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

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.

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About this Author

Marc E. Sorini Alcohol Distribution Attorney McDermott Will law firm
Partner

Marc E. Sorini is a partner in the law firm of McDermott Will & Emery LLP and is based in the Washington, D.C. office.  He heads the Firm’s Alcohol Regulatory & Distribution Group, where he focuses on regulatory and litigation issues facing the alcohol beverage industry and non-beverage alcohol users.

Marc's alcohol beverage practice covers licensing, labeling, advertising, trade practices, distribution, import-export, formulation and excise taxation.  He has represented alcohol beverage suppliers before federal and state courts, the Alcohol &...

202-756-8284
George Tzanetakos Healthcare Attorney Chicago
Associate

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.

During law school, George served as a law clerk for the general counsel of a large Iowa health system, held a research assistantship at the University of Iowa Department of Health Management and Policy’s Rural Policy Research Institute, and was an intern for the United States Attorney’s Office for the Northern District of Iowa.

COMMUNITY

  • American Health Lawyers Association

  • Hellenic Bar Association

CREDENTIALS

Education
University of Iowa College of Law, JD, 2018
University of Iowa College of Public Health, MHA, 2018
University of Iowa, BA, University Honors, 2014

Admissions
Illinois

Languages
Greek

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