The Food and Drug Administration is calling for a "new regulatory pathway” to allow for the use of cannabidiol, or CBD, in dietary supplements and food additives, after concluding that “it is not apparent how CBD products could meet safety standards” for those products.
FDA Principal Deputy Commissioner Janet Woodcock said the agency is prepared to work with Congress on the issue. Lawmakers and the CBD industry have been critical of the slow pace of FDA’s review of CBD’s health effects, even as CBD products derived from hemp or marijuana continue to appear on the market.
It was not immediately clear how the announcement might affect attempts to gain acceptance for the use of hempseed meal and cake in livestock feed. FDA received an application in 2021 seeking approval for use of hempseed meal and cake in poultry feed.
Hulled seeds from industrial hemp, and protein powder and oil derived from those seeds are allowed as ingredients in human food by FDA.
“This oil, as well as seeds and seed cake residue from the pressing of oil from industrial hemp, have been determined by independent experts to be generally recognized as safe (GRAS), and FDA has not objected to that determination, as those products do not, by their nature, contain more than trace amounts of THC or CBD,” USDA notes.
Woodcock, however, said the use of CBD “raises various safety concerns, especially with long-term use. Studies have shown the potential for harm to the liver, interactions with certain medications and possible harm to the male reproductive system. CBD exposure is also concerning when it comes to certain vulnerable populations such as children and those who are pregnant.”
Woodcock said that "CBD also poses risks to animals, and people could be unknowingly exposed to CBD through meat, milk and eggs from animals fed CBD. Because it is not apparent how CBD products could meet the safety standard for substances in animal food, we also do not intend to pursue rulemaking allowing the use of CBD in animal food."
“A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products,” she said. “Some risk management tools could include clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children. In addition, a new pathway could provide access and oversight for certain CBD-containing products for animals.”
Louise Calderwood, director of regulatory affairs at the American Feed Industry Association, said, “We maintain that all new ingredients used in food for domestic livestock or pets must be proven safe and effective for their intended purpose and are supportive of the Food and Drug Administration using the appropriate regulatory pathway it deems necessary to ensure that safety-first focus for CBD products.”
The U.S. Hemp Roundtable, however, said it was "extremely disappointed" by the announcement.
"When it comes to the safety of CBD, the FDA gets it wrong," said Jonathan Miller, the group's general counsel. "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."
The U.S.. Hemp Roundtable has provided FDA officials "safety studies showing that standard CBD serving sizes are safe, while the FDA continues to rely on pharmaceutical studies that show risk at significantly larger doses that are not commonly found in CBD products sold at retail," he said.
Miller said there is no need for FDA "to go through the lengthy, burdensome exercise of establishing a new regulatory pathway for CBD, or other hemp-derived cannabinoids. This action would be unprecedented and is unnecessary given the existing dietary supplement and food pathways provided under the Federal Food, Drug, & Cosmetic Act, which include robust, comprehensive requirements aimed at ensuring the safety and quality of products, in addition to extensive FDA regulations covering the manufacturing, labeling, and marketing of products.":
Eric Steenstra, president of the advocacy group Vote Hemp, said FDA’s announcement leaves “a lot to be clarified” but that the issue of whether hempseed cake, for example, could be used in animal feed “should have nothing to do with this.”
He also criticized FDA for not backing up its statement about liver toxicity with data. “They continue to reference this potential liver toxicity issue,” he said. But based on studies done to date, he said, “It’s a non-issue.”
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He saw the decision as FDA “punting this after four years of doing very little of anything” in an attempt to gain more regulatory authority from Congress.
Hunter Buffington, vice president of policy and advocacy for a company called element6 Dynamics, who prepared the poultry feed petition as head of the Hemp Feed Coalition, said “the concern over CBD products in animals and the connection to animal by-products for human consumption from animals fed CBD must be clarified.”
“In hemp grain products, only trace amounts of cannabinoids can be found, as recognized by the FDA in the GRAS notices for hempseed oil, protein and hearts in 2018. These amounts are often lower than the allowable limits of heavy metals in animal and human foods and orders of magnitude lower than amounts found in CBD products.”
“The hemp and animal feed industry cannot wait for a new pathway for feed products with the current drought and supply chain issues,” she said. “I urge the FDA and Congress to make clear the separation and regulatory approval process for hemp grain and whole hemp plant products."
Like Steenstra, Buffington also was concerned with the use of studies to support use of CBD as a drug to treat seizures.
“Epidiolex is manufactured from marijuana and is a concentrated dose with specialized use as a pharmaceutical,” she said. “When we consider botanical extractions that capture only naturally occurring cannabinoids (not isolates and distillates), the supplement pathway is appropriate and is currently the mechanism that most in the CBD marketplace use.”
Also Thursday, FDA rejected three petitions asking FDA to issue a regulation that would allow CBD products to be marketed as dietary supplements.
“In light of the available scientific evidence, it is not apparent how CBD products could meet the applicable safety standard for dietary supplements,” the agency said.
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