FDA, FTC Warn CBD Retailer Rooted Apothecary On Health Claims, Unapproved Products

The Food and Drug Administration and Federal Trade Commission issued a joint warning letter Tuesday a joint warning letter to CBD seller Rooted Apothecary LLC, of Naples, Florida. 

FDA: Company Marketing To Vulnerable Customers

The company is selling unapproved CBD products online with unsupported claims that thee products can help teething and ear pain in infants, ADHD, autism, Alzheimer’s and Parkinson’s disease and other ailments, the FDA said.

"Cannabis and cannabis-derived compounds are subject to the same laws and requirements as FDA-regulated products that contain any other substance. 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," Acting FDA Commissioner Ned Sharpless, M.D., said in a statement.

"This is especially concerning when companies are peddling unproven CBD products for use in vulnerable populations like infants and children." 

Rooted Apothecary illegally advertised some products as dietary supplements, despite the FDA's determination that CBD products can't be advertised that way, the agency said. 

Benzinga has contacted Rooted Apothecary for comment on the FDA letter via the CBD company's website. 

No FDA-Approved Products 

Some examples of those company’s questionable claims include the following, the FDA said: 

• "Instead of synthetic chemical[s] that can have safety concerns, this blend uses the best of nature to help calm the inflammation and pain of teething, while also promoting sleepiness for your little one."
• "Increasing evidence suggests that CBD oil is a powerful option for pain ... anxiety ... and autism ... It seems like an attractive and safe option for children."

Not a single product sold by Rooted Apothecary was FDA-approved, the agency said. 

The FDA and FTC are requesting responses from the company within 15 working days that explain how the company plans to correct the violations.

"The FDA is working quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD while using all available resources to monitor the marketplace and protect public health by taking action as needed against companies," FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., said in a statement.

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