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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"The use of these products during pregnancy and lactation raises additional questions and concerns,” says Kaveeta Vasisht, FDA Office of Women’s Health director. "There is a great deal that we simply do not yet know about CBD and beyond CBD, even more that we do not know about the other compounds found in hemp," said Douglas Throckmorton, Center for Drug Evaluation and Research deputy director.
US CBD consumers say scams and quality control are greatest concerns, and newer users are most concerned, according to a survey of 780 participants by Bigeye. Results also shed light on factors that could be keeping consumers from trying the products.
Two months after submitting CBD enforcement draft guidance for OMB review, FDA published separate draft guidance on studies for bioequivalents of an approved cannabidiol-based drug. But the draft guidance that the supplement industry awaits in pitched anticipation remains under review.