FDA SUED by the Supplement Industry Over NMN Legality

After a long wait and total inaction from the FDA, their hand has now been forced — the dietary supplement industry has made its move against the agency: The Natural Products Association (NPA) has sued the FDA over the status of NMN.^[1]

What is NMN, and is it Worth the Fight?

NMN is a dietary supplement ingredient that is a form of vitamin B3, as it’s an NAD+ precursor, supporting energy metabolism, DNA repair, liver detoxification, and countless functions in the body. It’s been repeatedly shown to be safe and effective as a direct NAD+ precursor, and was acknowledged by the FDA as a legal dietary supplement ingredient in 2022.^[2-4] However, the FDA is attempting to call a “takeback”,^[5,6] which the NPA argues they have no legal ability to do.

NPA is the industry’s oldest and most formidable trade association dedicated to the natural products industry, and it’s not their first time suing the government — they successfully rescued NAC in the FDA’s suspiciously-timed 2021 takedown attempt.^[7-9] Looks like they’re ready to do it again.

For a deeper look at the background, see our detailed article, “NMN, FDA, and the Supplement Industry’s Fight Against Pharma“, where we discuss the history, biochemistry, and legal background that set the stage for this lawsuit.

DC District Court Case 1:2024cv02479

This article will focus specifically on the lawsuit, which could shape the future of dietary supplements like NMN (β-Nicotinamide Mononucleotide). On the line is any ingredient where the pharmaceutical industry may try to use the “drug exclusion clause” to remove ingredients from the dietary supplement market.

This battle comes after a series of confusing and controversial decisions by the FDA, including NAC. A lot is on the line here, so let’s get into it, but first, sign up for our NPA and NMN alerts so you can get notified when there are updates:

Key Points of the NPA’s Lawsuit Against the FDA

The lawsuit revolves around the FDA’s interpretation of DSHEA (Dietary Supplement Health and Education Act) and its attempt to pull NMN from the market. Here are the key elements of the NPA’s case:^[1]

• FDA Misinterprets DSHEA

  

  After it received letter of non-objection as a legal dietary supplement ingredient, the FDA has gone back on its word and claimed that NMN is not an ingredient. Now it’s in the court system.

  The NPA argues that the FDA has misused the Drug Exclusion Clause of DSHEA to wrongfully classify NMN as a substance that cannot be sold as a dietary supplement. This, according to the NPA, is an incorrect reading of the law and puts many supplements at risk.

• FDA’s Reversal of NMN Approval

  After initially acknowledging NMN as a new dietary ingredient (NDI), the FDA suddenly reversed its decision, citing its status as a drug being investigated. This reversal is seen as arbitrary and harmful to the dietary supplement industry, and there’s no legal avenue for it to occur if there’s no adulteration or safety concerns at stake (and there aren’t).

• Lack of Transparency from the FDA

  The supplement industry claims that the FDA’s actions have been inconsistent, with poor communication and a lack of transparency. The agency has failed to respond to the NPA’s Citizen’s Petition, further delaying clarity on the matter.

• Economic Harm to NPA Members

  

  The FDA allowed NMN on the market for several months,^[4] and then reversed course^[5,6] — but do they even have the legal authority to do so without safety reasons?

  The lawsuit outlines the economic damage inflicted on NPA members, many of whom manufacture and sell NMN. The FDA’s decision has led to the detention of NMN products, costing these companies time and money.

• Request for Judicial Intervention

  The NPA is asking the court to overturn the FDA’s decision and compel the agency to respond to their Citizen’s Petition. This could set a precedent that secures NMN’s place as a dietary supplement.

• Broader Implications

  The NPA warns that if the FDA’s interpretation of DSHEA stands, pharmaceutical companies could use clinical trials to prevent the sale of safe and effective supplements. This could disrupt innovation in the dietary supplement industry and limit consumer access to vital products.

Stay Tuned to PricePlow for Updates

The outcome of this lawsuit could have major implications for the future of not only NMN, but other supplements under the FDA’s scrutiny that are desired. The case is being heard in the Washington DC District Court under case number 1:2024cv02479.

Again, for the full background and explanation, see our main FDA vs. NMN article.

Stay tuned to PricePlow for updates as this legal battle unfolds, and subscribe to our NPA and NMN news to learn about the latest developments in the world of supplements.