By: Tim Sawyer

Tim Sawyer — Tue, 16 Jul 2024 22:53:55 +0000

The FDA’s new dietary ingredient (NDI) notification process threatens access to thousands of dietary supplements. It is critical that the NDI guidance be revised again to reflect what was intended in the Dietary Supplement Health and Education Act of 1994 (DSHEA): to expand, not restrict, consumer access to supplements, and not to turn supplements over to drug companies.

The biggest problem with the guidance is that it takes what is supposed to be a pre-market notification process and morphs it into a pre-market approval process. This is not practical for supplement companies, which cannot recoup the costs of such approvals like pharmaceutical companies can for patentable drugs.

The FDA is also broadening the group of substances that must submit NDIs by adopting a loose definition of what it means for a supplement to be “chemically altered.” If a post-DSHEA ingredient has been present in the food supply and has not been chemically altered, it is exempted from submitting a NDI notification. The problem is that the FDA’s definition of “chemically altered” is so broad that only the most basic manufacturing methods would not “chemically alter” an ingredient. This language will stifle innovation in manufacturing.

The NDI guidance needs to be amended to protect my supplement access and to reflect what Congress intended when it passed DSHEA.

By: Amy Harlib

Amy Harlib — Sat, 13 Jul 2024 05:37:23 +0000

TRIED TO SEND THE MESSAGE OVER AND OVER AND KEPT GETTING:
One or more errors occured in ActivityScope.Dispose()

PLEASE FIX IT! THANKS.

Comments on: Bugging Out: Let’s Get Probiotics off the FDA’s Chopping Block!

By: Tim Sawyer

By: Amy Harlib