FDA will pursue a legislative fix for CBD – What does that really mean?
FDA recently denied three petitions requesting that the agency issue a regulation that would allow cannabidiol (CBD) products to be marketed as dietary supplements and announced that a legislative fix is needed to allow broader access to CBD products. While some may have been hoping for a more direct path forward under current authorities, the agency’s statement does indicate a desire to work toward a solution for the growing demand for these products.
With this announcement, two questions emerge: (1) what might potential legislation look like? and (2) when will the public have more certainty around a comprehensive regulatory approach for CBD products?
Under section 201(ff) of the Federal Food, Drug, and Cosmetic Act, if a substance is an active drug ingredient – meaning it has been approved or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and made public – then products with that ingredient are excluded from the definition of a dietary supplement. The agency has concluded that because CBD is the active ingredient in the drug Epidiolex, products containing CBD are excluded from the definition of a dietary supplement under this provision.
In three separate petitions, the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), and the Natural Products Association (NPA) requested FDA to use its authority under section 201(ff) to create an exception to the “drug exclusion provision” through notice and comment rulemaking. In separate letters dating January 26, FDA denied all three petitions, stating that the agency has “considerable safety concerns” with CBD’s potential use as a dietary supplement, and that it is unclear how CBD would ever meet existing safety standards for dietary supplements.
In a related announcement, FDA affirmatively stated, for the first time, that it did not consider its existing dietary supplement and conventional food pathways appropriate for CBD and that the agency is interested in working with Congress to develop a new pathway that balances consumers’ desire to access CBD products with the regulatory oversight necessary to better manage the risks these products present. Notably, such an announcement would not have been made without broader support in the Administration.
What could a new regulatory pathway look like?
While this announcement moves the ball forward for the legal marketing of CBD products in interstate commerce, it raises questions about what a new regulatory pathway would look like. The agency focuses on “risk management” tools,” that could include “clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children.” These tools are reminiscent of FDA’s approach to the regulation of tobacco products after Congress passed the Family Smoking Prevention and Tobacco Control Act, which created FDA’s Center for Tobacco Products in 2009. Therefore, the agency may be considering placing the regulation of CBD products in the Center for Tobacco Products (CTP) or creating a separate Center for Cannabis Products within FDA with similar authorities. Certainly, creating a new product center would take both time and resources.
While FDA focused its announcement on CBD in foods and dietary supplements, it does not make sense to think about a legislative change in that narrow context. Any legislation should at least consider the broader array of cannabinoids that are growing steadily in the marketplace (eg, CBG, CBN). The agency should also consider other product types, such as cosmetic and vaping products, to ensure they have adequate safety standards, manufacturing controls, and labeling.
While there have been many previous attempts to legislate in this space, this is the first time FDA will be taking an affirmative approach, actively seeking a legislative solution. In the past, attempts to legalize CBD centered around tweaking FDA’s authorities for dietary supplements, which opens the debate on broader legislative reforms for those products including reforms to the Dietary Supplement Education Act of 1994 (DSHEA)—what many refer to as “DSHEA 2.0.”
There have also been broader attempts to establish a broader federal cannabis policy that includes recreational use. This was the approach set out in the Cannabis Administration and Opportunity Act, sponsored by Senators Cory Booker (D-NJ), Chuck Schumer (D-NY), and Ron Wyden (D-OR). Notably, this bill underwent a round of revisions after public input. The revised bill clarified that a cannabis product that is also a food may be marketed, provided all applicable requirements for food are met. Similarly, the bill created transition periods for cannabis products and cannabis products already regulated by states to ensure continued availability during the transition to a new federal regulatory framework.
In contemplating legislation, FDA will also be thinking about how more widespread availability of CBD and other cannabis products will affect clinical research on the therapeutic aspects of cannabis. The agency has stated in the past that it has a policy interest in incentivizing rigorous scientific research to support beneficial therapies. Clinical research involving cannabis, after all, has begun expanding within the US after the Medical Marijuana and Cannabidiol Research Expansion Act (MMCREA) was passed in December 2022. Surely, any federal legislation that allows for medicinal use will have to consider the impact on the MMCREA and will raise the interest of pharmaceutical companies and others.
Lastly, FDA must also think about how any new program or center for cannabis products would be funded. CTP is funded entirely by user fees, and it is likely the agency be looking at a similar funding mechanism for cannabis products.
All of these issues will need to be contemplated when addressing new legislative authorities for FDA to regulate the cannabis industry. And, with a deeply divided Congress, it is unclear what, if anything, can be accomplished in the near future. While uncertainty continues, industry is left trying to balance risk mitigation with commercial success.
To learn more about this evolving area of law, please contact either of the authors.
Financial services in the cannabis industry: A compliance guide
30 March 2021 .2 minute read
FDA continues CBD enforcement and ramps up delta-8 THC enforcement; agency focuses on...
18 May 2022 .9 minute read