Feds threaten to shut down CBD company for making illegal health claims
It's unlawful to advertise that a product can prevent, treat, or cure human disease without reliable scientific evidence. There is very little for CBD.
The federal government threatened to shut down a Florida-based patent medicine company on Tuesday for illegally claiming its CBD products could treat teething pain, ear aches, autism, ADHD, Parkinson’s and Alzheimer Disease.
Rooted Apothecary, of Naples, was reprimanded for making unsubstantiated claims by the U.S. Food and Drug Administration and the Federal Trade Commission.
The company used its websites and social media to make the unfounded claims. On Tuesday afternoon, the offending material was still posted to Rooted Apothecary’s web pages. Rooted Apothecary also unlawfully markets its pricey products as dietary supplements, which is strictly forbidden by federal law.
Under the Federal Trade Commission Act, it is unlawful to advertise that a product can prevent, treat , or cure human disease unless the advertiser has reliable scientific evidence. There are no well-controlled human clinical studies proving CBD can be of help for anything but some rare forms of pediatric seizure disorders.
Rooted Apothecary’s products also failed to include adequate directions for use. That may be because there has been no standardized dosing established for CBD to treat anything but pediatric seizures. The FDA previously has sent warning letters to other companies making illegal claims for CBD. It’s unclear whether any of those letters have had their desired effect.
The FDA and FTC gave Rooted Apothecary 15 working days to correct the violations.
“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,” said a spokesman in a statement. “The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy.”