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FDA, FTC warn cannabis seller over unproven therapeutic claims

U.S. regulators issued a warning to an online cannabis retailer for illegally selling unapproved cannabidiol-infused products online with unproven therapeutic claims and said Food and Drug Administration is "working quickly" to set regulatory guidelines for various CBD products.

In a joint warning letter, FDA and the Federal Trade Commission said Rooted Apothecary LLC made unfounded claims on its website, online store and social media pages that its products can treat teething pain and earaches in infants, autism, attention-deficit/hyperactivity disorder, and Parkinson's and Alzheimer's disease.

The Naples, Fla.-based cannabis retailer was also accused of illegally marketing the products as dietary supplements. CBD-infused products cannot be marketed as dietary supplements.

Rooted Apothecary is the seventh CBD-products seller to receive FDA warning in 2019.

"We are working to protect Americans from companies marketing products with unsubstantiated claims that they prevent, diagnose, treat, or cure a number of diseases or conditions. This is especially concerning when companies are peddling unproven CBD products for use in vulnerable populations like infants and children," acting FDA Commissioner Ned Sharpless said.

"[T]hese actions should send a message to the broader market about complying with FDA requirements."

The FTC said Rooted Apothecary violated the FTC Act by advertising its products as having therapeutic properties without rigorous scientific evidence sufficient to substantiate the claims. The FTC also said the products also did not include ample directions for use.

The two federal agencies gave Rooted Apothecary 15 working days to respond to how it will correct the violations.