On On April 27, 2012, the U.S. Food and Drug Administration (“FDA”) issued warning letters to several dietary supplement manufacturers in connection with their alleged improper marketing of supplements containing dimethylamylamine (“DMAA”). DMAA, also referred to as geranium extract, is an ingredient found in many dietary supplements and is frequently marketed as a natural stimulant. As discussed in the FDA’s announcement, the Agency considers the marketing of products containing DMAA improper because the ingredient has not been proven to be safe for consumers. Accordingly, these products are considered adulterated under the Federal Food, Drug and Cosmetic Act (“FFDCA”).
Under the FDA’s regulatory regime, manufacturers and distributors of dietary supplements containing ingredients considered to be “New Dietary Ingredients” (“NDIs”) must submit notification to the FDA. Under the FFDCA, a NDI is an ingredient that was not marketed in the United States in a dietary supplement prior to October 15, 1994. For products that contain a NDI, the manufacturer or distributor thereof must submit a NDI Notification. This process, among other things, requires that evidence be provided to show the safety of the ingredient for conditions in labeling. More information about the NDI Notification process may be accessed here. Because marketing a product with a NDI without giving proper notification to the FDA can result in the product being adulterated under federal law, it is important to consider whether an ingredient is considered an NDI prior to marketing new products and even when developing product formulations.
