FDA calls for ‘data and information’ to inform regulatory oversight of CBD

In his final week at the U.S. Food and Drug Administration (FDA), outgoing Commissioner Dr. Scott Gottlieb made good on his promise to set a date for the first public hearing on CBD – but it won’t be this month, as he previously promised at a Congressional hearing in February.

The FDA will hold the public hearing on May 31 from 8 a.m. to 6 p.m. at its headquarters in Washington DC, the agency announced Tuesday in a bulletin posted on the federal register.

During the May public hearing, the FDA said it is looking to gather “scientific data and information” about products containing cannabis or derivative products, including:

  • Safety
  • Manufacturing
  • Product quality
  • Marketing
  • Labeling
  • Sale of products

The agency said it is looking at both “botanical and synthetic sources” to inform regulatory oversight of these products.

Written comments will be accepted electronically until July 2 or by mail with a postmark by that date, when the docket for public comment closes.

The public must register to attend the hearing, either in person or by webcast, which will be live-streamed during the May 31 event.

Those planning to attend can also register to make a formal presentation or present comments and must indicate by May 10 the topic they will address.

The Federal Register announcing the public hearing provides a full background that includes several questions that need to be answered as the FDA considers whether to allow the use of CBD in food and dietary supplements.

It clarifies that no rulemaking will occur immediately as a result of this meeting.

In March, Gottlieb said the regulations could take years – and may not even be done before his successor leaves office.

The current director of the National Cancer Institute, Dr. Ned Sharpless, was appointed to serve as acting FDA commissioner upon Gottlieb’s departure.

Gottlieb said the agency will appoint a high-level working group led by Amy Abernethy, the FDA’s principal deputy commissioner, and Lowell Schiller, the acting associate commissioner of policy.

With the process underway, the FDA could have recommendations ready for Congress this summer, Gottlieb said.

His last day is Friday, CNBC reported.

Subscribe to our Newsletter

Leave a Reply

Your email address will not be published. Required fields are marked *