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Here we go again: FDA rules NMN is not a supplement

nmn nad

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#31 parsons

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Posted 25 January 2023 - 10:03 AM

"In a recent letter to a trade association, an FDA official reiterated NMN is excluded from the definition of a dietary supplement and that its position has not changed, even after receiving additional materials from interested parties seeking to change FDA’s determination."



#32 osris

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Posted 27 January 2023 - 05:22 PM

Video by Brad Stansfield on companies defying NMN ban by FDA.

#33 Anthony_Loera

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Posted 27 January 2023 - 05:45 PM

New update:

First, It is commonly believed that the current FDA status of NMN is the same as CBD.


Yesterday, the FDA took a step against CBD
and declined three citizen petitions that had asked for a rulemaking to allow the marketing of CBD products as dietary supplements. The U.S. Food and Drug Administration has concluded that a new regulatory pathway for CBD products is needed to balance individuals' access to them with the regulatory oversight required to manage risks. They claim CBD can potentially harm the liver and interactions with certain meds and the male reproductive system.




In my personal opinion,
they want to set it up for Congress, so Congress can spike the ball and give the FDA a regulations power grab. I don't see how the FDA needs a different regulatory framework for CBD that they don't already have for other products, like alcohol. I don't believe this is about CBD anymore, but a way for Dick Durbin to choke Dietary Supplement companies through costly regulations and hand over more business to big pharma.


Coming back to the NMN,
current studies show no adverse effects on people (which was the case with CBD and the main reason the FDA says they needed more regulations from Congress and denied a citizen's petition). Now the FDA is still open to getting information from people that show purchases in 2018 and before, where the labels include "Nutritional Facts" rather than "Supplement Facts" on the label or say "Food Supplement" on the bottle.

If you have purchased anything and have an email record of it, purchase or marketing with an NMN product with this information on the label. Let me know or email me. The FDA has to consider the marketing of this type to determine whether NMN can be sold to the public without issues.


Much like all the ingredients that DSHEA grandfathered in, they needed to show they were marketed to the public before the FDA rules took effect. NMN product marketing and sales need to be shown to the FDA similarly, proving that it was sold before the IND paperwork was filed with the FDA.


#34 Mind

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Posted 27 January 2023 - 05:58 PM

This is a dangerous precedent for the future of rejuvenation supplements and therapies. Basically, any big corp asks the FDA to reclassify any supplement and they will do it - no matter the science. 


I have advocated for life extension and rejuvenation therapies and supplements for over 2 decades now, with the expectation they would be "available" to the average person. Increasingly, it looks like big pharma - with the help of the government - is going to hold the keys. They hate empowered individuals.

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#35 osris

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Posted 27 January 2023 - 10:36 PM




So, yes, in my opinion, the FDA's stance could theoretically wreck the dietary supplement industry if they simply went on the dates of the INDs from universities.





This is the general plan. A European Union version was in the pipeline in the early 2000s, if I recall correctly. For some reason it was abandoned.

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#36 osris

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Posted 27 January 2023 - 10:50 PM

This sort of FDA banning and Big Pharma bully boy tactics happened with alternative cancer treatments. One just has to look at the history of laetrile as a cancer therapy, or Big Pharma's attack on the theory that cancer is a fungal condition which alkaloids can treat.

#37 osris

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Posted 28 January 2023 - 12:38 AM

Maybe MNM takers should start taking NAM instead. It's certainly far cheaper.


"In fact, more recent studies have demonstrated that orally ingested nicotinamide riboside (NR) and nicotinamide mononucleotide (NMN) get almost entirely converted to nicotinamide (NAM) in the liver: “Intravenous administration of nicotinamide riboside or mononucleotide delivered intact molecules to multiple tissues, but the same agents given orally were metabolized to nicotinamide in the liver” (Liu, 2018). “Thus, the majority of the orally administered NR that reaches the muscle appears to enter in the form of liberated NAM. […] NR exerts only a subtle influence on the steady-state concentration of NAD in muscles” (Frederick, 2016)."




See also:


"Nicotinamide is an inhibitor of SIRT1 in vitro, but can be a stimulator in cells"
Just in case some of you are put off NAM thinking it will age you.

Edited by osris, 28 January 2023 - 01:16 AM.

#38 osris

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Posted 28 January 2023 - 01:46 AM

I forgot to add:


Nicotinamide Extends Replicative Lifespan of Human Cells
"We found that an ongoing application of nicotinamide to normal human fibroblasts not only attenuated expression of the aging phenotype but also increased their replicative lifespan, causing a greater than 1.6-fold increase in the number of population doublings. Although nicotinamide by itself does not act as an antioxidant, the cells cultured in the presence of nicotinamide exhibited reduced levels of reactive oxygen species (ROS) and oxidative damage products associated with cellular senescence, and a decelerated telomere shortening rate without a detectable increase in telomerase activity. Furthermore, in the treated cells growing beyond the original Hayflick limit, the levels of p53, p21WAF1, and phospho-Rb proteins were similar to those in actively proliferating cells. The nicotinamide treatment caused a decrease in ATP levels, which was stably maintained until the delayed senescence point. Nicotinamide-treated cells also maintained high mitochondrial membrane potential but a lower respiration rate and superoxide anion level. Taken together, in contrast to its demonstrated pro-aging effect in yeast, nicotinamide extends the lifespan of human fibroblasts, possibly through reduction in mitochondrial activity and ROS production."
"There has been criticism levied against niacinamide because its use might deny the caloric-restriction-type benefits of sirtuins. This has not been embraced by sirtuin pioneer Dr. David Sinclair, who has recently cautioned against the widespread belief that niacinamide is anti-sirtuin. 'One must be careful when calling niacinamide an ‘inhibitor’ in this experiment. While it is true that our lab showed that niacinamide is a direct inhibitor of SIRT1 enzyme, it is also a precursor of NAD+, and NAD+ is a co-substrate (i.e., activator) of SIRT1'. Moreover, 'We should entertain the possibility that niacinamide is activating SIRT1 in vivo, not inhibiting it. This would fit with other papers showing that SIRT1 is neuroprotective.'” 
The link for this last one is inactive. I've had the quote in my files for years.

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