ALL THINGS CONSIDEREDWHERE DO WE GO FROM

HERE?VAPING, MENTHOL,

OPPOSITION TACTICS, PUP LAWS AND CBD

CHERYL SBARRA, J.D., DIRECTOR OF LAW AND POLICY, MAHB

DJ WILSON, J.D., PUBLIC HEALTH LIAISON, MMA

MHOA CONFERENCE NOVEMBER 2019

DISCLAIMER

• This information is provided for legal

education purposes only. It is not

intended to constitute legal advice.

WHY?

• Met with addiction specialists,

pulmonologists and pediatricians who

warned the situation will only get

worse because the cause is unknown.

• “This is not something you should

screw around with.” (https://www.bostonglobe.com/metro/2019/09/24)

• US public health regulators agree and

are diligently investigating.

• CDC admits this should have happened

earlier.

CURRENT NATIONAL STATUS

10.22.19

• More than 1604 illnesses across 49 states

• 34 deaths in 18 states.

• 86% THC (but not exclusively THC)• 34% exclusively THC

• 64% Nicotine (but not exclusively Nicotine)• 11% exclusively Nicotine

• One common link – use of electronic cigarettes and other vaping products.

• CDC website has updated information.

CURRENT STATUS IN MASSACHUSETTS 10.30.19

• 200 reported cases.

• 61 confirmed and probable cases.• Two deaths – Northampton, 60-year old female, just nicotine

and 40-year old female, just nicotine.

• 82% required hospitalization.

• Of the confirmed and probable cases:• 30% nicotine only.

• 39% THC only.

• 25% both nicotine and THC.

• Other causes negligible.

SEVERE LUNG DISEASE ASSOCIATED WITH VAPING PRODUCTS 105 CMR 801.000

• Emergency Health Regulation adopted

by Public Health Council 10.25.19.

• Judge did not uphold Emergency

Order.

• Must hold public hearing by 12.24.19.

• Small business impact statement filed

with Secy. of State.

• $7 to $8 million lost business

cost.

• Effective for 3 months.

• Same enforcement mechanism.

ENFORCEMENT

• Nicotine vaping products found in convenience stores, gas stations, adult-only retail tobacco stores

• Boards of Health

• Police

• CBD vaping products• Massachusetts Department of Agricultural Resources (MDAR)

• Cannabis vaping products• Cannabis Control Commission

• Looking at regulations

VAPING BASICS

• Current use of cigarettes among high school students has decreased by 82% since 1995 (35.7% to 6.4%). (Youth Tobacco Use in Massachusetts, Department of Public Health, March 2019)

• In contrast, current use of e-cigarettes among students is 20.1%. (MA YRBS 2017)

• Increased 78% for high schoolers and 48% for middle schoolers.

• Juul’s unique design, high nicotine content and affordable price make it a student favorite (coupons, specials, etc.)

• Lots of negative publicity -- gets attention of U.S. Food and Drug Administration.

• Not regulated at the federal level.

“SMOKING IS GROSS,” A HIGH SCHOOLER SAID. “JUULING IS REALLY WHAT’S UP.” THE NEW YORKER, “THE PROMISE OF VAPING AND THE

RISE OF JUUL” 5.14.18

• 2018 report from National Academies of Science, Engineering and Medicine found substantial evidence that e-cigarette use increases the risk of ever using combustible cigarettes among youth and adults.”

• Youth 12 – 15: e-cig use associated with more than 4 times the odds of trying combustible products and 3 times the odds of current cigarette use.

• E-Cigarette Use and Youth – entryway to nicotine addiction, even for non-smoking youth.

• Most commonly used nicotine product among youth since 2014.

• From 2017 to 2018 e-cig use increased by 78% for high schoolers and 48% for middle schoolers. (https://www.fda.gov/tobaccoproducts/publichealtheducation/protectingkidsfromtobaccooo/ucm625887.htm

• 3.6 million high school and middle school students use e-cigs.

• Many of these kids have never used a tobacco product.

E-CIG USE AMONG YOUTH

• Juul is valued at $ 38 billion summer of 2018.

• Juul owns about 75% of the market.

• Philip Morris bought 35% of Juul for $12.8 billion.

• Thumbnail-size pod contains the same amount of nicotine in a pack of cigarettes.

