Silver Spring, MD—FDA and FTC posted a joint warning letter to Rooted Apothecary LLC for illegally selling unapproved products containing cannabidiol (CBD) online with claims that the products treat teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder, Parkinson’s, and Alzheimer’s disease, as well as other conditions or diseases.

A news releasefrom FDA quotes some of the claims made:
  • “Instead of synthetic chemical[s] that can have safety concerns, this blend uses the best of nature to help calm the inflammation and pain of teething, while also promoting sleepiness for your little one.”
  • “No matter what age, ear aches are a terrible, no good way to live each day! Our main priority was safety, effectiveness . . . as we formulated this for the entire family including our precious little ones. When the pain is bad, this roller goes to work for soothing pain, inflammation, and to battle against the bacterial/viral critters to blame.”
  • “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.”
  • “CBD oil may have neuroprotective properties and may protect against neurological conditions, such as Parkinson’s and Alzheimer’s disease.”
  • “[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.”
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Acting FDA Commissioner Ned Sharpless, M.D., said in the release: “Cannabis and cannabis-derived compounds are subject to the same laws and requirements as FDA-regulated products that contain any other substance. 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…We appreciate the FTC joining us on these and other actions to protect consumers from fraudulent CBD products.”

FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., added: “The FDA is working quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD while using all available resources to monitor the marketplace and protect public health by taking action as needed…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. 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.”
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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.