Ullman and NY Bar Association Panel Blast NDI Enforcement Efforts

February 2, 2022 | Compliance Investigations & White Collar

The Nutraingredients-USA article, “Bar association panel takes FDA to task over NDI enforcement,” details a January 29, 2022, New York Bar Association online panel discussion moderated by Marc Ullman. The program was intended to review the current status of the New Dietary Ingredient provision of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Via an NDI, ingredient manufacturers demonstrate to the FDA that their ingredient is expected to be safe.

At issue is whether an FDA-approved NDI extends to all products that use that ingredient or only covers the product for which the NDI was filed. The FDA continues to be opaque on this issue.

Marc represented a client who brought an ingredient to market. He noted: “Once the market developed for their ingredient they were confronted with serious competition from companies marketing knockoff ingredients of uncertain provenance.” In one case, FDA rejected an NDI due to the ingredient’s toxicity, but then FDA approved the GRAS (Generally Recognized as Safe) notification on the same ingredient.

“Back in May 2014 I wrote a review with the title ‘FDA is broken,'” Marc said. “If I did an update the headline would be ‘FDA is still broken.'”

 

 

 

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