Ullman Comments on FDA’s Guidance for NAC

April 21, 2022 | Compliance Investigations & White Collar | Health Services

Marc Ullman commented on the FDA’s recent announcement that it will exercise enforcement discretion on the use of NAC in the NutraIngredientsUSA article, “FDA formally announces NAC enforcement, but legal handover remains.”

The draft guidance came in response to two petitions, one referencing the DSHEA grandfather date of 1994. The FDA rejected the grandfather date approach, but it remains unresolved.

Ullman stated, “It’s a victory for the industry in that it provides a clear path to get NAC back on the market. I expect that FDA is banking that with this the trade will lose interest in the issue. Still unresolved is what takes precedence, the grandfather date, or the regulation for drug approvals?”

Read Ullman’s continued comments and the full article here.

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