The FDA and the Federal Trade Commission have issued a warning to Rooted Apothecary LLC of Naples, Florida, for illegally selling unapproved products that contain cannabidiol, or CBD, and claiming the products can treat health conditions in infants and adults.
“Cannabis and cannabis-derived compounds are subject to the same laws and requirements as FDA-regulated products that contain any other substance,” Ned Sharpless, MD, acting FDA commissioner, said in a press release. “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.”
In the warning, the FDA stated that the Rooted Apothecary used its online store and social media pages to make “unfounded” claims about its CBD products. The warning also states that the company unlawfully marketed some CBD products as dietary supplements, despite a previous FDA ruling that CBD products cannot be marketed as such.
The company claimed that some products could help ease pain from teething and earaches in infants. It also claimed that its CBD oil was an “attractive and safe option” to treat pain, anxiety and autism in children.
The company made other claims, including that certain products could protect against neurological conditions like Parkinson’s disease and Alzheimer’s disease.
According to the press release, the products also violate the Federal Trade Commission Act, which makes it illegal to market a product as able to prevent, treat or cure human diseases without competent and reliable scientific evidence.
The warning gives Rooted Apothecary 15 working days to respond to the FDA and FTC about how they plan to correct the violations.
Currently, the only CBD product approved by the FDA is a prescription human drug product that treats rare and severe forms of epilepsy.
“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,” Amy Abernethy, MD, PhD, FDA principle deputy commissioner, said in the release. “We are committed to advancing our regulation of these products through an approach that, in line with our mission, prioritizes public health, fosters innovation and promotes consumer confidence.” – by Erin Michael
References: Abernethy and Sharpless report no relevant financial disclosures.