CBD products will require a new regulatory pathway, the US Food and Drug Administration said Thursday, and the agency plans to work with Congress to develop a strategy.
It was already illegal to market products containing cannabidiol, known as CBD, as dietary supplements, and the agency has highlighted concerns around safety and unknowns about CBD.
The FDA now says CBD products cannot be considered dietary supplements or food additives, citing the findings from a working group review of studies, scientific literature and other information submitted by the public. This decision directly denies three citizen petitions with this request.
“We have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods,” FDA Principal Deputy Commissioner Dr. Janet Woodcock said in a statement.
CBD is part of the cannabis plant that does not cause the high associated with marijuana use. Some research has found that it can ease pain, and the FDA has approved one drug with CBD to treat rare, severe forms of epilepsy.
The FDA faces a unique situation with CBD, says Christopher McCurdy, president of the American Association of Pharmaceutical Scientists. Because the products have become so popular and proliferated so much, there’s much more anecdotal evidence than scientific evidence about how they work.
“The important thing to take away is that they’re trying to balance the consumer desire for the products with a regulatory framework to ensure the safety. That’s what the FDA’s role is,” said McCurdy, who is also a professor at the University of Florida’s College of Pharmacy.
“I think you’re always going to have the FDA being on the more conservative side because it’s always better to err on the safety side than not.”
Thursday’s statement from the FDA highlights potential risks and safety concerns around harm to the liver, interactions with certain medications and effects on the male reproductive system, as well as exposure among children and pregnant people.
According to the statement, possible strategies for “risk management” could include rules on labeling, content limits, minimum purchase age and oversight around CBD products for animals, as consumers could be exposed to CBD through animal products such as meat, milk and eggs.
An FDA report from 2021 noted that the CBD market has grown rapidly in recent years. It is estimated to be worth $4.6 billion, with forecasts predicting that the market will quadruple by 2026.
The same FDA report warns about Delta-8 THC, an emerging cannabinoid market that “typifies many of the safety concerns FDA has with products that contain these other emerging cannabinoids.”
Unlike CBD, the THC cannabinoid is psychoactive. The US Centers for Disease Control has issued an official health advisory for Delta-8 THC, warning that these products have the potential to be confused with hemp or CBD products that are not intoxicating, exposing consumers to the risk of an unexpected or increased intoxication.
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McCurdy says that CBD poses an “interesting test case” and that any steps taken will certainly set precedents.
“The whole dietary supplement industry is regulated to some extent, but it’s not really enforced because they don’t have enough people to oversee it,” he said. “I think it’s going to be interesting to see what happens in the larger picture around what we classify as food or what would classify as dietary supplements, and what type of regulatory pathways are going to move forward.”