The United States Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) today posted a warning letter sent to Rooted Apothecary LLC of Naples, Florida for selling unapproved cannabidiol (CBD) products with unsubstantiated claims that they can be used to treat autism, attention-deficit/hyperactivity disorder, Parkinson’s disease, Alzheimer’s disease, and other conditions.
The letter states that Rooted Apothecary used its online store, product web pages, and social media to make unfounded claims about its products and unlawfully market some CBD products as dietary supplements, which is not allowed by the FDA.
Acting FDA Commissioner Ned Sharpless says that cannabis and cannabis-derived compounds are governed by the same laws as FDA-regulated products that contain any other substance and that the Administration is working to protect Americans from companies that make unsubstantiated claims that their products can prevent, diagnose, treat, or cure diseases or health conditions.
“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,” says Sharpless. “As we examine potential regulatory pathways for the lawful marketing of cannabis products, protecting and promoting public health through sounds, science-based decision-making remains our top priority.”
The FDA and FTC have requested a response from Rooted Apothecary within 15 days outlining how they plan to correct the violations.
Failure to correct the violations in a timely manner could result in legal action such as an injunction or confiscation of product.
For the company’s violations of the FTC Act, the Commission may seek a Federal District Court injunction or an administrative cease-and-desist order and possibly require that Rooted Apothecary give refunds to customers.
FDA Principal Commissioner Amy Abernethy says that the Administration recognizes that there is significant public interest in cannabis products and is working on clarifying its regulatory approach for them while monitoring the marketplace, protecting public health, and taking action when needed.
The only CBD product currently approved by the FDA is Epidiolex from G.W. Pharmaceuticals which is used to treat seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients over the age of two.