AHPA recommends FDA implement policies to support innovation

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AHPA recommends FDA implement policies to support innovation

Published: Wednesday, July 17, 2019

The American Herbal Products Association (AHPA) submitted extensive and specific policy recommendations on July 15 to the Food and Drug Administration (FDA) to support responsible dietary supplement innovation while preserving and strengthening FDA’s ability to efficiently and effectively protect the public from unsafe and unlawful products.

AHPA submitted these recommendations to FDA in response to an April 11, 2019 Federal Register notice soliciting interested parties' input on various issues related to responsible innovation in dietary supplements through written comments and a public meeting held May 16, 2019.

"These comments provide several suggestions that are consistent with the shared goals of consumers, FDA and the supplement industry to

facilitate responsible dietary supplement product innovation while continuing to efficiently and effectively protect the public from unsafe and unlawful products.," said AHPA President Michael McGuffin.

AHPA's recommendations to FDA include:

  • Issuing targeted guidance on key new dietary ingredient notification (NDIN) issues, including ingredient identification, an optional process for submitting a “master file,” and how to describe broad conditions of use
  • Producing guidance on traditional use claims to harmonize with Federal Trade Commission (FTC) policies
  • Revising FDA's interpretation of the dietary supplement “drug exclusion clause"
  • Completing rulemaking to define the terms “natural” and “healthy”

"AHPA strongly encourages FDA to seriously consider these recommendations in order to support responsible innovation in dietary supplements," McGuffin said.

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