“We have no choice,” says Manufacturer

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“The FDA got it wrong every step of the way, and we have no choice but to seek redress from the courts”Said Daniel Manufacturer, PhD., President and CEO of the Natural Products Association (NPA).

The complaint names defendants like 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 the FDA).

“We are very concerned that a safe and legal natural product that has been sold for over thirty years is the subject of what appears to be a back door regulatory attack by the FDA, and even more concerned if this illegal approach can be used. for other ingredients. This is government regulation unleashed ”, says Manufacturer.

“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. ”

When asked for a response, an FDA spokesperson said the agency is not commenting on pending litigation.

CNA

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.

The FDA’s position to date is that NAC is not a legal dietary ingredient due to its pre-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. The FDA had not taken any action regarding the status of the ingredient until. ‘in the summer of 2020, when it sent seven warning letters to hangover businesses. treatment claims, which the FDA has interpreted as illegal disease treatment claims. Several of these companies used NAC in their products, and in these letters the FDA made its case against the ingredient.

Despite the statement made in the warning letters, the agency has repeatedly stated that it has “not yet reached a determination” on the status of the ingredient.

NAC has been widely used for many years in finished dietary supplements, often as a stand-alone product, without any significant safety concerns. A search of the NIH Office of Dietary Supplements Dietary Supplement Label Database found 1,470 products containing N-acetyl-L-cysteine ​​(database accessed November 24, 2021), including some of the most major brands in the industry. Earlier this year, however, Amazon confirmed reports it was removing NAC from its online marketplace.

In response to FDA statements and market concerns, citizen petitions were filed with the FDA by the NPA and the Council for Responsible Nutrition (CRN) regarding the ingredient this summer. CRN’s petition called on the Agency to reconsider its position that products containing NAC cannot be dietary supplements. The NPA petition has called on the FDA to determine that NAC is not excluded from the definition of a dietary supplement or, failing that, to initiate regulation to make NAC a legal dietary supplement under the United States Act. food, drugs and cosmetics.

As reported by NutraIngredients-USA, the FDA released interim responses to the two citizen petitions just before Thanksgiving and requested additional information from CRN, NPA, and other stakeholders.

In a press release, the NPA says its members and the industry are “Concerned that the FDA is overstepping its authority and that the uncertain regulatory climate created by this action is having 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. “

Watch the video above for an in-depth conversation with Dr. Manufacturer on this new trial.

NPA’s complaint can be read HERE.


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