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DSHEA co-author is ‘alarmed’ by NDI guidance

2 commentsBy Elaine Watson, 22-Aug-2011

Related topics: New ingredient approvals, NDI draft guidance, Regulation

The chief architect of the 1994 Dietary Supplement Health and Education Act (DSHEA) does not believe the Food and Drug Administration’s (FDA’s) draft guidance on new dietary ingredients (NDIs) is consistent with the legislation he co-authored, his office has confirmed.

Hatch: 'Alarmed' by NDI draft guidance

Hatch: 'Alarmed' by NDI draft guidance

Speaking to NutraIngredients-USA about last week’s town hall meeting called by Senator Orrin Hatch (R-Utah) to discuss the controversial document, Hatch’s press secretary said: “Senator Hatch was alarmed by the guidance. He does not believe it is consistent with DSHEA.”

He would not confirm whether Hatch was preparing to file comments to this effect with the FDA, but added: “We continue to review the guidance, but one of the main reasons we had this town hall was to encourage companies to submit comments of their own.”

Everything is on the table

Asked what might happen if the FDA did not substantially revise the guidance, he said: “Everything is on the table … We’re in the process of exploring what other options may be available but it would be premature to discuss that right now.

“There is a process to go through and Senator Hatch believes that we need to make sure we follow it.”

Asked whether there was much sympathy in the senate for the supplement industry’s concerns about the guidance, he added: “Certainly there will be senators on both sides of the guidance.

“But our concern remains in ensuring that Utah businesses have the opportunities and information they need to voice their concerns to the FDA.”

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2 comments (Comments are now closed)

FDA Speed Bump

Thank you Sen. Hatch for all you have done to ensure we have access to life enhancing supplements. The NDI requirement is just another speed bump that the FDA routinely uses to restrict/impede our access to cheap, safe, and effective supplements.

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Posted by Dean Mindock
21 September 2011 | 13h33

Guidelines are directed to squash the natural science

Censorship does exit in America.And how unforturnate that it is on the food and supplement front. The American people are facing more polluants than ever before on the known history of planet earth.
The lack of understanding with the American Medical Association and the Pharmacuetical Companies is because of the lack of understanding of natural science in medical college. How can anyone have an opinon with missing science lacking at it's base?
Dick Durbin had the change to get the deadly narcotic oxycodan or oxycotton off the market from a Mother's plea for help since her son and his best friend died of an over dose in 7th grade. Have you noticed dangerous drugs get to prevail?

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Posted by Sandra Hornsby White
24 August 2011 | 00h28

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