FDA Sets Oct. 3 for Pre-DSHEA Ingredients Hearing

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Washington, DC — FDA’s Center for Food Safety & Applied Nutrition will meet Oct. 3 from 8am to 5pm to discuss development of a list of pre-DSHEA dietary ingredients.

More meeting specifics, including how to register, will be available later this month through a Federal Register Notice and on the FDA public meetings website. Meeting location will be the Wiley Auditorium, 5001 Campus Drive, College Park, MD, 20740.

The Dietary Supplement Health and Education Act of 1994 (DSHEA) amended the Food, Drug & Cosmetic Act (FD&C) to require the manufacturer or distributor of a new dietary ingredient (NDI) or supplement that contains the NDI to submit a premarket notification to FDA at least 75 days before introducing the product into interstate commerce or delivering it for introduction.

Using its historic trade publications, the Natural Products Association (NPA) has compiled a pre-DSHEA list containing more than 2,000 ingredients it believes meet the FDA standard of “independent and verifiable” but says the agency has delayed the sharing of the list.

NPA encouraged its members to contact their congresspeople to accelerate the process.

“We don’t believe this is an acceptable use of agency discretion and doesn’t show an open or flexible approach (as required by the Regulatory Flexibility Act) in considering data for development of a list going forward,” the NPA wrote in an email.

“You can also contact Steven Tave Steven.Tave@fda.hhs.gov or Cara Welch Cara.Welch@fda.hhs.gov and let them know that development of a pre-DSHEA list shouldn’t wait,” NPA asserted.

The American Herbal Products Association (AHPA) “has long suggested that FDA approach specific subject areas of the complex new dietary ingredient (NDI) provisions in the Food, Drug & Cosmetics Act separately, rather than in a single guidance document,” said Michael McGuffin, AHPA president. “While we might not have chosen development of a list of pre-DSHEA dietary ingredients as a first priority, we are hopeful that FDA’s more focused attention on this specific detail can lead to a process that will provide useful guidance for the supplement trade.

AHPA will be actively engaged in the public meeting, he said, and “will pay particular attention to whether the agency has accepted some of the comments submitted by AHPA and others to push back against extra-legal ideas proposed by FDA in relation to pre-DSHEA dietary ingredients in FDA’s 2016 revised draft NDI guidance document and its 2011 predecessor, especially those that would create a new burden to demonstrate the pre-DSHEA status of old ingredients.”

Published on WholeFoods Magazine Online, 8/16/17. (Updated 8/17/17)

 

 

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