FDA Rules NMN to be a Drug Not a Supplement

U.S. regulators have determined an ingredient marketed on Amazon for such health conditions as anti-aging and energy production cannot be sold in dietary supplements due to being investigated as a pharmaceutical drug.

Several companies were recently advised that β-NMN (beta-nicotinamide mononucleotide) is excluded from the definition of a dietary supplement.

A recent batch of FDA letters to Inner Mongolia Kingdomway Pharmaceutical Ltd. (Kingdomway) and others stand in contrast to the position previously taken by the agency in its review of β-NMN ingredient submissions made to FDA to establish the safety of the ingredient in supplements.

In publicized responses to five new dietary ingredient notifications (NDINs) filed with FDA between the summer of 2020 and the spring of 2022, FDA did not conclude NMN was precluded from use in dietary supplements due to it being investigated as a drug. The agency objected to four of the five notifications for reasons unrelated to its status as a new drug under investigation.

https://www.naturalproductsinsider.com/regulatory/fda-says-ingredient-studied-drugβ-nmnis-excluded-supplements

1 Like

Well, that certainly is going to open a can of worms. This may even be entertaining. At least to me, since I am not taking it.

What about NR? They probably paid the bribe to get this done.

Frankly I tried both and never noticed a thing.

2 Likes

This is because of David Sinclair’s company Metro Biotech

Fabricant, a former FDA official who oversaw the Division of Dietary Supplement Programs from 2011 until 2014, added, “There’s no reason why the agency couldn’t begin a policy of enforcement discretion here on NMN immediately, even if it is draft or interim.”

Such a proposal could keep NMN available as a dietary supplement in the U.S. but is likely to face resistance from the clinical-stage pharma company researching the ingredient as a drug: Metro International Biotech.

1 Like

This is type of FDA / Fed / State Gov’t actions I always worry about – and more recently possibly making Rapa more difficult to obtain for anti-aging.

IMO, likely some FDA, etc., personnel do nothing but look for how non-Rx meds are getting popular. Aside that some of them know what is good for everybody, likely there is also a pharma behind, that just happens to have a patented Rx to fill the void.

Even tightening / enforcing import rules would be a big negative for many of us.

As I mentioned previously apparently an FDA letter issued re thyroid compounding.

I don’t know if it is because I moved to a different state, but I have had great difficulty in filling an Rx I asked my holistic MD for, vials of heparin. I’ve had for maybe 10 years, but esp since Covid, good to have. Basically covid kills by clotting blood. Having heparin SC or IM, is just far more useful than taking a baby aspirin.

1 Like

No - this is purely a defensive action by Metro Biotech to keep the market for NMN to iteself. They’ve been asking the FDA to do this for quite some time…

The Birmingham, MI, firm, which operates as MetroBiotech, suggests the FDA apply to the use of NAD+ in supplements the same scrutiny it’s showing concerning N-acetyl-L-cysteine (NAC) in the products.

Through corporate counsel Michael Willis, MetroBioTech also suggests dual enforcement of separate FDA rules under the Dietary Supplement Health and Education is appropriate concerning the use of NAD+ in supplements.

https://www.naturalproductsinsider.com/regulatory/pharma-company-raises-questions-over-race-market-between-drugs-supplements

https://hbw.pharmaintelligence.informa.com/RS152012/In-NAC-Docket-NAD-Drug-Firm-Suggests-US-FDA-Get-Serious-About-Dietary-Ingredient-Regulations

1 Like

I don’t think this will affect many people.

First, rapamycin is also a drug, but a real aging fighter will always find a way to get what we want.

Second, considering what happened to the NAC supplement which is sold on Amazon now after the FDA warned it is a drug, I am afraid NMN will follow the same way.

See what happened to NAC:

1 Like

I was making a general point, re FDA. I understand this case may have been generated from another manufacturer trying to protect its turf

More bad news on NR (and NMN?):

The international team of researchers led by Elena Goun, an associate professor of chemistry at MU, discovered high levels of NR could not only increase someone’s risk of developing triple-negative breast cancer, but also could cause the cancer to metastasize or spread to the brain.

Once the cancer reaches the brain, the results are deadly because no viable treatment options exist at this time, said Goun, who is the corresponding author on the study.

