CDB Supplements Next On FDA's Investigational New Drug Warning List
This article was originally published in The Rose Sheet
The agency published warnings to four firms marketing supplements containing CDB ingredients with claims to treat or cure cancer made in statements including testimonials on their websites for products varying from oils, capsules, tinctures and lotions to snacks including gummies and lollipops.
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RAAS Nutritionals tells FDA “it proceeded without an IND because it believed that if it was legally able to sell its nutritional supplements ... it should be able to test and observe the effects of those supplements without an IND.”
Digital Citizens Alliance found an average 30% discrepancy between labeled and actual CBD amounts in nearly 60 products. The group says more than half the products tested contained CBD levels 20% higher or lower than labeled, which is particularly problematic since nearly half US consumers use the products as alternatives to Rx drugs.
As FDA announces its first-ever approval of a drug that contains a substance derived from marijuana, officials say the agency's policy that prohibits CBD's use in dietary supplements or food will not change. They also say, however, that FDA's priority for enforcement actions against dietary supplements containing CBD, an extract from cannabis and hemp plants, will remain on products marketed with drug or disease claims.