FDA issues flurry of Warning Letters to companies marketing DMBA as a dietary ingredient in dietary supplements.
- By law, a “dietary ingredient” is defined as a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by humans to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. To be marketed lawfully in the United States as a dietary ingredient in dietary supplements, a substance must either be an “old” dietary ingredient marketed in the United States before October 15, 1994 or a “new” dietary ingredient (NDI) introduced to the market after that date. For a dietary supplement containing an NDI, either: (1) the product containing the dietary ingredient must contain only dietary ingredients that have been “present in the food supply as an article used for food in a form in which the food has not been chemically altered”; or (2) the manufacturer or distributor of the product must notify FDA of the basis on which that party has concluded that that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe. The notification (called an NDI Notification or NDIN) must be submitted at least 75 days before marketing and must describe the history of use of the ingredient or other evidence establishing a reasonable expectation of safety when the dietary ingredient is used under the conditions recommended in the labeling.
- On April 24, 2015, FDA issued Warning Letters to 14 companies regarding the marketing of products that identify the presence of 1,3-Dimethylbutylamine or “DMBA” on the product label. FDA considers these products to be adulterated because, according to the Agency’s allegations, there is no evidence that DMBA is an “old” dietary ingredient and it does not meet the requisite NDI marketing conditions described above. The Warning Letters also note that DMBA used in supplement products may be produced synthetically; if this is the case, FDA takes the position that synthetically produced DMBA is not a “dietary ingredient” at all under the statutory definition of that term, even though industry has strongly disagreed with this interpretation for many years.
- FDA’s action marks a second wave of dietary ingredient-related Warning Letters within a one-week period. As in the Agency’s recent Warning Letters related to BMPEA, FDA has not actually cited any specific health or safety concerns related to the use of supplements containing DMBA. Instead, these enforcement actions focus squarely on the “administrative problem” of selling dietary ingredients that do not meet FDA’s requirements for lawful marketing. For years, FDA has taken relatively little enforcement action in the dietary supplement marketing arena unrelated to specific health or safety concerns. These recent actions indicate that the Agency can strike at any time, however, and that dietary ingredient suppliers and dietary supplement manufacturers should ensure the existence of a valid legal and regulatory basis for the marketing of their products.