FDA, FTC Crack Down On Unproven Autism Treatments
Federal regulators are warning a company against using unsubstantiated claims to illegally peddle a slate of supposed treatments for autism and other conditions.
In a joint letter this week, the Food and Drug Administration and the Federal Trade Commission said that bogus claims are being used to suggest that unapproved products containing cannabidiol, or CBD, can treat everything from autism and attention deficit hyperactivity disorder to teething or ear pain in infants as well as Parkinson’s and Alzheimer’s diseases.
The letter cites claims made on the website of Rooted Apothecary LLC, a Naples, Fla. company.
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“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,” the government agencies indicate that the website states. “[P]ossible uses for CBD include helping with skin problems such as acne, autism, ADHD, and even cancer. It’s often used in conjunction with traditional treatments to provide extra help. Children can use high amounts of CBD safely and without any risk.”
None of Rooted Apothecary’s products are FDA approved, regulators said. Further, they noted that it is illegal to advertise that products can “prevent, treat, or cure human disease” without “competent and reliable scientific evidence” to support the claims.
The FDA and FTC have asked for written responses from Rooted Apothecary within 15 business days detailing how the company will correct the violations cited. If the problems aren’t remedied, the agencies said they may take legal action that could result in the seizure of products and back pay to consumers.
The FDA said it has only approved one CBD product, a prescription drug for a rare, severe form of epilepsy.
“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. This is especially concerning when companies are peddling unproven CBD products for use in vulnerable populations like infants and children,” said Acting FDA Commissioner Ned Sharpless.
Infants and children may be particularly at risk for reactions, the warning letter states.