As OFW Law’s Cannabis Team launches our new blog, CannaSweep, the team thought it would be helpful to explain what all is “swept” under the cannabis umbrella. For our first post, we describe what “cannabis” is and how it has found its way into agriculture, foods, cosmetics, drugs, and other commercial applications.
It’s all Cannabis
Cannabis sativa (cannabis) is an herbaceous flowering plant originally native to Asia but now cultivated worldwide. It is a very complex plant. The leaves and flowering tops of cannabis contain hundreds of distinct compounds, including cannabinoids, terpenes, flavonoids, terpenoids, and other substances. Cannabis contains over 80 different cannabinoids, with delta-9 tetrahydrocannabinol (delta-9 THC) and cannabidiol (CBD) being the most abundant. Other cannabinoids include cannabinol (CBN), cannabigerol (CBG), tetrahydrocannabivarin (THCV), and many others. THC is psychoactive, CBD is not psychoactive, and investigation is ongoing as to the conditions under which other cannabinoids might be psychoactive.
The complexity of the plant leads to a similarly complex legal and regulatory framework. Federally, cannabis is regulated specifically under the Controlled Substances Act of 1970 (CSA) and the Agriculture Improvement Act of 2018 (the 2018 Farm Bill). If cannabis is added to a product intended to be a food, drug, dietary supplement, or cosmetic, it will also be regulated separately under the Federal Food, Drug, and Cosmetic Act (FDC Act).
Hemp
The 2018 Farm Bill created a sub-category of Cannabis sativa defined as “hemp.” “Hemp” means:
- [T]he 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.
As discussed further below, Cannabis sativa with more than 0.3% delta-9 THC is marijuana under the CSA.
The effect of the 2018 Farm Bill was to legalize the cultivation and production of hemp. This, in turn, opened the door to commercial development, including the production of CBD and other cannabinoids, so long as they were derived from hemp and did not contain more than 0.3% delta-9 THC on a weight basis.
The U.S. Department of Agriculture (USDA) is responsible for overseeing hemp production standards and has established the U.S. Domestic Hemp Production Program. Under that program, State and Tribal authorities submit plans for the cultivation and production of hemp in their area of authority. The plan includes protections and provisions to ensure that producers cultivate and produce hemp – Cannabis sativa with no more than 0.3% delta-9 THC on a weight basis – and not federally illegal marijuana.
Marijuana
The CSA defines marijuana (“marihuana” in the CSA) as “all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin” and then exempts hemp from that definition. Consequently, Cannabis sativa with more than 0.3% delta-9 THC on a dry weight basis is marijuana and hemp is Cannabis sativa with no more than 0.3% delta-9 THC on a dry weight basis.
Marijuana is classified as a Schedule I drug, that is, a drug with “a high potential for abuse” with “no currently accepted medical use.” Heroin is another example of a Schedule I drug.
Regulatory efforts have been underway to “reschedule” marijuana. Just last week, in response to a Freedom of Information Act lawsuit, the U.S. Department of Health and Human Services (HHS) released a 252-page analysis of why, in the collective judgment of HHS and the Food and Drug Administration (FDA), the Drug Enforcement Agency (DEA) should remove marijuana from Schedule I and place it in Schedule III (drugs with a moderate to low potential for physical and psychological dependence, such as ketamine, anabolic steroids, and testosterone). The HHS analysis justifies its rescheduling recommendation from Schedule I to Schedule III in part by stating:
- On balance, the available data indicate that there is some credible scientific support for the use of marijuana in the treatment of pain, anorexia, and nausea and vomiting (e.g., chemotherapy-induced), with varying degrees of support and consistency of findings. Additionally, no safety concerns were identified in our review that would indicate that medical use of marijuana poses unacceptably high safety risks for the indications where there is some credible scientific evidence supporting its therapeutic use.
DEA has the authority to schedule and reschedule controlled substances and will evaluate the HHS recommendation and render a decision. The Congressional Research Service (CRS) concluded that it was “likely” that DEA would follow the HHS scheduling recommendation. However, DEA emphasized in a letter to Congress last month that it alone, not HHS, has final authority over scheduling decisions.
