On Monday, the Natural Products Association (NPA) filed a complaint in the District of Maryland against the Food and Drug Administration (FDA) and Department of Health and Human Service (HHS) for declaring that N-acetyl-L-cysteine (NAC) is no longer a dietary supplement under the Food, Drug and Cosmetic Act.
According to the complaint, the FDA has been tasked by Dietary Supplement and Health Education Act of 1994 (DSHEA) to review the ingredients included in supplements for their safety. However, the “FDA’s enforcement of its enabling statutes and promulgated regulations has been slipshod at best” which has led to the retroactive removal of NAC from the list of dietary supplements. The plaintiff claimed that this was an improper application of DSHEA and that the “NPA’s members have suffered harm as a direct and proximate result” of this decision.
The NPA detailed that NAC contains essential amino acids, and that several of its ingredients had been approved as drugs in the past, satisfying the definition of a dietary supplement. Thus, “NAC was continuously sold for many years as a food ingredient, dietary ingredient, or dietary supplement after NAC delivery forms were approved as a drug (e.g., as an inhalation product) and before the passage of DSHEA in 1994.” Furthermore, the NPA claimed that “there is no evidence” that it is harmful to consumers. The plaintiff also elaborated that “there is no provision in DSHEA or any indication in its legislative history to overcome the presumption against statutory retroactivity,” and their claim was backed up by the American Herbal Products Association. Thus, the NPA said that the FDA’s decision is “not in accordance with law” and is arbitrary and capricious.
The NPA is seeking declaratory relief so that the drug exclusion does not retroactively apply to NAC, injunctive relief prohibiting the FDA from acting against manufacturers, sellers, or distributors of NAC, attorney’s fees and costs, and other relief.
The plaintiff is represented by Arnall Golden Gregory LLP.
