Introduction: FDA to Hold Public Hearing

The U.S. Food and Drug Administration (FDA) recently announced it will hold a public hearing on May 31, 2019. This important hearing presents an opportunity for consumers, industry, and other interested parties to share their experiences, data, and information about cannabis and cannabis derivative-containing products. Every manufacturer, distributor, and packer of dietary supplements, food, beverages, and topical products that contain, or are contemplated to contain, cannabis or cannabis-derivative products, e.g., CBD (cannabidiol), should consider submitting comments and attending. Doing so will help the FDA shape this important regulatory landscape. WSGR can assist with preparation and submission of comments.

The FDA’s Dilemma

The legal and regulatory landscapes for hemp, cannabis, and cannabis derivatives, e.g., CBD, are changing. CBD-containing products are approaching a significant regulatory inflection point. On one hand, the FDA has taken the position that dietary supplements containing CBD are misbranded and adulterated under the Federal Food, Drug, and Cosmetic Act because CBD is an active ingredient in an approved drug.

On the other hand, the number of marketed, CBD-containing dietary supplements is rapidly increasing. In addition to dietary supplements, manufacturers are marketing, or are contemplating marketing, traditional foods with CBD ingredients. CBD-containing topical products are entering the marketplace, too. And this upward trend in CBD-containing products is expected to continue—in part because of the recently enacted the Agriculture Improvement Act of 2018, or the Farm Bill.

The Farm Bill defines hemp to mean "the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis." And, the Farm Bill amends the Controlled Substances Act to state that "marihuana" [sic] does not include "hemp" and excludes from schedule I controlled substances "tetrahydrocannabinols in hemp."

Because hemp and its extracts—which would include CBD—are not included in "marihuana" under the Controlled Substances Act, the Farm Bill provides for: the broad cultivation of hemp, the transfer of hemp-derived products in interstate commerce, and the sale of these; so long as all of the above are done in a manner consistent with all federal and state laws.

By announcing the public hearing, the FDA appears to be looking to understand if there are data and information that could support including CBD as an ingredient in foods, beverages, dietary supplements, and topical products. Having this data and information could allow the FDA to fulfill its mission of making sure CBD-containing dietary supplements, food, beverages, and topical products are safe for consumption and use. This, in turn, could allow the FDA to avoid facing potentially significant manufacturer, consumer, and political backlash for removing these products from the market.

Information Sought by the FDA

The FDA’s public hearing notice provides examples of the type of information the FDA is looking to gather, including:

• What levels of cannabis and cannabis-derived compounds present safety concerns?
• How does the mode of delivery . . . affect the safety and exposure to cannabis and cannabis-derived products?
• How do cannabis and cannabis-derived compounds interact with other substances (e.g., active ingredients in prescription and over-the-counter drugs)?
• Are there special human populations . . . or animal populations . . . that should be considered when assessing the safety of products containing cannabis and cannabis-derived compounds?
• What margin of exposure would represent an appropriate and safe level from anticipated cumulative exposure?
• How does the existing commercial availability of food products containing cannabis-derived compounds, such as CBD . . . affect the incentives for, and the feasibility of, drug-development programs involving such compounds?
• What are the functional purposes of adding cannabis-derived compounds, such as CBD, to foods (e.g., nutritional value, technical effect), both in terms of manufacturer intent and consumer perceptions and/or expectations?

FDA Forms Internal Working Group

The FDA also announced the formation of a high-level, internal agency working group to explore potential pathways for dietary supplements and conventional foods containing CBD to be lawfully marketed. The FDA intends for its internal agency working group to consider as well the type of statutory and regulatory changes that might be needed in order to lawfully bring such products to market. Scott Gottlieb, M.D., stated: “I’m also asking the group to consider whether there are legislative options that might lead to more efficient and appropriate pathways than might be available under current law—again, with the same science-based, public health focus that the FDA endeavors to bring to all matters before it.” Gottlieb also noted that this “is a complicated topic and we expect it could take some time to fully resolve.”

Conclusion

The FDA’s public hearing will be held May 31, 2019. The hearing and opportunity to submit comments are important. Comments, data, and information, both confidential and non-confidential, may be submitted in electronic or written form until July 2, 2019. Manufacturers, packers, marketers, and consumers of cannabis-containing and cannabis derivative-containing (e.g., CBD) products are strongly encouraged to help the FDA shape this important regulatory landscape by submitting comments, data, and information; and attending the public hearing.

Charles Andres contributed to the preparation of this WSGR alert.