Unveiling the NMN Saga: The Unspoken Truth

Unlocking the Power of NMN: A Dive into its Benefits

NMN, or Nicotinamide Mononucleotide, stands out for its exceptional absorption in the body. Recent studies reveal that just one week of NMN supplementation not only elevates blood NAD levels but also enhances NAD levels within cells and, crucially, within mitochondria.

Benefits

Energy Boost:
- As we age, the energy-producing mitochondria in our cells start to decline. By supporting and amplifying NAD+ production, NMN revitalizes cellular function. Low NAD+ levels are closely tied to aging signs like mental decline, fatigue, poor glucose control, and compromised skin quality.
Brain Power:
- Research in mice (2019) indicates that NMN improves cerebral blood flow, essential for maintaining healthy brain function. This enhanced blood flow facilitates the removal of harmful metabolites and ensures the delivery of oxygen and nutrients to the energy-demanding brain

Natural Sources vs. Supplements

While NMN is found in foods like broccoli, cucumber, and avocado, the amounts are minimal (around 0.25-1.9 mg per 100g). To match the NMN content in a 500mg capsule, one would need to consume a kilo of broccoli daily. Hence, supplementation is the most efficient route.

Safety of NMN:

A 2019 study on healthy individuals demonstrated that daily NMN doses of up to 500mg are safe. Renowned longevity experts, such as Prof. David Sinclair, confidently take up to 1g daily. Studies with doses up to 1200mg have reported no adverse effects. NMN is recognized as non-pharmaceutical, exists naturally, and is deemed generally safe (“GRAS”).

Supplement Synergy:

Enhance the longevity benefits with a comprehensive approach:

NMN: Elevates energy production, activates AMPK, and stimulates sirtuins.
Quercetin: Boosts NAD+ levels by inhibiting CD38, enhancing NMN effects.
Resveratrol: Activates sirtuin pathways, working synergistically with NMN.
Coenzyme Q10: Supports mitochondrial function and acts as an antioxidant.
D3 and K2, B complex (methylated active form): Essential for overall well-being.

NMN vs. Niacin (Vitamin B3)

Choosing NMN over niacin is crucial to elevate NAD levels and activate sirtuin pathways effectively. Niacin, being a step behind in the process, can inhibit sirtuins. Excessive niacin intake may also cause flushing.

NMN vs. NAD+

NMN acts as the fastest way to boost NAD+. Unlike NAD+, NMN can be transported into cells and mitochondria directly. No transporter has been identified for NAD+, suggesting it needs conversion into NMN or NR before being transported and converted back into NAD+.

In conclusion, NMN proves to be a dynamic and safe supplement with multifaceted benefits. Its ability to enhance energy, support brain health, and synergize with other supplements makes it a compelling choice for those seeking holistic well-being.

In addressing the crucial issue of FDA transparency concerning NMN, our concern stems from the lack of clarity, especially when big pharmaceutical companies become involved. The efficacy of NM N becomes evident when it attracts the attention of major players in the industry. The decision to transition a supplement like NMN into a prescription drug and patent it raises concerns about profit motives.

Despite this, as the FDA hasn’t issued a directive to all supplement companies, NMN remains available from various vendors. Explore the link below to access high-potency NMN.

BUY NMN FOR ANTI-AGING

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The online retail giant AMAZONE has moved to remove supplements containing NMN, an anti-aging ingredient, from its platform following an FDA announcement that is not a legal dietary ingredient

When a supplement exhibits an exceptionally strong efficacy, this is the underlying phenomenon at play.

Recently, the US Food and Drug Administration (FDA) said that beta-nicotinamide mononucleotide (Β-NMN) — a popular longevity supplement ingredient — is under investigation as a potential new drug. Therefore, companies can no longer market it as a dietary supplement. This decision has sparked concern among those who use NMN and the dietary supplement industry.

The FDA had previously accepted NMN as a New Dietary Ingredient (NDI), which allowed supplement manufacturers to market it. But, on October 11, 2022, they revoked the NDI, so companies can no longer sell it in the United States.

This decision has created concern among proponents of natural supplements, practitioners, and the dietary supplement industry.

What happened to NMN?

On July 25, 2022, Inner Mongolia Kingdomway Pharmaceutical Limited voluntarily submitted an NDI for NMN because the company planned to market an NMN-containing dietary supplement.

However, on October 11, 2022, the FDA sent a letter to Kingdomway regarding the company’s NDI. The FDA document states that “NMN has been authorized for investigation as a new drug” and “may not be marketed as a dietary supplement or as a food.”

The FDA can do this because of the preclusion provision of Section 201(ff) of the Federal, Food, Drug, and Cosmetic Act. Officials created this provision to protect the commercial interests of pharmaceutical companies developing new drugs. It also prevents unscrupulous individuals or groups from bypassing the drug approval process by categorizing their ingredients as dietary supplements.

