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Lawyer on NDI guidance: FDA is trying to ‘dismantle’ DSHEA

By Elaine Watson , 18-Jul-2011
Last updated on 18-Jul-2011 at 17:32 GMT2011-07-18T17:32:27Z

The argument that the FDA has overstepped its legal remit in its draft guidance on new dietary ingredients (NDIs) is gaining ground, with one food law expert claiming the FDA is “trying to dismantle” the legislation it is supposed to be clarifying.

Speaking to NutraIngredients-USA.com on Friday, Wes Siegner, a director at Washington DC-based legal firm Hyman, Phelps & McNamara, said: “The bottom line is that the FDA is trying to dismantle the legislation [Dietary Supplements Health and Education Act or DSHEA].

"They don’t like supplements because they don’t approve them before they go to market.”

Clearly never intended by Congress

By questioning the legal status of thousands of ingredients assumed to be grandfathered in under DSHEA by imposing “unachievable documentation requirements to prove prior marketing and/or the requirement that there be no change in the manufacturing method”, the FDA had “exceeded the statutory authority granted by DSHEA”, claimed Siegner.

Meanwhile, FDA's insistence that NDI notifications were applicable only to the specific manufacturer that submitted them, and that firms making even small changes to formulas/target groups/conditions of use for supplements containing NDIs must prepare fresh notifications for each new supplement, was also inconsistent with DSHEA, which was designed to foster innovation, he said.

“That clearly was never intended by Congress.”

Lacking in scientific and legal merit

Commenting on FDA dietary supplements chief Dan Fabricant’s claim that there were no real surprises in the guidance, he added: “I don’t think he’s been at the agency long enough to really believe what he’s saying right now.”

While he conceded that the FDA’s view that synthetic equivalents of botanical constituents did not qualify as dietary ingredients was not new, it was still “lacking in scientific and legal merit”, he argued.

“Yes, the FDA has voiced its views on this before [in recent responses to citizen’s petitions] but the issue is nowhere near being resolved. This is going to shut off innovation.”

Instead of outlining a workable system that would incentivize more companies to follow the law, the guidance (if followed) would just “swamp the FDA with pointless work”, he added.

“When the agency comes out with something this dramatically wrong, it’s hard to know what will happen next.”

ANH-USA: FDA disregards clear and compelling evidence of the law’s intent

As regards the safety requirements in the NDI guidance, DSHEA had made it very clear that “dietary supplements are not drugs or food additives” and that “regulations relating to food additives are not applicable to dietary supplements”, added The Alliance for Natural Health (ANH) USA.

“Under DSHEA, dietary ingredients were intentionally exempt from those food additive provisions [enshrined in the Federal Food, Drug, and Cosmetic Act] to ensure that the FDA would not ban new supplement dietary ingredients as illegal unapproved food additives.

“[But with this guidance, the FDA] simply disregards clear and compelling evidence of the law’s intent.”

It added: “This [guidance] essentially ensures that many—and eventually, most—dietary ingredients currently on the market will be considered an NDI, subject to notification, and therefore to disapproval.”

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