On August 28, 2024, the Natural Products Association (NPA) filed a lawsuit against the U.S. Food and Drug Administration (FDA) to stop the illegal retroactive application of the Federal Food, Drug and Cosmetic Act to nicotinamide mononucleotide (NMN).
Dr. Daniel Fabricant, President and CEO of the Natural Products Association, said: "We are grateful for the outstanding leadership of the association members in deciding to face this issue head-on, and we also thank all members who provided financial support in the process. The issue of drug bans is not just about NMN, but involves the FDA The bigger problem is abuse of the law. NMN is just another example of the FDA abusing the Federal Food, Drug, and Cosmetic Act. Unfortunately, like NAC (N-acetylcysteine) and CBD (cannabidiol), the FDA's negligence has caused significant economic damage to a key part of the dietary supplement industry. "
He also said: "On the other hand, the FDA's decision weakens the integrity of the new dietary ingredient (NDI) process and is not conducive to manufacturers introducing emerging and innovative ingredients to the US market. It is worth noting that the FDA claims that it has only received approximately 1,200 NDI notifications since the passage of the Dietary Supplement Health and Education Act (DSHEA), which is only a small part of the total number of NDIs placed on the market during the same period, and the FDA estimates that more than 4,600 notifications should have been submitted but were not submitted. "
On March 7, 2023, NPA and the Alliance for Natural Health (ANH) jointly filed a citizen petition asking the FDA to confirm that NMN is not excluded from the definition of dietary supplements or to commit to exercising enforcement discretion for the sale of NMN as a supplement. In its reply to NPA and ANH, the FDA stated that "due to the multitude of agency matters, the FDA was unable to make a decision on your petition within 180 days of receipt of the petition" and that staff "is evaluating your petition."
This is the third time that NPA has sought regulatory clarity through this avenue. Previously, NPA had filed a citizen petition and lawsuit against the FDA regarding NAC, and for the first time in its history, the FDA exercised its enforcement discretion on drug exclusion issues, setting an important precedent for the dietary supplement industry.
Review of the NAC Incident
1963
Approved by the U.S. Food and Drug Administration (FDA) as a drug ingredient. NAC is used as a drug mainly to treat liver complications caused by anesthetics and as an antidote for ethanol poisoning. In addition, it is also used to treat acute phenolic acid poisoning and as a cough suppressant and mucolytic.
Subsequently, NAC has also been sold on the market as a dietary supplement since the 1990s due to its excellent antioxidant and other health benefits, and has gradually gained widespread popularity. That is to say, for nearly 30 years, NAC has been sold on the market as both a drug and a dietary supplement.
2020
The FDA issued a warning letter stating that NAC cannot be sold as a dietary supplement because it was approved as a drug ingredient in 1963, and under US law, any substance that has not been widely used in food before being approved as a drug ingredient cannot be used as a dietary supplement ingredient. In order to avoid risks, Amazon, a mainstream foreign shopping platform, removed all NAC dietary supplements in 2021.
But after the FDA issued a warning, some industry organizations and stakeholders such as the Natural Foods Association (NPA) and the Council on Nutrition (CRN) began to take action, including submitting citizen petitions and legal challenges to the FDA to reevaluate the decision. These actions are intended to push the FDA to reconsider its position and seek clarity on the legality of NAC as a dietary supplement.
2022
On April 21, 2022, the U.S. Food and Drug Administration (FDA) announced the release of the FDA's "Draft Policy Guidance on Dietary Supplement Products Containing NAC". The FDA document stated that no safety issues have been found for NAC as a dietary supplement ingredient or as a dietary supplement. The FDA intends to exercise its enforcement discretion, that is, they do not intend to take enforcement action against dietary supplement products containing NAC on the market. This means that although the FDA's previous position was that NAC did not qualify as a dietary supplement, they will temporarily allow these products to continue to be sold.
So far, the storm over NAC as a dietary supplement has temporarily come to an end, and it can continue to be legally sold as a dietary supplement.
Review of the NMN incident
May 2022
Shangke Bio obtained the first NDI certification for NMN raw materials (NDI 1247).
October 11, 2022
In its response to the NDI notice submitted by Jindawei, the FDA pointed out that NMN does not fall within the definition of dietary supplements and cannot be sold as a dietary supplement.
November 4, 2022
Shangke Bio also received a notice from the FDA to withdraw its original NDI.
August 28, 2024
The Natural Products Association (NPA) filed a lawsuit against the U.S. Food and Drug Administration (FDA), demanding that it stop illegally retroactively applying the Federal Food, Drug and Cosmetic Act to nicotinamide mononucleotide (NMN).
This article was independently created and published by Herbfields.net.