FDA sends warning letter to company illegally selling CBD products

The US Food and Drug Administration (FDA) and the US Federal Trade Commission (FTC) have sent a joint warning letter to Rooted Apothecary for illegally selling unapproved products containing cannabidiol (CBD).

The products were sold online with unsubstantiated claims that they could treat teething pain and earaches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), Parkinson’s and Alzheimer’s, as well as other conditions.

The FTC is also concerned that one or more of the efficacy claims made by the company is not supported by competent and reliable scientific evidence such as human clinical trials.

The products are also misbranded, according to the Federal Food, Drug, and Cosmetic (FD&C) Act, as their labelling fails to include adequate directions for use.

“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,” said Acting FDA Commissioner Ned Sharpless.

The FDA and FTC have requested that the company responds within 15 working days with a proposal to correct the violations. Failure to correct these could result in legal action.