The Federal Trade Commission (“FTC”) announced on September 10, 2019 that it sent warning letters to three unidentified companies for making claims regarding their products that contain cannabidiol (“CBD”), a compound derived from cannabis. The products, which range from “gummies,” and creams to oils, tinctures and capsules were advertised with claims that the products could treat serious diseases and conditions.
In prior posts, we have mentioned Food and Drug Administration (“FDA”) regulation of drug claims. When claims are made regarding the diagnosis, cure, mitigation, treatment, or prevention of disease or that a product affects the structure or function of the body, the product’s intended use switches to being a drug –which requires pre-approval by the FDA based on detailed clinical evidence. The FDA and FTC both have some jurisdiction over marketing and advertising with the FDA taking the lead with respect to labeling under the Federal Food, Drug and Cosmetic Act (“FD&C Act”) and the FTC with respect to advertising under the Federal Trade Commission Act (“FTC Act”). The FTC is the primary, although not the only, regulator of advertising in the U.S. Similar to the FDA, the FTC requires that any advertisement that claims that a product can prevent, ameliorate, treat, or cure human disease be supported by competent and reliable scientific evidence. As the FTC and FDA work together, such a claim must be pre-approved by the FDA.
According to the FTC, one company’s website called CBD a “miracle pain remedy” for pain, including pain from arthritis and cancer and stated that CBD products are proven to treat autism, anorexia, bipolar disorder, post-traumatic stress disorder, schizophrenia, anxiety, depression, Alzheimer’s disease, Lou Gehrig’s Disease (ALS), stroke, Parkinson’s disease, epilepsy, traumatic brain injuries, diabetes, Crohn’s disease, psoriasis, MS, fibromyalgia, cancer, and AIDS.
Another company advertised that its products could treat arthritis, heart disease, fibromyalgia, cancer, asthma, and other autoimmune disorders, relieve arthritis pain and treat depression, PTSD, and epilepsy.
Finally, one company claimed its product was more effective at relieving pain than prescription opioids, worked “like magic,” and that it had participated in “thousands of hours of research” with Harvard researchers.
The FTC told the companies to review their claims to confirm they are supported by competent and reliable scientific evidence. The letters include the warning that advertising such claims without substantiation could subject them to legal action and would likely violate Section 5(a) of the FTC Act which prohibits “unfair or deceptive acts or practices in or affecting commerce” and Section 12 of the FTC Act, which prohibits “dissemination of any false advertisement in or affecting commerce for the purpose of inducing, or which is likely to induce, the purchase of food, drugs, devices, services or cosmetics.” The FTC instructed the companies to notify the FTC within 15 days about the specific actions that they had taken to address the FTC’s concerns.
The FTC also regulates the use of testimonials and endorsements. The letters included the reminder that any claims made by consumer testimonials must likewise be supported by competent and reliable scientific evidence. The FTC’s Guides Concerning Use of Endorsements and Testimonials in Advertising make clear that “the advertiser must possess and rely upon adequate substantiation, including, when appropriate, competent and reliable scientific evidence, to support such claims made through endorsements in the same manner the advertiser would be required to do if it had made the representation directly, i.e., without using endorsements.”
In late March of this year, the FTC and the FDA jointly sent letters to three different companies for making similar advertising claims about CBD and its medicinal qualities. Those letters and the companies to whom they were sent have been made public (Relievus, PotNework, NutraPure) and the letters may be instructive given that the substance of the September CBD letters has not been made public. The Relievus letter concludes with respect to FTC Act violations:
it is unlawful … 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. More generally, to make or exaggerate such claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims, violates the FTC Act.
The list of claims made by Relievus at its websites and on Facebook that the FTC and FDA specifically pointed out included treatments and cures for a myriad of conditions and diseases, including Alzheimer’s disease, Amyotrophic Lateral Sclerosis (ALS), anxiety, autoimmune disorders, cancer, chronic inflammation, chronic pain, Crohn’s Disease, depression, diabetes, inflammatory bowel disease, obsessive compulsive disorder, panic disorder, Parkinson’s disease, post-traumatic stress disorder (PTSD), rheumatoid arthritis, schizophrenia and substance abuse disorders.
The claims made by PotNetwork appeared to be more carefully worded and made reference to some research, but the FTC made the same warnings with regard to the FTC Act and the FD&C Act.
Finally, with regard to Nutra Pure, the FDA/FTC letter notes that the claims made “establish the intended use of your products as drugs.” The claims included:
- “For Alzheimer’s patients, CBD is one treatment option that is slowing the progression of that disease.”
- “For many, CBD holds the answers to treating depression.”
- “Cannabidiol (CBD) . . . is building a reputation as an effective and safe treatment alternative in the battle against chronic inflammation.”
Clearly, both the FDA and the FTC continue to be interested in these types of claims with regard to CBD products. The type of cure, mitigation, amelioration, and treatment claims being made by the three companies targeted in March and the three companies targeted in September are an invitation to enforcement by the FTC and the FDA and should be avoided.
