On April 2, 2019, outgoing U.S. Food and Drug Administration (FDA or the Agency) Commissioner Scott Gottlieb, M.D., further addressed FDA’s approach to cannabis-containing and cannabis-derived products (e.g., cannabidiol (CBD)-containing products).
As discussed previously, in response to the Agriculture Improvement Act of 2018 (2018 Farm Bill) being signed into law, which legalized hemp, Gottlieb was quick to remind the public about what the legislation did not change: the Agency’s authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) and section 351 of the Public Health Service Act. In short, FDA has taken the position that it is unlawful under the FD&C Act to introduce food containing added CBD or delta-9-tetrahydrocannabinol (THC) into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. The Agency’s justification for its position is that, in its view, CBD and THC are active ingredients in FDA-approved drug products and were the subject of substantial clinical investigations before they were marketed as food.
Following his December 2019 Farm Bill reaction statement, Gottlieb testified on Capitol Hill that the Agency was putting together a CBD working group, and that FDA would hold a public hearing in April to outline potential regulatory pathways. He also previewed in his responses to legislators’ questions a potential hybrid approach to CBD regulation, with products containing low levels of CBD being regulated as foods, and products containing high levels of CBD being regulated as drugs. Just a few days after appearing before Congress, however, Gottlieb unexpectedly announced that he was leaving his post at the Agency, thus putting the future of CBD regulation in a state of flux.
Recent FDA Developments
Despite his impending departure from FDA, Gottlieb continues to remain engaged, including with regarding to CBD. In his April 2nd statement, Gottlieb announced a number of new steps and actions to advance FDA’s consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under the Agency’s existing authorities. These new steps include:
- A public hearing on May 31, as well as a broader opportunity for written public comment, for stakeholders to share their experiences and challenges with these products, including information and views related to product safety.
- The formation of a high-level internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed, including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health.
- Updates to FDA’s webpage with answers to frequently asked questions on this topic to help members of the public understand how the Agency’s requirements apply to these products.
- The issuance of multiple warning letters to companies marketing CBD products with “egregious and unfounded claims” that are aimed at vulnerable populations.
In addition to allowing stakeholders an opportunity to provide the Agency with input on the future of CBD regulation, FDA will use the May 31st hearing to address, among other things:
- Concerns with regard to cumulative exposure if people access CBD across a broad range of consumer products;
- How cannabis and cannabis-derived compounds interact with other substances such as drug ingredients; and
- How the incentives for, and the feasibility of, drug development with CBD and other cannabis-derived compounds would be affected if the commercial availability of products with these compounds, such as foods and dietary supplements, were to become significantly more widespread.
CBD Working Group
Beyond previewing the May 31st meeting, Gottlieb used the April 2nd announcement to provide details regarding the Agency’s high-level internal CBD working group. He has tapped Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. and Principal Associate Commissioner for Policy Lowell Schiller to co-chair the group and has charged them with considering what CBD regulatory options might be appropriate under FDA’s current authorities. Gottlieb has also asked the group to consider whether there are legislative options that might lead to more efficient and appropriate pathways than might be available under current law. As Gottlieb discussed with Members of Congress, FDA’s notice-and-comment rulemaking process in this area could take years, whereas legislators could want a quicker fix. His call to the CBD working group to evaluate whether congressional intervention is the best solution for CBD regulation echoes that timing theme. Gottlieb noted that, while CBD regulation is complicated, and that it could take some time to resolve fully, the working group plans to begin sharing information and/or findings with the public as early as Summer 2019.
FDA and FTC Warning Letters
Gottlieb also outlined new compliance actions that FDA, in collaboration with the Federal Trade Commission (FTC), is taking against companies illegally selling products containing CBD.
Prior to the 2018 Farm Bill, the Agency took a largely hands-off approach to enforcement in this area, absent aggressive disease claims, which we wrote about previously. While the April 2019 enforcement actions follow that approach, one has to wonder whether FDA will become more active in policing the CBD space given the explosion of the product category.
On March 28, 2019, FDA and FTC issued warning letters to Advanced Spine and Pain LLC (d/b/a Relievus), Nutra Pure LLC and PotNetwork Holdings Inc. in response to the firms making “unsubstantiated claims related to more than a dozen different products and spanning multiple product webpages, online stores and social media websites.” The companies have claimed that their products can limit, treat, or cure cancer, neurodegenerative conditions, autoimmune diseases, and opioid use disorder, among other serious conditions. More specifically, these firms have claimed that:
- “CBD successfully stopped cancer cells in multiple different cervical cancer varieties.”
- “CBD also decreased human glioma cell growth and invasion, thus suggesting a possible role of CBD as an antitumor agent.”
- “For Alzheimer’s patients, CBD is one treatment option that is slowing the progression of that disease.”
- “Fibromyalgia is conceived as a central sensitization state with secondary hyperalgesia. CBD has demonstrated the ability to block spinal, peripheral and gastrointestinal mechanisms responsible for the pain associated with migraines, fibromyalgia, IBS and other related disorders.”
- “Cannabidiol May be Effective for Treating Substance Use Disorders.”
- “CBD reduced the rewarding effects of morphine and reduced drug seeking of heroin.”
- “CBD may be used to avoid or reduce withdrawal symptoms.”
USDA Weighs In
Finally, in recent days, the U.S. Department of Agriculture (USDA) posted answers to frequently asked questions regarding hemp production. Not surprisingly, in response to a question regarding whether or not producers can grow hemp for production of food and pharmaceutical products, USDA indicated that “the circumstances under which industrial hemp may be grown for food and pharmaceutical products remains a question for the FDA, because the hemp production provisions of the 2018 Farm Bill expressly did not affect FDA authorities and regulations.”
We are continuing to monitor developments in this area, and will attend the Agency’s May 31st hearing. Please stay tuned for a follow-up post regarding what we learn at the hearing.
In the meantime, if you are interested in submitting comments to FDA, or if you have questions regarding an issue raised in this post, please contact the author or the attorney at the firm with whom you are regularly in contact.