• “I took a hit, and another. Each one was a white spike of nothing: a pop, a flavored coolness, as if the idea of a cucumber had just vanished inside my mouth. . . To Juul . . . is to inhale nicotine free from the seductively disgusting accoutrements of a cigarette: the tar, the carbon monoxide, the garbage mouth, the smell.” (New Yorker article)

HEALTH CONCERNS (WWW.MASS.GOV/INFO-DETAILS-/LEARN-ABOUT-YOUTH-USE-OF-E-CIGARETTES-AND-OTHER-

VAPING-DEVICES)

• Heat oils or liquids into vapor to be inhaled/aerosolized

• NOT WATER VAPOR.

• Nicotine – Juul contains 5% nicotine salts –extremely high level (not permitted in UK).

• Causes dependence and addiction.

• Damages developing adolescent brain.

• Can prime developing adolescent brain for addiction to other substances.

• FDA/CDC investigating 13 deaths and more than 805 illnesses. (In APRIL 2019)

• Known potential side effect of nicotine toxicity (mostly youth and young adults).

INCIDENCE OF DISEASE PROBABLY UNDERESTIMATED

• Especially among

youth.

• Boston Children’s

Hospital – confident

that reports are

underestimated. “We

weren’t asking the right

questions.”

HEALTH CONCERNS

• Ultrafine particles that can be inhaled deep into the lungs.

• Flavoring, like diacetyl, a chemical linked to serious lung disease.

• Bacterial and fungal contaminants found. (www.hsps.harvard.edu/news/press-releases/microbial-contaminants-found-in-popular-e-cigarettes/)

• Substantial evidence that e-cigarette use results in symptoms of dependency. (NASEM 2018 report).

• Conclusive evidence that exposure to nicotine from e-cigarettes is highly variable. (NASEM 2018 report).

• Not regulated.

• Long-term health effects are unclear.

CURRENT TOBACCO SALES TEMPLATE HIGHLIGHTS

• New statement of purpose sections to include

menthol.

• New definition of “tobacco products”.

• New definition of “adult-only retail tobacco store”

• New option to cap number of “adult-only retail

tobacco stores”.

STATEMENT OF PURPOSE

• Whereas the U.S. Food and Drug Administration and

the Tobacco Products Scientific Advisory Committee

concluded that menthol flavored tobacco products

increased nicotine dependence and decreased success

in smoking cessation;

• Whereas menthol makes it easier for youth to initiate

tobacco use;

• Citations included.

“TOBACCO PRODUCT” DEFINITION

• Any products containing, made, or derived from tobacco or nicotine that is intended for human consumption, whether smoked, chewed, absorbed, dissolved, inhaled, snorted, sniffed, or ingested by any other means, including, but not limited to: cigarettes, cigars, little cigars . . . electronic cigarettes . . . liquid nicotine, “e-liquids” or other similar products, regardless of nicotine content, that rely on vaporization or aerosolization.” (Does not include FDA approved cessation devices).

DEFINITION OF ADULT-

ONLY RETAIL TOBACCO

STORE(“SPECIALTY

STORE”)

• An establishment that does not share space with another business, that has a separate public entrance, that does not sell food or alcohol, that does not have a restaurant license or lottery license, whose only purpose is to sell or offer for retail sale tobacco products and/or tobacco paraphernalia, in which the entry of persons under the age of 21 is prohibited at all times, and which maintains a valid permit for the retail sale of tobacco products from the Board of Health and applicable state licenses. Entrance to the establishment must be secure so that access . . . is restricted to employees and to those 21 years old or older.

CAPPING OF PERMIT OPTIONS

• Basic cap: “At any given time, there shall be no more than _____ Tobacco Product sales Permits issued in ___________.

• When a municipality has the maximum number of permits, a waiting list should be started – “first come, first served”.

• Advanced cap: “As of the effective date of this regulation, any permit not renewed wither because a retailer no longer sells tobacco products, or because a retailer closes the retail business, shall be returned to the BOH and permanently retired and the total allowable number of permits shall be reduced by the number of retired permits.

• The only way a new retailer can obtain a permit would be to buy an existing business.

• Dual cap: “There shall be no more than ______ Tobacco Product Sales Permits issued to Adult-Only Retail Tobacco Stores.”

MAIN PURPOSE OF NEW TOBACCO SALES REGULATION

• Restrict the sale of ALL flavored tobacco products to

adult-only retail tobacco stores.

