or n icotine delivery products shall verify by means ofgovernment- issued photographic identification conlaining the bcarer's date of birth that no person purchasing the tobacco or nicotine containlng products was born on or after January l, 2005. Proposed amendments to sectk)n 220-10 Posting of state law required; All retail establishments shall conspicuously post signage, made available from the Board of Healtlt" Such signage shall include: (i) a copy of G.L. c. 270, $$ 6 and 6A; (ii) rcferral information for smoking cessation resourcesl (iii) a statement that sale oftobacco products, including e-cigarettes, to a person born on or aft€r January l, 2005 is prohibited; (iv) health warnings associated rvith using electronic nicotine delivery systemsl and (v) except in the case of smoking bars, notice t0 consumers that the sale offlavored tobacco products are prohibited at all times. Such signage shall be posted conspicuously in the retail establishment or other place in such a manner so that it may be readily seen by a person standing at or approaching the cash register. The notice shall directly face the purchaser and shall not be obstructed from view or placed at a height ofless than four feet or greater than nine feet from the floor. The signage may be in a form developed and made available by the Massachusetts Department of Public Health' Proposed amendmenls to section 220-16 Ellective date; amendments: This regulation shall take effect 30 days aftcr publication of a summary o fthe regrrlation in a newspaper disxibuted in the Torvn of Dover'. As requiredby M(iL c. I I l. \\ 31. an attested copy has been filed u'ith DEP on Junc 8. I 994. 'l-his rcgu lation was votccl by a majority o I th is Board on April 25. 1994. amcndcd on Mav f f , l 998, Scptembe r 24.200l . Novcnrbcr l.3.20l3.July l0. 2023, and llNSERT DATE OF voTEl. I'l'hat is Nicotine: The term nicotine includes all tobacco and synthetically derived nicotine products such as vapes or e- cigarettes, cigarettes, cigars, chew, and pouches. The Problem: Nicotine containing tobacco products remain the single greatest cause of addiction and death in Massachusetts with over 9,000 deaths each year,l more than three times the number of deaths from the state's opioid crisis. Tobacco kills onc-half of its users,ll accounting tir I out ol'cver-v- -5 tlcaths in the US.lll Despite decades of control efforts, the tobacco industry continually innovates new products and nicotine delivery methods, undermining regulation and targeting susceptible young adult populations. Nicotine-Free (;cneration : Nicotine-Frce Generation (NFG) proposes a definitive, streamlined approach to tobacco control. NFG policy prohibits the sale of nicotine products to anyone bom after a chosen datc (c.g. January 1, 2004). Thosc born before this date, who curently usc nicotine, may be sold products indefinitcly. The policy prevents sales to the next generation, phasing out sales slowly over time. Respects the rishts of users: Those who alrcady use nicotine products can continuc to be sold nicotine indefinitely. NFG doesn't shame or stigmatize users. Considers retailer needs: NFG is gradual, proyiding retailcrs time to adjust their business model so it does not depend on selling a deadly, addictive product-thc markct dcclines only- margrnally cach ycnr. ls socilllv reinlbrcing: Olcr timc. tccns anrl young adults will bc lllthcr rcmovcd irr agc fiofir those rvho can bc sold nicotinc. dccrcasing carly oicotiuc initiation that sparks lilclong addiction ,\ccounts for personal riglrts and frccdoms: I-he l{assiichusctts SLrpreme (iourt unanirrrousiv upheld the policy in Ulookline.iV Like asbestos or lead paint. selling tohacco is nol a constitutional right. Thc purchasc, usc. or possession o1'tobacco is never crirninalizcd. Tobacco dcpcndcncc nrcans thc loss of free choice and l'r'eedom--alnrost all tobacco users wish thev'd never starled. Prolidcs a smooth transition: NF'G avoids blrck markct salcs. rrs clrrrcrlt dcpcndcnt uscrs arc ncver cul oll-from legal nicoline access. Additionally. NFG curlails fulure demand try preventing th'l next gencratioll lrom becorrring addicted. . C0nrcs at the ht tinre and Iace:NFC policy is spreading quickly ud has alrcady bccn adopted by ninc Massachusctts lowns. MA has lcd thc corullry in spcahcading nicotinc policics such as tlavor restrictioN and minimum sales age of 2l . Many places are meaningtirlly considering NFG. including other jurisdictions in the US and the countries of UK. EU. Malaysia. Singapore. Ireland. Denmark. France, Spain. and Canada. ()pposed stronglv b\, Big Tobacco: Will rcducc salcs over time, and improvc public hcalth a a a a a ' Campargn r"rl h...o-Free Krd,,''The L'Llnll.,ha.co rn Masslchuse(s, AIril l7,l0l4.hlrps: w r w.t)ba.