FDA, FTC Issue More CBD Manufacturer Warnings

Government agencies continue to take enforcement actions against cannabidiol (CBD) product manufacturers that make unsubstantiated medical claims about their products.

On October 22, the FDA and the Federal Trade Commission issued a joint warning letter to Rooted Apothecary LLC, of Naples, FL, for illegally selling unapproved products containing CBC online with unsubstantiated claims.

Rooted Apothecary claimed that the products treat teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder, as well as Parkinson’s and Alzheimer’s disease, among other conditions or diseases, the FDA says in a press release.

“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,” says Acting FDA Commissioner Ned Sharpless, MD. “This is especially concerning when companies are peddling unproven CBD products for use in vulnerable populations like infants and children.”

In July, the FDA said it issued warnings to four CBD manufacturers that are marketing the products as drugs with claims to treat conditions or diseases.

“As part of these actions, FDA has tested the chemical content of cannabinoid compounds in some of the products, and many were found to not contain the levels of CBD they claimed to contain. It is important to note that these products are not approved by FDA for the diagnosis, cure, mitigation, treatment, or prevention of any disease. Consumers should beware purchasing and using any such products,” FDA says in a notice on its website.

“We’ve sent numerous warning letters that focus on matters of significant public health concern to CBD companies, and these actions should send a message to the broader market about complying with FDA requirements,” Sharpless said in the October 22 press release. “As we examine potential regulatory pathways for the lawful marketing of cannabis products, protecting and promoting public health through sound, science-based decision-making remains our top priority. We appreciate the FTC joining us on these and other actions to protect consumers from fraudulent CBD products.”

According to the FDA, Rooted Apothecary used its online store and social media websites to make unfounded claims about its CBD products, and some of the products were also unlawfully marketed as dietary supplements. The agency has determined that CBD products cannot be marketed as dietary supplements.

Examples of the unsupported claims made by the company include:

• “No matter what age, earaches are a terrible, no good way to live each day! Our main priority was safety, effectiveness . . . as we formulated this for the entire family including our precious little ones. When the pain is bad, this roller goes to work for soothing pain, inflammation, and to battle against the bacterial/viral critters to blame.”
• “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.”
• “CBD oil may have neuroprotective properties and may protect against neurological conditions, such as Parkinson’s and Alzheimer’s disease.”

Under the Federal Trade Commission Act, it is unlawful to advertise that a product can prevent, treat, or cure human disease unless the advertiser possesses competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made.