I found this on a regulatory website. Buyer beware. The FDA cannot keep up with all the new manufacturers.
In a joint warning letter from FDA and the Federal Trade Commission (FTC), the two agencies cite Rooted Apothecary for making unsubstantiated claims that their CBD products can treat a range of health conditions from minor ailments such as teething pain to serious conditions including cancer and Alzheimer’s disease.
The warning letter comes as FDA considers how it will regulate CBD-based products and other products derived from cannabis after the Agriculture Improvement Act of 2018, also known as the 2018 Farm Bill, legalized the cultivation and sale of hemp (cannabis containing less than 0.3% delta-9 tetrahydrocannabinol (THC)).
CBD-based products have proliferated amid the regulatory uncertainty, with major pharmacy chains and retailers including CVS, Walgreens, Rite Aid and Urban Outfitters announcing plans to carry CBD products in their stores.
“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, noting that the agency has sent dozens of warning letters to other companies making similar claims about CBD-based products over the last few years.
The warning letter itself cites Rooted Apothecary for claims made on its website and Facebook page that include various unsubstantiated claims such as “CBD may reduce the risk of cancer or help cancer treatment” and “CBD can have rapid and sustained antidepressant-like effects.”
The FTC also adds to the citations in the warning letter noting that it is unlawful “to advertise a product that can prevent, treat, or cure human disease unless you posses 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.”
As in previous warning letters to CBD-sellers, FDA has taken the stance that CBD is excluded from the definition of a dietary supplement as CBD is the active ingredient in an approved drug and “has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted.”