Signature Formulations' CBD Products Meet FDA Drug Policy On Claims, GMPs
This article was originally published in The Rose Sheet
FDA's warning letter to Phoenix firm lists violations of the agency's GMP regulations for drug products found in an October-November 2017 inspections in addition to identifying violative claims for its balms, creams, gels, oils, salves and toothpastes containing CBD and other botanicals.
You may also be interested in...
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.
As a Schedule I controlled substance, CBD is not allowed by FDA for use in dietary supplements. Although CBD will be rescheduled by DEA to a less prohibitive Controlled Substances Act classification before GW Pharmaceuticals can launch its drug FDA approved June 25, its status for use in supplements won't change.
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.