• OR

• Restrict the sale of ALL TOBACCO PRODUCTS to adult-

only retail tobacco stores.

WHY RESTRICT THE SALE OF FLAVORED TOBACCO PRODUCTS?

• Same rationale the FDA used in 2009 when they banned flavored cigarettes.

• 59% of high school smokers in Massachusetts have tried flavored tobacco products and 96.1% of youth who smoked cigars reported smoking cigars that were flavored. (MA Dept. of Public

Health 2015 Massachusetts Youth Health Survey; Delneve CD et al., Tob Control, March 2014: Preference for flavored cigar brands among youth, young adults and adults in the USA.)

• FDA and U.S. Surgeon General both stated that flavored tobacco products are considered to be “starter” products that help establish smoking habits that can lead to long-term addiction. (FDA 2011. Fact Sheet: Flavored Tobacco Products, Preventing Tobacco Use Among Youth and Young Adults: A report of the Surgeon General.)

AGGRESSIVE MARKETING OF FLAVORED TOBACCO PRODUCTS IN RETAIL

ENVIRONMENT

• The tobacco industry spends more than 96% ($9 billion) of its total marketing budget in convenience stores, gas stations and other non-age restricted retail outlets. (Federal Trade Commission (FTC), Cigarette Report for 2017, 2019 ).

• 2/3 of teenagers visit a convenience store or other neighborhood retailer at least once a week. (Hendrickson, L. et al., Association of retail tobacco marketing with adolescent smoking, (American Journal of Public Health 94 (12)2081-3, 2004).

• Exposure to tobacco marketing in stores and price discounting increase youth smoking. (HHS, Preventing Tobacco Use Among Youth and Young Adults, A report of the Surgeon General, 2012).

• Smart, intentional marketing to youth demonstrated by the following body of evidence.

BODY OF EVIDENCE REVIEWED BY THE SURGEON GENERAL

Cross-sectional studies on exposure to advertising and use of tobacco;

Longitudinal studies with non-susceptible, never-users of tobacco and subsequent initiation;

Examination of industry marketing efforts and use of specific brands;

Evidence from tobacco industry documents on their marketing practices. (U.S. Surgeon General’s Report, 2012).

RESULTS

• “Flavored tobacco availability decreased significantly in Lowell . . . by 70 percentage points . . .,whereas no significant changes in flavored tobacco availability were seen in Malden. In addition, current use of both flavored and non-flavored tobacco decreased in Lowell, but increased in Malden from baseline to follow-up . . .”

• “Conclusions: Policies that restrict the sale of flavored tobacco have the potential to curb youth tobacco use in as few as 6 months.” (emphasis added).

RE-DEFINE “CHARACTERIZING FLAVOR” TO INCLUDE MENTHOL

• “A distinguishable taste or aroma, other than the

taste or aroma of tobacco . . . Including, but not

limited to tastes or aromas relating to any fruit,

chocolate, vanilla, honey, candy . . . menthol, mint

and wintergreen. . .”

• “menthol, mint and wintergreen” language in FDA exemption.

• Includes ALL mint flavors.

• Endorsed by the NAACP and the Urban League.

WHY?• Same reason FDA banned flavored cigarettes in 2009.

• Mint is a flavor – the only flavor left on the market.• Should have been banned in 2009.• Only reason FDA didn’t include it was because of

lobbying efforts and ultimate “compromise”.• Even though FDA’s Tobacco Products Scientific

Advisory Committee (TPSAC) concluded that “Removal of menthol cigarettes from the marketplace would benefit public health . . .”

• Industry has effectively been able to sell a flavored product (mint) for 10 years, even though the same arguments apply to apple that apply to mint.

• In fact, more compelling arguments apply to mint, than to apple.

MORE COMPELLING ARGUMENTS• It’s not just a flavor.

• Anesthetic quality which numbs user’s throat, making it

easier to inhale harsh tobacco.

• “Healthier alternative” 1940’s ads for Julep

• “Even if you’re a chain smoker, your mouth feels clean, refreshed at end of day.” (script)

• Kool (1933 – 1960) “Willie”

• Smoking cartoon penguin (

www.bestoldcommercials.com/kool-cigarettes-willie-

penguin/ )

• “Snow Fresh” think skiing, skating, snow.

AND HERE HE IS.

