FDA’s Position on CBD and Public Hearing
2019 has been the year of the cannabidiol (“CBD”). CBD-infused beverages, food, and cosmetics products are becoming mainstream commodities that are flying off the shelves. The CBD craze exploded after Congress passed the Farm Bill in late 2018, despite the fact that the passage of the legislation has not legalized many of the CBD-infused products that are now being sold across the country in major grocery stores, gas stations, and online.
2018 Farm Bill
The 2018 Farm Bill (“Farm Bill”) legalized the production of hemp as an agricultural commodity and removed it from the Controlled Substances Act. For purposes of the Farm Bill, hemp is defined as the plant Cannabis sativa L. and any part of that plant, including the seeds and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol (“THC”) concentration of not more than 0.3 percent on a dry weight basis. In other words, the cannabis plants and derivatives that contain no more than 0.3 percent THC on a dry weight basis are no longer controlled substances under Federal Law.
FDA’s Position on CBD
Despite this significant change in the law, CBD cannot lawfully be added to food, beverages, and cosmetics. The Farm Bill explicitly preserved the Food and Drug Administration’s (“FDA”) authority to regulate cannabis products or products that contain cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”). The FD&C Act includes various provisions governing human drugs, human foods and dietary supplements, animal food and drugs, cosmetics, tobacco products, and medical products. Consequently, cannabis and cannabis-derived products, including hemp that contains less than 0.3 THC, are still regulated by the FDA and FD&C Act.
The FDA requires that a hemp and hemp-derived product that is marketed with a claim of therapeutic benefit to be approved by the FDA for its intended use before it can be introduced into interstate commerce. To date, the FDA has approved only one drug that contains CBD for the treatment of seizures associated with two rare and severe forms of epilepsy. Further, it is unlawful under the FD&C Act to introduce food containing added CBD into interstate commerce or to market CBD as a dietary supplement. Currently, the only path that the FD&C Act allows for such substances to be added to foods or marketed as a dietary supplement is if the FDA first issues a regulation through notice-and comment rulemaking that allows such use. In December, the FDA announced that foods containing hulled hemp seeds, hemp seed protein and hemp seed oil could be marketed as long as they made no disease treatment or dietary claims. This announcement clarifies that hemp seed-derived ingredients contain only trace amounts of THC and CBD which may be picked up during harvesting or processing when in contact with other parts of the plants. CBD can be introduced into cosmetics so long as the product is not intended to affect the structure or function of the body, or to diagnose, cure, mitigate, treat or prevent disease. The FDA maintains its authority to take action if it has information that an ingredient or cosmetic product is unsafe to consumers.
Despite these limited opportunities for the use and marketing of products with hemp derivatives, companies continue to introduce new CBD-infused products at rates never seen before. Many of the CBD-infused products currently in the marketplace make unapproved therapeutic claims or include CBD in food products, both of which are clearly illegal under the FD&C Act. In 2019, the FDA has issued warning letters to companies that market unapproved new drugs or other products that allegedly contain CBD. However, the FDA’s enforcement measures seem to be a little late to the game and are not deterring other companies from introducing similar CBD-based products into interstate commerce.
According to the FDA, significant questions remain regarding the safety of products infused with CBD. However, the FDA recognizes the substantial interest in CBD products and the legality of these products under the Farm Bill. As a result, the FDA held a public hearing as a first step in developing a regulatory framework for the use of CBD in consumer products, like food and beverages.
On Friday, May 31st, the FDA held a hearing to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds. The public hearing provided stakeholders an opportunity to present the FDA with input relevant to the agency’s regulatory approach to existing products as well as to discuss the lawful pathways by which products containing CBD and other cannabis or cannabis-derived compounds can be marketed. The hearing included comments and presentations from more than 100 speakers who offered various views on the issues, including researchers, public officials, health professionals, advocates, manufacturers and opponents.
Overall, the hearing exemplified the general confusion surrounding the current legality of CBD infused food and beverages, and highlighted the fact that these illegal products have become commonplace in the market. Many speakers called upon the FDA to develop a regulatory framework that provides testing, labeling, and safety standards for such products. Throughout the hearing, the FDA requested the speakers to submit all studies and data referenced in their presentations and additional comments to the docket. The future of CBD regulation is now in the hands of the FDA and we encourage all stakeholders to participate in the public comment period by submitting relevant research and data to the FDA docket below.
The docket (docket number FDA-2019-N-1482) will remain open for public comment until July 2, 2019. Electronic comments can be submitted here: https://www.regulations.gov and written comments can be mailed to Division of Docket’s Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
To learn about DP&F’s cannabis group, click here.