Lawful Use Of Cannabidiols In Supplements ‘Different Than The Rest’ Of US FDA Regulations?
CFSAN regulatory affairs chief Douglas Stearn says a regulatory pathway wouldn’t be an open door for CBD-containing food and supplements due to concerns about the ingredients’ safety. Legislation from Congress might "do something with CBD that’s different than the rest of the Food, Drug and Cosmetic Act," he says.
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Acting commissioner Woodcock reminds manufacturers and marketers that a consumer’s exposure to cannabidiol and other cannabinoids likely comes from using multiple products daily. “How do you control exposure of people in a nonprescription setting?”
House legislation to exempt hemp-derived cannabinoids from FDA rule that an “article” previously studied or approved for use as drugs is not allowed for use in dietary supplements either resolves a conundrum or raises additional questions for the agency and the industry.
A WHO recommendation to explicitly exempt low-THC CBD from international narcotics controls has been emphatically rejected by UN member states. The CBD industry had hoped for a positive outcome to remove regulatory pressure on product manufacturers in Europe and around the world.