Ullman Reacts to FDA’s Amnesty for NDIN Non-FilersJune 10, 2022 |
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?”
- Marc S. Ullman