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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At FDLI annual meeting, attorneys cast doubt on CBD rules outlook. Paul Joseph says regulations are at least a year away while Jonathan Havens doubts FDA is even working on regulations, including GMPs, because it is still asking industry for specific safety details.
Four major trade organizations applauded the introduction of HR 8179, which would remove statutory impediments to CBD’s lawful use in dietary supplements, subjecting CBD to the same requirements in place for any new dietary ingredient. The Natural Products Association, on the other hand, is calling the bill a misstep.
Supplements containing hemp-derived cannabidiols aren’t typical products subject to FDA’s regulatory oversight, and the document stating its thinking on enforcement in the market submitted to the Office of Management and Budget isn’t a typical draft guidance.