Burton Proposes New Grandfathered Dietary Ingredient Date of January 1, 2007

November 9, 2011

By Riëtte van Laack

Last week, Rep. Dan Burton (R-IN) introduced the “Dietary Supplement Protection Act of 2011.”  Referencing the exemplary safety record of dietary supplements, the bill proposes to amend section 413(d) of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to significantly increase the number of “grandfathered” dietary ingredients.  Currently, section 413(d) defines a new dietary ingredient (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.”  The amendment would move this date from October 15, 1994 to January 1, 2007.

As we previously reported, FDA’s recently issued draft guidance on NDIs suggests that, to qualify for grandfathered status, a manufacturer must possess both proof of prior marketing and proof that the current manufacturing method for the dietary ingredient is identical to the method used before the grandfather date.  This standard could be difficult to meet for many dietary ingredients due to the lack of information on manufacturing methods used before the grandfather date.  Moving the date for grandfather status to January 1, 2007, would reduce the number of dietary ingredients for which the manufacturing method may have changed, and reduce the chance that industry no longer possesses information about the manufacturing method for a grandfathered dietary ingredient.

Rep. Burton’s bill does not address any other issues raised by FDA’s draft guidance, e.g., FDA’s interpretation of what constitutes “chemical alteration” and the meaning of “presence in the food supply” as those terms are used in section 413(a)(1).