MORE COMPELLING ARGUMENTS ( WWW.TOBACCOFREEKIDS.ORG/ASSETS/FACTSHEETS/0390.PDF)

CITATIONS IN PDF FACT SHEET

• Menthol makes it easier for youth to initiate tobacco use.

• History of using flavors to reduce harshness.

• Menthol is the only flavor left on the market.

• After FDA’s 2009 ban on other flavors, use of menthol cigarettes increased significantly.

• Youth smokers more likely to use menthol cigarettes than any other age group.

• 54% of youth smokers (12-17) use menthol vs. less than 33% of adult smokers.

• Prevalence even higher among African American youth (7 out of 10).

• 1 in 5 smokers ages 12 – 17 prefer Newport.

• 52% of new young adult smokers initiated with menthol (18 – 34)

• 93% of African American smokers vs. 44 % of white smokers.

MENTHOL CIGARETTES AND THE PUBLIC HEALTH STANDARD: A SYSTEMATIC REVIEW

• “Eighty-two studies on menthol cigarette initiation (n=46), dependence(n=14), and cessation (n=34) were included. Large, representative studies show an association between menthol and youth smoking that is consistent in magnitude and direction. One longitudinal and eight cross-sectional studies demonstrate that menthol smokers report increased nicotine dependence compared to non-menthol smokers. Ten studies support the temporal relationship between menthol and reduced smoking cessation, as they measure cessation success at follow-up.”

• “The strength and consistency of the associations in these studies support that the removal of menthol from cigarettes is likely to reduce youth initiation, improve smoking cessation outcomes in adult smokers, and in turn, benefit public health.” Villanti et al. BMC Public Health (2017) 17:983

AND THEN WE HAVE JUULS (AND OTHER E-CIGARETTES)

VAPING BASICSREFRESHER

• Current use of cigarettes among high school students has decreased by 82% since 1995 (35.7% to 6.4%). (Youth Tobacco Use in Massachusetts, Department of Public Health, March 2019)

• In contrast, current use of e-cigarettes among students is 20.1%. (MA YRBS 2017)

• Increased 78% for high schoolers and 48% for middle schoolers.

• Juul’s unique design, high nicotine content and affordable price make it a student favorite (coupons, specials, etc.)

• Lots of negative publicity -- gets attention of U.S. Food and Drug Administration.

• Not regulated at the federal level.

YOUTH ADDICTION CONCERNS

• E-cigarette use has increased 900% among high school students in the U.S. (E-Cigarette Use Among Youth and Adults: A Report of the Surgeon General, 2016).

• 3.6 million high school and middle school kids use e-cigarettes.

• Nicotine is highly addictive, notably high nicotine concentration in popular products, like Juul

• E-cigarette among youth is unsafe.

• Kids are getting “nic sick”.

• E-cigarette use increases the risk of ever using combustible cigarettes.

• Youth 12 – 17: e-cig use associated with more than 4X the odds of trying combustible products.

OPPOSITION ARGUMENTS

“WE ARE THROWING ADULT SMOKERS UNDER THE BUSBY RESTRICTING E-CIGS TO ADULT-ONLY STORES.”

• Quote from Michael B. Seigel, MD,

Professor, Community Health Sciences,

Boston University School of Public Health

in letters to Lynn, etc.

• NO, WE AREN’T.

• Adults can still get e-cigarettes.

ADULTS CAN STILL GET E-CIGS

• Nearly 75% of (US) daily vapers get their products online or from a vape shop (adult-only).

• 70% of (US) adult flavor users get their products online or from a vape shop.

• Where do Vapers Buy Their Vaping Supplies? Findings from the International Tobacco Control (ITC) 4 Country Smoking and Vaping Survey, Int. J. Environ. Res. Public Health. 2019 Feb; 16(3) 338.

• The FDA “ . . . won’t tolerate a whole generation of young people becoming addicted to nicotine as a trade-off for enabling adults to have unfettered access to these same products.” (Gottlieb).

• They can still get them, just not with “unfettered access” in convenience stores.

YOUTH ADDICTION CONCERNS

• The FDA “ . . . Won’t tolerate a whole generation of young people becoming addicted to nicotine as a trade-off for enabling adults to have unfettered access to these same products.” (Gottlieb).

• Jason Jeong, Junior at Cornell University in a column entitled “Juul Season is Over.”

• “No analysis or criticism of our collective fervor for the Juul will ever be as compelling as the fact that we have all become addicted to nicotine.”

