Ullman Cited in Missing NDI Filings Article

June 8, 2022 | Compliance Investigations & White Collar

Marc Ullman was cited in the NutraIngredientsUSA article, “FDA announces enforcement discretion amnesty window on missing NDI filings.”

The article explains the FDA’s announcement that it will exercise enforcement discretion on missing New Dietary Ingredient Notifications.

Ullman stated that the announcement has less impact than it should.

“When that window closes, what are they going to do? Send another letter?” Ullman asked. “We have brought specific cases to them, of astaxanthin with residual formaldehyde, of PQQ on the market with unknown peaks and failed NDI notifications, and beta alanine with residual e coli, and the Agency did nothing about any of that.”

Ullman alleges that the FDA has been engaging in the “enforcement theater” to support the Mandatory Product Listing requirement that has recently been proposed and he suspects that this is more of it.

“I know I sound like a broken record, but it’s because I hear this nonsense of FDA saying they don’t know what’s on the market. Here they are saying they know exactly what’s on the market, and yet they did nothing. The trade needs real enforcement,” Ullman commented.

Read the full article here.

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