The U.S. Food and Drug Administration has begun to look into whether hemp-derived CBD is safe in food or supplements. The substance has been federally legal since 2018 but remains largely unregulated.
According to a Dec. 29, 2022, article in the Wall Street Journal, FDA officials said that in the coming months they planned to make recommendations on regulating CBD and other hemp-derived products.
FDA Principal Deputy Commissioner Janet Woodcock signaled a skeptical approach.
“Given what we know about the safety of CBD so far, it raises concerns for FDA about whether these existing regulatory pathways for food and dietary supplements are appropriate for this substance,” she said.
Woodcock will be in charge of the agency’s review of the regulations.
Patrick Cournoyer, who heads the FDA office that will develop the agency’s cannabis strategy, told the Wall Street Journal that the agency, concerned about possible effects on fertility, wanted to know whether CBD could be safely eaten every day during a pregnancy or for another long period.
Current FDA rules state that CBD cannot be added to foods or marketed as a supplement. Companies make therapeutic claims about their products are required to present clinical trial results showing that the agency’s standard for new drugs has been met. The FDA recently issued warning letters to companies for breaking these rules.
To date, the FDA has approved only one hemp-derived pharmaceutical drug, Epidiolex, which was developed to treat certain types of epilepsy.
After weighing the evidence, the FDA will decide within months how legal cannabis should best be regulated and whether that regulation will require new agency rules or new legislation from Congress, FDA officials said.
Senior FDA adviser Norman Birenbaum urged a tempered agency approach but said the market needed guidance.
“I don’t think that we can have the perfect be the enemy of the good when we’re looking at such a vast market that is so available and utilized,” Birenbaum told the Wall Street Journal. “You’ve got a widely unregulated market.”
State markets have developed quickly in the gray areas of federal regulation, with state governments taking action to regulate on their own. Aaron Smith, CEO of the National Cannabis Industry Association, a trade group for small cannabis businesses, said federal regulations should complement, rather than contradict, state rules.
“The states are decades ahead of the federal government,” he told the Wall Street Journal.
CBD isn’t the only hemp-derived substance in the FDA’s sights. The agency is also concerned about delta-8 and its proliferation in the market. The FDA has “growing and more intensifying short-term concerns” about intoxicating hemp-derived products such as delta-8, Birenbaum said, noting that the agency’s regulation of intoxicating products involves a more stringent set of considerations.
Meanwhile, U.S. Hemp Roundtable leaders reported that they would meet with the FDA in early January to discuss and clarify proposed regulations. More significantly, the Roundtable also said it would keep in close touch with congressional sponsors to help create legislation to regulate hemp-derived substances.
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