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# Products Association Sues FDA Over NAC
- URL: https://www.fdaweb.com/products-association-sues-fda-over-nac/
- Published: 2021-12-07T12:00:00.000Z
- Updated: 2026-09-14T17:24:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150713

The Natural Products Association (NPA) has filed suit against FDA to make the agency cease its “unlawful retroactive application of the Federal Food, Drug, and Cosmetic Act against N-acetyl-L-cysteine (NAC).” NPA [says](https://www.npanational.org/news/npa-sues-fda-asks-courts-to-block-unlawful-action-in-nac-situation-calls-fda-actions-on-nac-a-regulatory-sneak-attack/?ref=fdaweb.com) it is “defending the industry’s right to provide a product with an exceptional 30-plus year safety record and for consumers’ access to safe and well-regulated supplements. Furthermore, FDA has not established a public health risk for NAC or any other substantiated basis as to why they are spending effort and resources to damage the industry. Not only has NAC been used safely in products pre-DSHEA (Dietary Supplement Health and Education Act), but it is also a common amino acid that’s been found in food we eat every day like onions and garlic.”

In 2020 FDA sent Warning Letters to NAC manufacturers saying it could not be sold as a dietary supplement because it was first approved as a drug.

According to WebMD, doctors use NAC as a prescription drug to treat [acetaminophen](https://www.webmd.com/drugs/2/drug-362/acetaminophen+oral/details?ref=fdaweb.com) overdose. It may also help break up mucus in people with some [lung diseases](https://www.webmd.com/lung/lung-diseases-overview?ref=fdaweb.com), like chronic bronchitis. As a supplement, it says, some people use it to try to protect the [liver](https://www.webmd.com/digestive-disorders/picture-of-the-liver?ref=fdaweb.com). And there’s evidence it can help prevent kidney or neurologic damage caused by some drugs, according to WebMD.