• “It is time to address the Juul as what it is: the public health crisis of our generation.”

• “Wooo!! Juul!! I hit it from the moment I wake up to the moment I can’t go to sleep and keep Juuling.”

YOUTH AREN’T GETTING THE PRODUCTS IN STORES

• Yes, they are.• See truth initiative survey results from 1000 12-17-year-olds.

• 74% said they got them in brick and mortar stores.

• Internet retailers that aren’t checking drivers’ licenses and public records for

exact matches are being shut down.

• Parents’ testimony.

• “E-cigarettes are marketed by promoting flavors and using

a wide variety of media channels and approaches that have

been used in the past for marketing conventional tobacco

products to youth and young adults.” (E-cigarette use among

youth and Young Adults”)

TICKET THE KID

• Not according to police.

• Ticketing in ineffective, especially since enactment of Criminal Justice Reform Act

• Purpose to support youngest and most vulnerable.

• Expunges criminal records.

• Decriminalizes first offense.

• Immunity from prosecution now for minor in possession of alcohol.

• Virtually impossible to enforce.

• Can target individuals.

• AND – MA has been able to reduce youth cigarette use significantly during the past 20+ without PUP laws.

WAIT FOR THE FDA TO COMPLETE THE RESEARCH

THEY HAVE MORE RESOURCES• Why don’t we wait for the FDA to determine that e-cigarettes

are safe?

• If we wait for the FDA, my 1-year-old grandbaby will be 11 years old.

• Graphic warnings – still waiting . . .

• And what happens during those 10 years? OH, AND THERE’S THIS . . .

LANDMARK 2006 FEDERAL DISTRICT COURT JUDGMENT

DO YOU BELIEVE THAT

NICOTINE IS NOT

ADDICTIVE?

COURT FINDING

• U.S. tobacco companies violated civil racketeering laws (RICO) and engaged in a decades-long conspiracy to deceive the United States people about the health effects of smoking and their marketing to youth.

• Judge Kessler ordered the tobacco companies to publish statements telling the American public the truth about the deadly consequences of smoking and secondhand smoke.

• Tobacco companies fought for more than 11 years to delay doing this. (tobaccofreekids.org).

• Finally published in 2017 – in places youth don’t read. (the Boston Globe, etc.)

“85% OF ADULT VAPERS IN LYNN [OR ANOTHER CITY/TOWN] PREFER FLAVORED E-CIGARETTES”

• Quote in letters to municipalities considering restricting all flavored tobacco products to adult-only retail stores.

• Inaccuracies:

• NATIONAL data, not Lynn specific- attribution incorrect.

• WHO CARES?

• Most people who vape prefer flavors

• 3% of adult population

• More than 20% of youth

• Youth are more than 6 times more likely to be current e-cig users than adults. (MA YRBS 2017).

“. . . [N]ATIONAL ESTIMATES SUGGEST THAT THERE ARE AT LEAST 2.5 MILLION ADULT VAPERS WHO RELY UPON E-CIGARETTES TO KEEP

THEMSELVES OFF HIGHLY ADDICTIVE AND DEADLY

TOBACCO-BURNING CIGARETTES.”

PROBLEMS WITH THIS STATEMENT

• Questionable accuracy

• Not calculated by CDC or FDA or any government agency.

• No “national” estimates.

• Data from a blogger who took results from the 2014 National Health Interview Survey (NHIS) to do a crude calculation of number of former smokers who vape.

• Blogger himself says he doesn’t know if these 2.5 million former smokers are actually vaping as a means of quitting.

LET’S ASSUME THE BLOGGER GOT IT RIGHT

• Who cares?

• Youth are more than 6 times more likely to be current e-cig users than adults. (MA YRBS 2017).

• 3.6 million young people are now vaping.

• The number is growing exponentially.• That is a 71% increase in youth use.

• Houston, we have a problem.

• This is an epidemic.

• Preserving “unfettered access” to e-cigarettes for both adults and kids is threatening to undo a quarter century worth of tobacco control efforts, permit the industry to addict another generation of tobacco users.

“THE MAJORITY OF YOUTH SMOKERS PREFER NON-MENTHOL CIGARETTES.”

• Actual quote from the report: “Analysis of 2012-2016 National Youth Tobacco Survey data found that Marlboro, Newport and Camel were the most commonly reported usual brands smoked by middle and high school current (past 30 day) cigarette smokers.”