(o licc(rds o rg prob lenr ro I I -u! mrtsachuse{s. II tturL,r tt."trt, o.!"u 1rir.r.,'lob.r.rn. rrL\ rilolr hrrt\ NN\\lrd'trr'rN:,fftrli\1 '[.arr J.1,,,i 1!il.i..!]. lll ccntc* t. oiseasc control and Pr.vcnrion, 'llcallh Ettacis olcrgarcnc snrokr.8,- ociober29,20l l, https://www cdc.gov/robnoco/dala slalislrcs/llcl-sh&ts/hcalth-cftictsrellcds-_cig,snroking. rupEme{oun-uphrldrrobacco-fte€ Fnerar,on l]* (Ll.Ir..:Sr\.,*-lrh.{i\.1(,\\rfr.lnr',Jl'\r.,,r'f(1r..(,.n..]rirn()n(l'r*-()1r^c\Vcrir.illil-:rrli Nicotine-Free Generation (Nl-G) Overview NFG: Municipalities That Have Adopted Nicotine Free Generation Betc he rtown Brookline Chetsea Concord Conway Dover (added Nov.1, 2025) Hopkinton Malden Ma nchester-By-The-Sea Metrose Needham Newton Pelham Reading Somervitte South Hadtey Stoneham Wakefietd Winchester Massachusetts update ASH Monday. November3.2025 12:00 PM Good morning. We've had a very busy year and l'm happy to report that we have severat updates for you. Eighteen Massachusetts municipatities have adopted NFG, and 580,000 MA residents now Live in a community that has an NFG poticy. South Hadtey was the latest - - just two weeks ago. Amherst held a pubtic hearing this past Thursday. Dover is hotding a pubtic hearing this evening. As we say, stay tuned. ln January 2025 NFG bilts were fited in the State Senate and in the House. ln Juty the State's Joint Commiftee on Pubtic Heatth hetd a Pubtic Hearing. So many peopte showed up to testify they had to cut us off and not everyone got to speak. But there witt probabty be at teast one more hearing before the Joint Gommittee on Pubtic Heatth and a hearing before Ways and Means. Written testimony is always wetcome! The Gommittee on Pubtic Heatth has reported out favorabty on an internet sates ban bitt. This legistation was proposed by a 16 year-old Natick high schoot student. The MA Tobacco Cessation and Prevention Program at DPH funds technicaI assistance providers to support municipatities in promulgating tocat policies. Nicotine Free Generation is inctuded in the TA "model reg", which is a guidance document so any Board of Heath consideringtobacco control updates wilt have readyaccess to the regutation tanguage. My direct supervisor, who is the Heatth Director for three Massachusetts municipalities, and I wilt be presenting at the Massachusetts Heatth Off icers Association's Annua I Conference later this week, atong with Dr. Howard Koh, whom many of you probably know. Dr. Koh is a former Massachusetts Commissioner of Pubtic Heatth. He also served as Assistant Secretary of Heatth and Human Services in the Obama Administration. Dr. Koh is currently at The Harvard Chan School of Public Heatth and witt receive the Btake Cady award from Tobacco Free Mass on December 4th When Anthony and I first started thinking about NFG (catted TFG at the time) back ln 2O23 we knew we needed to make sure we had support, especiattyfrom municipat leaders, but from other community stakeholders as well. We tatked to Mayors, Town Managers, City and Town Council members, Schoot Committee members, educators, students, parents, coaches, heatth care professionals, hospitat administrators, and others. ln addition to youth, some of the most important support came from locat substance use prevention coatitions. The 84 Movement, a youth advocacy program funded by MTCP, is offering a stipend projectto engage and understand youth perspective and awareness related to NFG policies. Youth from across the state are being asked to share their voice and hetp inform and lead progress being made around NFG and other tobacco regulation policies. We soticited support from both individuals and groups, some of whom testified in person, and others who submitted written testimony. Support from subject matter experts is very hetpfut. However, it's most important to hear from tocal residents, especialty youth! The tobacco industry, as you can imagine, is not in favor of this poticy. Retailers, distributors, trade association execs, and smokers'rights groups show up to testify against the poticy. Municipa[ [eaders received