WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) on Wednesday published a report in response to the U.S. Congress’ request for guidelines pertaining to the use of CBD in pharmaceutical medicines and products.
In the report, the FDA did not issue regulatory guidelines, but instead decided to continue the public comment period on CBD “indefinitely,” effectively putting no end to the waiting period for governmental regulation of CBD products.
The FDA was expected to produce guidelines by the end of February. Guidelines have been anticipated since soon after bipartisan Congressional approval of the 2018 Farm Act, which included provisions legalizing cultivation of hemp in the U.S. for the first time since the 1930s.
The FDA’s initial public comment period on CBD, which ran between April and June 2019, was extended previously to continue until July 2019.
In today’s report, the FDA said, “To provide a public and transparent way for stakeholders to provide new and emerging information to us in real time as it becomes available, we are reopening the comment period and extending it indefinitely to allow interested parties to continue to comment.”
The FDA explained further, “We are particularly interested in data that may help to address uncertainties and data gaps related to the CBD.” A long list of points that the agency expressed interest in receiving comments on followed, and included:
- The risk of liver injury from CBD use.
- Toxicities of some of the active metabolites of CBD.
- The impact of CBD on the male reproductive system.
- The effects of CBD when taken with “medicines, alcohol, dietary supplements, tobacco products, and herbal products.”
- CBD’s effect on neurological development.
- The sedative effects of CBD.
- Long-term, repeated CBD use and any related toxicity.
- CBD’s effects on pets and animals.
- Potential bioaccumulation of CBD with repeated use.
- The effects of CBD on the eyes.
The FDA provided the following link, for those who would like to submit online public comment on CBD regulation: https://www.regulations.gov/.
For individuals who prefer to comment anonymously or submit their comments by mail, the mailing address is: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
“If, in the future, we decide to close the comment period, we will publish a Federal Register notice to that effect,” the FDA added in its report.
CBD, or cannabidiol, is the cannabinoid derived from cannabis that is non-psychoactive and touted for its anti-inflammatory benefits. Most CBD extract used in consumer products is derived from hemp, which is a low-THC variety of cannabis. Hemp must contain less than 0.3mg of cannabinoid THC, which is the plant compound that causes the “high.”
