FDA CRACKDOWN ON CBD PRODUCTS FOR HUMAN CONSUMPTION AND A POSSIBLE LOOPHOLE

The FDA made clear that it will not hesitate to warn consumers and initiate enforcement actions against CBD companies. On January 3rd, 2019 the FDA seized CBD products from Neverlow Glass Gallery smoke shop in Arizona. The FDA seized eight chocolate bars, gummies, and K-cups. https://www.phoenixnewtimes.com/news/fda-confiscated-cbd-edibles-yuma-shop-owner-says-11092133

According to the owner, the FDA officials told the store owners that CBD wasn’t for human consumption, and that the edibles had to be labeled as a pet product. However, the label could state that “if consumed by a human, there’s no concern.” Reading between the lines, the FDA is suggesting a loophole for manufacturers and distributors until the FDA issues guidelines for CBD foods, cosmetics and dietary supplements.

According to the FDA,

[I]t’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements. Under the FD&C Act, it’s illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements. This is a requirement that we apply across the board to food products that contain substances that are active ingredients in any drug.

 

The FDA has also made clear that products containing hemp or hemp-derived CBD that are “marketed with a claim of therapeutic benefit, or with any other disease claim” must be approved by the FDA before being introduced into interstate commerce. It also stated that hemp or hemp-derived CBD products marketed “for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases” are considered drugs and must be approved by the FDA before they are marketed for sale in the United States.

The FDA has indicated that its position on CBD products is clear. CBD manufacturers and distributors should watch this issue closely to see if the FDA will escalate enforcement against CBD companies and consider label changes to avoid product seizure, fines and penalties.

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