The Real Reason the FDA Banned NMN: NMN Also on the FDA's radar

NMN (Nicotinamide Mononucleotide) is a key anti-aging ingredient that has been receiving worldwide attention as it was mentioned in the book 'The End of Aging' by Dr. David A. Sinclair of Harvard Medical School.

NMN is a precursor of NAD+, a key substance in energy metabolism in the human body, and has recently become known as a hot topic substance that enables 'reverse aging'.

"Why didn't the FDA approve NMN as a dietary supplement?"

→ We conclude that NMN is excluded from the definition of a dietary supplement under 21 USC § 321(ff)(3)(B)(ii) and cannot be marketed as a dietary supplement or included in a dietary supplement.

Key reason: NMN's IND (new drug clinical trial) approval history has been made public.

→ NMN has been announced as a substance that has been approved for investigational (clinical trial) as a new drug by the FDA.

The FDA said this was because a company seeking to develop NMN as a new drug had filed an Investigational New Drug (IND) application for NMN and it had been made public.

According to 21 USC § 321(ff)(3)(B)(ii) , ingredients that are undergoing clinical trials as new drugs cannot be classified as health functional foods because this is a legal process to protect the rights of the company.

Therefore, the FDA's decision was not a question of denial of NMN's efficacy or safety, but rather a legal action to protect the rights of companies developing new drugs.

② March 2023: NMN industry rebuttal, citizen petition, and lawsuit

→ The Natural Products Association (NPA) and the Alliance for Natural Health (ANH) today filed a citizen petition with the Food and Drug Administration (FDA), requesting that the FDA take the following actions:

On March 7, 2023, the Natural Products Association (NPA) and the Alliance for Natural Health (ANH) appealed the FDA's decision.

< Key Demands of the Petition >

“Don’t exclude NMN from dietary supplements.”

“We will not enforce the existing ban on the sale of NMN as a dietary supplement.”

On August 28 of the same year, a lawsuit was also filed against the FDA.

<Key Points>

1. NPA pointed out that the FDA's unilateral exclusion of NMN from the dietary supplement category lacked procedural transparency in that it did not disclose the timing or scope of IND approval.

2. Despite the existing NDI acceptance history, the FDA revoked the status without clear criteria, raising questions about consistency and legitimacy.

3. With so many NMN products in circulation, this action could cause serious harm to the industry and consumers.

There were also concerns that if NMN were converted from a supplement to a prescription drug, accessibility would be limited and consumer prices could skyrocket.

③ October 2024: Court orders FDA to temporarily halt further sanctions or enforcement actions against NMN.

→ FDA responds to NPA's citizen petition regarding NMN and orders the parties to provide joint status.

In 2024, a U.S. federal court ruled in favor of the NPA and issued a preliminary injunction against the FDA's ban on NMN . This is a temporary injunction issued by the court before a final ruling, temporarily prohibiting the FDA from restricting the sale of NMN and preventing market damage while the lawsuit is pending.

This decision was made for the following reasons:

1. The FDA failed to secure procedural justification in its process of excluding NMN from the dietary supplement category.

2. Because the action could cause irreparable harm to the NMN industry and consumers.

Accordingly, the court ordered the FDA to refrain from taking any further sanctions or enforcement actions against NMN products until the litigation is concluded.

④ July 2025: FDA delays official response

The FDA was originally supposed to provide a formal response to the citizen petition by July 28, 2025.

We were unable to respond within the deadline and requested an extension until September 30th. Under the preliminary injunction, NMN products remain available for sale.

Tips for choosing a real NMN!

NMN is not just a fad; it is a scientifically proven and proven key anti-aging ingredient.

※However, not all NMN on the market is the same.※

<Checkpoints to consider when choosing an NMN>

1. Content and purity of NMN

Clinical studies have shown that taking 250 mg of NMN daily is effective in increasing NAD+ levels.

There are many products on the market that only emphasize the content of NMN and do not indicate the exact NMN content.

Check: Check the specific content of pure NMN, such as 250mg of NMN per serving!

2. Are the raw material sources and processes transparently disclosed?

Products with unknown ingredients or no process details are difficult to trust.

Check: Make sure that clean raw materials are used and that it is pure NMN that does not contain impurities!

3. Are there any official test scores or third-party verification materials?

Products that only use the term “high purity” without test results are not trustworthy.

Check: Make sure the product is made with ingredients that have passed toxicity tests and have been officially tested for safety, such as no heavy metals or organic solvents!

4. Are there enough actual customer reviews?

NMN products that have little or no effect may have quality or absorbency issues.

Check: Check if there are many reviews of continuous consumption, not just exaggerated reviews that say it works after 1-2 doses!

In an era where various NMN products are pouring out,

More important than being swayed by marketing is the 'real content of the ingredients that go into my body.'

ROKIT NMN is to create “NMN that you can really feel” .

We are transparent in every step of the process, from raw materials to manufacturing, test reports, and feedback.

[source]

• US Food and Drug Administration. (2022). Attachment 2 – Supplemental Response to NDI Notifications 1240, 1247, etc. (Docket No. FDA-2022-S-0023-0051). Retrieved from https://downloads.regulations.gov/FDA-2022-S-0023-0051/attachment_2.pdf

• Natural Products Association & Alliance for Natural Health. (2023, March 7). NPA and ANH File Citizen's Petition with FDA on Specific NMN Relief . NPA National. Retrieved from https://www.npanational.org/news/npa-and-anh-file-citizens-petition-with-fda-on-specific-nmn-relief/

• United States District Court for the District of Columbia. (2025, July 28). Status Report (Case No. 1:24-cv-02479-PLF). Retrieved from https://www.npanational.org/wp-content/uploads/2025/07/Status-report.pdf