FDA and FTC Issue Joint Warning to Pharmacy Selling Unapproved Products containing CBD

Earlier this month, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued a warning letter to Rooted Apothecary LLC (Rooted Apothecary) for illegally marketing and selling unapproved cannabidiol (CBD) products with unsubstantiated claims that these products treat teething and ear pain in infants, autism, attention-deficit/hyperactivity disorder (ADHD) and Parkinson’s and Alzheimer’s diseases.

According to the letter, Rooted Apothecary, through its webpage and social media websites, made unfounded claims about its CBD-containing products, some of which were also unlawfully marketed as dietary supplements.

Examples of Rooted Apothecary’s unsubstantiated claims about its CBD products include:

  • . . . “this blend uses the best of nature to help calm the inflammation and pain of teething, while also promoting sleepiness for your little one.”
  • “This blend works great for jaw and TMJ dysfunction pain.”
  • “Lavender . . . Antidepressant properties.”
  • “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 pain is bad, this roller goes to work for soothing pain, inflammation, and to battle against the bacterial/viral critters blame.”
  • “Increasing evidence suggests that CBD oil is a powerful option for pain . . . anxiety . . . and autism . . . It seems like an attractive option for children.”
  • “CBD oil may improve depression, anxiety, and PTSD.”
  • “CBD oil may reduce the risk of diabetes.”
  • “[P]ossible uses for CBD including 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.”

The FDA and FTC have given Rooted Apothecary 15 days to respond to the warning letter to inform them how the violations will be corrected.

The FDA continues to be vigilant in identifying products claiming to contain CBD that are marketed for therapeutic and medical uses that have not been approved. CBD, while marketed in a wide variety of products such as capsules, creams, lotions, oil drops, syrups and teas, has not been approved by the FDA.

Currently, the only approved CBD product is Epidiolex (cannabidiol) [CBD], an oral solution used for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome.