CHPA Calls on FDA to Withdraw its New Dietary Ingredient Draft Guidance

FDA guidance as written would negatively impact consumer access to dietary supplements

Washington, D.C. (December 2, 2011)—The Consumer Healthcare Products Association (CHPA) filed comments today with the U.S. Food and Drug Administration (FDA) seeking withdrawal of its New Dietary Ingredient (NDI) Draft Guidance and calling upon the agency to work with stakeholders on a revised version that will maintain the current scope and intent of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

CHPA’s submission, filed jointly with the Council for Responsible Nutrition (CRN), notes that the agency’s proposed guidance would impose significant and unnecessary new burdens on the dietary supplement industry without conferring additional benefits to consumers.

“We had hoped FDA would propose a reasonable guidance related to new dietary ingredients, but this guidance goes far beyond what Congress authorized under the Dietary Supplement Health and Education Act of 1994,” CHPA President and CEO Scott Melville said. “Rather than developing standards and a process for new dietary ingredients in accordance with DSHEA, this guidance would impose significant new burdens that would impact consumer access to dietary supplements as well as reduce innovation and growth of this industry.”

CHPA’s comments highlighted five areas of concern, including the draft guidance’s requirement of notifications for individual supplements by each manufacturer rather than for the ingredient—a process that, if realized, would result in duplicative and unnecessary notifications.

“CHPA member companies are committed to ensuring that consumers have access to safe and beneficial dietary supplements,” Melville said. “But this guidance goes beyond what is authorized under DSHEA and could have a negative impact on product availability. We hope FDA will carefully review our comments and reconsider how to establish a process that is more consistent with DSHEA.”

Contacts:  Jenni Terry or Elizabeth Funderburk, 202.429.9260

CHPA is the 130-year-old-trade association representing U.S. manufacturers and distributors of over-the-counter medicines and dietary supplements.