FDA Developing Regulating Pathways For Cannabis-Derived Ingredients In Foods, Supplements; Oversight Plan

In 2018, when Congress legalized cannabinoids, the FDA was put in charge of regulating the related products.
“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,” said FDA Principal Deputy Commissioner Janet Woodcock.
Patrick Cournoyer, who heads the FDA office developing the agency’s cannabis strategy, writes in Wall Street Journal, said the agency wants to know whether CBD can be safely eaten every day for an extended period or during pregnancy, for example.
Companies making CBD-based products have operated without specific federal rules guiding their manufacture or marketing.
Large companies have shelved evaluating the safety of CBD despite the increasing number of cannabis-derived products.
The agency says CBD and similar chemicals cannot be added to foods or marketed as supplements. If companies make therapeutic claims about their products, they should do so via clinical trials to meet the agency’s standard for new drugs.
After weighing the evidence, the FDA will decide within months how legal cannabis should be best regulated and whether that will require new agency rules or legislation from Congress, agency officials said.

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