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Hemp Cannabinoid Regulation After the 2018 Farm Bill

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Hemp Cannabinoid Regulation After the 2018 Farm Bill Hemp Cannabinoid Regulation After The 2018 Farm Bill August 26, 2021 Agenda > Overview of the 2018 Farm Bill > Current Regulatory Enforcement by the FDA and FTC > Hot Topics in State Compliance > Registration > Labeling Cover option 2 > Specific Prohibitions Subtitle or Company Name > New York Month Day, Year > Delta-8 THC Please ask questions throughout the program using the Q&A feature. Proposal or event name (optional) © 20152021 Foley Hoag LLP. All Rights Reserved. 2 2018 Farm Bill . Agriculture Improvement Act of 2018 (the “Farm Bill”). • Legalized hemp and hemp derived products. • Created regulatory framework at both federal and state level. • Carved out hemp from definition of “marihuana” under the Controlled Substances Act. Primary Regulatory Authority. • Split between and among: oUnited States Department of Agriculture (“USDA”). oState Departments of Agriculture. oIndian tribes. Preserved Ancillary Federal Oversight. • Expressly recognized continued oversight of: oFood and Drug Administration (“FDA”); oDepartment of Health and Human Services (“HHS”). © 20152021 Foley Hoag LLP. All Rights Reserved. 3 2018 Farm Bill . Removal from CSA and Purview of Regulatory Oversight. • Regulatory framework all boils down to the carveout for, and definition of, hemp. • Hemp defined under the Farm Bill as: othe plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis. • What is a hemp derivative? • What is a hemp extract? • What is a hemp cannabinoid? • What is a hemp isomer? • What is a hemp acid? • What is a hemp salt? • What is a salt of isomers? . Hemp derivatives seemingly broadly defined – but – continued jurisdiction of other federal agencies. © 20152021 Foley Hoag LLP. All Rights Reserved. 4 2018 Farm Bill . USDA – Primary Regulatory Authority • USDA has created, and states may adopt, default hemp production plans. • USDA may approve State proposed hemp regulatory plans. • State’s plan to license and regulate hemp can only commence once the Secertary of USDA approves. Preemption • Farm Bill makes clear that federal law does not preempt state law adopted and approved by the USDA governing hemp. • “Nothing in this section preempts or limits any law of a State or Indian tribe that . Regulates the production of hemp; and . Is more stringent than this subtitle.” © 20152021 Foley Hoag LLP. All Rights Reserved. 5 2018 Farm Bill . State Regulatory Authorities • As of early summer, USDA approved 23 state hemp plans. • 3 remained under USDA review. • 20 continued to operate under legacy hemp programs previously approved under the 2014 Farm Bill (which will sunset at the end of 2021). • 3 States had adopted USDA hemp producer rules. • ALL 50 STATES HAVE APPROVED SOME STATE LEVEL HEMP LAW . Flavors of State Regulation • Certain states require hemp cannabinoid product registration as a condition precedent to sales. • Fewer states even still require licensure to both distribute hemp cannabinoid products (B2B) and retail products (B2C), even if seller never steps foot inside the individual state. • Majority of states have minimal regulation on sales and products, but larger states are beginning to take notice, and air on the side of regulating. Distinguishing Between and Among State Authorities • States vs. Regulation vs. Subregulatory Guidance © 20152021 Foley Hoag LLP. All Rights Reserved. 6 2018 Farm Bill . Examples of State Regulation • Alaska: oOperating under legacy 2014 Farm Bill approvals. oRegulates cultivation through retail sales. oRequires product endorsement as condition precedents for sale. oLabeling rules and requirements. • California: o2018 Farm Bill program still under USDA review. oCalifornia Department of Health guidance indicating that CBD is not permitted as a food additive. oCalifornia Department of Food and Agriculture directs businesses to contact local public health officials for clarity on permissibility of introduction of hemp CBD into food. oBill pending that would expressly legalize CBD as an additive. • Florida: oRobust manufacturing and retail rules for in-state actors, but not out-of-state actors. © 20152021 Foley Hoag LLP. All Rights Reserved. 7 2018 Farm Bill . Examples of State Regulation (continued) • New Jersey: oFirst 2018 Farm Bill approved program. oBroadly defines “hemp product” to include food products intended for human consumption. oNo regulatory oversight for either post-extracted hemp-cil or retail sales. • New York: oContinues under legacy 2014 Farm Bill program. oRobust regulatory oversight under the New York Department of Health, and soon the Cannabis Control Board. oLicensing for both in-state and out-of-state actors. © 20152021 Foley Hoag LLP. All Rights Reserved. 