FDA has banned the OTC sales of NMN

[David PS]

David's Sinclair has spoken about a new NMN pharmaceutical under development (MIB-626). Incidently, David is a co-founder of Metro International Biotech

Metro Biotech Publishes MIB-626 NMN Human Data

A study published by a research team from Metro International Biotech and Harvard Medical School shows that a pharmaceutical-grade preparation of NMN known as MIB-626 increases blood levels of NAD+ in one week in middle-aged and older adults.

www.nmn.com

In addition, David is a named inventor on the US patent application assigned to Metro.

https://patentimages.storage.googleapis.com/19/2f/0b/1f9c71b0a65726/US9919003.pdf

The two relevant documents describing the FDA's justification are at this deep link to the relevant page:

Regulations.gov

www.regulations.gov

From the end of the second and most recent document (supplemental response letter)

3. Conclusions
After evidence that is irrelevant under section 201(ff)(3)(B) for the reasons discussed above has been eliminated, two possible dates of first marketing for NMN are left:
February 16, 2021 – First date on which another notifier could have marketed its NMNcontaining dietary supplement lawfully after submitting an NDI notification to FDA on December 3, 2020; however, it is unclear whether NMN was actually marketed on that date.
September 2021 – Month during which Kingdomway first marketed Doctor’s Best Instant Whey Protein Concentrate Plus NMN as a conventional food. Both of these dates are after the first date on which NMN was authorized for investigation as a new drug.24 Accordingly, we reaffirm our earlier conclusion that NMN is excluded from the dietary supplement definition under 21 U.S.C. § 321(ff)(3)(B)(ii) and may not be marketed as or in a dietary supplement. Today we are sending letters communicating this conclusion simultaneously to all firms that have submitted an NDI notification for NMN.:

 

[Mister]

Unbelievable.

***holes made it harder to get HCG too in the states some time ago...

 

[haidut]

David's Sinclair has spoken about a new NMN pharmaceutical under development (MIB-626). Incidently, David is a co-founder of Metro International Biotech

Metro Biotech Publishes MIB-626 NMN Human Data

A study published by a research team from Metro International Biotech and Harvard Medical School shows that a pharmaceutical-grade preparation of NMN known as MIB-626 increases blood levels of NAD+ in one week in middle-aged and older adults.

www.nmn.com

In addition, David is a named inventor on the US patent application assigned to Metro.

https://patentimages.storage.googleapis.com/19/2f/0b/1f9c71b0a65726/US9919003.pdf

The two relevant documents describing the FDA's justification are at this deep link to the relevant page:

Regulations.gov

www.regulations.gov

From the end of the second and most recent document (supplemental response letter)

Yep, the attack on B3 is under way. Both aspirin and vitamin B3 had a number of studies come out during the "pandemic" and say they are viable treatments/prevention. Within a month, the deluge of "studies" showing aspirin to "dangerous" started and has not really stopped since. Same for vitamin D.
Oh, and speaking of B3, another studies just came out arguing another commercialized NAD precursor - nicotinamide riboside (NR) - to be "carcinogenic".

Study: Popular dietary supplement increases breast cancer risk, brain metastasis

This release has been posted with updated text at: https://www.eurekalert.org/news-releases/971934

www.eurekalert.org

So, it won't be long before NR is either outlawed due to being "unsafe" or due to being studies by ChromaDex as a drug. We will soon be left with only niacniamide and niacin as options, and I fear both are vulnerable under the "studied as a drug before" claim. So, as it turns out FDA can easily go after vitamins, and the precedent was established years ago with the FDA's banning of pyridoxamine - one of the naturally occurring B6 analogs.

Pyridoxamine - Wikipedia

en.wikipedia.org

Clown world, that has gone fully fascist.

 

[Tarmander]

damn

 

[Kram]

Yep, the attack on B3 is under way. Both aspirin and vitamin B3 had a number of studies come out during the "pandemic" and say they are viable treatments/prevention. Within a month, the deluge of "studies" showing aspirin to "dangerous" started and has not really stopped since.

Clown world, that has gone fully fascist.

I noticed this last year too. The below study came out in August 2021 and a few weeks later, an official recommendation from a "US Task Force" saying the elderly should not take aspirin. The amount of vile, evil people in this world is hard to grasp sometimes.

https://www.generalsurgerynews.com/In-the-News/Article/07-21/Aspirin-Reduces-the-Need-for-Mechanical-Ventilation-by-Nearly-Half-For-COVID-19-Patients/64048

US task force proposes adults 60 and older should not start daily aspirin to prevent heart disease or stroke | CNN

The US Preventive Services Task Force is considering making several changes to its guidance on taking a daily aspirin to prevent heart disease and stroke.

www.cnn.com

 

[Krigeren]

Do insect burgers provide a quality source of niacinamide? I jest of course, .

 

[haidut]

I noticed this last year too. The below study came out in August 2021 and a few weeks later, an official recommendation from a "US Task Force" saying the elderly should not take aspirin. The amount of vile, evil people in this world is hard to grasp sometimes.

https://www.generalsurgerynews.com/In-the-News/Article/07-21/Aspirin-Reduces-the-Need-for-Mechanical-Ventilation-by-Nearly-Half-For-COVID-19-Patients/64048

US task force proposes adults 60 and older should not start daily aspirin to prevent heart disease or stroke | CNN

The US Preventive Services Task Force is considering making several changes to its guidance on taking a daily aspirin to prevent heart disease and stroke.

www.cnn.com

Yep, and they recently came out with an "advisory" for the endocrine specialists to stop prescribing vitamin D even if deficient since it is only a symptom and never a causal factor in any disease and they cite their carefully selected meta-analysis showing vitamin D interventions are not worth it. Interestingly, even their meta-analysis showed vitamin D was often effective, but just like aspirin, the findings were twisted around the risk-benefit ratio and concluded that the "risks" of vitamin D outweigh its effectiveness. Hence the recommendation to stop advising its usage.

