On January 26, 2023, the Food and Drug Administration (FDA or Agency) announced its conclusion that existing regulatory frameworks for human and animal food and dietary supplements are not currently appropriate for the use of cannabidiol (CBD) in those products. Concurrently, FDA also denied three separate citizen petitions requesting that FDA issue a regulation allowing CBD products to be marketed as dietary supplements. The Agency determined that these uses of CBD raise a number of safety concerns, especially with long-term use and for certain sub-populations, and that a new regulatory pathway is needed to provide safeguards and oversight to minimize potential safety risks that FDA believes cannot be adequately managed under current food and dietary supplement regimes. The Agency intends to work with Congress to develop a cross-agency strategy for regulating such CBD products.
CBD Regulatory Landscape for Food and Dietary Supplements
FDA currently takes the position that CBD may not be sold as or in food (including beverages) for humans or animals or in dietary supplements in the United States because CBD was not marketed in dietary supplements or food before the start of substantial drug clinical investigations on CBD. Sections 201(ff)(3)(B) and 301(ll) of the federal Food, Drug, and Cosmetic Act (FDCA) respectively prohibit the use of an ingredient in a dietary supplement or food if that ingredient has been previously studied in substantial clinical investigations under an IND or approved as a drug. These statutory provisions are often referred to as the “exclusionary clause.” If an ingredient is precluded from use in food or dietary supplements under the exclusionary clause, FDA can still take action to authorize that use through rulemaking. See our previous alert for a more complete discussion of FDA’s conclusion about the exclusionary clause and related regulatory action FDA has taken based on that conclusion.
Proposed New Pathway
In this week’s statement, FDA Principal Deputy Commissioner Dr. Janet Woodstock announced that, after a number of years of review of data and other information on CBD, FDA has concluded that CBD cannot currently be regulated under FDA’s existing food and dietary supplement authorities – i.e., that FDA will not, under the exclusionary clause, authorize any use of CBD in food or dietary supplements through rulemaking. Instead, FDA has determined that a new regulatory pathway is needed for such products, and commits to working with Congress to address this matter.
In the statement, FDA reasons that a new regulatory pathway is necessary to provide better safeguards and oversight to manage and minimize risks related to CBD in food and dietary supplements. The Agency identified several risk management tools that could be included as part of this new landscape:
- Clear labels on products;
- Prevention of contaminants;
- CBD content limits; and
- Measures to mitigate ingestion by children, like minimum purchase age.
FDA notes that a new regulatory pathway could also provide access and oversight for CBD-containing animal products.
Citizen Petitions for Marketing CBD Products as Dietary Supplements
Between 2019 and 2022, FDA received three citizen petitions requesting that the Agency conduct rulemaking to allow the marketing of CBD products as dietary supplements. Consistent with Dr. Woodstock’s announcement, FDA’s concurrent denial of three separate citizen petitions rests on FDA’s conclusion that:
- The Agency has the authority to engage in rulemaking when a substance is excluded from the dietary substance definition, but chooses not to exercise this authority for CBD.
- There are “considerable safety concerns” with CBD’s potential use as a dietary supplement, especially with long term use.
- Scientific studies show possible harm to the male reproductive system, harm to the liver, and negative interactions with certain medications.
- CBD supplements being readily available to vulnerable populations, like children, the elderly, those with chronic illnesses, or individuals who are pregnant or nursing is concerning because little research exists on CBD’s safety in these populations.
- Rulemaking on CBD-containing products would not be “justified if safety problems exist,” and the product would not meet the FDCA’s relevant safety standard.
- The new dietary ingredient notification process is not “sufficiently robust to protect the public” from unsafe CBD-containing dietary supplements.
Specifically regarding FDA’s decision not to pursue rulemaking, FDA explained its view that, when deciding whether to undertake rulemaking pursuant to the exclusionary clause, the Agency needs to consider safety concerns about the substance at issue. More specifically, in its response to one of the petitions, FDA expressly states: “it is not apparent" from the available scientific evidence proffered "how a CBD product would be able to meet the applicable safety standard that the law provides for dietary supplements." This conclusion is broadly notable in understanding how FDA interprets its authority and discretion under section 201(ff).
To better understand the ways FDA seeks to structure a potentially new regulatory pathway, industry members should engage with the cross-agency Cannabis Product Committee and Congress on the issue.
If you have any questions concerning the material discussed in this client alert, please contact the following members of our Food, Beverage, and Dietary Supplements practice: Miriam Guggenheim, Deepti Kulkarni, Jessica O'Connell, Jeannie Perron, Brian Sylvester, Tiffany Rodriguez.
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