DSHEA co-author is ‘alarmed’ by NDI guidance

21-Aug-2011 - Last updated on 22-Aug-2011 at 14:48 GMT

Related tags Orrin hatch

Hatch: 'Alarmed' by NDI draft guidance

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1994 Dietary Supplement Health and Education Act (DSHEA) does not believe the Food and Drug Administration’s (FDA’s) draft guidance on new dietary ingredients (NDIs) is consistent with the legislation he co-authored, his office has confirmed.

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.”