Advertising Law Blog

As part of its efforts to curtail the dietary supplement industry, the FDA and FTC sent out 12 warning letters and five online advisory letters to companies, many of which are marketing their products as dietary supplements. The FDA warns that to the extent the products display unproven claims to prevent, treat, or cure Alzheimer’s disease (in addition to a number of other diseases and health conditions), such products are being illegally marketed as unapproved new drugs.

As detailed in the letters sent to Gold Crown Natural Products, TEK Naturals, and Pure Nootropics, LLC, the government warned companies’ that their advertisements alleging to treat Alzheimer’s disease and remediate or cure other serious illnesses, including Parkinson’s, heart disease, diabetes, ADHD, epilepsy, and cancer, were unlawful. The FDA and FTC went on to state that unless such claims were remedied, the companies would be subject to enforcement, including seizure and an injunction. For example, the FDA and FTC sent a joint warning letter to Pure Nootropics concerning the claim that its supplement “prevents cognitive decline (such as senile dementia and Alzheimer’s disease).” The FDA also sent a warning letter to Nutrition Coalition for selling a nutritional supplement with claims that it “may also … possibly reduce Breast Cancer risk by 90%, possibly Double the chance of surviving breast cancer, decrease risk of ALL cancers by 77% at just moderate levels of Vitamin D, lower LDL Cholesterol, help prevent Autism...” (bold font in original).  Moreover, the FTC raised concerns about the lack of substantiation surrounding these claims in its joint warning letters.

The concept of the FDA issuing warning letters in the context of unapproved claims is consistent with the processes outlined in its FDA Regulatory Procedures Manual, where such process is defined as “the principal means by which the agency provides prior notice of violations and of achieving voluntary compliance.” The issuance of warning letters by the FTC in this context, however, is markedly different than the more common use of enforcement proceedings without issuance of a warning letter. Whether the FTC’s use of the warning letter represents a revamped method of addressing what it perceives to be improper claims, or this cluster of warning letters is merely an isolated occurrence remains to be seen. 

In addition to the issuance of the warning and advisory letters, the FDA announced a new comprehensive framework for addressing regulatory concerns relating to dietary supplements.   Commissioner Gottlieb announced the formation of a Dietary Supplement Working Group at the FDA, which he has tasked with examining the FDA’s “organizational structures, processes, procedures and practices in order to identify opportunities to modernize” the FDA’s oversight of dietary supplements. Further, Commissioner Gottlieb announced that the FDA is developing a “new rapid-response tool” that will be used to alert consumers when a particular unlawful ingredient is used in a certain product so that they can avoid purchasing such products, and also to notify industry participants so that they avoid making or selling such products. The FDA is planning a public meeting this Spring on the topic of responsible innovation in the dietary supplement industry.

Finally, the FDA announced its intention to “engage in a public dialogue” related to modernizing the Dietary Supplement Health and Education Act (DSHEA), including potential changes to the law and changes to the regulatory processes in place with respect to dietary supplements.

Takeaway: The warning letters and other implementations are a clear signal to the dietary supplement industry that regulators are serious about addressing disease claims and unsubstantiated advertising. Industry, including manufacturers and marketers of dietary supplements, should take note of the types of claims the FDA and FTC have identified, and revise their marketing materials accordingly.