CHPA Submits Comments to FDA Regarding the Development of a Pre-DSHEA Ingredients List

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Press Releases and Statements | Dec 7, 2017

(WASHINGTON, D.C.) —  The Consumer Healthcare Products Association (CHPA) submitted comments this week to the Food and Drug Administration (FDA) regarding the proposed development of an authorized list of dietary ingredients marketed prior to the Dietary Supplement Health and Education Act (DSHEA).

 “CHPA members are committed to maintaining the highest levels of quality in the manufacture and marketing of dietary supplements,” said CHPA president and CEO Scott Melville. “We applaud FDA for their thoughtful, inclusive approach to the development and implementation of a process that will ensure continued consumer access to safe and beneficial dietary supplements that have been marketed for decades.”

 To date, FDA has not recognized an authoritative list of dietary ingredients considered to be marketed prior to October 15, 1994. This fall, FDA solicited public comment on the standard of evidence and the process used to develop the list of pre-DSHEA dietary ingredients.  The CHPA submission builds upon concepts initially presented at an October 3, 2017, FDA public meeting and provides key considerations regarding the following:

  • Evidence supporting pre-DSHEA marketing of a dietary ingredient, including the types and quantity of evidence supporting pre-DSHEA marketing, consideration of probiotic ingredients, and the impact of manufacturing changes or chemical alterations.  
  • Process for development of a list of pre-DSHEA dietary ingredients, including review panel composition and role, the process for nominating ingredients, and the format of the final pre-DSHEA list. 

 “An authoritative list of pre-DSHEA dietary ingredients would benefit both industry and FDA by reducing the burdens associated with the preparation and review of New Dietary Ingredient notifications,” said Melville. “We appreciate the opportunity to provide comments and look forward to ongoing discussions with FDA and other stakeholders.” 

Read the full submission

Founded in 1881, the Consumer Healthcare Products Association (CHPA) is the national trade association representing the leading manufacturers and marketers of over-the-counter (OTC) medicines, dietary supplements, and consumer medical devices. Every dollar spent by consumers on OTC medicines saves the U.S. healthcare system more than $7, contributing a total of $146 billion in savings each year. CHPA is committed to empowering consumer self-care by preserving and expanding choice and availability of consumer healthcare products.