• “As was the case with middle school students, Newport was the most prevalent brand among black high school students (47.5% in 2016), and Marlboro was the most prevalent brand among white students (59.5% in 2016).”

• Do we only care about white middle and high school students?

• I don’t think so . . .

LAKE QUANNAPOWITT, WAKEFIELD EARTH DAY CLEAN-UP

AND NOW SHE IS A JUUL EMPLOYEE IN GOVERNMENT RELATIONS . . . MAYBE SHE WAS PART OF JUUL’S RECENT DOWNSIZING.

“LITIGATION IS US”TOBACCO INDUSTRY STRATEGY

• Current regulatory status in Massachusetts

• 165 cities and town restrict flavored tobacco, except menthol, mint and wintergreen to adult-only retail tobacco stores.

• 17 remove the menthol, mint and wintergreen exemption and restrict ALL flavored tobacco products to AORTS.

• Somerville, Ashland, Needham, Barnstable, Charlton, Sharon, Norwood, Brookline, Swampscott, Walpole, Harvard, Chatham, Harwich, Stoughton, Framingham, Norfolk, North Andover.

• At least 2 towns are considering restricting ALL TOBACCO PRODUCTS to AORTS.

FLETCHER TILTON LAWSUITS

• Offices in various parts of the state, including Worcester, Boston and Centerville.

• Claim to represent the Coalition of Responsible Retailers.

• Prior to a hearing, they send a letter describing their lawsuits.

• Organize local retailers before a public hearing.

• If regulation passes and includes restricting menthol, they recruit a few independent retailers to be “plaintiffs” in a lawsuit against the city or town.

• Sued Somerville, Framingham, Swampscott, Walpole, Norwood (5 municipalities).

• Haven’t sued Brookline or Needham.

PRINCE LOBEL TYE LLC

• Large Boston law firm, represents lots of businesses.

• Represents Cumberland Farms and the New England Convenience Stores and Energy Marketers Association (NECSEMA, Jon Schaer, Executive Director).

• Cumberland Farms recently sold to U.K. conglomerate.

• Increasing the number of stores.

• Often sue municipalities that rule against them for zoning denials, etc.

• Defendants: Barnstable, Billerica, Framingham, Sharon, Somerville and Walpole.

• If there are no Cumberland Farms in the municipality they cannot sue.

BASIS FOR LAWSUIT

• The regulations are arbitrary because they leave combustible products (Marlboro) in convenience stores and these are the most dangerous products.

• Regulation not arbitrary where it is rationally related to a legitimate, health-related purpose, i.e., protection of youth from harmful effects of tobacco. (RYO Cigar Association, Inc. & another vs. Boston Public Health Commission, 79 Mass. App. Ct. 822). Specifically permits a BOH to act incrementally and “is not saddled with a choice between comprehensive regulation and no regulation at all.”

• The regulations make it harder for adults to get e-cigarettes.

• Not a reason for adults to have “unfettered access” to e-cigarettes.

BOARDS OF HEALTH ARE BATTING 1000

• Motions for Preliminary Injunctions filed by retailers in all cases.

• Attempt to stop enforcing of the regulations until the case is brought to trial.

• Every Judge who heard arguments denied these Motions.

• The plaintiffs (retailers) have not demonstrated any likelihood of success on the merits.

• Suffolk, Essex, Barnstable, Norfolk and Middlesex Counties.

• Motions to Dismiss filed by municipalities.

• Arguments in November.

CBD AND HEMP PRODUCTS

IS IT POT OR IS IT NOT? BOTH CONTAIN THC

• Marijuana has more than 0.3% THC.

• Hemp has less than 0.3% THC.

• Hemp is exempted from the MA Adult-Use Cannabis Law.

• What about CBD that is not hemp-derived?

• Some marijuana plants can contain less than 0.3% THC.

• MA law is silent.

• MDAR says “legal” definitions create the distinction, not science.

• Need to test THC level to distinguish.

IN THE OLDEN DAYS OF WEED AND HEMP

• “Old Fashioned” Hemp plants

• Grown for fiber and seed oil.

• Industrial hemp – sourced from a low-resin agricultural crop.

• “Old Fashioned” Drug plants

• Include euphoric THC-rich plants and non-euphoric CBD-rich plants.

