FDA Announces Public Hearing on Products Containing Cannabis or Cannabis-Derived Compounds

Posted In Cannabis

On May 31, 2019, the Food and Drug Administration (FDA) will hold a public hearing on cannabis products. The hearing seeks to obtain scientific data on cannabis and cannabis-derived compounds, along with additional information regarding health and safety risks, manufacturing and product quality, marketing, labeling and the sale of such products.

The FDA’s notice announcing the hearing recognizes that the regulatory landscape surrounding cannabis continues to evolve at both the federal and state levels. At the state level, 33 states and Washington, DC, allow for the medical use of marijuana and 14 additional states have medical programs limited to cannabidiol (a/k/a CBD) products. Moreover, 10 states and Washington, DC have legalized marijuana for recreational use, while 13 additional states have decriminalized recreational marijuana possession in some form.

At the federal level, the Agriculture Improvement Act of 2018, Pub. L. 115-334 (often called the 2018 Farm Bill), removed hemp and its derivatives from the Controlled Substances Act, so they are no longer classified as controlled substances under federal law. This has prompted an avalanche of businesses marketing products containing hemp-derived compounds – most notably CBD – in ways that the FDA views as violations of the federal Food, Drug, and Cosmetic Act. According to the FDA, many questions remain concerning the safety implications of the widespread use of these products. Therefore, the FDA seeks relevant information to inform its position in regulating the development and marketing of cannabis products.

Additional Information:

The public hearing will be held from 8 am to 6 pm at the FDA White Oak Campus, located at:

10903 New Hampshire Ave.,
Building 31 Conference Center, the Great Room (rm. 1503),
Silver Spring, MD 20993

Written comments can be submitted to:

Dockets Management Staff (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852

Electronic comments can be submitted via the Federal eRulemaking Portal.

Interested individuals can register to attend the public hearing, either in person or by webcast, via the FDA’s announcement page.

Interested individuals can join the hearing via the FDA’s webcast.

George Tzanetakos
George Tzanetakos advises hospitals, health systems and other health industry clients on a variety of regulatory and transactional matters, including mergers, acquisitions, affiliations and joint ventures. Read George Tzanetakos' full bio.

McDermott Will & Emery