8 Agenda > Overview of the 2018 Farm Bill > Current Regulatory Enforcement by the FDA and FTC > Hot Topics in State Compliance > Registration > Labeling Cover option 2 > Specific Prohibitions Subtitle or Company Name > New York Month Day, Year > Delta-8 THC Please ask questions throughout the program using the Q&A feature. Proposal or event name (optional) © 20152021 Foley Hoag LLP. All Rights Reserved. 9 FDA Regulation and Enforcement . Congress preserved the FDA’s authority to . Examples of claims regulate products containing cannabis or - “Increasing evidence suggests that CBD oil is a cannabis-derived products under the Federal powerful option for pain . anxiety . and autism Food, Drug, and Cosmetic Act (FDCA). It seems like an attractive and safe option for . The FDCA prohibits the introduction or delivery for children.” introduction into interstate commerce any - “CBD oil may have neuroprotective properties and adulterated or misbranded food, drug, medical may protect against neurological conditions, such device, dietary supplement, cosmetic, or tobacco as Parkinson’s and Alzheimer’s disease.” product. - “[P]ossible uses for CBD include helping with skin problems such as acne, autism, ADHD, and even New drugs may not be introduced or delivered for . cancer.” introduction into interstate commerce without an approved new drug application or approved over- - “Relieves headaches” the-counter (OTC) monograph. - “Relieves sinus pressure” - Depends largely on its intended use - “Reduces the risk of osteoporosis and osteoarthritis.” FDA has issued several warning letters to . - “May Help Improve Cholesterol and Decrease the manufacturers and retailers to cease making Risk of Cardiovascular Diseases” statements that CBD products can be helpful in treatment or curing diseases. © 20152021 Foley Hoag LLP. All Rights Reserved. 10 FDA Enforcement . Types of violations • Unapproved new drug oIntended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body • Misbranded drug oLabeling fails to bear adequate directions for use • Dietary supplement oExcluded from the definition of dietary supplement - CBD and THC are active ingredients in FDA approved drugs and/or were the subject of substantial clinical investigations before being marketed as foods or dietary supplements oNew dietary ingredient application rejected • Adulterated food oCBD and THC are unapproved food additives oGenerally Recognized as Safe (GRAS): hulled hemp seeds, hemp seed protein, & hemp seed oil © 20152021 Foley Hoag LLP. All Rights Reserved. 11 FDA Regulation - Epidiolex EPIDIOLEX is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in patients 1 year of age and older © 20152021 Foley Hoag LLP. All Rights Reserved. 12 FDA Regulation and Enforcement . FDA issued a draft guidance “Encouraging Cannabis-Related Clinical Research” – to support the development of drugs that contain cannabis or cannabis-derived compounds. Working to evaluate “potential lawful pathways” for the marketing of CBD. FDA will take action in consult with federal and state partners “where necessary to protect the public health” • Protect against unsubstantiated medical claims • Concern about products marketed for infants and children, pregnant, breastfeeding • Concern about products with contaminants such as heavy metals, THC, or other potentially harmful substances . FDA warns consumers about potential harm and side-effects, including liver injury, contraindications with other medicines, use of CBD with alcohol, toxicity, and long-term use. FDA is evaluating the issuance of a “risk-based enforcement policy”. • CBD Enforcement Policy Draft Guidance was under review by Office of Management and Budget but was withdrawn in January 2021. Has not since appeared on the regulatory agenda. © 20152021 Foley Hoag LLP. All Rights Reserved. 13 FTC Regulations and Guidance . Broad mandate to protect against unfair and deceptive practices as well as the making of false advertisements . Standard for health claims is competent and reliable scientific evidence, including well-controlled human clinical studies, substantiating that the claims are true at the time they are made . Enforces against claims about products already on the market . FTC enforcement against unfair and deceptive acts - False and misleading advertisements and mislabeling - includes blog and social media posts - Unsubstantiated medical claims - Operation CBDeceit - Consent Orders . Joint FDA/FTC actions . Good way to attract attention? Market as
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