In December 2018, Congress made significant changes to the Farm Bill, which legalizes industrial hemp. It also removes hemp-derived products such as cannabidiol (CBD) from Schedule I status under the Controlled Substances Act. Under the amended Farm Bill, CBD may be cultivated and used for commercial purposes if it does not contain more than 0.3 percent tetrahydrocannabinol on a dry-weight basis.
Nonetheless, whether CBD is in food, dietary supplements or other over-the-counter products, the legality of industrial hemp-based CBD remains uncertain. The following points highlight key areas businesses should consider regarding the current state of CBD:
- CBD is a drug, but it is not a dietary supplement. The Food and Drug Administration (FDA) has approved only one drug that directly uses CBD — Epidiolex, which treats two rare forms of childhood epilepsy. Other forms and dietary supplements have not been approved yet, and the FDA announced in April 2019 that it will continue to clarify its regulatory authority over CBD products and examine the variety of approaches in marketing cannabis and cannabis-derived products. CBD also has not been formally accepted by FDA as a new dietary ingredient subject to the requirements of the Dietary Supplement Health and Education Act of 1994.
- CBD is not a GRAS food additive. To be included in a food product, an additive must be proven safe through generally available and accepted scientific data obtained through scientific procedures. Additionally, it must be demonstrated safe under the conditions of its intended use. Food additives that have been subjected to appropriate notice and reviewed for safety are considered “generally recognized as safe” (GRAS) products. The FDA does not classify CBD as a GRAS food additive.
- Marketing and advertising concerns. Before considering selling CBD, note that the FDA has issued several warning letters to businesses that made unsubstantiated claims related to their CBD products’ ability to “limit, treat, or cure cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder, and other serious diseases.” Avoid making unsubstantiated disease claims about CBD, such as “CBD may be used to avoid or reduce withdrawal symptoms” or “For Alzheimer’s patients, CBD is one treatment option that is slowing the progression of that disease.”
- Differences between federal and state law. Under the changes to the Farm Bill, CBD in a vacuum is legal at the federal level. However, states concerned about CBD becoming part of the food supply have enforced laws absent FDA guidance. For example, in early 2019, Maine, Ohio and New York announced that restaurants and retailers may not sell food products containing CBD. Further, in New York, officials with the Health Department confiscated $1,000 worth of CBD pastries from a local bakery.
- Potential interactions with other medications. Although CBD is gaining popularity, the extent of CBD’s interaction with daily medications remains relatively unknown. Many medications on the market are metabolized through liver enzymes, which are the same enzymes that break down CBD. CBD could affect these medications. For example, prior research suggested potential interactions between CBD and warfarin. Warfarin is the most commonly used oral blood thinner, and reduces the risk of stroke, heart attack and blood clots. Research suggests that using CBD while on warfarin could block the effects of warfarin or allow more of the blood thinner into one’s system.
Federal rules governing CBD’s inclusion in the food, drug and dietary supplement supply are evolving, as are state rules and regulations. It’s important to consider the above areas for any product intended to be sold with CBD.
For further information about the legalities of the newly emerging CBD industry, see McGuireWoods’ June 17 alert, “Investing in a CBD Business: Five Regulatory Concerns.” If you have questions regarding the regulation or marketing of CBD, please contact one of the authors of this alert or your regular McGuireWoods attorney.