The Natural Products Association (NPA) filed a lawsuit against the U.S. Food and Drug Administration (FDA) requesting that the agency cease its unlawful retroactive application of the Food, Drug and Cosmetic Act against N-acetyl-L-cysteine (NAC).
“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,” said Daniel Fabricant, PhD, president and CEO of NPA. “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.”
Below is additional information provided by NPA:
Why is NPA filing this lawsuit against the Food and Drug Administration?
We are defending the industry’s right to provide a product with an exceptional 30 plus year safety record and for consumers’ access to safe and well-regulated supplements. Furthermore, the FDA has not established a public health risk for NAC or any other substantiated basis as to why they are spending effort and resources to damage the industry. Not only has NAC been used safely in products pre-DSHEA, but it is also a common amino acid that’s found in food we eat every day like onions and garlic.
How did we get to this point?
July 29, 2020: The FDA issues warning letters to companies stating that NAC cannot be sold as a dietary supplement because it was first approved as a drug in 1963.
May 6, 2021: Amazon confirms reports that it would be removing NAC from its online marketplace.
July 27, 2021: In a letter to FDA Acting Commissioner Janet Woodcock, Senator Mike Lee (R-UT) requests a hearing and asks the agency to answer detailed questions related to NAC, including the specific date FDA identified the ingredient being used as both a drug and supplement in the U.S.
August 18, 2021: NPA files a citizen petition expressing concerns about the FDA’s regulatory actions against NAC.
August 22, 2021: FDA denies Senator Lee’s request to hold a hearing and fails to answer questions related to the agency’s actions on NAC requesting that FDA begins rule writing to ensure consumer access to NAC.
August 22, 2021: Senator Lee follows up with another letter to the FDA asking the agency to answer his questions related to NAC by September 21, 2021. FDA fails to meet Senator Lee’s deadline to respond.
October 29, 2021: Congressman Jeff Duncan (R-SC) sends a letter to the FDA asking the agency to produce evidence of adverse events related to NAC by November 24, 2021. FDA fails to meet the deadline set by Congressman Duncan.
November 24, 2021: The FDA issues a tentative response to NPA’s citizen petition. The FDA requests additional information, noting that the FDA needs more time to respond. FDA asks interested parties to respond by January 25, 2022.
What do NPA member companies and the industry think about this?
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.
Why is the FDA doing this?
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.
For more information, visit www.npanational.org.