Proposed Legislation Would Clamp Down on New Dietary Ingredients

By Ricardo Carvajal

In an effort to grant FDA additional authority over dietary supplements, Senators John McCain and Byron Dorgan have introduced the Dietary Supplement Safety Act of 2010. The bill would require dietary supplement facilities to provide FDA with information on supplements and their ingredients on an ongoing basis, would substantially alter the requirements applicable to new dietary ingredients ("NDI’s"), would give FDA mandatory recall authority, and would expand adverse event reporting requirements, among other changes.

Particularly noteworthy are the changes in the requirements applicable to NDI’s that would take effect if the bill were to become law. Currently, FDCA § 413(c) 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.” If a dietary ingredient meets the definition of an NDI, then a manufacturer or distributor must submit a 75-day premarket notification to FDA that provides the basis on which the manufacturer or distributor has concluded that a dietary supplement containing the NDI will reasonably be expected to be safe, with one exception. A premarket notification need not be submitted if “the dietary supplement contains only dietary ingredients which 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.”

In conjunction with the passage of the Dietary Supplement Health and Education Act of 1994, dietary supplement trade associations developed “grandfather” lists of dietary ingredients that were marketed in the U.S. before October 15, 1994, and therefore were not subject to regulation as NDI’s. Although FDA does not regard these lists as dispositive of a dietary ingredient’s status as a grandfathered dietary ingredient, manufacturers and distributors continue to rely on the lists. The proposed legislation would amend the existing definition of an NDI to eliminate the references to October 15, 1994, and instead authorize FDA to establish a list of “accepted dietary ingredients.” Dietary ingredients not on that list would be regulated as NDI’s. Further, all such ingredients would have to be the subject of a 75-day premarket notification to FDA because the proposed legislation would abolish the exception to the premarket notification requirement described above.

In proposing the legislation, Sen. McCain referenced a previous GAO report that made numerous recommendations with regard to FDA’s regulation of dietary supplements, including a recommendation that FDA issue guidance to clarify when a dietary ingredient is a new dietary ingredient (that guidance has yet to issue). Notably, GAO just sent out letters to a number of supplement manufacturers seeking information on specific dietary ingredients, including substantiation of any company determinations that submission of an NDI notification is not required. Just as the previous GAO report is being cited in support of calls for reform, the results of the current GAO inquiry could well be seized upon by advocates of reform if that inquiry reveals any apparent shortcomings in FDA’s oversight of NDI’s.