Clarifying the Confusion over New Dietary Ingredient Notifications

By Wes Siegner & Cassandra A. Soltis –

There has been a buzz in the trade press and industry over when a company is required under the Federal Food, Drug, and Cosmetic Act ("FDC Act") to submit to the Food and Drug Administration ("FDA") a 75-day premarket notification for a new dietary ingredient ("NDI").  Although parts of section 413 of the FDC Act are certainly confusing, the law is clear that an NDI does not need to be notified if it is “present in the food supply as an article used for food in a form in which the food has not been chemically altered.”  FDC Act § 413(a)(1).  Contrary to what has been reported in the press, to qualify for this alternative to the notification requirement, it is not necessary that the NDI be present and marketed in the food supply as an article used for food prior to October 15, 1994.  Presence in the food supply at any time, in any part of the world, is sufficient under the terms of § 413(a)(1).

Section 413 of the FDC Act defines an NDI as “a dietary ingredient that was not marketed in the United States before October 15, 1994 and does not include any dietary ingredient which was marketed in the United States before October 15, 1994” (emphasis added).  In other words, dietary ingredients that are first marketed in the United States on or after October 15, 1994 are, by definition, new dietary ingredients. 

A new dietary ingredient may be marketed immediately—that is, without FDA notification—if it is “present in the food supply as an article used for food in a form in which the food has not been chemically altered.”  FDC Act § 413(a)(1).  If there is no such evidence, however, the new dietary ingredient may still be marketed provided that a 75-day premarket notification is submitted to FDA and the notification contains, among other things, evidence that the dietary supplement containing the new dietary ingredient will “reasonably be expected to be safe.”  FDC Act § 413(a)(2).  In contrast, dietary ingredients marketed in the United States before October 15, 1994 are generally referred to in industry as “old dietary ingredients.”  Old dietary ingredients may be immediately marketed in dietary supplements; there is no notification required. 

Unlike § 413(c), which specifies that to be an old dietary ingredient, an ingredient must have been marketed in the United States prior to October 15, 1994, § 413(a) makes no such specification; the text “present in the food supply” is not qualified and, therefore, applies to any country’s food supply.  Thus, for example, if oat extract is eaten in Scotland (and assuming oat extract is not an old dietary ingredient), then oat extract is “present in the food supply”—the Scottish food supply—and is an “article used for food in a form in which the food has not been chemically altered.”  FDC Act § 413(a)(1).  Therefore, no NDI notification would need to be submitted.