Ullman Reacts to FDA’s Amnesty for NDIN Non-Filers

June 10, 2022 | Compliance Investigations & White Collar

Marc Ullman spoke with Natural Products INSIDER for the article, “FDA hoping to shrink pool of noncompliant ingredient notifications.

The story discusses the U.S. Food & Drug Administration’s recent guidance that it is providing a 180-day amnesty to manufacturers of nutritional products that failed to file a New Dietary Ingredient (NDI) notification.

Marc is not convinced that FDA’s latest move will be productive.

“When I discussed with FDA the residual formaldehyde in knockoffs of my clients’ astaxanthin, I had hope for enforcement. Nothing happened,” he said . “When I went in and I met with FDA to discuss the presence of a variety of unknown peaks, and knockoffs of my client’s PQQ, I had hopes that there would be some enforcement. Nothing happened.”

Marc added, “Why would we think they’ll do anything other than complain they need more authority?”

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