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FDA CBD Docket Closed, Agency to Soon Provide Status Report

The Food and Drug Administration (FDA) has increased its efforts to follow through on its commitment to provide guidance to stakeholders on the regulatory landscape for products containing CBD. On May 31, 2019, the FDA held 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. Following the hearing, the FDA established a docket to allow the public to submit additional comments, research and information to the Agency.

The docket closed on July 16 and received nearly 5,000 comments. On July 12, FDA Chief Information Officer and Principal Deputy Commissioner Dr. Amy Abernethy confirmed via Twitter that the Agency is “expediting its work to address” questions surrounding CBD and plans “to report on [its] progress around end of summer/early fall.” Due to the significant number of comments to the docket, it remains to be seen whether FDA will provide any material development that impacts the regulation of CBD products beyond a progress report on its review of the docket.

© 2022 McDermott Will & EmeryNational Law Review, Volume IX, Number 205
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About this Author

McDermott’s Food, Beverage & Agribusiness team comprises leading regulatory lawyers who advise on the regulation, licensing, distribution, labeling, current Good Manufacturing Practices, e-commerce, advertising, false claims and marketing of food and beverage products, as well as their related inputs.

We regularly represent clients and trade groups in preparing and submitting comments to agencies on emerging regulatory issues. For example, the passage of the Food Safety Modernization Act has ushered in a new wave of regulatory proposals and challenges for those involved in the...

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