However, the FDA does not disclose when a pharmaceutical company submits an Investigational New Drug (IND) application. So, it is unclear when NMN was authorized for investigation. This led Kingdomway to question the FDA’s decision.

In a supplemental letter explaining its decision, the FDA wrote, “the evidence on which Kingdomway relies to show that Β-NMN was marketed as a dietary supplement or food before it was authorized as a new drug is too recent, not relevant, or both.”

The FDA cites February 16, 2021, as the first date on which another manufacturer could have marketed its Β-NMN product lawfully after submitting an NDI notification to the agency on December 3, 2020. However, the FDA noted that it’s unclear whether Β-NMN was actually marketed on that date.

The second timeframe the FDA points out is September 2021 — the month that Kingdomway first marketed its NMN-containing whey protein concentrate.

“Both of these dates are after the first date on which Β-NMN was authorized for investigation as a new drug,” the FDA wrote

Pharmaceutical companies interested in NMN

Metro International Biotech is one privately owned pharmaceutical company currently involved in studies examining MIB-626— a pharmaceutical grade Β-NMN formulation.

One study looking at Β-NMN’s effect on Alzheimer’s disease was first publicly posted on September 10, 2021. Another investigation MIB-626 treatment in adults with COVID-19 and kidney injury was posted on September 9, 2021. A third study, first posted on March 25, 2021, is testing the safety of MIB-626 in adults with Friedreich’s Ataxia (FA).

In December 2021, Metro Biotech posted a comment to the FDA regarding NMN. The company wrote:

“As a company that has instituted publicly available clinical trials on β-Β-NMN, we request that FDA take the preclusion provision of Section 201(ff) of the Federal, Food, Drug, and Cosmetic Act seriously to protect the right of companies that have spent significant time and research to develop drugs products from competition from dietary supplements that are clearly new dietary ingredients that have never filed a new dietary ingredient notification prior to the institution of substantial clinical trials.”

Industry reactions to the decision

Steve Mister, President & CEO of the Council for Responsible Nutrition (CRN), a leading trade association for the dietary supplement and functional food industry, told Healthnews:

“We are very disappointed with the FDA decision here. We think it is the wrong decision. We think it has a potential negative precedent for other ingredients in the space.”

“This issue is part of a much bigger concern for the industry around something called drug preclusion,” he said.

“There’s a provision in the statute in the Food Drug and Cosmetic Act that says that if an article is either marketed as a pharmaceutical or substantively studied as a pharmaceutical prior to it being introduced as a dietary supplement, the pharmaceutical side of the industry gets a monopoly over the article,” Mister explained.

According to Mister, if the dietary supplement industry markets an ingredient first, then the ingredient is shared with the pharmaceutical industry.

“One of the best examples of that has been omega-3 fish oils,” he explained. “Because we marketed that as supplements going back decades, and now you can buy highly purified versions of omega-3s as prescription pharmaceuticals. But we did not lose it just because they decided to start marketing highly purified versions of it,” Mister said.

Mister suggests that the statute sets up a one-sided monopoly for pharmaceuticals. “I think the industry will be looking for a long-term solution that goes beyond NMN and looking to actually amend the statute because this is not working,” he said.

Mister told OneStopAging

“This same provision is what is keeping cannabidiol off the market. The FDA says that it was first marketed by pharmaceutical companies, so we can’t bring CBD to market as a supplement. It’s not a safety question for the agency — they’re relying on drug preclusion language.”

Mister is concerned because the FDA does not disclose when a pharmaceutical company submits an IND application. So, it becomes a transparency issue.

A doctor weighs in

According to Jeff Gladd, MD, practicing integrative medicine physician and chief medical officer at Fullscript, sudden FDA decisions to exclude existing ingredients from being defined as dietary supplements are frustrating for practitioners, consumers, and retailers alike.

“While I support investments in clinical research to prove the claims for dietary supplements, protecting the pharmaceutical industry often leads to very high-priced options that are difficult for the average patient to consider,” he told Healthnews.

“I have concerns about the potential for other dietary supplement ingredients to become pharmaceutical industry targets of FDA’s efforts to exclude them from the marketplace, and I support the work being done by advocacy groups to petition [the] FDA,” he said.

Is NMN banned?

According to Mister, when the FDA decides an ingredient no longer meets its definition as a dietary supplement, they issue a letter to companies that market it.

“But unless the FDA decides to then go out and exercise some enforcement, it does not require that the companies pull the ingredients,” he explained.

For example, when the FDA decided that companies could no longer market [N-acetyl cysteine] NAC, “most retailers continued to sell it because the warning letter was only directed to one company, it was not enforced against the rest of the industry,” Mister said.

“I think that’s what you will see happen again with NMN,” he added. “Many companies will continue to market it until they see whether [the] FDA is really so confident in its decision that it is ready to actually exercise enforcement against the products.”

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