Archive for September, 2011

FDA’s New Dietary Ingredient guidelines

The U.S. Food & Drug Administration finally delivered new guidance on New Dietary Ingredients (NDIs)

  • FDA will take an unexpectedly broad view of NDI notification requirments, and an extremely narrow view of grandfathered dietary ingredients
  • U.S. Capitol BuildingThis guidance could have adverse impact on up to 70% of supplement products now in the marketplace
  • This is only a guidance document with a 90-day comment window
  • Next steps for FDA beyond the comment window remain unclear
  • FDA’s reduced budget further hampers the agency’s ability to enforce stricter regulation
  • The political machine is now churning, and industry’s best advocate in this arena remains Senator Orrin Hatch (R-UT)

After a series of articles questioning FDA’s ability to effectively monitor food safety in this country, the agency decided to bare its teeth and fight back. The NDI guidance now in the public arena continues a larger trend of FDA upping its scrutiny of supplements, and it also follows in the footsteps of aggressive regulatory posturing from EFSA, its European peer, around supplement health claims.

Sen. Orrin Hatch’s remarks:

“I encourage you all to take a very active role as the FDA moves this guidance forward. Inaction from your industry could result in federal bureaucrats dictating every last detail of how your businesses should be run. That is not what I want, and it is not what you or your consumers need.

“I am conscious that FDA has devoted significant resources to this guidance, but a policy needs to be more than manageable for the FDA. It also must enjoy the support of the industry.

“All of us share the common goal of consumer safety, and the present task is to do so as efficiently, and in as market-friendly a way, as possible. I worry that this guidance misses the mark.

Rod Cook, our Industry Watchdog has put together a simple opy and paste letter at:

PLEASE Take Action

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