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FDA & FTC Bust Rooted Apothecary for Illegal CBD Product Marketing

FDA & FTC Bust Rooted Apothecary for Illegal CBD Product Marketing

The FDA has been relentlessly cracking down on firms distributing CBD products that violate FDA or FTC regulations; Rooted Apothecary is the seventh company to be warned this year.

Can cannabidiol (CBD) treat autism, acne, infant teething, attention-deficit/hyperactivity disorder, earaches, chronic pain, Parkinson’s, Alzheimer’s and cancer? There’s no good science to support it, says the US Food and Drug Administration (FDA), so companies should stop advertising it that way.

On Tuesday, the FDA and Federal Trade Commission (FTC) posted a joint warning letter that was sent to Rooted Apothecary, a vitamins and supplements store in Naples, Florida.

CBD, better known as the non-psychoactive component of Cannabis sativa, continues to be a major public health interest. Legal or not, the compound has made its way into food, drinks, supplements and in only one case, a prescription drug for a rare form of epilepsy.

Driving this interest is a rise in global legalization and several scientific studies that support some health claims of CBD. However, without robust safety and efficacy data, the FDA and other regulators must remain vigilant when it comes to unfounded claims.

“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,” said FDA principal deputy commissioner Dr. Amy Abernethy, in a statement. “We recognize that there is significant public interest in cannabis and cannabis-derived compounds; however, we must work together to fill in the knowledge gaps about the science, safety and quality of many of these products.”

Additionally, the FDA-released statement indicates that, “Unlike drugs approved by the FDA, the manufacturing process of unapproved CBD products has not been subject to FDA review as part of the drug approval process.”


RELATED: FDA Cracks Down on CBD Marketers for “Unfounded” Claims


The warning letter lists several infractions against the Rooted Apothecary, including illegal sale of unapproved CBD-containing products, misbranding, making unsubstantiated advertising claims and mislabeling certain products as dietary supplements. Many of these claims are found throughout the company’s website, on product webpages and across social media.

Acting FDA commissioner Dr. Ned Sharpless pointed out that the claims made about CBD use in children and infants are “especially concerning.” Two specific products, “Teeth/TMJ – Essential Oil + CBD Infusion” and “Ears – Essential Oil + CBD Infusion,” are marketed for soothing teething pains in infants and earaches, respectively. Children and infants are particularly vulnerable to drug products as they may have a different ability to absorb, metabolize, distribute or excrete such drug products.

The FDA has been relentlessly cracking down on firms distributing CBD products that violate FDA or FTC regulations; Rooted Apothecary is the seventh company to be warned this year.

The company has 15 days to correct its violations against the FTC Act and the Federal Food, Drug and Cosmetic Act (FD&C Act).