FDA’s interpretation of 21 U.S.C. § 350b limits “grandfathered” dietary ingredients to those marketed in the United States before October 1994. The FDA has focused 21 U.S.C. 350b(c) narrowly, concluding that the statutory language does not extend to include components or articles of food that were not specifically marketed. For example, in 2009, the FDA concluded that pyridoxamine (one of three primary natural forms of vitamin B6) had not been marketed in the food supply as a dietary ingredient and, thus, was preempted by an investigational drug study. This week FDA published its draft guidance: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues. The guidance includes FDA’s interpretation of key language in the New Dietary Ingredient statute, particularly the prior marketing terminology.
Dietary supplement companies should observe that “grandfathered” status is limited to only certain dietary ingredients that were in the United States food supply prior to 1994. An ingredient must have been directly marketed to achieve grandfathered status. Showing that the ingredient simply appeared in conventional foods is insufficient, unless the ingredient was specifically marketed for inclusion in food manufacturing. The focus remains on promotion of the ingredient or component itself. For example, a chemical component of Food X may require a NDI even if Food X was served on dinner tables for generations. You can market Food X in a form that has not been chemically altered, but you cannot market a component of Food X unless the component itself was marketed as a dietary ingredient before 1994. A synthetic copy of Food X (or any of its components) will be considered a NDI. FDA concludes that synthetic copies of dietary ingredients require NDIs because the synthetic article, even if bioidentical, was not actually marketed to consumers.
The guidance identifies record evidence required to establish prior-marketing in the United States, and reiterates FDA’s position that industry lists of grandfathered ingredients are not prima facie evidence.
As we move further from the passage of the DSHEA, the cost and effort needed to demonstrate grandfathered status will become increasingly burdensome. Companies with doubts about the grandfathered status of ingredients should review the FDA’s latest guidance carefully.
– Peter Arhangelsky can be reached at (202) 466-6937.