 

[sunny]

 

[Badger]

On nicotinamide riboside (NR):

Study: Popular dietary supplement causes cancer risk, brain metastasis

Study: New imaging technique in animal study gives insight to popular supplement's potential role in cancer progression

While previous studies have linked commercial dietary supplements like nicotinamide riboside (NR), a form of vitamin B3, to benefits related to cardiovascular, metabolic and neurological health, new research from the University of Missouri focused on imaging technology in an animal model has...

medicalxpress.com

 

[Mister]

On nicotinamide riboside (NR):

Study: Popular dietary supplement causes cancer risk, brain metastasis

Study: New imaging technique in animal study gives insight to popular supplement's potential role in cancer progression

While previous studies have linked commercial dietary supplements like nicotinamide riboside (NR), a form of vitamin B3, to benefits related to cardiovascular, metabolic and neurological health, new research from the University of Missouri focused on imaging technology in an animal model has...

medicalxpress.com

"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."

Wonder how much they used of NR in the study.

 

[aguilaroja]

Yep, the attack on B3 is under way....
Oh, and speaking of B3, another studies just came out arguing another commercialized NAD precursor - nicotinamide riboside (NR) - to be "carcinogenic".

Study: Popular dietary supplement increases breast cancer risk, brain metastasis

This release has been posted with updated text at: https://www.eurekalert.org/news-releases/971934

www.eurekalert.org

So, it won't be long before NR is either outlawed due to being "unsafe" or due to being studies by ChromaDex as a drug.

"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."

Wonder how much they used of NR in the study.

The single research paper source is behind a paywall:

A bioluminescent-based probe for in vivo non-invasive monitoring of nicotinamide riboside uptake reveals a link between metastasis and NAD+ metabolism

Nicotinamide riboside (NR) is a form of vitamin B3 and is one of the most studied compounds for the restoration of cellular NAD+ levels demonstrating …

www.sciencedirect.com

A bioluminescent-based probe for in vivo non-invasive monitoring of nicotinamide riboside uptake reveals a link between metastasis and NAD+ metabolism - PubMed

Nicotinamide riboside (NR) is a form of vitamin B₃ and is one of the most studied compounds for the restoration of cellular NAD⁺ levels demonstrating clinical potential in many metabolic and age-related disorders. Despite its wide commercial availability as a powerful...

pubmed.ncbi.nlm.nih.gov

Study: Popular dietary supplement increases breast cancer risk, brain metastasis // Show Me Mizzou // University of Missouri

University of Missouri researchers made the discovery while using bioluminescent imaging technology to study how nicotinamide riboside supplements work inside the body.

showme.missouri.edu

The study appears to be done in cell culture and experimental animals.

It appears overgeneralized to designate the research tool as valid for generalizing about human health, with no human data. Let alone from a single study.

Two study authors are directly affiliated with "Nestlé Research", and the remainder of authors originate from the same city.

There is a long history of alleged nutrient dangers getting much press, and nutrient benefits getting little notice. So far, there is one alarmist research abstract, which reporters do not appear to have actually read through.
OTOH, there is safety data in actual people, showing impressive safety compared to most pharmaceuticals.

Nicotinamide: An Update and Review of Safety & Differences from Niacin

Oral nicotinamide is an affordable OTC supplement with demonstrated benefit in the treatment of a range of skin conditions, most notably AK and NMSC.

www.skintherapyletter.com

"In the two largest phase 3 studies involving nicotinamide, the ONTRAC study (n = 386) outlined above and the ENDIT study (n = 552) involving patients at risk of developing Type 1 diabetes mellitus, both showed that there was no difference in patient tolerability and laboratory adverse events between nicotinamide (1-3 g/day) and placebo. Other reported adverse events of nicotinamide include thrombocytopenia and hepatotoxicity, however, the ONTRAC study showed no difference in platelet counts between nicotinamide versus placebo groups, and evidence of liver toxicity has only been reported at extremely high dosages of nicotinamide in excess of 3 g/day.
Nicotinamide is renally cleared and 1 study in patients with ESRD on dialysis receiving nicotinamide reported thrombocytopenia, though reassuringly all cases resolved upon cessation of nicotinamide."

"In summary, 1g daily of nicotinamide is well tolerated as highlighted by multiple reports of minimal if any adverse events.... Unlike niacin, nicotinamide does not cause flushing, and thrombocytopenia and hepatotoxicity are rare, isolated effects in patients receiving hemodialysis or at extremely high dosages in excess of 3 g per day."

 

[David PS]

Well, they did it.

Amazon bans NMN in dietary supplements

Amazon has advised sellers of NMN it can no longer sell the anti-aging ingredient as a dietary supplement, Natural Products Insider has learned.

www.naturalproductsinsider.com

 

[ecstatichamster]

We won’t take this sitting down (or standing up.) It can be overturned. There is a long path to go. F*** these peeps. We know that Big Pharma owns the gubmint but that doesn’t mean we have to put up with it.

 

[David PS]

We won’t take this sitting down (or standing up.) It can be overturned. There is a long path to go. F*** these peeps. We know that Big Pharma owns the gubmint but that doesn’t mean we have to put up with it.

Now it the time to stock up if it important to you.

In the email, Amazon said the seller could continue to offer NMN-containing products until March 13, 2023.

 

[Limon9]

NMN is maddeningly expensive. I don't use any B3 derivatives, but do have a few kilograms of niacinamide kept cool, dry and well-sealed (which should last a few years).