The Food and Drug Administration said there are too many unknowns about CBD products to regulate them as foods or supplements under the agency's current structure and called on Congress to create new rules for the massive and growing market.
The marijuana-derived products have become increasingly popular in lotions, tinctures and foods, while their legal status has been murky in the U.S.
There’s not enough evidence about CBD to confirm that it’s safe for use in foods or as a dietary supplement, FDA Deputy Commissioner Dr. Janet Woodcock said in a statement. “For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm,” she said.
The FDA has oversight of CBD because it is the active ingredient in an approved prescription drug, Epidiolex, used to treat two rare seizure disorders. Under FDA regulations, a drug can’t be added to food or sold as a dietary supplement if officials haven’t determined if it’s safe or effective for other conditions.Questions remain about CBD’s effects on the liver, the male reproductive system and on pregnant women and children, the statement said.
New rules could include clear labels, regulations regarding contaminants, limits on CBD levels and requirements, such as a minimum purchase age. Regulations are also needed for CBD products for animals, the agency said.
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