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The Natural Products Association filed suit against FDA on December 6, calling FDA’s action to “retroactively” apply the drug-exclusion clause of the Food, Drug, and Cosmetic Act in order to ban N-acetyl-L-cysteine (NAC) unlawful.
The Natural Products Association (NPA; Washington, DC) filed suit against FDA on December 6, calling the agency’s actions to “retroactively” apply the drug-exclusion clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in order to ban the ingredient N-acetyl-L-cysteine (NAC) in dietary supplements unlawful.
In July 2020, FDA sent warning letters to companies declaring that NAC is not a lawful dietary ingredient per the FD&C Act’s drug-exclusion clause because the ingredient was first authorized for investigation as a new drug before it was marketed as a dietary supplement.
This summer, NPA, along with other industry associations such as the Council for Responsible Nutrition (CRN; Washington, DC) and the American Herbal Products Association (AHPA; Silver Spring, MD), filed citizen petitions and/or comments requesting that FDA not exclude NAC from the definition of a dietary supplement. They stated that NAC meets the definition of a dietary supplement because there is evidence showing NAC was marketed in the U.S. food supply since 1991, before the drug-exclusion clause became law. The drug-exclusion clause cannot be retroactively applied, they said. (Furthermore, they point out that the NAC drugs that were approved in 1963 are not administered orally, and that it’s unclear whether the drug-exclusion clause even applies to them.)
NPA’s new legal complaint states that FDA “has taken final agency action in their determination that the provision at issue applies retroactively as a matter of law. There is, however, nothing the relevant statue that allows for retroactive application.” It also states: “DSHEA did not include any provision indicating that any of its regulations, including the drug exclusion provision, was intended to operate retroactively,” and points to example of L-carnitine, an ingredient that was marketed as both a supplement and a drug prior to the passage of DSHEA, which still coexist in the market.
NPA filed its lawsuit after, on November 24, FDA issued a tentative response to CRN and NPA’s citizen petitions. Instead of fulfilling the associations' requests and affirming that NAC is a lawful dietary ingredient, FDA instead said it “continues to evaluate both citizen petitions” and said it is “interested in receiving data and information on the earliest date that NAC was marketed as a dietary supplement or as a food, the safe use of NAC in products marketed as a dietary supplement, and any safety concerns.”
NPA’s lawsuit, filed in the U.S. District Court for the District of Maryland by the law firm Arnall Golden Gregory LLP (Washington, DC), seeks declaratory and injunctive relief and asks the court to “hold unlawful and set aside FDA’s final actions that are arbitrary, capricious, an abuse of discretion, and contrary to law. Moreover, NPA requests that this Court order that FDA cease its unlawful retroactive application of the Food, Drug, and Cosmetic Act, as amended by the Dietary Supplement Health and Education Act.”
In a December 7 press release from NPA, the association warned the dietary supplements industry that FDA’s attempt to ban NAC sets a dangerous precedent for the agency to ban other dietary ingredients by invoking the drug-exclusion clause retroactively. Said NPA in its press release: “Our 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.”
Daniel Fabricant, PhD, president and CEO of NPA, said in the press release: “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. This is government regulation run amok. 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. 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.”
There is no safety risk at issue over NAC, the associations point out. Said NPA’s press release: “It’s unclear what the FDA is motivated by in this case, which is even more alarming because the agency claims that its resources are stretched thin. We are concerned that the agency is focusing its 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.”
FDA’s stance on NAC has already negatively impacted supplement companies that sell the ingredient. This past May, Natural Products Insider reported that Amazon.com confirmed it aimed to stop NAC products from being sold on its site. NPA’s legal complaint states that “NPA members who have been selling NAC for years, if not decades, have seen their sales dry up as a result of having to preemptively pull products from the shelves by virtue of FDA’s unlawful decisions.” It also stated that: “NPA’s members have lost and will continue to lose significant revenue because Amazon, among other online retailers, will no longer allow companies to sell NAC.” NPA also stated that NPA members have had export certificates denied for products containing NAC.
Read NPA’s full complaint here.