• High-resin horticultural crop, hand-harvested, dried, trimmed and cured.

• Fewer and fewer differences between the two.

• Really depends on amount of THC.

Hemp or Marijuana?

IN TODAY’S WORLD

CBD CAN BE FOUND IN EACH TYPE OF PLANT.

IN MASSACHUSETTS, IF CBD IS MARIJUANA-DERIVED, IT’S NOT LEGAL EVEN IF THE THC CONTENT IS LESS THAN .3%.

HD 4339 “AN ACT RELATIVE TO HEMP AND HEMP PRODUCTS IN THE COMMONWEALTH”

“IT’S A PICKLE”

“POLICY STATEMENT”SALE OF HEMP-DERIVED PRODUCTS IN THE COMMONWEALTH

MASSACHUSETTS DEPARTMENT OF AGRICULTURAL RESOURCES (MDAR) INTERIM POLICY

• Commercial Industrial Hemp Program – April 30, 2018

• Hemp and Industrial Hemp (Hemp) are not Cannabis.

• Must be a Massachusetts licensed “grower and/or processor”.

• Remains in place until final regulations are promulgated.

• No retail licenses are available in MA currently.

• As of October 15th in an FAQ document, MDAR states that no license is needed for a retailer to sell hemp derived products.

2018 FARM BILL – 12.20.18LEGAL AGRICULTURAL CROP

• Cultivation governed by USDA and MDAR.

• FDA has legal authority to address public health requirements for hemp-derived products.

• FDA prohibits any food or other “consumable” product containing CBD from interstate commerce without its approval.

• Cannot claim “therapeutic benefit” unless approved by FDA.

• Epidiolix is approved.

• Cannot sell food containing CBD (or THC).

• Hemp seed oil, hulled hemp seeds and hemp seed protein are generally recognized as safe (GRAS).

STATE LAW – GENERAL LAWS CHAPTER 128, §§ 116 – 123

(AGRICULTURE)

• MDAR must regulate ALL hemp and industrial hemp activities.

• Must administer a licensing and registration program:

• Cultivation, processing, and sale.

• Oversight responsibility for approving the sale.

• DPH is responsible for food safety.

• Issued policy guidance

• Prohibits the manufacture or sale of any food or other consumable products containing CBD.

• Local boards of health have the authority to enforce public health laws.

• Cannabis-infused products are not food, but CBD-infused products are pursuant to state regulation (at least so far).

“MDAR CONSTRUES THE TERM ‘SELL’ OR ‘SALE’ TO INCLUDE THE FOLLOWING TRANSACTIONS.”

• Massachusetts licensed grower to Massachusetts licensed grower.

• Massachusetts licensed grower to Massachusetts licensed processer.

• Massachusetts licensed processor to Massachusetts retail facility (store).

• Any person or entity that engages in the activities listed above are deemed to be licensed provided:

• They are selling “approved” hemp-derived products AND

• They are licensed as a “grower” or “processor”.

• WHAT ABOUT A RETAILER?

CHALLENGES FOR GROWERS

• Licensed by MDAR

• Ask MDAR to come test seeds• Time sensitive – if in ground too long, % THC increases

• MDAR comes to test 3 weeks later

• THC % now too high

• MDAR orders farmer to stop harvesting until they test.• This increases % of THC

• This compromises the crop.

• Heated, emotional testimony in hearings on Rep. Cusack’s bill.

APPROVED HEMP-DERIVED PRODUCTS

• Hemp seed, hemp seed oil, hulled hemp

• Hemp seed powder

• Hemp protein

• Clothing

• Building material

• Items made from hemp fiber

• Flower/plant from a Mass. licensed grower to a Mass. licensed grower or processor, but can’t be sold by retailer.

HEMP PRODUCTS NOT APPROVED FOR SALE

• Food product containing CBD;

• Any product containing hemp-derived CBD that makes therapeutic/medicinal claims;

• Any product that contains hemp as a dietary supplement;

• Animal feed that contains any hemp products;

• Unprocessed or raw plant material, including the flower that is meant for end use by a consumer.

SO WHAT ARE WE (LOCALS) SUPPOSED TO DO ABOUT CBD?• CBD Sales Permit

• Age-restrict product

• Prohibit vending machines

• Prohibit self-service displays

• Enforce against edible CBD products

• Report illegal sales to MDAR

• Report illegal sales of edibles to MDAR and DPH?