Washington, D.C.—The Natural Products Association (NPA) hasfiled a Citizen’s Petitionwith the Food and Drug Administration, requesting that N-acetyl-L-cysteine (NAC) not be excluded from the definition of a dietary supplement.

As WholeFoods previously reported, despite decades on the marker as a dietary supplement, in July 2020, FDA issued multiple warning letters asserting that products containing NAC cannot be marketed as supplements, due to the drug preclusion clause of the FD&C Act, which states that supplements cannot contain articles that FDA has approved as a drug, unless the ingredient was used before it was tested as a drug.

Natural products industry experts take issue with this. “The Food and Drug Administration has not established a public health risk for NAC,” said Daniel Fabricant, PhD., President and CEO of NPA, in a press release. “Not only has NAC been used safely in products pre-DSHEA, 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.”

WholeFoods legal editorScott C. Tipsaddressed the issue in hisLegal Tipscolumn, outlining legal arguments that "destroy the FDA's stance on NAC." Tips conclusion: "As NPA has correctly pointed out, there has been no final agency action taken on NAC sales. So, why are so many companies dashing for the exit doors? Stand and fight. And win." Read the full columnhere.
Related: NAC—The Latest Health-Success Story to Become an FDA Target CRN Files Citizen Petition with FDA over NAC Legal Status