ALCOHOL LAW ADVISOR
ALCOHOL LAW ADVISOR
Regulatory and Distribution Law Updates for the Alcohol Industry
ALCOHOL LAW ADVISOR
Regulatory and Distribution Law Updates for the Alcohol Industry

FDA CBD Docket Closed, Agency to Soon Provide Status Report

By on July 24, 2019

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.

Khelin N. AikenKhelin N. Aiken
Khelin Aiken supports life sciences companies as they develop innovative products and bring them to market, with particular focus on therapeutic product development plans and marketing applications for prescription drugs, including therapeutic biologics and generics. She also advises on policies related to over-the-counter (OTC) drugs. Prior to joining McDermott, Khelin served as regulatory counsel at the Food and Drug Administration (FDA) in the Center for Drug Evaluation and Research, first in the Office of Regulatory Policy, and most recently in the Office of New Drugs with the Therapeutic Biologics and Biosimilars Staff. Read Khelin N. Aiken's full bio.

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