FDA To Consider Regulatory Shift Making Cannabis Ingredients Officially Eligible For Use In Dietary Supplements
FDA's prohibition against using ingredients derived from the cannabis plant in supplements and food isn't lifted by the farm bill President Trump signed on Dec. 20, but the agency recognizes sales of supplement and food products containing cannabidiol and other cannabis derivatives are exploding in the US.
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Two months after submitting CBD enforcement draft guidance for OMB review, FDA published separate draft guidance on studies for bioequivalents of an approved cannabidiol-based drug. But the draft guidance that the supplement industry awaits in pitched anticipation remains under review.
FDA schedules public meeting for 19 November to discuss sex and gender differences in the use and response to cannabidiols. The meeting will address the issue of CBD use in pregnancy, for which no human data currently is available.
As draft guidance receives OMB review, FDA’s determination of no economic significance reflects its official position that the thousands of supplements, food and personal care products containing CBDs available in the US are unlawful.