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FDA to Hold Public Hearing May 31 Regarding Cannabis

On May 31, 2019, the Food and Drug Administration (FDA) will hold a public hearing to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds, including cannabidiol (CBD). The hearing comes approximately five months after the Agricultural Improvement Act of 2018 (more commonly known as the Farm Bill), went into effect and removed industrial hemp from the Schedule I prohibition under the Controlled Substances Act (CSA) (industrial hemp means cannabis plants and derivatives that contain no more than 0.3 percent tetrahydrocannabinol, or THC, on a dry weight basis).

Though the Farm Bill removed industrial hemp from the Schedule I list, the Farm Bill preserved the regulatory authority of the FDA over cannabis and cannabis-derived compounds used in food and pharmaceutical products under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act. The FDA has been clear that it intends to use this authority to regulate cannabis and cannabis-derived products, including CBD, in the same manner as any other food or drug ingredient.

For example, FDA has issued warning letters to companies illegally selling CBD products intended to treat diseases such as cancer, which did not obtain new drug approvals. FDA's warning letters also cited food products to which CBD had been added and CBD products marketed as dietary supplements. To date, the FDA has only approved one product containing CBD for use as a drug; in June 2018, the FDA approved Epidiolex for the treatment of epilepsy. Epidiolex is classified as a Schedule V substance, and is currently available by prescription in all 50 states.

The agenda for the public hearing is available here. Parties interested in viewing the hearing via webcast may do so by registering on the FDA website here. A link to the recorded webcast will also be posted after the hearing. In addition to holding the hearing, the agency has requested comments by July 2, 2019 regarding any health and safety risks of CBD use, and how products containing CBD are currently produced and marketed. Comments may be submitted to the docket here.

© 2020 Beveridge & Diamond PC National Law Review, Volume IX, Number 150
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About this Author

Mackenzie S. Schoonmaker Environmental Litigation Attorney Beveridge & Diamond New York, NY
Principal

Mackenzie’s practice includes both litigation and regulatory matters arising under FIFRA, the Clean Water Act, and related environmental laws.

She is passionate about conserving air, water, wildlife, and land for future generations, and enjoys helping clients navigate and enforce the detailed framework of environmental law because she believes compliance is key to preventing adverse impacts to the environment.

Mackenzie is a co-chair of Beveridge & Diamond’s Industrial Hemp & Cannabis industry team. She advises clients, and regularly writes and presents, on federal...

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