The Hazy Relationship between the FDA and CBD
By: Jon Avidor, Sarah Siegel and Liam McKillop
Walking around New York City, it could be easy to be under the impression that the sale of certain CBD products is legal. You can walk into your local convenience store and buy CBD-based chocolate candies over the counter, or you may have walked by one of the various CBD dedicated stores operating in Manhattan. However, in most instances, that is not the case. The legality of the CBD industry is not clearly defined, especially when it comes to CBD-based products such as foods, drinks, cosmetics, and pet goods and how the Food and Drug Administration (“FDA”) regulates the manner in which these products are sold and marketed.
The FDA, which operates as a science-based regulatory agency committed to protecting and promoting public health, has worked to balance the significant public interest and demand for CBD products while continuing to maintain their rigorous public health standards as it relates to drug approval. However, as the popularity of CBD and the industry in general continues to grow—evidenced by estimates that U.S. consumers spent $300 million on CBD foods and drinks throughout 2018—the FDA has continued to come under public pressure to regulate and stay up to date on the legal status of CBD products.
There are two types of CBD: (1) hemp-based CBD, and (2) THC-based CBD. While both types come from the same plant—Cannabis sativa L.—there are major differences between the chemical makeup of the two after post-harvest, leading to a difference in how the two products are regulated by the FDA. As both types of CBD are common, the legal status of the two individual products has created confusion throughout the CBD industry.
When the 2018 Farm Bill was signed into law in December 2018, the definition of “hemp” was amended to now be defined as “all parts of the plant Cannabis sativa L. with a delta-9 tetrahydrocannabinol concentration (the component of the plant which is responsible for the “high” attributed to cannabis) of not more than 0.3%.” Further, hemp was removed from the Controlled Substances Act, allowing for hemp-based CBD products to be put into interstate commerce. The result of this is that a majority of CBD products that are sold commercially are hemp-based. However, the Farm Bill ensured that the FDA would continue to have the authority to regulate products that contain cannabis or cannabis-derived compounds under the Federal Food, Drug & Cosmetics Act (“FDC Act”). The FDA has continued to maintain its position that it is currently illegal for THC-based CBD products like foods and drinks to be placed into interstate commerce and/or marketed as a dietary supplement.
Under the FDC Act, any product (excluding foods and drinks) which intends to provide either a therapeutic or medical effect on the body of humans or animals, is a drug. To date, Epidiolex—which is used as a treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome—is the only drug containing CBD which has been approved by the FDA. Further, the FDA has different regulatory standards when it comes to products like foods and drinks and even further differing standards for cosmetic products, with the latter being generally considered to be much less rigorous. For example, with cosmetic products (products which are considered to be “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the body”), there are no pre-approval requirements when it comes to the addition of CBD into these products.
Meeting the definition “hemp” is only the first step to legally sell a specific type CBD product. The legal status of the product will also depend on its intended use, how the product is labeled and how the product is marketed. For instance, the FDA has concluded that no THC-based CBD product can be marketed or advertised as a dietary supplement, as the FDA has yet to discover scientific evidence which backs up the proposition. The FDA is currently unaware of any evidence which supports CBD products being used as a dietary supplement, and will therefore enforce against companies that market products as such. it looks to enforce against products which market themselves as such. The FDA worries that such deceptive marketing claims can put the public at risk as individuals may be inclined to attempt to use such products instead of approved treatment methods for their conditions.
Due to the rapid rise in popularity of CBD and the recent law changes related to hemp and cannabis (which continue to vary at the state and local level), it seems that the goalposts for FDA regulation of CBD products continue to be moved. While the FDA continues to consider public health above and beyond public demand, the FDA also understands that companies are begging for clearer guidelines related to the marketing and sale of their products and that the public wants to know more about the prospective therapeutic and medical benefits of CBD. However, as an agency, the FDA needs to be comfortable with the scientific evidence which supports the purported benefits, and due to the current status of tests and clinical trials, the FDA is not yet there.
