NPA Sues FDA: Asks Courts to “Block Unlawful Action in NAC Situation”

“We are very concerned that a safe, legal natural product that has been sold for over 30 years is under what appears to be a regulatory sneak attack by the FDA, and even more concerned if this illegal approach may be used for other ingredients," said NPA's Daniel Fabricant, Ph.D.

Washington, D.C.—The Natural Products Association (NPA) announced that it has filed a lawsuit against the Food and Drug Administration (FDA). At issue: the status of N-acetyl-L-cysteine (NAC). NPA is requesting that FDA “cease its unlawful retroactive application of the Food, Drug, and Cosmetic Act” against NAC. 

As WholeFoods has previously reported, industry experts point out that NAC has been marketed as a dietary supplements for decades with FDA’s knowledge. NPA notes that NAC been used safely in products pre-DSHEA, and that it is a common amino acid found in common foods including onions and garlic. Yet in July 2020, FDA issued warning letters asserting the product was previously approved as a drug, and therefore is not a supplement.

NPA explained in the release that 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.” NPA also pointed out that FDA has not established a public health risk for NAC, or any other substantiated basis to justify why the agency is “spending effort and resources to damage the industry.” 

The lawsuit outlines NPA’s position, and notes: NPA members who have been selling NAC for years, if not decades, have seen their sales dry up as result of having to preemptively pull products from the shelves by virtue of FDA’s unlawful decisions. 

FDA’s actions could have implications beyond NAC, NPA pointed out in its release, noting:  Our members and the industry are concerned that the FDA is exceeding its authority, and that the uncertain regulatory climate created by this action will have a damaging economic impact on supplement manufacturers. Retroactively applying DSHEA to a product that was clearly being marketed as a dietary supplement prior to 1994 sets a precedent that could extend to other popular products, including vitamin C, and theoretically, everyday products like table salt and caffeine.    

NPA also noted that FDA’s motivation in the case of NAC is unclear. This is alarming, the association stated, because the FDA claims its resources are stretched thin, yet it is  focusing “valuable time and resources—during a pandemic—to go after a product that has an outstanding safety record, and that has been legally marketed and sold as a dietary supplement for decades.”