Bad news for the healthcare sector

If you’ve tried to buy NMN supplements on Amazon recently, you may have found that you cannot find them anywhere. This is not because there are safety or efficacy issues with NMN. The new rules are the reason.

These changes put this popular anti-aging supplement in a difficult position. On February 16, 2023, Amazon notified NMN sellers. They stated that sellers cannot sell or distribute NMN products as dietary supplements on their platform.

This decision stems from regulatory changes that began in 2021. The FDA has decided to reclassify NMN as a drug. This is because there is more evidence that NMN helps with metabolic health and longevity.

Nothing has changed since classifying NMN as a drug. However, NMN is no longer a dietary supplement. They have removed it from major platforms such as Amazon.

In this article, we will look at the reasons why Amazon banned the sale of NMN. We will also discuss how people who want anti-aging products can still buy high-quality NMN supplements despite this ban. You will definitely benefit a lot from reading this article.

When NMN was banned by Amazon, many people were devastated

Why Amazon Bans the Sale of NMN Products

Caused by FDA

On November 4, 2022, the FDA announced that NMN is no longer a dietary supplement. They will now classify it as a drug or drug ingredient. This change means that NMN must obtain FDA approval to be sold.

This decision came after reviewing studies on NMN. The earlier approval for research as a drug forms the basis for it. This approval disqualifies NMN under the Dietary Supplement Health and Education Act (DSHEA).

The FDA first rejected NMN as a new dietary ingredient (NDI). Later, they clarified that it falls under DSHEA's drug exclusion rule.

In response, Amazon said it would take NMN products off its site by March 13, 2023. This will happen unless sellers can show FDA approval. The company stressed the need to follow federal rules.

The situation is similar to the FDA’s 2021 decision regarding N-acetylcysteine ​​(NAC). After public backlash, the FDA reconsidered the decision. This allowed NAC to return to store shelves.

NMN’s current regulatory status puts it in a gray area. While it is popular for its anti-aging benefits, this also complicates its development and market availability.

Ban the nmn

NPA: Another slippery slope for the FDA

The Natural Products Association (NPA) is against the FDA's choice to label NMN as a drug ingredient. They are urging retailers to keep selling NMN, even though Amazon has banned it.

NPA President and CEO Dr. Daniel Fabricant criticized the FDA's view of the law. He said it causes market disruption, confusion, and economic losses.

He emphasized that this is the first time the FDA changed its position on a new dietary ingredient. They did this without mentioning any safety concerns. This sets a worrying example for the industry.

Fabricant warned that these decisions hurt trust in the regulatory process. He questioned the FDA’s ability to revoke approvals randomly. He also emphasized the FDA's inconsistent approach to other supplements like NAC and CBD.

The NPA dedicates itself to holding the FDA responsible. They aim to protect both consumers and the dietary supplement industry.

The decision mainly affects the U.S. market. However, many sellers still offer NMN on independent websites or international channels. This shows the regulatory challenges and confusion around NMN.

FDA Ban NMN

CRN: I'm not surprised the FDA made this move

Steve Mister, the president and CEO of the Council for Responsible Nutrition (CRN), was disappointed. He was unhappy with Amazon's choice to remove NMN products from its platform. "We are not surprised that it has chosen to prematurely ban NMN, just as it did with NAC," Mister said. He noted that both ingredients have a history of safe use in supplements, which the FDA acknowledges.

Mister criticized Amazon's choice as too careful. He thinks the FDA's poor reasoning may influence it. The FDA believes that NMN qualifies as a drug and should receive exclusion.

"This move has bad effects on consumers, nutrition experts, and even Amazon," he said. He suggested that the FDA might have wanted this overreaction to avoid defending its position in court.

The situation is still evolving as the industry grapples with the FDA's decision.

Check out NAC events!

This is not the first time Amazon has removed a specific dietary supplement from its shelves following FDA action. Industry stakeholders often reference the case of N-acetylcysteine (NAC) between 2021 and 2022.

Manufacturers have used NAC in dietary supplements since the early 1990s. A “traditional dietary ingredient” falls under the Dietary Supplement Health and Education Act of 1994 (DSHEA).

