FDA warns Florida-based CBD company about unsubstantiated medical claims

The FDA and the Federal Trade Commission sent a warning letter yesterday to a Florida-based CBD company, Rooted Apothecary, about unproven claims on their products.

Last year, lawmakers in the United States legalized industrial hemp via the 2018 Farm Bill, adding to an already growing interest in CBD-based products. 

However, as the US Food and Drug Administration works on developing a regulatory framework for cannabis-derived products in the food and cosmetic industries, it warned companies several times this year not to employ what the FDA says are unsubstantiated claims about the benefits of CBD. 

“Selling unapproved products with unsubstantiated therapeutic claims — such as claims that CBD products can treat serious diseases and conditions — can put patients and consumers at risk by leading them to put off important medical care.”

“Additionally, there are many unanswered questions about the science, safety, effectiveness, and quality of unapproved products containing CBD,” acting FDA commissioner Ned Sharpless said in July. 

Some reasons behind FDA warning letters

The latest to be issued a warning from the FDA and FTC is Rooted Apothecary.     

The vitamin and supplement retailer made “unsubstantiated claims” that their products can be used to treat autism, ADHD, Parkinson’s disease and Alzheimer’s disease, the FDA claims. 

Some of their products, such as hemp capsules and hemp oil, are being marketed as dietary supplements, again going against FDA regulations, because hemp capsules and hemp oils do not meet FDA definitions of dietary supplements.

The FDA also found issues with Rooted Apothecary marketing drugs for “vulnerable populations” such as children, because these products haven’t been tested and the consequences for children could be even more adverse than for adults.

In addition, the FTC said the company violated a law that requires businesses to market their products as medically beneficial only if they can provide scientific evidence to back up the claims. 

“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,” Sharpless stated this week. 

Senate Majority Leader Mitch McConnel, who spearheaded the passage of the Farm Bill last year, has been urging the FDA to speed up its regulations for hemp-derived CBD in food products as farmers and producers need clarity on the issue. 

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