The FDA’s Decision Regarding the Pathway Forward for Cannabidiol
Navigating the Changing Regulations in the United States
21 March 2023
As cannabidiol (CBD) has been investigated as a drug product, it is unlawful to introduce CBD to foods and dietary supplements in the United States, as a food/dietary supplement cannot contain drugs. Nevertheless, with the passing of the Hemp Bill in 2018, the general public assumed that a regulatory pathway forward for CBD would be provided, as this bill removed hemp from the Controlled Substances Act. However, the passing of this bill still maintained the Food and Drug Administration's (FDA's) ability to regulate products containing cannabis-derived compounds (including CBD) under the Federal Food, Drug, and Cosmetic Act and section 351 of the Public Health Service Act.1 The FDA has made its stance on the inclusion of CBD in foods and dietary supplements widely known over the years.2 For example, since 2015, the Agency has sent numerous warning letters to companies selling CBD products with drug claims, and many of these products were found to have discrepancies against the quantities of CBD they claimed to have.3
Because CBD is being investigated as a drug product, a regulatory pathway to allow the marketing of CBD in dietary supplements was requested by three citizen petitions—one each from the Consumer Healthcare Products Association, the Council for Responsible Nutrition, and the Natural Products Association. However, the FDA recently rejected these request due to safety concerns.4 After reviewing the studies conducted on Epidiolex (a prescription CBD product), published scientific studies, studies conducted and commissioned by the FDA, and data submitted to a public docket, the Agency determined that data were inconclusive regarding "how much CBD can be consumed, and for how long, before causing harm." The Agency also has concerns regarding the effects of CBD on the liver and male reproductive system, as well as concerns about the effects on vulnerable populations such as children and pregnant women.5 The Agency is also unsure how the inclusion of CBD in animal feed could affect foods for commerce such as meat, eggs, and milk.
Therefore, the FDA has decided that a new regulatory pathway is required to introduce CBD to the marketplace in foods, dietary supplements, and animal feed, and the Agency will work in conjunction with Congress to develop these new regulations. Suffice to say, until Congress can devise a new pathway forward, there is currently no federal regulation that would allow CBD in non-prescription forms such as foods and dietary supplements. While the regulatory pathway for CBD has already been long and challenging to navigate, it looks like there finally may be a light at the end of the tunnel.
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Disclaimer: The foregoing does not constitute legal or regulatory advice and the reader should seek professional guidance for their specific requirements and conditions. Please contact our expert compliance team for further assistance in this regard. Intertek has extensive experience with overcoming regulatory hurdles and developing unique strategic pathways.
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