On February 16, Amazon sent a notice to all companies selling NMN products on its platform. The notice stated that manufacturers and retailers in the United States could no longer sell or distribute products containing NMN as a dietary supplement. As a result, Amazon has implemented a ban on the sale of NMN on its website.
The letter discusses a decision made by the FDA in October 2022 regarding NMN. The FDA has now classified NMN as a drug or drug ingredient, which means that it must be approved by the FDA before it can be sold. This change came after Metro International Biotech submitted its own version of NMN to the FDA for review as an Investigational New Drug (IND) in July 2022.
As per the FDA, once a substance is being studied as a potential drug, it cannot be marketed or sold as a dietary supplement anymore. It must undergo the appropriate approval process first.
NMN is a molecule found in all living organisms and is commonly included in dietary supplements for its potential anti-aging properties. It is believed to have the ability to increase levels of nicotinamide adenine dinucleotide (NAD+), which plays a critical role in DNA repair, protecting DNA integrity and promoting healthy mitochondria and cellular energy production. However, NAD+ levels tend to decline with age.
Amazon requirements for suppliers
NMN sellers have a limited amount of time to make important decisions about their future actions. Amazon has outlined three key requirements for these sellers to have their products relisted:
- Provide detailed information about the product’s ingredients on the item page.
- Submit clear and legible labels that include a National Drug Code (NDC).
- Request reinstatement using Amazon’s standard seller appeal process.
If companies do not request reinstatement and still have remaining inventory of these items in Amazon’s warehouses after March 13, 2023, they must initiate either a return or disposal order for that remaining inventory.
If they do not submit a removal request within one month of receiving a removal notice, Amazon has the authority to dispose of this inventory in accordance with its terms and conditions and legal policies.
Has Amazon banned NMN because of a security issue?
Amazon’s cessation of NMN sales isn’t due to safety issues. On November 4, 2022, the FDA issued a controversial letter withdrawing NMN’s previous designation as a dietary supplement and removing it from the dietary supplement category. This decision stems from the ongoing review of NMN as a potential drug. As a result, Amazon has decided to stop offering NMN products on its platform.
While Amazon’s decision to delist NMN products isn’t primarily due to safety concerns, it’s important to recognize that such issues have surfaced before. Specifically, there have been reports of NMN supplements available primarily on Amazon that lack purity, stability assessments, and GMP certifications. However, we advise consumers to remain optimistic and continue to incorporate NMN supplements into their wellness regimens. Always make sure they are sourced from trustworthy companies.
A situation similar to the recent rulings on NAC
In July 2020 the FDA implemented a ban on a supplement known as N acetyl L cysteine (NAC). The FDA determined that NAC could no longer be classified as an ingredient or supplement since it was initially authorized for investigation, as a new drug before being marketed as a supplement.
Reflecting on our discussions, it’s clear that Amazon’s decision to remove NMN products is not primarily based on safety concerns. However, historical issues related to the authenticity and quality of these supplements on Amazon are significant. There have been instances where NMN supplements have failed to meet standard criteria for purity, stability testing, and GMP certification. Interestingly, in our recent checks on Amazon, we have occasionally found some NMN products available for purchase. Nevertheless, consumers should remain optimistic about the potential benefits of NMN supplements, but must be diligent. Sourcing these products from trustworthy companies is paramount to ensuring one’s safety and the supplement’s efficacy.
Please be aware that the FDA is currently investigating NMN as a potential new drug, starting from autumn 2022. This investigation raises questions about its legal classification as a dietary supplement. The situation is complex and still unresolved. However, it’s important to note that since we are neither manufacturers nor sellers, we cannot be held responsible for the availability of the product as a dietary supplement after it loses its designation as a dietary ingredient.
Zhang H, et al (2016). NAD⁺ repletion improves mitochondrial and stem cell function and enhances life span in mice
Yoshino M, et al (2021). Nicotinamide mononucleotide increases muscle insulin sensitivity in prediabetic women