“Some people take them [vitamins and supplements] because they automatically assume that vitamins and supplements only have positive health benefits, but very little is known about how they actually work,” Goun said. “Because of this lack of knowledge, we were inspired to study the basic questions surrounding how vitamins and supplements work in the body.”

Since NR is a known supplement for helping increase levels of cellular energy, and cancer cells feed off of that energy with their increased metabolism, Goun wanted to investigate NR’s role in the development and spread of cancer.

1 Like

Could be a significant financial hit to some supplement companies

Yes. Even David Sinclair mentioned that since NMN turbo charges all cells, it would probably do the same for cancer. If you have cancer, you should not take NR or NMN!

Now should that extend to those who are cancer free? Antioxidants fall into the same boat IMHO as they.protect normal cells and cancerous ones. When do we stop taking supplements that are good for our cells for fear of cancer? These supplements can be a real double edged sword!

3 Likes

One of the members of vitamin B family, in hundreds of foods, for man’s total approx 500,000 years, MAY increase some possible health risks.

Nonsense – and IMO does not deserve any attention.

It has been one of the top anti-aging supplements for years, with hundreds / thousands of studies, & used by millions. Poor Assist Prof Goun was unable to find actual cases of deaths, cancers, etc, caused by NR?

related:

1 Like

Context matters. The study is specific to triple negative breast cancer (in mice). Don’t know how they induced TNBC in mice.

Lastly, we used BiNR to investigate the role of NR uptake in cancer prevalence and metastases formation in triple negative breast cancer (TNBC) animal model. Our results demonstrate that NR supplementation results in a significant increase in cancer prevalence and metastases of TNBC to the brain.

Triple-negative breast cancer (TNBC) accounts for about 10-15% of all breast cancers. The term triple-negative breast cancer refers to the fact that the cancer cells don’t have estrogen or progesterone receptors (ER or PR) and also don’t make any or too much of the protein called HER2. (The cells test “negative” on all 3 tests.) These cancers tend to be more common in women younger than age 40, who are Black, or who have a BRCA1 mutation.

Wonderful. The entire research team can now support Angelina Jolie, whom not only removed her breasts because of BRCA1 mutation, but her ovaries & fallopian tubes as well. Amazing how human race has survived 500,000 years without such actions.

Are you implying she wouldn’t have gotten breast cancer if she hadn’t had them removed? If you had a very high genetic risk of deadly prostate cancer and had the option to have it removed to prevent the entire ordeal, are you claiming you would not?

2 Likes

Impossible to talk about a specific case, but BRCA1 mutations, may not only NOT be dangerous, there is evidence they help to protect re cancers.

Just to add to the criticism of this paper, it was published in a biosensors and bioelectronics journal… which seems perhaps a little bizarre, or at least less than ideal (compared to say, Nature).

Original Research: Closed access.
A bioluminescent-based probe for in vivo non-invasive monitoring of nicotinamide riboside uptake reveals a link between metastasis and NAD+ metabolism” by Tamara Maric et al. Biosensors and Bioelectronics

So, while this specific papers has its criticisms, the broader issue of how this and probably numerous other supplements can help cancer grow if you take them after cancer has started is an issue I think that remains. As you get older and the risk of cancer goes up, I suspect that the risk of taking supplements that may feed the cancer also goes up.

A similar issue has been reported with spermindine and related polyamines:

1 Like

Now there’s a buzz kill. :slightly_smiling_face:

Yes, sorry.

So, keep in mind this graph as you add new supplements to your stack (Cancer risk increases with age):

Source: Risk Factors: Age - NCI

The study by Kuniyasu Soda was published on October 11, 2011. Here is a more recent publication (October 29, 2018).

A recent prospective, observational epidemiological study revealed that individuals that have been eating a diet that is spermidine-rich are characterized by a reduced overall mortality, as well as a decreased mortality by each of the major causes of death, namely (i) cardiovascular, (ii) cancer and (iii) ‘other’ causes [1]. The association between high spermidine uptake and reduced mortality is independent from confounding factors including age, sex, body mass index, consumption of alcohol or aspirin, metabolic syndrome, diabetes, physical activity, and socioeconomic status, as well as conventional dietary scores distinguishing healthy from unhealthy eating.

2 Likes