robo emails. Window and counter ftyers as wett as petitions were delivered to locaI stores encouraging owners and customers to speak out against the poticy and to show up at public hearings. Lastty, l'm sure you've a[[ seen or heard about some of the newer products that are being peddted to our children by a predatory industry intent on continuing to make bittions. . Toy guitar . Teddy bear . A CD styte device so you can play music or video games white you vape. There are vapes with LED screens that tett you how much battery tife and who many puffs you have left. You know, so you'll be sure to gas up before you run out. At the National Conference on Tobacco Or HeaLth I learned about the next iteration of vape devices which wit[ collect data on the user's puffing habits to send backto the manufacturers so they can recatibrate - to make sure you get higher and higher nicotine levels which witt of course increase the chance you, or your young child, wilt become addicted and the industry gets another customer-for-tife. Because, as we a[[ know, that is the goal. Thank you! Nicotine-Free Generation Frequently Asked Questions and Answers Won't youth just go to the next town over? When Needham Massachusetts became the first town to enact Tobacco 21, opponents of the policy made the argument that youth between 18-21 would jusi buy from the next town over. Yet following the passage of Tobacco 21, Needham witnessed over a 50o/o decrease in high school smoking. The percentage of high schoolers who smoked declined at nearly kiple the rate in Needham compared to surrounding towns that had not adopted the policy (Winickoff 20141 Sc hneider 2016). Decreasin g access to tobacco in even one town has been proven to work. Doesn't NFG take away free choice for adults? Doesn't it infringe on personal rights? The tobacco industry likes to frame NFG as a free choice issue. However, 95% of tobacco use beqins before the aqe of 21. and 99% before 26. Early tobacco use is more likely to lead to addiction, which by definition means the loss of free choice. There rs no free choice when addiction drives desire. Tobacco is nol a freedom, it is an addiction to nicotine and a burden- just ask people who use tobacco. Do they smoke because they want to, or because they need to? Almost all current smokers wish they had never started. People who are addicted to nicotine continue to use tobacco not because they enjoy it but because they are treating the intolerable negative effects of nicotine withdrawal whenever the level gets too low in their brain. Because tobacco has been sold legally for so long, it's understandable why it might feel like a right or freedom. However, halting the sales of lead paints, asbestos, or FDA-banned supplements for public health reasons obviously don't take away any "personal rights." Tobacco has caused the greatest health detriment of any consumer product in history, causing more annual deaths than AIDS , alcohol, care accid ents, illeqal druqs,murders. and suicides combined. NFG does not take away personal rights or freedoms, it phases out the sale of a dangerous and addiciive product over years. ls NFG constitutional? Nicotine is not a constitutional right. The Massachusetts Supreme Judicial Court upheld the legality of NFG policy in Brookline, affirming that it was "not inconsistent with the Constitution" and was "ratronally related to the town's legitimate interest tn mitigating tobacco use overall and in particular by minors'(see Six Brothers lnc. v. Town of Brookllne pg. 11 and 32). Doesn't NFG split adults into two groups? Why are we judging who is "adult enough" to buy nicotine? It is important to remember that tobacco products are dangerous at all ages; there is no safe age of nicotine sale. NFG recogntzes that tobacco industry nicotrne is a harmful and highly addictive product that should not be sold to anyone: it's not about who is an adult or not. The goal of the cutoff date is to ensure a smooth, practical transition lo a nicotine-free future. The distinction NFG makes is rational, because it allows sale to individuals already using nicotine, and curtails sales to those too young to be using at the time the law is passed. This approach avoids a black market, safeguards future generations from addiction, gives retailers time to adjust, and continues nicotine access for current users. What about our military readiness? Men and women who serve in the United