Enforcement Is Key Concern About Forthcoming FDA "New Ingredient" Guidelines

Food industry experts are saying there’s little to fear about the forthcoming “new dietary ingredients” guidelines from the FDA -- which are focused on whether ingredients are safe rather than effective -- except the possibility of aggressive enforcement. Some companies may have to worry about whether they can prove their ingredients qualify as “old dietary ingredients,” which are exempt from the 1994 federal dietary supplements law. The FDA may look more closely at whether an “old” ingredient has been chemically altered enough – to increase potency, for example – to make it a “new” ingredient under the law. Another key concern about the revised NDI rules is whether the FDA will look differently at new ingredients that have already achieved GRAS (generally recognized as safe) status.