The U.S. Food and Drug Administration said Thursday it does not intend to pursue rulemaking that would allow for the inclusion of CBD in dietary supplements or conventional food.
Janet Woodcock, principal deputy commissioner, said the agency’s working group reviewed studies commissioned and conducted by the FDA, and those related to CBD-based drug Epidiolex, alongside published scientific literature and information submitted to a public docket before the announcement.
“Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives,” she said. “For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm.”
Woodcock’s statement comes as part of a larger announcement around how the FDA will approach CBD. The agency said a “new regulatory pathway” is needed for the cannabinoid, and that it is prepared to work with Congress to balance CBD access with regulatory oversight.
The FDA also denied petitions from the Consumer Health Products Association, the Council For Responsible Nutrition and the Natural Products Association to make rules allowing the marketing of CBD products as dietary supplements.
Woodcock pointed to potential risks of CBD use — particularly in the long term — such as harm to the liver and the male reproductive system, as well as interactions with medications. She also cited concerns over CBD use by pregnant people and vulnerable populations.
Among the possible tactics Woodcock cited for regulating CBD are clear labels, prevention of contaminants, CBD content limits and measures to mitigate the risk of ingestion by children.
The FDA said it does not intend to pursue rulemaking around the use of CBD in animal food, but it said a new regulatory pathway could “provide access and oversight for certain CBD-containing products” for animals.
The U.S. Hemp Roundtable opposed the FDA’s announcement, noting it had recently met with the agency to share studies around safety of CBD in standard serving sizes. Jonathan Miller, general counsel of the U.S. Hemp Roundtable, said the FDA relies on pharmaceutical studies that show risks at larger doses in products not sold at retail.
“When it comes to the safety of CBD, the FDA gets it wrong,” Miller said. “Contrary to the FDA’s continued assertions regarding the safety of CBD, there is clear, established evidence of safety over the years. CBD products have been sold at retail for nearly a decade with no significant safety issues.”
Miller added creating a new regulatory pathway would be “unnecessary,” given existing dietary supplement and food pathways provided under the Federal Food, Drug, & Cosmetic Act, which includes requirements for the safety and quality of products.
“With all of these tools in place as part of the existing, well-established pathways, the FDA’s decision is unwise,” Miller said. “To the extent FDA believes its current resources are not sufficient to implement and enforce existing requirements, the Roundtable supports additional appropriations to assist FDA in its compliance efforts.”
The U.S. Hemp Roundtable said it still supports a legislative solution for regulating CBD and other hemp-derived cannabinoids, adding it plans to work with a bi-partisan coalition within Congress to reintroduce legislation soon.
cbdMD, Inc., which had the National Products Association submit a petition on its behalf, noted it has been adhering to safety rules for dietary supplements, including pursuing third-party cGMP certifications, posting current COAs for products on its site and investing in safety and clinical studies.
"As pioneers of the federally legal hemp industry and public leaders in the research of cannabinoids and their benefits to humans and animals, we will continue to work with Congress to further substantiate the evidence and the legal framework for all cannabinoids to be accessed safely and legally," said cbdMD, Inc. President Kevin MacDermott. "We have attempted to work through this process with the FDA to no avail, it's time to start making some real changes here."
Charlotte's Web Holdings also issued a statement about Congress addressing CBD.
"Charlotte's Web is encouraged that the Administration has agreed that it is necessary for Congress to act for the regulation of hemp-derived cannabidiol," the statement reads. "The FDA position has taken four years to come together while the CBD industry has matured without a clear regulatory pathway for CBD products that are already available for sale in all 50 states and consumed safely by millions of Americans. This includes professional athletes, veterans, and everyday wellness seekers. The company looks forward to continuing its work in Washington, DC to forward this process."
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