FDA calls for ‘data and information’ to inform regulatory oversight of CBD
CBDIndustrial Hemp NewsMarijuana Laws, Regulations, & Politics April 2, 2019 MJ Shareholders 0
In his final week at the U.S. Food and Drug Administration (FDA), outgoing Commissioner Dr. Scott Gottlieb has 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 stated at a Congressional hearing in February.
FDA will hold the public hearing on May 31 from 8 a.m. to 6 p.m. at its headquarters in Washington, D.C., the agency announced Tuesday in a bulletin posted on the federal register.
During the May public hearing, FDA is looking to gather “scientific data and information” about products containing cannabis or cannabis-derived 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 event on May 31.
Those planning to attend can also register to make a formal presentation or present comments and must indicate the topic they will address by May 10.
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 rule-making 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 FDA will appoint a high-level working group led by Amy Abernethy, the FDA’s principal deputy commissioner, and Lowell Schiller, the agency’s acting associate commissioner of policy.
With the process underway, the FDA could have recommendations ready for Congress this summer, Gottlieb said.
Gottlieb’s last day is Friday, CNBC reported.
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