10/21/19 1 Hemp: Positioning Yourself as the Truth Expert Hyman Phelps & McNamara, P.C. Karla L. Palmer, Esq. Director 2 1
10/21/19 LEGAL NOTE • Nothing set forth in this slide deck or anything communicated by me constitutes the rendering of legal advice • There are no relevant financial relationships with ACCME- defined commercial interests for anyone who was in control of the content of the activity. 3 Pharmacist & Pharmacy Technician Learning Objectives • Discuss federal and state laws related to hemp-based products and associated risks and opportunities. • Identify potential uses, formulation considerations, and potential side effects of hemp. • Describe strategies for educating prescribers, patients, and the community on hemp. 4 2
10/21/19 Cannabis as a Controlled Substance Under Federal Law • Regulation Depends on THC Content and Plant Material • The CSA defines “marijuana” as: • All parts of the Cannabis sativa L. plant whether growing or not; • Its seeds; • Resin extracted from any part of the plant; and • Every compound, manufacture, salt, derivative, mixture or preparation of the plant, its seeds or resin. • Marijuana is a Schedule I controlled substance. 5 Cannabis as a Controlled Substance Under Federal Law (cont’d) The Controlled Substances Act (CSA) definition of “marijuana” expressly excludes : 1. Hemp (cannabis and derivatives with a THC content < 0.3% by dry weight) 2. The following plant parts and products derived therefrom: Mature stalks of the plant; • Fiber produced from such stalks; • Oil or cake made from the seeds; • Any other compound, manufacture, salt, derivative, mixture • or preparation of the mature stalks (except extracted resin) fiber, oil or cake; and • sterilized seeds incapable of germination. 6 3
10/21/19 Hemp-Related Legislation • Agricultural Act of 2014 • Authorized institutions of higher education and state departments of agriculture to grow or cultivate industrial hemp for research under an agricultural pilot program or for other agricultural or academic research. • “Industrial hemp” was defined as the Cannabis plant and any part of the plant with a THC concentration of not more than 0.3 % on a dry weight basis. • Did not authorize general commercial activity. • Hemp Farming Act of 2018 • Proposed to remove “hemp” from the CSA definition of “marijuana” and exclude THC in “hemp” from control. • Proposed to define “hemp” as the Cannabis plant and any part with a THC concentration of not more than 0.3 % on a dry weight basis. 7 *** Agriculture Improvement Act of 2018 (a/k/a “The Farm Bill”)*** • Adopted the definition of “hemp” proposed in Hemp Farming Act • Authorized interstate commerce in hemp-derived products • Established a framework for regulation of hemp production by USDA pursuant to USDA-administered plans or state plans approved by USDA • Left it up to states to decide whether to allow hemp production and marketing within their borders • Disclaimed any intent to affect or modify the Federal Food, Drug and Cosmetic Act (FD&C Act) 8 4
10/21/19 Then FDA Commissioner Gottlieb’s Statement: • December 2018 • Recognizes “hemp” as defined is no longer controlled under federal law • FDA still has authority to regulate cannabis and cannabis-derived compounds under the FD&C Act. • Aware of growing interest in CBD • Continue to be concerned about drug claims of therapeutic benefit made about unapproved products https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-signing-agriculture- improvement-act-and-agencys 9 Then FDA Commissioner Gottlieb’s Statement: • “Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective. This deceptive marketing of unproven treatments raises significant public health concerns, as it may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.” • “… it’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements.” 10 5
10/21/19 Then FDA Commissioner Gottlieb’s Statement: • Most importantly: “We’ll take enforcement action needed to protect public health against companies illegally selling cannabis and cannabis-derived products that can put consumers at risk and are being marketed in violation of the FDA’s authorities .…” 11 FD&C Act: Prohibited Acts • The FDCA is a strict liability statute that specifies a number of prohibited acts • Examples of prohibited acts: • introduction into interstate commerce of an adulterated food • introduction into interstate commerce of an unapproved, adulterated, misbranded drug • Prohibited acts are potentially punishable by civil and criminal penalties 12 6
10/21/19 FDA Enforcement Actions • CBD companies in question allegedly marketed their products for, among other things, Alzheimer’s disease, fibromyalgia, inflammation, skin conditions, autoimmune disorders, anxiety, cancer pain, PTSD and depression, to name a few symptoms. • Companies are making food, dietary supplements, and cosmetic products, as well as products for pets (CBD for dogs). 13 FDA Enforcement Actions • CBD isolate product not permissible. • Products are misbranded, unapproved new human or animal drugs. • FDA says the products are marketed as dietary supplements, but do not meet the definition of a dietary supplement. • Can’t say CBD fights cancer and has an anti-tumor effect. • Use of a nutrition facts panel on a CBD oil is inappropriate because the oil is a food to which a drug (CBD) has been added (FDCA prohibits the introduction into interstate commerce of any food to which a drug has been added). 14 7
10/21/19 Federal Trade Commission • Also issued warning letters in 2019: • Claims must have “competent and reliable scientific evidence to support such claims.” • Claims that have drawn scrutiny: • CBD “works like magic” against “even the most agonizing pain.” • “Clinically proven” to treat diseases like cancer and multiple sclerosis, • Reference to “thousands of hours of research” the firm has participated in, in conjuncture with Harvard University. 15 Federal Trade Commission (cont’d) • “Miracle pain remedy” for a variety of chronic and acute pain, autism, anorexia, bipolar disorder, post-traumatic stress disorder, schizophrenia, anxiety, depression, Alzheimer’s disease, Lou Gehrig’s Disease (ALS), stroke, Parkinson’s disease, epilepsy, traumatic brain injuries, diabetes, Crohn’s disease, psoriasis, MS, asthma, fibromyalgia, cancer, and AIDS. • Highly effective at treating “the root cause of most major degenerative diseases, including arthritis, heart disease, fibromyalgia, cancer, asthma, and a wide spectrum of autoimmune disorders.” • CBD oil, gummies, tinctures • FTC cautions: Unproven health claims could result in a federal injunction and forced reimbursements to customers who purchased the products. 16 8
10/21/19 FD&C Act: Intended Use • “Intended use” determines regulatory status • An article is potentially a drug or medical device if it is intended to • Affect a structure or function of the body (unless it’s food) • Treat, cure, prevent, mitigate, or diagnose a disease • Structure/function claims are permitted for dietary supplements and food, but not cosmetics • “Disease claims are not permitted for dietary supplements, food, or cosmetics” 17 BUT…. CBD is an “FDA-Approved Drug” • FDA approved Epidiolex, an oral CBD solution derived from cannabis, for treatment of seizures associated with Lennox-Gastaut and Dravet syndromes on June 25, 2018. • On September 28, 2018, DEA rescheduled FDA-approved drugs that contain CBD derived from cannabis with no more than 0.1 % THC in Schedule V. • NOT SO FAST… • DEA closed its Epidiolex Federal Register scheduling notice stating: • “[A]ny material, compound, mixture, or preparation other than Epidiolex that falls within the CSA definition of marijuana set forth in 21 U.S.C. 802(16), including any non-FDA-approved CBD extract that falls within such definition, remains a schedule I controlled substance under the CSA.” 18 9
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