Loyola University Chicago School of Law JD 2020
On January 15, 2019, Senators Ron Wyden and Jeff Merkley sent a letter to the U.S. Food and Drug Administration (FDA) urging the agency to update its federal regulations governing the use of certain cannabis-derived ingredients in food, beverages and dietary supplements. As writers of the Hemp Farming Act, Wyden and Merkley, initiated the removal of the hemp plant and derivatives of Cannabis sativa from the list of controlled substances under the Controlled Substance Act. The Hemp Farming Act passed as a provision in the Agriculture Improvement Act of 2018, and thus, legalized the production and sale of industrial hemp and hemp-derived compounds, including cannabidiol (CBD).
Why were CBD and other hemp-derived compounds illegal?
Prior to the legislative changes in 2018, the Controlled Substances Act ruled that CBD and other hemp-derived compounds were a Schedule I substance because of the chemical component of the cannabis plant. However, CBD and the hemp plant does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol, the primary psychoactive component of cannabis.
Nonetheless, the FDA consistently asserted that products containing CBD cannot be sold as dietary supplements and that it is illegal to sell a food that included CBD as a component. Moreover, the FDA has held that CBD and/or other hemp-derived compounds do not fall under the dietary supplement definition because an article cannot be a dietary supplement after there has already been substantial clinical investigation on CBD as a new drug and these investigations have been made public.
To enforce this stance, the FDA regularly issued warning letters to manufacturers that marketed products that allegedly contained CBD and/or other hemp-derived compounds. The FDA asserted that these products were a violation of the Federal Food, Drug, and Cosmetic Act (FDCA) because the manufacturers claimed that that the products either cure, mitigate, treat, or prevent disease and/or because they are intended to affect the structure or any function of the body. And thus, the products were unapproved new drugs.
FDA’s Response to the Hemp Farming Act
In response to the passing of the Hemp Farming Act, the FDA Commissioner Scott Gottlieb made a press announcement. The statement confirmed that the Act removed cannabis and cannabis-derived compounds from the Controlled Substances Act, which means that industrial cannabis and cannabis-derived compounds will no longer be considered an illegal substance under federal law. However, the statement also noted that when passing the Act, Congress explicitly preserved FDA’s authority to regulate products containing hemp and hemp-derived compounds, under the FDCA and section 351 of the Public Health Service Act. Thus, Commissioner Gottlieb stated that the FDA will continue to protect patients and the public by enforcing the law, while also beginning to develop potential regulatory pathways for products containing hemp and hemp-derived compounds.
FDA’s Response to the Senator’s Letter
Additionally, the Senator’s letter requested the FDA to answer four specific questions. The questions ask 1) what are the step the FDA is taking to inform the public of its authority in the production and marketing of hemp and hemp-derived compounds, 2) how manufacturers may lawfully introduce hemp and hemp-derived compounds in food, beverages, or dietary supplement into interstate commerce, 3) what are the circumstances in which hemp and hemp-derived compounds may be legal as a food, beverage, or dietary supplement, and 4) whether the FDA will issue a regulation or process that would legalize hemp and hemp-derived compounds in food, beverages or dietary supplements crossing state lines.
Although the FDA has not publicly responded to these questions, in the FDA press announcement, Commissioner Gottlieb contended that the FDA has provided pathways for manufacturers who seek to lawfully introduce hemp and hemp-derived into interstate commerce. Particularly a pathway for a human or animal drug that is marketed with therapeutic claims, such as the FDA’s approval of Epidiolex in June 2018. Epidiolex is a drug that contains cannabis-derived CBD and is used for the treatment of seizures associated with two rare and severe forms of epilepsy. Commissioner Gottlieb confirmed that the FDA’s approval of Epidiolex was based on adequate and well-controlled clinical studies, which gave the FDA the confidence that Epidiolex consistent delivered positive results for treating patients with these complex and serious epilepsy syndromes.
Despite the fact that Epidiolex was the first drug approved by the FDA that comprised of CBD, its approval as a drug does not encourage the FDA to approve food, beverage, or dietary supplements with CBD.