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NDIs pot now on simmer, AHPA counsel says


FDA's New Dietary Ingredients were the subject of a session at Engredea/Expo West. The key takeaway: Don't fear your regulations before they're finalized.

NDIs were on the front burner at Nutracon/Engreda/Expo West, even though an industry expert advised we move it to the back burner.

A panel of speakers expounded on FDA’s draft guidance on New Dietary Ingredients on Saturday at the Anaheim Convention Center as part of the show education.  The headline speaker, Anthony Young, general counsel for the American Herbal Products Association, advised those in attendance to turn down the temperature on the topic. It’s a draft guidance, he reminded the audience, not a formal rule.  FDA is not legally empowered to enforce the vision set out in the guidance as it now stands. And considering that FDA has received 146,000 pages of comments on the draft, all of which must be at least read and catalogued, Young said revision and final adoption of the guidance is years away...  assuming, that is, that it ever moves to a final form, which he said is not a given.

I was one of the speakers, too, and I laid out the sticking points industry has with the guidance, including whether the process is based on ingredients or finished products, and what constitutes “chemical alteration” that would move an ingredient from the Old Dietary Ingredient column into the New. Other points I covered included the status of synthetic botanicals and probiotics.  My colleague Carlotta Mast, editor in chief of and Natural Foods Merchandiser, covered the NDI issue from a retailer’s perspective.

A question from the audience about a letter Rep. Ron Paul, R-TX had written to FDA on the draft guidance stumped me. I was stumped because Paul did indeed sign such a letter, but hadn't sent it under his own auspices.  He was one of 17 members who sent a letter asking FDA Commissioner Margaret Hamburg to withdraw the guidance.  The tone and substance of the letter closely mirrored a previous letter to Hamburg from Senators Orrin Hatch, R-UY, and Tom Harkin, D-IA.

Discuss this Blog Entry 1

on Mar 13, 2012

Thanks for your post, Hank. NDI needs to be on the front burner so that after the elections we are not suddenly taken by surprise. The FDA was not "empowered" to re-interpret the law it was given by the American people through Congress to regulate, but it did go ahead and do that anyway. Plus, FDA is already citing this "informal" Guidance as if it were already finalized. Regarding Dr. Paul's letter, Congressman Paul sent a letter to his entire Congressional District after we met with Norm Singleton on December 2nd, which can be accessed here:

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