It is not known when DEA will act on the HHS recommendation. Until DEA does so, Cannabis sativa remains illegal under Federal law if it has more than 0.3% delta-9 THC on a dry weight basis.
Stalks, Fibers, And Seeds
The CSA excludes certain parts of the cannabis plant from the definition of marijuana. Specifically,
the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.
These parts of the Cannabis sativa plant typically contain no or only negligible amounts of delta-9 THC. The stalks and fiber of the cannabis plant have traditional, industrial applications in textiles, packaging, paper, and other products.
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Cannabis In FDA-Regulated Products
FDA regulates human drugs and biological products, animal drugs, medical devices, tobacco products, food and dietary supplements (including those for animals), cosmetics, and electronic products that emit radiation. Though the 2018 Farm Bill removed hemp from the CSA and DEA authority, the legislation expressly preserved FDA’s authority under the FDC Act and section 351 of the Public Health Service Act (PHSA). FDA has and continues to exercise its authority to regulate products containing hemp, hemp derivatives, and other cannabis and cannabis-derived compounds. Regardless of their status under the CSA, or whether, like hemp, they are outside the CSA altogether, cannabis compounds are lawful in FDA-regulated products only under certain prescribed conditions.
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- Human and Animal Drugs. FDA oversees and pre-approves the approval of pharmaceutical drugs derived from cannabis. The FDA has not approved a marketing application for cannabis for the treatment of any disease or condition. However, FDA has approved one cannabis-derived drug product, Epidiolex (cannabidiol), and three synthetic cannabis-related drug products, Marinol (dronabinol), Syndros (dronabinol), and Cesamet (nabilone). Based upon the applications and clinical data submitted to the agency, FDA concluded that these prescription drugs are safe and effective under labeled conditions for use to treat certain illnesses and medical conditions. Companies wishing to develop cannabis or cannabis-derived human or animal drugs may do so lawfully by proceeding via an Investigational New Drug (IND) application or an Investigational New Animal Drug (INAD) application submitted to FDA.
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- Food/Dietary Supplements: FDA has determined that certain seed products from the Cannabis sativa hemp plant are permissible in certain foods. Hulled hemp seed, hemp seed oil, and hemp seed protein powder are Generally Recognized As Safe (GRAS) and may be added to a variety of foods, including confectionery, snacks, cereals, ready-to-drink beverages, and baked goods. Cannabis and other cannabis compounds are otherwise not permissible ingredients in human and animal foods and dietary supplements. In January 2023, FDA concluded that CBD’s safety concerns make the agency’s existing regulatory framework under the FDC Act inappropriate for permitting CBD in dietary supplements and foods. FDA has also stated it is unlawful to add CBD or THC to any animal food.
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- Cosmetics: FDA does not prohibit topical cosmetics from including cannabis or cannabis-derived ingredients. FDA does caution that no cosmetic may not contain any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling, or under such conditions of use as are customary or usual.
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Like the cannabis plant itself, the legal and regulatory framework for the lawful marketing of cannabis and cannabis-derived ingredients is complex. Hemp and hemp-derived products, like CBD, are not controlled substances; marijuana remains (for the moment) a Schedule I drug under the CSA. Federal restrictions exist regardless of whether cannabis or a cannabis-derived ingredient is lawful under State law. Hemp-derived cannabinoids such as delta-8 THC are (generally) not prohibited by the CSA though many States now limit or ban hemp derivatives if they are intoxicating. Some cannabis compounds are lawful in some FDA-regulated products; others are not.
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For companies currently operating or seeking to enter the cannabis market, this patchwork landscape can pose real business challenges.
If you are interested in exploring commercial opportunities in the cannabis space, we would be happy to assist you with any of your cannabis law questions, comments, or concerns. Please contact Tish Pahl (tpahl@ofwlaw.com), Kyla Kaplan (kkaplan@ofwlaw.com), Denise Calle (dcalle@ofwlaw.com), and/or Ben Dash (bdash@ofwlaw.com) for assistance.
