Bipartisan Lawmakers Urge FDA to Speed up CBD Regulation
Senate Majority Leader Mitch McConnell and other members of Congress are urging the Food and Drug Administration (FDA) to speed up its guidance on hemp-derived CBD products. Specifically, Congress wants the FDA to issue formal “enforcement discretion” regarding CBD.
Hemp was legalized last year thanks to the 2018 Farm Bill, which made CBD legal as well. However, without guidance from the FDA, hemp and CBD are in a regulatory gray area. Lawmakers say that the FDA’s current approach to CBD has “created significant regulatory and legal uncertainty for participants in this quickly evolving industry.”
Currently, the FDA prohibits adding CBD to food or drinks marketed beyond a single state or to be added to food as a dietary supplement. Because of the regulatory confusion, some local governments have insisted that CBD is illegal in their state.
“Given the widespread availability of CBD products, growing consumer demand, and the expected surge in the hemp farming in the near future, it’s critical that FDA act quickly to provide legal and regulatory clarity to support this new economic opportunity,” lawmakers wrote.
The FDA has said it could take years to finalize CBD regulations. Congress isn’t waiting, and the US Senate Appropriations Subcommittee on Agriculture is working on guidelines to submit to the FDA. According to U.S. Hemp Rountable, Congress is working on rules that would require the FDA to:
- Within 90 days, provide Congress a report outlining its efforts to develop an enforcement discretion policy on hemp CBD;
- Within 120 days, issue its formal enforcement discretion policy on hemp CBD;
- Keep the enforcement discretion policy in effect until the agency has implemented its final regulatory process; and
- Ensure that going forward, CBD manufacturers would be able share safety data through existing FDA notification procedures to be fully compliant with federal law and policy.
Lawmakers wrote that they appreciate that the FDA has pursued “enforcement actions against the worst offenders,” but that “it can do so while eliminating regulatory uncertainty for farmers, retailers, and consumers.”
“Without a formal enforcement discretion policy, anyone participating in the growing marketplace for legal hemp-derived products will continue to face significant legal and regulatory uncertainty.”
McConnell, who has been supportive of the hemp industry, does not support ending marijuana prohibition. Asked to comment of legalizing hemp but not cannabis, McConnell said that hemp is “a different plant. It has an illicit cousin which I choose not to embrace.”