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FDA Silent on CBD Regulation at Cosmetics Conference, But Legislation May Be Imminent

Regulation of cannabidiol (CBD) was a hot topic on Day 1 of ACI’s Cosmetics & Personal Care Products conference on March 28, 2019. Attendees asked many questions about legitimate uses of and claims for CBD, but definite answers were in short supply due to the current confusion over the legality of CBD as a product itself or other products, such as food or cosmetics, with CBD added.

When asked a direct question about FDA’s perspective on and plans for CBD regulation, Dr. Linda Katz, Director of FDA’s Office of Cosmetics and Colors and Acting Chief Medical Officer for Food Safety and Applied Nutrition, did not comment directly but referred all attendees to an upcoming public meeting on CBD in April 2019. It is possible that the public meeting could be the start of an FDA rulemaking process for CBD regulations. Even though Dr. Katz was unable to comment, there was still plenty of CBD advice to share with industry attendees.

Current State of Regulatory Risks Related to CBD

While the legality of CBD as a product and as an ingredient is still in flux at the federal and state levels, there are a few things we can glean from recent government action relating to CBD products.

First, FDA does not consider adding CBD as an ingredient of food products or dietary supplements permissible under the law. Indeed, before 2018, FDA issued 18 Warning Letters relating to drug claims associated with dietary supplement products containing CBD. However, since October 2018, FDA has not taken any enforcement action against CBD product manufacturers.

Second, FDA has taken no enforcement action against manufacturers of cosmetic or topical products containing CBD and has not made any public statement about the possible safety risks of using CBD cosmetic products. Since FDA has not taken a policy position on CBD in cosmetics, such products remain in a regulatory gray area for now. However, FDA is still likely to take enforcement action if a manufacturer makes drug claims regarding a cosmetic product with CBD as an ingredient.

Third, while the Agriculture Improvement Act of 2018 (the "Farm Bill") legalized the production of industrial hemp and products derived from hemp, it did not legalize all uses of and products containing hemp derivatives (such as CBD).

The above information can be condensed into the following risk hierarchy: 

Low Risk

  • Labeling a product as containing "hemp seed oil"

Moderate Risk

  • Including CBD in a cosmetic product formulation

High Risk

  • Including THC or cannabinoids other than CBD in any product

  • Adding CBD as an ingredient to any food product or dietary supplement

  • Making any drug claims relating to CBD

In addition, manufacturers of any CBD product must be sure that their CBD oil suppliers provide certification of the following testing and verify that such testing is qualified:

  • CBD potency (concentration of CBD, THC, and other cannabinoids)

  • Presence of pesticides

  • Microbiological testing for harmful bacteria or mold

  • Mycotoxin testing

  • Presence of terpenes

  • Presence of residual solvents

Even though the Farm Bill gave some manufacturers confidence that CBD products can be sold legally in major commercial outlets, it is far from certain that federal agencies like FDA and DEA, or even local authorities, will abstain from taking enforcement action against CBD product manufacturers and retail outlets.

Potential Legislation on CBD

In one of his final public appearances as Commissioner of Food and Drugs, Dr. Scott Gottlieb at a March 28, 2019 Senate Appropriations Committee hearing discussed FDA action related to CBD. In response to questions from Vermont Senator Patrick Leahy about CBD regulation, Dr. Gottlieb said FDA will take action against CBD products on the market if manufacturers are making “over the line claims” such as that their products can treat cancer or Alzheimer’s disease. Further, he noted that a working group led by Principal Deputy Commissioner Amy Abernethy is exploring what legislative solutions may be worth proposing to Congress regarding FDA oversight of CBD. We’ll be keeping an eye out for any proposals and any other action from FDA, DEA, and states on CBD.

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About this Author

Benjamin Zegarelli, Mintz Levin Law Firm, New York, Health Care Law Attorney
Associate

Benjamin provides counsel on compliance and regulatory issues to clients in the pharmaceutical, medical device, and biotech industries. With a clear focus on FDA regulatory counseling, Benjamin advises a breadth of health care industry clients on the federal and state laws surrounding manufacturer product development and marketing. His practice also includes advising clients on research approval, sales, and negotiating contractual relationships.

Benjamin has experience representing medical device companies in responding to significant...

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Senior Director

Aaron is based in our Washington, DC office and is a Senior Director of ML Strategies. He advises clients on health care policy issues related to medical devices and pharmaceuticals. 

Prior to joining ML Strategies, Aaron spent 10 years with the US Food and Drug Administration, most recently as a senior policy advisor in the Center for Devices and Radiological Health where he led legislative policy development activities related to all aspects of medical device regulation and oversight. He also apprised members of Congress and their staffs about FDA policies and programs and advised multiple FDA Commissioners and other senior officials on strategy and content for meetings with Congress, industry representatives, and other stakeholders. In addition to negotiating the reauthorization of the medical device user fee program (MDUFA), Aaron led FDA’s implementation of key provisions of the 21st Century Cures Act and the FDA Reauthorization Act.

Earlier, Aaron was a budget analyst in the FDA’s Center for Drug Evaluation and Research, where he developed the center’s annual budget and provided information to the Congressional Budget Office (CBO) and congressional authorizers. He began his FDA career in the Center for Biologics Evaluation and Research as an information management specialist responsible for data analyses to support FDA policies and programs.

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