Last week, in one of his last actions as acting commissioner of the FDA, Scott Gottlieb issued a statement on the FDAâ€™s next steps to evaluate potential regulatory pathways to legalize cannabis-containing and cannabis-derivative products. In short, the agency is:
Read on to see how the FDAâ€™s statement provides guidance for the hemp and CBD industry, and what to expect in the months ahead.
Despite the 2018 Farm Bill, which removed hemp and its derivatives, like cannabidiol (CBD), from being a Schedule I Controlled Substance, the FDA continues to view the addition of CBD to food and beverage products or dietary supplements as a violation of the Food, Drug & Cosmetic Act. This is because CBD is considered a drug in the eyes of FDA, since the agency approved a CBD drug, Epidiolex, to treat seizures in 2018, and the FDA does not allow drugs to be used in food and beverages or as dietary supplements under the Food, Drug and Cosmetics Act. FDAâ€™s policy has caused some apprehension in the hemp industry during the first quarter of 2019, especially as some states, acting on FDAâ€™s policy, have started seizing consumable CBD products from retail stores within their jurisdiction.
FDAâ€™s statement confirms, in writing, what its recent actions have shown the industryâ€” the FDA will continue enforcement actions against CBD companies that make any treatment, health or disease claims (i.e. this product will cure or treat cancer) on a product or in marketing. The FDA sent three warning letters to companies making what it called, â€śegregious health claimsâ€ť in tandem with this press release, and the FDA clearly stated that it plans to, â€śprotect consumers from companies illegally selling CBD products that claim to prevent, diagnose, treat or cure serious diseasesâ€¦â€ť
Previously, we have written that companies who have evaluated the risks and chosen to operate in the industry should avoid making any health or disease claims to minimize the risk of state or Federal enforcement actions, as well as product liability claims, should a consumer abandon an existing disease treatment due to unfounded health claims related to CBD. Whether the FDAâ€™s recent policy will influence state health departments and limit the seizure of CBD products for companies making unfounded health claims in places like New York City remains to be seen.
Legislative or Regulatory Fix:
The FDAâ€™s call for the formation of an internal working group is a positive step forward for the industry. Gottlieb seems to recognize that the rule making process within the FDA is likely to take years to regulate an industry that is on track to reach over $40 billion dollars in sales by 2024. Facing that reality, the agencyâ€™s calls for the working group to explore legislative changes that may offer a faster solution. Gottlieb even offered a hypothetical scenario where both prescription CBD and lower strength CBD food and beverage products could co-exist under separate regulatory schemes. This is an optimistic outlook for the industry from its principle regulatory agency, but many questions remain and challenges are likely to present themselves, especially given that Gottlieb is passing the reins on to a successor to chart the agency through the next steps in the regulatory process.
The next major step for the FDA will be the upcoming public hearing on May 31, 2019. The agency has requested the industry provide any data it may have regarding correct dosage amounts, how various methods of taking CBD (vapor, food, topical) may impact the dosage amount, how CBD may interact with other substances in a person, and any other concerns regarding safety risks with CBD.
The FDA is accepting requests to make oral presentations or comments at the public hearing through May 10, 2019. Those wishing to file written comments have until June 2, 2019. Please let us know if you would like our assistance in drafting or reviewing your comments to FDA.