“The FDA has gotten this wrong at every step of the way, and we’ve been left with no choice but to seek relief from the courts,” said Daniel Fabricant, PhD., President and CEO of the Natural Products Association (NPA).
The complaint names the defendants as the Food and Drug Administration (FDA), the Department of Health and Human Services (HHS), Xavier Becerra (as Secretary of HHS), and Janet Woodcock (as Acting Commissioner of FDA).
“We are very concerned that a safe, legal natural product that has been sold for over thirty 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. This is government regulation run amok,” said Fabricant.
“The FDA’s actions against NAC represent a reckless misuse of government resources and will do nothing to protect public health. We are hopeful that the agency will get back to its job of appropriately regulating the U.S. food and drug supply.”
When asked for a response, a spokesperson for the FDA said the Agency does not comment on pending litigation.
NAC is naturally occurring and is found in foods like onions and garlic. It is a derivative of the amino acid L-cysteine and is a precursor of the cellular antioxidant glutathione.
FDA’s position to date has been that NAC is not a legal dietary ingredient because of its prior approval as a drug. NAC was first approved as an inhaled mucolytic drug in 1963. There was also a new drug approval for NAC in 1985. FDA had taken no action regarding the status of the ingredient until the summer of 2020 when it sent seven warning letters to companies making hangover treatment claims, which FDA construed to be illegal disease treatment claims. Several of those companies were using NAC in their products, and in those letters FDA spelled out its case against the ingredient.
Despite the statement made in the warning letters, the Agency has repeatedly stated that it has “not yet reached any determination” on the ingredient’s status.
NAC has been widely used for many years in finished dietary supplements, frequently as a standalone product, without any substantial safety concerns. A search of the Dietary Supplement Label Database from the NIH’s Office of Dietary Supplements yields 1,470 products containing N-acetyl-L-cysteine (database accessed Nov 24, 2021), including some of the biggest brands in the industry. Earlier this year, however, Amazon confirmed reports that it would be removing NAC from its online marketplace.
In response to the FDA statements and market concerns, Citizen’s Petitions were filed with the FDA by NPA and the Council for Responsible Nutrition (CRN) relating to the ingredient this summer. The CRN petition asked the Agency to reverse its position that NAC-containing products cannot be dietary supplements. The NPA petition asked FDA to either determine that NAC is not excluded from the definition of a dietary supplement or, in the alternative, initiate rulemaking to make NAC a lawful dietary supplement under the Food, Drug, and Cosmetic Act.
As reported by NutraIngredients-USA, the FDA issued tentative responses to both citizen petitions just before Thanksgiving, and requested additional information from CRN, NPA, and other stakeholders.
In a press release, NPA states that its members and the industry are “concerned that 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.”
Watch the video above for an in-depth conversation with Dr Fabricant on this new lawsuit.
NPA’s complaint can be read HERE.