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."
Thelawsuitoutlines 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.
Related: CRN Disappointed With FDA Tentative Response to NAC Citizen Petition AHPA to FDA: Clarify that NAC is a Lawful Dietary Ingredient NAC—The Latest Health-Success Story to Become an FDA TargetFDA'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."