The U.S. Food and Drug Administration and the Federal Trade Commission posted a joint warning letter
dated October 10, 2019 to Rooted Apothecary LLC,
of Naples, Florida, for illegally selling unapproved products containing cannabidiol
(CBD) online with unsubstantiated claims that the products treat teething pain and earaches in infants, autism, attention-deficit/
hyperactivity disorder (ADHD), as well as Parkinson’s and Alzheimer’s disease, among other conditions or diseases.
The company used product webpages to make unfounded medical claims about its CBD products, and some of the products were also unlawfully marketed as dietary supplements. The agency has determined that CBD products cannot be marketed as dietary supplements.
The letter read, “The FDA has determined that your “Teeth/TMJ – Essential Oil + CBD Infusion,” “Ears – Essential Oil + CBD Infusion,” “Hemp Capsules, 750 mg,” “Hemp Infused Body Butter,” and “Hemp Oil” products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, these products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). “
The letter noted that “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended. “Your products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes.”
It went on to say “It is unlawful under the FTC Act, 15 U.S.C. § 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made.” The letter cited the product POM Wonderful, a pomegranate beverage that is suggested to be healthy.
The company has 15 days to correct its violations.