States armed forces have greater military readiness, including increased stamina, fitness, and work capacity, when they do not use tobacco products. (lnstitute of Medicine 2009). Someone who is addicted to tobacco will have more trouble hauling gear over distance due to their diminished lung capacity. Additionally, non-users enjoy superior wound healing so they can get back faster after injuries (Silverstein 1992) and are nearly tvvice as likely to successfully complete basic kaining (Klesqes 2000). The US military now views E-cigarette and cigarette use as a military threat. (Keltner 2021). The US military has banned the sale of all E-cigarette products from their bases. NFG will improve our military readiness over time because fewer and fewer recruits will use lobacco products. NFG aids the creation of a stronger and more resilient American fighting force. What about the history of tobacco and our military? The tobacco industry has targeted military personnel since the beginning of the 20'r'century, marketing products to servicemen at deeply discounted rates in order to get young recruits addicted for life. (Fahev 2020). The US N/ilitary has seen the toll tobacco has taken on its servicemen and veterans. The Department of Defense spends 1.6 billion dollars a year on medical and non-medical costs related to tobacco use. (CDC.qov). Tobacco causes more deaths each year in the United States than the number of US soldiers who died in all of WWll. What about our Yeterans? Following service, veterans who are dependent on nicotine are more likely to experience psychiatric and medical conditions including alcohol use disorder, depression, and PTSD. Baldassarri 2022 Over time NFG will lessen the number of veterans addicted to nicotine, thereby supporting the mental health and well-being of our veterans. NFG does not change current veterans access to tobacco in any way. What about young people who have already been trapped by their tobacco addiction? What happens to them with NFG? Over time, there will be fewer and fewer users who fall into this category. However, safe and effective FDA-approved nicotine (NRT) is available throughout Massachusetts over the counter and is covered by all Massachusetts insurance programs. ln addition, the lvlA quitline gives away free NRT as part of their program. As an outcome of NFG, those who are already addicted to tobacco products will now use safe and freely available FDA-approved nicotine, retaining more money to spend on basic necessities, experiencing a lower incidence of disease, and living longer, more productive lives. What about those who smoke and want to switch to less harmful forms of nicotine like e- cigarettes? NFG prevents addictive products from falling into the hands of those who have never tried nicotine, and doesn't limit access for those who already smoke. While established cigarette smokers may switch to e-cigarette products in an effort to reduce their risk of health complications, young adults and adolescents covered by NFG policies are commonly becoming Will a "Black Market" develop? NFG doesn't create additional black market sales. ln fact, the policy attem pts to avoid further black market nicotine, because current users can continue to legally be sold nicotine, and therefore have nO need to tUrn lo a black market. NFG also prevents future generalions from becoming addicted, gradually shrrnking the dependent user base the black market relies on. Reducing demand for nicotine products means reducing black market sales. A 2015 study found that banning menthol cigarettes resulted in no su e in illicit c rettes. NFG is even safer than menthol bans because it never removes access to nicotine where a demand exists. NFG allows safe, FDA approved nicotine to be sold over the counter in the form of nicotine patches, nicotine gum, and nicotine lozenges. These forms of nicotine have low addicttve potential because of the slow onset of their effect. Keeping these slow release forms of nicotine on the market is important so that people who are addicted to tobacco products can continue transitioning to safer, FDA approved products. lsn't NFG like Prohibition? NFG is nothing like Prohibition. Prohibition fueled a massive Black Market because it immediately removed access to a substance that at least half of the adult population wanted to ggg. lt removed the supply of alcohol while demand remained high, creating a huge