Ullman: NDI draft guidance withdrawal unlikely, but industry deserves timely response

By Elaine Watson

- Last updated on GMT

Related tags Draft guidance Dietary supplement Fda

Ullman: NDI draft guidance withdrawal unlikely, but industry deserves timely response
While it is possible that the FDA could withdraw its draft guidance on new dietary ingredients (NDIs), such a move would be “highly unusual”, according to one leading food law attorney.

Ullman, Shapiro & Ullman partner Marc Ullman, who himself called for the “fatally flawed​” document to be immediately withdrawn in his formal comments to the FDA, said: “I think it is very unlikely they will withdraw it and start again. It would be highly unusual.”

Ullman, who was speaking to NutraIngredients-USA after Randy Hultgren (Rep, IL-14) took to the floor of the House of Representatives to urge the FDA to “go back to the drawing board​” on the guidance, added:

“And as it was mandated by law, withdrawing it and then doing nothing is not an option either.”

A chilling effect on industry

The worst scenario, he said, is if the FDA lets it "languish for months or years as draft guidance, as has happened with the draft guidance on the line between liquid dietary supplements and conventional foods and beverages. This would have a chilling effect on the industry.

“However, I don’t think this will happen. I would be surprised and disappointed if the agency doesn’t address the substantial concerns of the industry over this.”

Taking the fight to Capitol Hill or the courts

As for legal avenues, options were fairly limited in the short term unless the FDA attempted to enforce the guidance, in which case its legal status could be challenged, he said.

“Alternatively we could see a hearing led by Senators Hatch and Harkin into why the FDA is totally disregarding the intent of the Dietary Supplement Health and Education Act.”

Natural Products Association (NPA) chief executive John Gay added: “If we see that FDA does not make significant alterations, then NPA and our allies will have to seriously consider taking the fight to Capitol Hill or the courts.”

Speaking in the House of Representatives on December 8, Rep Hultgren said:

“Now that they ​[the FDA] have heard from the public, and now that I'm sure they've heard from countless Americans who share my concern, I urge them to go back to the drawing board and ensure that they do not limit Americans' access to dietary supplements​.”

Related topics Regulation NDI draft guidance

Related news

Show more

Follow us


View more