U.S. Food and Drug Administration and the Federal Trade Commission posted a joint warning letter to Rooted Apothecary LLC, of Naples, Florida, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), as well as Parkinson’s and Alzheimer’s disease, among other conditions or diseases.
As described in the warning letter issued to Rooted Apothecary, the company used product webpages, through 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.
Additionally, 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. More generally, to make or exaggerate such claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims, violates the FTC Act. The FTC is concerned that one or more of the efficacy claims cited may not be substantiated by competent and reliable scientific evidence. These products are also misbranded under the Federal Food, Drug, and Cosmetic (FD&C) Act, because the products’ labels and product information fail to include adequate directions for use. Drugs in the United States must contain directions explaining how a consumer can use a drug safely for its intended purpose. Under the law, there is an exemption for this labeling requirement for prescription drugs that have FDA-approved applications in effect. However, none of Rooted Apothecary’s products are FDA-approved.
The FDA and FTC have requested responses from Rooted Apothecary within 15 working days stating how the company will correct the violations. Failure to correct the violations promptly may result in legal action, including product seizure and/or injunction. Violations of the FTC Act may result in legal action seeking a Federal District Court injunction or administrative cease and desist order, and an order also may require that a company pay back money to consumers.
The FDA continues to be concerned about the proliferation of products claiming to contain CBD that are marketed for therapeutic or medical uses that have not been approved by the agency. The FDA approval process ensures that drugs on the market are safe and effective for their intended therapeutic uses. CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, teas and topical lotions and creams.
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. Further, there has been no FDA evaluation of whether these products are effective for their intended use, what the proper dosage is, how they could interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns. Consumers may put off getting important medical care, such as proper diagnosis, treatment and supportive care due to unsubstantiated claims associated with CBD products. For that reason, it’s important that consumers talk to a health care professional about the best way to treat diseases or conditions with existing, approved treatment options.
