FDA Rejects NMN Supplement, Amazon Pulls Products

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The FDA’s recent decision to reject the notification for Uthever NMN, a popular dietary supplement, has led to its removal from Amazon’s US website. This has left millions of users wondering about the future availability and cost of the supplement.

While no safety or efficacy objections were cited, the FDA’s decision means that NMN may soon be classified as a drug rather than a supplement and only available through pharmacies and by prescription.

The decision has sparked concerns about the future of the supplement industry, as many other supplements could also face similar scrutiny from the FDA. The rejection of NMN highlights the regulatory challenges faced by supplement manufacturers and the need for greater clarity and transparency in the industry.

As the popularity of dietary supplements continues to grow, regulators must strike a balance between ensuring consumer safety and supporting innovation and access to beneficial products.

Note: NMN supplements are still available is Singapore.

Key Takeaways

• FDA rejected notification for Uthever NMN’s new dietary ingredient, potentially leading to NMN being classified as a drug rather than a supplement.
• Despite no safety or efficacy objections mentioned by the FDA, Amazon has removed all NMN products from their US website.
• The Natural Products Association and Alliance for Natural Health filed a citizens’ petition with the FDA to change their position on NMN, to which the FDA has 180 days to respond.
• The pharmaceutical company behind the refined form of NMN has a strong financial interest in making NMN only available as a drug, potentially leading to higher prices and limited availability.

FDA and NMN Classification

The FDA’s recent rejection of Uthever NMN’s new dietary ingredient notification has sparked controversy within the health and wellness industry. Despite the lack of safety or efficacy objections mentioned by the FDA, the reclassification of all forms of NMN as a drug has raised concerns about the future availability of the supplement, which has been sold as a supplement for 10 years in the US.

The FDA determines the classification of new ingredients as either a drug or supplement based on the first paperwork filed. In the case of NMN, a pharmaceutical company submitted paperwork to classify a refined form of NMN as an investigational drug, which was approved by the FDA. As a result, the FDA retracted supplement approval and changed the designation of all forms of NMN as a drug.

This decision could potentially lead to the withdrawal of NMN from the market, leaving it only legally available through pharmacies and by prescription.

Availability and Price of NMN

Currently, the cost of NMN has decreased significantly over the past few years. This is good news for people who rely on the supplement for their health. ForYouth, a company that sells NMN, is working with suppliers to bring costs down even further.

Efforts to reduce the cost of NMN are important, especially since the supplement may soon only be legally sold by pharmacies and with a prescription. However, it is also important to consider the quality of the product when purchasing NMN. ForYouth’s NMN is tested and guaranteed to be stable, but not all NMN products on the market may meet the same standard.

As new NAD+ supplements become more concentrated, it may be possible to achieve the same outcome with less NMN, making it even more important to choose a high-quality, stable product. ForYouth guarantees that their NMN product is stable for at least 2 years.

Citizens Petition and Amazon’s Response

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Efforts to change the position of a certain dietary ingredient have been made through a citizens’ petition, which has prompted Amazon to remove related products from its US website.

The Natural Products Association and Alliance for Natural Health have filed a citizens’ petition with the FDA to change the regulatory position on nicotinamide mononucleotide (NMN).

The FDA has 180 days to respond to the petition.

The petition argues that NMN should be allowed to be sold as a dietary supplement, as it has been for the past ten years, and not be treated as a drug.

The decision by Amazon to remove all NMN products from its US website has created concern among NMN users and businesses.

While the FDA has not raised any safety or efficacy objection to NMN, it has withdrawn the supplement approval for NMN and classified it as a drug.

If the FDA enforces this position, NMN will only be legally sold by pharmacies and with a prescription.

This would have significant implications for the availability and price of NMN.

New NAD+ Supplements

New NAD+ supplements offer a more concentrated form of the compound, requiring a smaller dosage to achieve the same results as previous supplements. NAD+, or nicotinamide adenine dinucleotide, is a coenzyme found in every cell of the body and is essential for many biological processes, including energy production and DNA repair. As we age, NAD+ levels naturally decline, leading to a range of health issues.

The table below shows some of the benefits of NAD+ supplementation. While more research is needed, initial studies suggest that NAD+ supplements may improve metabolic function, increase endurance, and improve cognitive function. Additionally, NAD+ supplements may have anti-aging properties, as they have been shown to improve mitochondrial function and increase lifespan in animal studies. 

Frequently Asked Questions

What is NMN and how does it work in the body?

NMN (nicotinamide mononucleotide) is a naturally occurring molecule in the body that helps with cellular energy production and DNA repair. It works by increasing levels of NAD+ (nicotinamide adenine dinucleotide), an essential coenzyme involved in many biological processes. Learn how much NMN should you take.

Are there any potential side effects of taking NMN supplements?

Limited research on the side effects of NMN supplements exists, but no major adverse effects have been reported in human studies. Long-term safety and efficacy of NMN supplementation require further investigation.

What are some alternative supplements that can be used to support NAD+ levels?

Alternative supplements to support NAD+ levels include resveratrol, nicotinamide riboside, and quercetin. These supplements have been shown to increase NAD+ levels and may offer similar benefits as NMN. Further research is needed to confirm their effectiveness.

How will the reclassification of NMN as a drug affect its availability and pricing?

The reclassification of NMN as a drug may result in its limited availability and higher pricing. The pharmaceutical company has a strong financial interest in making NMN only available as a drug, and it is unclear for what diseases it would be prescribed.

What actions can consumers take to advocate for the availability of NMN as a supplement?

Consumers can advocate for the availability of NMN as a supplement by submitting comments to the FDA during the 180-day response period for the citizen’s petition, contacting their representatives, and supporting organizations lobbying for NMN’s supplement classification.

Conclusion

In conclusion, the FDA’s rejection of Uthever NMN’s notification has raised concerns among millions of supplement users. The decision may lead to NMN being classified as a drug, resulting in limited availability and increased costs. Amazon’s removal of all NMN products from its US website has added to the uncertainty surrounding the future of this supplement.

However, this setback has led to the emergence of potential alternatives such as new NAD+ supplements. Additionally, a citizens’ petition has been filed urging the FDA to reconsider its decision.

As the debate continues, it is essential to prioritize safety and efficacy while ensuring that consumers have access to the supplements they rely on for their health benefits. Ultimately, a transparent and collaborative approach between regulatory bodies, manufacturers, and consumers may pave the way for a more sustainable and equitable supplement industry.