economic incentive for illegal Sales. On the other hand, NFG naturally reduces nicotine demand over time by preventing those under a certain age from becoming addicted. Additionally, NFG never removes the nicotine access of cunent users like Prohibition did, preventing any increase in illegal sales. ln addition, safer FDA approved nicotine will continue to be available. How can lsuppo( this while Marijuana access is increasing, etc.? what about existing tobacco control programs Nicotine-Free Generation addresses the specific issue of nicotine use, and does not hinder other public health initiatives in any way. Supporters of NFG recognize that nicotine is uniquely dangerous and addictive, and that the policy offers a practical way to prevent tobacco-related deaths among the next generation. Additionally, as NFG starts to reduce the scope of the tobacco issue, it will allow more public health resources to be allocated towards addressing other problems over time. Whydon'twejustwaitfortheStateortheFederalGovernmenttoenactNFG? Histcrically, local tobacco control regulation has led to state level action. The more cities and towns thai pass Nicotine Free Generation, the greater the chance that a state level bill will pass and protect the entire state. ln the case of Tobacco 21and the state flavor restriction law, over 100 cities and towns in MA passed their regulations before state laws was passed. Tobacco 21 won federal passage after 19 states passed their own laws. Flavor restriction bills are also following the lead of Massachusefts and spreading across the country Local action first is the addicted to nicotane by those same vape products. NFG retains alternatives for current combustible tobacco users who might seek harm reduction through vapes, while limiting the most common source of youth nicotine initiation and use (Centers for Disease Control and Prevention 2023, American Lunq Association 2024). primary way that state and federal bills gain traction. ln summary, putting a local regulation in place now will help make a state law possible and will protect your community sooner lhan waiting for any potential state or federal action in the future. ls NFG too experimental? ls it actually being considered anywhere else? NFG is innovative, and builds on the success of tobacco age restrictions such as Tobacco-21. Though it is a relatively new approach, NFG has already received serious consideration globally. British Prime Minister Sunak proposed an NFG law in 2023, which received endorsemenl from King Charles and the Opposition Party. ln New Zealand, NFG was nearly enacted on a nationwide scale unlil a new government came in and succumbed to tobacco industry pressure in eady 2024. Balls have been forwarded in California, Hawaii, Minnesota, the Philippines, Singapore, ltilalaysia, Denmark, Spain, France, and the European Union. Nine towns in Massachusetts have already adopted the policy, likely with more to come following the l\,4A Supreme Judicial Court ruling that upheld the policy in Brookline. Policymakers everywhere are recognizing the ef{ective approach and public benefit that NFG provides. Will NFG hurt small-business retailers? Nicotine-Free Generation laws are gradual, and the market for tobacco will only decline gradually each year. Most retailers won't see a difference tor years. The policy provides time for retailers to develop their business model so as to not depend on selling a harmful and exploitative product. Since Brookline enacled their policy in 2019, not a single tobacco retailer has gone out of business. Why are we preventing nicotine from being sold to adults? Shouldn't we focus on youth use? NFG aims to tackle youth nicotine addiction first, by preventing youth from ever trying nicotine and becoming addicted. 