Joint letters from the FDA and the FTC about CBD claims and advertising went out to three companies selling CBD oils and other CBD products online in interstate commerce.
The letters provide some insight about the outer-limits of unacceptable claims, statements, assertions and other representations in advertising and selling CBD products across state lines.
The letters went to Advance Spine Pain, LLC (dba Relievus), PotNetwork Holdings, Inc., and Nature Pure LLC, (links to letters).
The FDA found issue with the claims made by these companies related to their CBD products like oil, gels, capsules, as they related to the Federal Food, Drug and Cosmetic Act. In brief the companies made claims that their products treat conditions like Alzheimer’s disease, Parkinson’s disease, Huntington’s disease, or can help with chronic inflammation, psychosis, schizophrenia, depression, Fibromyalgia, arthritis, Psoriasis (the list goes on and one – and pretty much reads as though CBD is a cure-all). These claims meant the FDA viewed the products as “drugs” under the FD&C Act because they state that the CBD products are “intended for use in the diagnosis, cure, Mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or any function of the body.”
To the extent the products were marketed as supplements, the FDA found issue with the marketing and the description because the products contain CBD as an ingredient. And under the FD&C Act, if the active ingredient in a drug product is one that has been approved under the FD&C act (CBD has) or authorized for investigation as a new drug then products containing that substance are outside the definition of a dietary supplement.
The FTC raised issues with the companies’ statement as unsubstantiated advertising claims. Under the FTC Act a company cannot advertise products as something that can prevent treat or cure human diseases unless there is competent and reliable scientific evidence including, if appropriate, well-controlled human clinical studies substantiating the claims.
Also, making or exaggerating those claims directly or indirectly through the use of a product name, website name, meta tags, or other means, without rigorous scientific evidence sufficient to substantiate the claims, violates the FTC Act. The FTC was concerned that one or more of the claims made by these companies on their websites were not substantiated.
The Takeaways:
Your online presence, both your website and social media, function as sources of information that create liability – monitor them and ensure claims in any forum don’t exceed permissible statements. Again, perhaps a social media post limited in character length is it not the best method for advertising a product that requires disclosures.
The FDA and FTC appear to be monitoring interstate commerce regarding CBD products and companies making cure-all claims without evidence should be on notice that unsubstantiated claims, and improper marketing, will result in liability.
Substantiation remains king when it comes to claims.