Hatch, Harkin pressure FDA to withdraw NDI guidance

Sens. Orrin Hatch and Tom Harkin have called on FDA to immediately withdraw its draft NDI guidance. The senators said the guidance does not match their intent when they wrote DSHEA, and asked for a meeting soon with FDA to discuss a rewrite of the guidance.

The pressure continues to build on the U.S. Food and Drug Administration (FDA) to withdraw its New Dietary Ingredients (NDI) draft guidance. Before Christmas, two longtime industry stalwarts, Sens. Orrin Hatch, R-UT and Tom Harkin, D-IA,  sent a letter to FDA director Margaret Hamburg asking her to immediately withdraw the agency's NDI draft guidance and to meet with the senators sometime this month to talk about writing a new draft.

There has been no response yet from FDA.

This move was not unexpected, given that all the main industry associations and many other influential industry figures have called for the same thing. But given that Hatch and Harkin are the main authors of the Dietary Supplement Health and Education Act (DSHEA), and therefore can comment definitively on what they meant when they wrote it in 1994, the request carries added weight. In the letter they used, for example, the phrase “it diverges from our intent” when discussing provisions of the draft guidance. In industry, this is like Moses weighing in on what was on the tablets.

“It is extremely valuable to have the original authors of DSHEA in Congress to offer their perspective. With the amount of turnover in Congress, you have to stop and pause and to realize how remarkable this is,” said Loren Israelsen, executive director of the United Natural Products Alliance. It's inconceivable, Isrealsen added, that FDA will not respond in some way to Hatch's and Harkin's request.

Why the DSHEA authors oppose FDA's NDI guidance

The senators’ main objection is the bottom line for everyone: FDA’s interpretation requiring new NDI filings on finished products, as opposed to ingredients, “would impose substantial additional costs on manufacturers without providing additional safety benefits.”

The senators took issue with the (short) list included in the guidance of what can be done to an ingredient without having that ingredient be considered chemically altered and therefore subject to a NDI filing. The guidance document erred, the senators wrote, by “incorrectly construing the list in DSHEA legislative history as an exclusive rather than illustrative list.” The result of this error would be to require hundreds of NDI filings in ingredients that have been in the marketplace for decades and which have undergone relatively minor manufacturing updates.

The senators also took issue with FDA’s stance on synthetic botanical ingredients. The draft guidance specifically excludes these substances, which include synthetic versions of resveratrol and lycopene (not called out by name in the guidance document, by the way). The senators objected to this exclusion, calling it “wholly without statutory basis, and in fact contradicts longstanding FDA policy.”

It is reminiscent of the scene in Woody Allen’s move Annie Hall in which the late media theorist Marshall McLuhan appears in person to upbraid a pretentious sophisticate who was blathering on (incorrectly) about McLuhan’s theories. “I heard what you were saying,” McLuhan said. “You know nothing of my work!” “Boy, if life were only like this!” Woody Allen’s character said. Well, now it is.

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