99% of smokers start before they are 26 (2014 Surqeon General Report). The tobacco industry relies on older peers sharing and distributing tobacco to youth Over time, youth will be further removed in age from anyone who can be sold nicotine legally and any peers who use. The 2024 Surgeon General Report states that endgame efforts to eliminate tobacco-related disease, disability, and death should create opportunities and conditions for all people to live healthy lives that are free from commercial tobacco.l Are there equity issues to consider with NFG? Tobacco product use is highest among lower income and other disadvantaged populations. Tobacco product addiction itself can worsen the cycle of poverty for families because each pack of cigarettes for example costs over $10. Nicotine addiction takes no days off, therefore the pack a day smoker spends over $3,500 on their nicotine addiction after taxes instead of better food, clothing, and rent for lhejr family. ln addition, tobacco retailer density tends to be highest in poorer neighborhoods, placing lhose community members at higher risk of exposure to 1 u.s. Depaftment of Health and Human services. Eliminating Tobacco-Related oisease and Death:Addressing Disparities-A Report of the surgeon General. Ailanta, GA: u.s. Department of Health andHuman Services, Centers for Disease Control and Prevention, National Center for Chronic DiseasePrevention and Health Promotion, Office on Smoking and Heafth,2024. advertising and greater access to unsafe products. These facts make lobacco use an equity issue and protecting the next generation from worsening economic and health harms due to nicotine will disproportionately benefit disadvantaged groups.l How does NFG help level the playing field with municipal employment opportunities? Tobacco use is prohibited in all basic military, police, and fire fighter training programs.2 For a person to get to be one of these respected members of our communities they cannot be addicted to tobacco products. Fire fighters and police officers cannot be smokers and keep their jobs, it is prohibited by law.3 Therefore, NFG is an important step toward these high paying and upstanding opportunities to be fully available for all our community members. Suggested Citation for this NFG FAQ: Savage T., lshak A., Silbaugh K., Chadwick G., Haftmann L., Goftlieb M., Buzby M.. Winickoff JP. Nicotine-Free Generation Frequently Asked Questions and Answers. Version 12072024 z DOD.httos:rwww.mititarvonesource.mil/militarv-basics/new-to{he-militarv/what-to-oack-for-basic- traininq/ Imilitarvonesource.mill; httos://msotroooer.oro/wo-content/uoload si 2016/04/Ma-State-Police- Rules-and -Reo ulations-Combined. gdf Imsotroooer.orol ; ranklinma.qov/sit es/o/files/vvhlif 1 0036/f/uoloads/academv {rained -o atro l-o ff ic er-Dostinq-11-httos://www.f 19-24.dl Ifranklin a.oovl mas u 3/download Imass.qovl sectiion ll. D 3 httDS://casetext,com/statute/qeneral-laws-of-massachusetts/oart-j-ad ministration-of {he-oovemmenUtitle- ,ii-"il,es-towns-and{ istricts/chaoter-41-of f icers-and+moloveesof +ities{owns-anddistricts/section- 4'1'101a-police-of f icers-o r-f iref io hters-to b acco-s mo k ino [casetext coml Other ideas for inclusion: Economic argument... consider keeping that money in the community rather than funding factories in China where much of the newer tobacco product is created. IrcTHINGSTOK}IOW ABOUT NFG Policy innovotion lo end nicotine crddiction A policy thot prohibits soles of niiotin6 orodlcts to indivlduols born ofidr o certoin dote {e.g. Jon l,2OO4).li phoses out soles over trme, preventrng youth initiotion without offecting current users. .. nicotine concentrotions. These newer devices ore of'ten pockoged in child {riendly desrgns (eg. teddy beors, toy guitors), cleorly oppeoling to very young users ond undermining prevention e{fort NFG's phosed opprooch gives retoilers time to odopt therr business models, with soles declining slightly eoch yeor. The Mossochusetts Supreme Jud icio I Court upheld the policy in Brookline. NFG does not criminolize Dossessron or use-just retoil soles to {uture generotions. lncludes tobocco ond syntheticolly derived nicotin products: vopes, e- cigoreties, cigorettes, Icigors, chew, ond pouches. e 1 , The nicotine industry is evolving. creoting more oddictive producis with higher Curreni nrcotine users ore not restricted-ihey con continue buying products. NFG ovoids stigmo or shoming ond supports groduol chonge. ,,& As time posses, new generotrons grow {urther removed lrom those who con legolly buy nicotine-decreosing peer inf luence ond eorly initiotion. By preserving occess for current users ond cuiting demond from future ones, NFG reduces risk of illicit soles. NFG threotens iobocco industrv Drof its-which is exoctlf why i{s o strong public heolth policy. lllrt S a A.I1 ) Whot is t{icotine? OEOT' E Why Now? Retoiler-Friendly Reinforces Sociol Norms Prolecls Personol Ri hts Prevents Block Morkets Opposed by Big Tobocco Adopted in '17 MA towns, with growing interest f rom iurisdictions in ihe US, UK, EU, Singopore, Moloysio ond more lr Whor is NFG? Respacts Aduh Ueera Growing Momenlum 1 BOARD OF HEALTH MEETING MINUTES 1146 Route 28, South Yarmouth November 3, 2025 Board Members Present: Hillard Boskey, M.D., Charles T. Holway, Mary Craig, Laurance Venezia DVM, Eric Weston Others Present: Barry Lewis, Assistant Health Director, Riley Niederberger, Division Assistant 1. Call to Order The meeting was called to order at 5:00 p.m. 2. Declaration of a Quorum Quorum Present 3. Public Comment None 4. Smoke Detector Awareness & Education – Yarmouth Fire Department Rescheduled to next meeting. 