The comments were submitted in response to a Constituent Update titled FDA Requests Information Relevant to the Use of NAC as a Dietary Supplement, which was issued on November 24, 2021, requesting evidence that NAC was sold before DSHEA.
The UNPA NAC Working Group undertook an “exhaustive” search for pre-DSHEA evidence of the sale, marketing, and manufacturing of NAC, the press release states, and were able to submit a number of relevant documents establishing definitive sale of NAC as a dietary ingredient prior to the October 15, 1994 grandfather date.
The press release summarized UNPA’s position on the matter as of January 25, 2022, when the comments were submitted:
- The FDA, in attempting to exclude NAC from the dietary supplement market, is acting outside of its statutory jurisdiction and authority.
- UNPA provided definitive evidence of pre-DSHEA use of NAC – it is an ODI (Old Dietary Ingredient), NAC is safe, and there is broad agreement on this.
- The UNPA NAC Working Group will pursue this important issue until a proper outcome is reached, which is recognition of NAC as a lawful ODI and FDA abandons its misguided retro lookback policy.
“We want to thank all of the volunteers of the NAC working group for their efforts and contributions,” said Larisa Pavlick, VP, Global Regulatory & Compliance, UNPA. “We provided critical documentation to the FDA regarding NAC as a supplement. This project was a challenge after so many years have passed since DSHEA.”
Related: Associations Submit Comments on FDA’s Tentative Response to NAC Petitions NPA Sues FDA: Asks Courts to “Block Unlawful Action in NAC Situation” Are Your Supplements Really Regulated and How?Some of the UNPA members and MOU partners in the NAC Working Group include:
- Arizona Nutritional Supplements
- American Association of Naturopathic Physicians (AANP)
- Bastyr University
- FDA Compliance Simplified
- Holistic Primary Care
- NOW Foods
- Ortho Molecular