On September 6, 2012, the U.S. Food and Drug Administration (“FDA”) issued warning letters to two dietary supplement companies in connection with promoting unapproved products as drugs. According to the FDA, the firms cited by the Agency, PruTect Rx and Trinity Sports Group, Inc., were targeted for the improper marketing of products labeled as dietary supplements. The FDA alleges that despite being labeled as dietary supplements, these products were labeled with a variety of claims to treat concussions and prevent concussion-related disorders. Accordingly, the FDA has found these products to be unapproved new drugs, in violation of the Federal Food, Drug and Cosmetic Act (“FFDCA”). The full-text of the FDA’s announcement may be found here.
Under the FFDCA and FDA regulations, dietary supplements are categorized as a type of food product. While federal law and regulations allow certain types of claims to be made about dietary supplements, i.e., structure-function claims and/or health claims, these products may not be represented as being effective in the treatment of any disease or condition in man. Thus, claiming that a product is beneficial in the treatment of a disease, known as a “disease claim,” is sufficient to cause a product to be deemed a drug by the FDA. Further, because new drugs require pre-approval by the FDA prior to marketing, allegedly improper claims may not only render a supplement to be deemed a drug – but an unapproved new drug at that. Thus, it is critical to ensure that only permissible claims appear on product labeling, including product labels and other marketing materials.
Warning letters are typically the FDA’s first course of action against companies for alleged non-compliance with the FFDCA and/or FDA regulations. Under the terms of a warning letter, the FDA gives recipients fifteen (15) business days to respond in writing, detailing the specific steps taken to correct violations the FFDCA and accompanying regulations. Firms must respond to all violations, including those not explicitly cited by the Agency. Because appropriate corrective measures often preclude further enforcement, it is critical to be vigilant when mounting a response to perceived deficiencies in compliance. For more information about establishing or maintaining compliance with the regulations or laws FDA enforces, please contact us at firstname.lastname@example.org.