The Natural Products Association (NPA; Washington, DC) filed a lawsuit against the FDA on December 6, calling for the agency’s actions to “retroactively” enforce the Federal Food, Drug, and Cosmetic drug exclusion clause. Act (FD&C Act) to illegally ban the ingredient N-acetyl-L-cysteine (NAC) in food supplements.
In July 2020, the FDA sent warning letters to companies stating that NAC is not a legal dietary ingredient under the Drug Exclusion Clause of the FD&C Act because the ingredient was first cleared for investigation as a new drug before being marketed as a dietary supplement.
This summer, the 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 petitions and / or comments from citizens asking that the FDA not exclude NAC from the definition of a dietary supplement. They said NAC meets the definition of a dietary supplement because there is evidence showing that NAC has been marketed in the US food supply since 1991, before the drug exclusion clause became law. . The drug exclusion clause cannot be applied retroactively, they said. (Further, they point out that the NAC drugs that were approved in 1963 are not administered orally, and that it is not clear whether the drug exclusion clause even applies to them.)
The NPA’s new legal complaint states that the FDA “made the agency’s final decision in determining that the provision at issue applies retroactively in law.” However, there is nothing in the relevant law that allows retroactive application. He also states: “The DSHEA did not include any provision indicating that any of its regulations, including the drug exclusion provision, were intended to operate retroactively,” and cites the example of L-carnitine. , an ingredient that was marketed as both a supplement and a drug before the passage of DSHEA, which still coexist in the market.
The NPA filed a complaint after, on November 24, the FDA released an interim response to petitions from CRN and NPA citizens. Instead of responding to requests from associations and asserting that NAC is a legal dietary ingredient, the FDA instead said it “continues to assess the two petitions from citizens” and said it was “interested in receive data and information on the earliest date 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 problems with security.
The NPA lawsuit, filed in the U.S. District Court for the District of Maryland by law firm Arnall Golden Gregory LLP (Washington, DC), seeks declaratory relief and injunction and asks the court to “declare illegal and overturn FDA’s final actions that are arbitrary, capricious, an abuse of power and against the law. Further, the NPA is asking this court to order that the FDA cease its unlawful retroactive application of the Food, Drug and Cosmetic Act, as amended by the Diet Supplements Health and Education Act.
In a December 7 NPA press release, the association warned the dietary supplement industry that the FDA’s attempt to ban NAC sets a dangerous precedent for the agency to ban other food ingredients by retroactively invoking the drug exclusion clause. The NPA said in its press release: “Our members and the industry are concerned that the FDA is overstepping its authority and that the uncertain regulatory climate created by this action has a damaging economic impact on supplement manufacturers. The retroactive application of DSHEA to a product that was clearly marketed as a dietary supplement before 1994 sets a precedent that could extend to other popular products, including vitamin C, and theoretically, everyday products like table salt and caffeine.
Daniel Manufacturer, PhD, President and CEO of NPA, said in the press release: “We are very concerned that a safe and legal natural product that has been sold for over 30 years is the subject of what appears to be a sneaky regulatory attack by the FDA. , and even more concerned if this illegal approach can be used for other ingredients. This is rampant government regulation. The FDA got it wrong every step of the way, and we have no choice but to seek redress 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 hope that the agency will resume its work of properly regulating the supply of food and drugs in the United States. “
There is no security risk involved on NAC, the associations point out. Says the NPA press release: “It is not clear what the FDA is motivated by in this matter, which is even more alarming as the agency claims its resources are limited. We’re concerned that the agency may be spending its precious time and resources – during a pandemic – tackling a product that has an exceptional safety record and that has been marketed and sold legally as a dietary supplement for decades. “
The FDA’s stance on NAC has already had a negative impact on supplement companies that sell the ingredient. Last May, Introduced to natural products reported that Amazon.com has confirmed its intention to prevent the sale of NAC products on its site. NPA Legal Complaint Says “NPA members who have been selling NAC for years, if not decades, have seen their sales dry up due to the preventive removal of products from shelves due to illegal decisions by the FDA.” . He also said that “NPA members have lost and will continue to lose significant revenue because Amazon, among other online retailers, will no longer allow businesses to sell NAC.” The NPA also said that members of the NPA have been denied export certificates for products containing NAC.
Read NPA’s full complaint here.