However, in July 2020, the FDA said NAC is not a legal dietary ingredient. This is because the authorities approved it as a drug before people used it in supplements. The FDA first approved NAC as an inhaled mucolytic drug in 1963.

Amazon took down supplements with NAC from its site in May 2021. This was in line with the FDA’s stance.

Industry Opposition to FDA’s NAC Ruling

When the FDA decided to exclude NAC from dietary supplements, it sparked a backlash from manufacturers, nonprofits, and citizens. Organizations such as the Natural Products Association (NPA), the Council for Responsible Nutrition (CRN), and the American Herbal Products Association (AHPA) actively opposed the ruling.

On December 6, 2020, the NPA filed a citizen petition and lawsuit challenging the FDA’s actions. Key arguments included:

- NAC has been part of the U.S. food supply since 1991. This occurred before Congress passed the Federal Food, Drug, and Cosmetic Act. Some believe this makes it a dietary supplement.

- The FDA approved the drug version of NAC in 1963. The instructions did not specify oral use. This raises questions about the drug exclusion rule in the Federal Food, Drug, and Cosmetic Act.

- Alleged that the FDA’s decision retroactively applies the drug exclusion rule to NAC.

Despite these efforts, the court dismissed the lawsuit without prejudice on November 4, 2022. Interestingly, by August 2022, Amazon started selling these products again.

This happened after the FDA gave new guidance. The FDA said they would be flexible about enforcing rules on NAC. The guidance essentially allowed the sale of NAC, as long as the product avoided illegal disease claims.

actively opposed the ruling

Impact on NMN

The precedent set by NAC offers a glimmer of hope for NMN, another dietary supplement currently under review. NMN supporters hope the FDA will create a policy. They want to continue selling NMN in the U.S. as a dietary supplement. This outcome would make possible NMN sales, echoing the resolution reached with NAC.

Is NMN really harmful?

The answer is definitely no harm!

Nicotinamide mononucleotide (NMN) is a popular supplement. It is a precursor to nicotinamide adenine dinucleotide (NAD+). NAD+ is a coenzyme needed for energy production. It also helps with DNA repair, protein regulation, and keeping mitochondria healthy.

As we age, NAD+ levels go down. This happens because our bodies make less of it and use more. This decline can speed up aging. It can also raise the risk of chronic diseases like heart disease, Alzheimer's, and type 2 diabetes.

NMN supplements have become popular because they may boost NAD+ levels. This can help fight age-related decline and support overall health. Research from clinical-stage pharmaceutical company Metro International Biotech further highlights the importance of NAD+ cycling in combating aging and rare diseases.

NMN effect: anti-aging and anti-wrinkle

Where to buy safe NMN supplements?

Interestingly, there may be a silver lining to Amazon’s ban on NMN. Professor Michael Levitt of AIDEVI says this change could make consumer safety better. It would remove fake brands that make low-quality NMN in unregulated factories.

These non-GMP certified manufacturers often use Amazon to sell their products. If they were not there, it could make the market safer and more reliable for NMN buyers in the United States.

Despite the recent Amazon ban on NMN sales, consumers can still obtain high-quality NMN supplements from reputable sources. NMN supplements and other anti-aging products are still easy to find on special websites.

Trusted brands like AIDEVI support their NMN products with clinical studies. They keep prices low by making and shipping directly from GMP certified facilities. They also ensure strict testing in-house and by third-party labs.

aidevi has passed multiple certifications

Hope people live healthy life

AIDEVI helps people begin a healthy new life. We offer pure, natural, and affordable dietary supplements.

We support the protection of medical innovation. However, we believe that this should not prevent the public from having access to safe and affordable supplements. The development of NMN and its over-the-counter products has a strong business model. The supplement industry can use it to allow people to enjoy low-priced, high-quality products.

We follow the founding principles of health and wellness. We are committed to providing natural solutions supported by strong scientific research. Thousands of Americans have safely benefited from NMN supplements. Many AIDEVI NMN users, especially middle-aged women, have regained their youthful vitality.

Amazon’s recent ban on the sale of NMN has frustrated many people who use the site to shop. We ask the FDA to consider the needs of the public. Consumers must have access to safe and effective products like NMN.

If you are interested in this product or our brand, please visit the AIDEVI official website for more information. If you have any questions, you can send us an email and we will reply to you as soon as possible.