In a Citizen’s Petition to the U.S. Food and Drug Administration (NPA), the Natural Products Association (NPA) requested that N-acetyl-L-cysteine (“NAC”) not be excluded from the definition of a dietary supplement.

“The Food and Drug Administration has not established a public health risk for NAC,” said Daniel Fabricant, PhD, president and CEO of NPA. “Not only has NAC been used safely in products pre-DSHEA (Dietary Supplement Health and Education Act of 1994), but it is also a common amino acid that’s found in food we eat every day like onions and garlic. We are continuing to tell our members to sell the product directly, and today’s action is another signal to the FDA that we are going to stand up for the industry and consumers’ access to safe and well-regulated supplements.”

In a recent letter to Acting Food and Drug Administrator Janet Woodcock, Senator Mike Lee (R-UT) requested a public hearing for the Agency to clarify its position on the use of NAC in dietary supplements.

NPA’s Citizen’s Petition comes after the FDA issued a series of warning letters in 2020. FDA claimed NAC was previously approved as a drug by FDA prior to marketing as a supplement. At the time of these warning letters 1,170 products containing NAC were listed in the National Institutes of Health (NIH) Dietary Supplement Label Database.

For more information, visit www.npanational.org/wp-content/uploads/2021/08/naturalproductsscann_20210818_112910.pdf.