Under the 2018 Farm Bill, CBD derived from industrial hemp falls outside the Controlled Substances Act, but CBD-infused food and beverages and dietary supplements must still comply with the Food, Drug, and Cosmetic Act and are subject to the authority of the FDA. In light of the Farm Bill, as well as new and pending laws at the state level concerning the use of CBD, the FDA recently published an update, “FDA is Committed to Sound, Science-based Policy on CBD,” emphasizing that science “forms the basis” of FDA decisions about products that “impact the health and safety of the American public,” including CBD products. The FDA also published a related consumer update, “What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD,” again emphasizing its commitment to public health and “sound, science-based policy.”
The FDA reiterated its position that it is illegal to put into interstate commerce any CBD-infused food or dietary supplement. The FDA further emphasized that it believes that the drug approval process is the best way to ensure public safety as to new medicines, including drugs derived from cannabis. The FDA continues to be concerned with the potential dangers of misleading and false claims associated with CBD products. As addressed during the May 31, 2019 hearing, many CBD products were tested and did not have the advertised levels of CBD, or also contained THC or other dangerous synthetic compounds.
However, the FDA is aware of the marketplace influx of CBD products for non-drug uses. The FDA recognizes that these non-drug products present a conflict between public safety and public demand. But before issuing regulations on CBD-infused food and beverages and dietary supplements, the FDA has embarked on a data-gathering phase, seeking scientific information on the impact of CBD on consumers as seen through the hearing it held on May 31, 2019, and the public docket that is now open until July 16, 2019.
In particular, the FDA is seeking to answer questions outside of the approved drug context:
- How much CBD is safe to consume in a day? Does safety vary depending on the form in which CBS is taken?
- Are there drug interactions that need to be monitored?
- What are the impacts to special populations, like children, the elderly, and pregnant or lactating women?
- What are the risks of long-term exposure?
Stakeholders have voiced concerns about the ability to provide scientific answers without having the ability to conduct research with cannabis and CBD. As a proposed remedy to this issue, the FDA has invited researchers to submit an Investigational New Drug application to the FDA’s Center for Drug Evaluation and Research.
But not everyone is happy with this response. Senator Ron Wyden (D-OR), whose Hemp Farming Act was included as a provision in the 2018 Farm Bill, sent a letter to Alex Azar, Secretary of the U.S. Department of Health & Human Services, and Ned Sharpless, Acting Commissioner of the FDA, soon after the FDA’s updates were published. In the letter, Senator Wyden reprimanded the FDA for its lack of expediency:
I, and many in the CBD industry, find FDA’s indication that it may take three to five years to issue a final regulation authorizing the lawful use of hemp-derived CBD in foods and dietary supplements fully unacceptable. The regulatory confusion and uncertainty surrounding CBD cannot continue for that length of time.
Sen. Wyden urged the FDA to issue enforcement discretion guidance by August 1, 2019, and to “promptly” issue an interim final rule to ensure a regulatory pathway for the lawful use of CBD as a food additive and ingredient in dietary supplements.
FDA regulations will not only aim to protect public health, but will also provide much-needed certainty in a largely unregulated market. To that end, CBD businesses, consumers, and stakeholders await further guidance from the FDA, but as noted by Senator Wyden, the market will not be able to wait three to five years. For now, owners of CBD businesses will have to continue to navigate the legal haze of CBD.
If you have any questions about this post or any other related matters, please feel free to contact our Cannabis Law Practice Group.