5. 24 Grove St, West Yarmouth, MA 02673 – Variance Request David Coughanowr, R.S. attended the meeting as a representative for 24 Grove Street, West Yarmouth, MA 02673 to request septic variances due to the small size of the property. Barry noted design options are limited for this property and supported the engineer plan. Variances requested: - 310 CMR 15.211(1) Septic tank to cellar wall ten (10) foot minimum required. Variance to seven (7) foot separation requested. - 310 CMR 15.211(1) Septic tank to property line ten (10) foot minimum required. Variance to five (5) foot separation requested. - 310 CMR 15.211(1) Soil absorption system to cellar wall twenty (20) foot minimum required. Variance to five (5) foot separation requested. - 310 CMR 15.211(1) Soil absorption system to property line ten (10) foot minimum required. Variance to five (5) foot separation requested. The existing cesspool is starting to fail and there is an Accessory Dwelling Unit (ADU) currently on the property. The system upgrade will be in compliance with MA Title five (5) regulations. The Board raised concerns with abutters. David showed certified mailing receipts that he notified beyond direct abutters. Motion: Eric Weston moved to approve all four (4) septic variances for the property located at 24 Grove Street, West Yarmouth, MA 02673. Second: Mary Craig T O W N O F Y A R M O U T H 1146 ROUTE 28, SOUTH YARMOUTH, MASSACHUSETTS 02664-24451 Telephone (508) 398-2231, ext. 1241 Fax (508) 760-3472 Board of Health - Health Division 2 All in favor 6. Plastic Product Waiver - Review In preparation for review of the Disposable Plastic Reduction Regulation at Town Meeting, the Health Department has been working on a Plastic Product Waiver. Format edits will be made to the waiver. The waiver will be for plastics number one (1), two (2), and five (5) only. All other plastics excluding number six (6) will require a variance, which is a separate application available on the Town of Yarmouth website. The Board reviewed a video on the Yarmouth plastic reduction and would like to see other content that focuses on how the new regulation is more cohesive and achievable than the original bylaw. The Board noted the importance of providing guidance on how to follow the new plastic reduction regulation. On November 17th, the item of rescinding the current plastic reduction bylaw will be on the special Town Meeting Warrant. 7. Review & Approve of Minutes Motion: Laurance Venezia moved to approve the minutes from October 6, 2025, with one edit. Second: Eric Weston All in favor 8. New/Old Business Barry noted that there were fifty-one (51) participants at the October Flu Clinic at the Yarmouth Senior Center, the event went smoothly, and the department saw a larger turnout than the previous year. As November is Diabetes Awareness Month the Health Department is hosting a free A1C screening event on November 14th from 1:30 p.m. to 3:00 p.m. in partnership with the Barnstable County Public Health Nursing Division. The event is at the Yarmouth Town Hall, 1146 Route 28, South Yarmouth, MA 02664. Hillard noted that A1C testing is a great way to assess average blood glucose over about three (3) months. The Barnstable County Health & Environment Division will host Buried in Treasures workshops starting November 18th. This is a sixteen (16) week commitment open to all who may need resources for decluttering, hoarding, or supporting others with compulsive acquiring. For more information, the public can call 774-330-3001. Barnstable County has a food assistance information page on their website, capecod.gov with several helpful resources on locating food pantries, information on SNAP/HIP, transportation, and educational materials available in English, Spanish, and Portuguese. Cape Cod Community Food Pantry: Tuesdays & Thursdays 5:30-6:30 p.m. 2nd Friday of the month 3:00-4:00 p.m. 3rd Saturday of the month 10:00-11:00 a.m. 4th Friday of the month 10:00-11:00 a.m. Senior Hours: 2nd & 4th Wednesdays 10:00-12:00 p.m. 3 Eric shared that the Family Table Collaborative provides heathy prepared meals to the community, offers cooking classes and other resources to assist families struggling with food insecurity. The Family Table Collaborative can be contacted at 508-348-9777. Barry shared a message from Roby Whitehouse, Assistant Public Works Director stating that the Town of Yarmouth has two (2) licensed pesticide applicators and ensured only licensed applicators can apply on town property. The Board discussed the new Town of Bourne health regulation banning the sale of Kratom. Hillard described Kratom in low doses as a stimulant and when used in high doses can act similar to an opioid with the addictive nature. Barry wanted to bring this to the Board’s attention as the Health Department received a call from a concerned parent that her son was struggling with addiction to Kratom products. The Board expressed concern for public health and would like to discuss further options at the next meeting. Hillard shared a recent announcement that was made by the Health and Human Services Secretary claiming a connection between circumcision and autism. Hillard stated the medical community is not aware of any scientific research to support this connection and encouraged parents and future parents who may have concerns for their children to speak with their medical providers. Hillard also advised any parents who have concerns regarding a previous announcement from the government regarding a link between Tylenol usage during pregnancy and autism to also speak with their medical providers. Next Meeting: December 1, 2025 9. Adjournment 6:15 P.M. Motion: Laurance Venezia Second: Eric Weston All in favor 1 BOARD OF HEALTH MEETING MINUTES 1146 Route 28, South Yarmouth December 18, 2023 Board Members Present: Hillard Boskey, M.D., Charles T. Holway, Mary Craig, Laurance Venezia DVM, Eric Weston Others Present: Jay Gardiner, Health Director 1. Call to Order The meeting was called to order at 5:00 p.m. 2. Declaration of a Quorum Quorum Present 3. Public Comment None 4. 3-Month Update – Migrant Family Relocation Hillard noted that there is a fact sheet on the web-site available to the public with information relative to this topic. Dr. Mark Smith, Superintendent of DY Reginal School District 28 students into the system. Living Harborside suites, fully integrated into the system. Created an additional bus stop on route 28. Since all are living in one location – it was not as big of an issue as logistically. Set up to support language need. . Next Meeting: 5. Adjournment 6:15 P.M. Motion: Laurance Venezia Second: Eric Weston All in favor T O W N O F Y A R M O U T H 1146 ROUTE 28, SOUTH YARMOUTH, MASSACHUSETTS 02664-24451 Telephone (508) 398-2231, ext. 1241 Fax (508) 760-3472 Board of Health - Health Division Town of Yarmouth Health Department Blood Drive – January In recognition of National Blood Donor Month, the Yarmouth Health Department invites community members to help save lives by donating blood! January is a critical month for blood donations. Holiday schedules, winter weather, and the cold and flu season often lead to a drop in donations—creating a higher risk for blood shortages. Your contribution this month can make a meaningful difference for patients in need. Community Blood Drive Details Date: Friday, January 23, 2026 Time: 10:30 a.m. – 3:00 p.m. Location: Lorusso Lodge at Flax Pond 31 Dupont Avenue, South Yarmouth Hosted in partnership with the American Red Cross Donation Options Whole Blood Donation The most common and flexible type of donation. About one pint of blood is collected, and the process generally takes about one hour. Power Red Donation This procedure collects a concentrated dose of red blood cells while returning most plasma and platelets to the donor. Specific eligibility requirements apply; donors must have Type A Negative, B Negative, or O blood. How to Schedule an Appointment Visit the American Red Cross website: https://www.redcrossbloyod.org/give.html/drive-results?zipSponsor=YARMOUTHREC Or go to “Find a Drive” and enter the sponsor code YARMOUTHREC Walk-ins are welcome, but we encourage appointments to help minimize wait times. Juice, water, and small snacks will be provided for all donors.