39 replies to this topic

[timedilation]

https://www.naturalp...ded-supplements

 

Our regulatory system needs a serious overhaul.

[pamojja]

Also here in Europe. Just found LEF Europe doesn't offer PQQ anymore. Worse, even iherb doesn't sell it to Europe because of regulations anymore.

[parsons]

Anyone know if this affects reduced NMN?  afaik, they only mentioned beta NMN?

[Phoebus]

NMN is still all over amazon.

 

what gives? 

[Turnbuckle]

NMN is still all over amazon.

 

what gives? 

 

Fortunately for some vendors, their NMN doesn't actually have any NMN. 

 

Supplement manufacturer ChromaDex alleges that testing has revealed that more than half of NMN anti aging supplements being sold on Amazon contained almost none of the bioactive molecule.

https://www.nutraing...ive-ingredient#

 

 

[Mind]

This is worrisome. More effective supplements are being created from "natural" ingredients and combined in different ways. The FDA might be more of a roadblock to individual health choices in the near future.

[TheFountain]

I notice when ever there's democratic control of ANYTHING, they take away our civil liberties and the FDA grows like a Fungus. Should I stock up on my Renuebyscience orders?

[QuestforLife]

David Sinclair showing his is more bothered about making money than helping people (it was lobbying by his company that caused the FDA to make this decision).

 

NMN will remain on sale until vendors empty their stocks, then it will be gone - atleast in the US. 

 

Doesn't seem that difficult to challenge however, surely adequate safety data can be demonstrated?

[parsons]

I notice when ever there's democratic control of ANYTHING, they take away our civil liberties and the FDA grows like a Fungus. Should I stock up on my Renuebyscience orders?

liposomal nmn at least is already back ordered to Dec 20.  They just got it restocked on Nov 7

[Dallasboy]

I notice when ever there's democratic control of ANYTHING, they take away our civil liberties and the FDA grows like a Fungus. Should I stock up on my Renuebyscience orders?

 

Demorats have been the enemy of the people and corrupt for decades.  My crypto dem frens are finding this all out!

[Steve H]

Reversing its own earlier decision, the FDA has informed an NMN manufacturer that the molecule can no longer be marketed as part of dietary supplements. Another company that is testing NMN as a drug probably contributed to the decision, which is not being enforced as of now.

NAD and NMN

NAD+ is a multi-role coenzyme central to metabolism. It facilitates energy production in cells and acts as a substrate for important enzymes, such as sirtuins and PARP. NAD+ levels decline with age, contributing to multiple age-related diseases [1]. Studies have confirmed various health benefits of NAD+ supplementation in animal models [2], although human trials are scarce.

https://www.lifespan.io/wp-content/uploads/2019/08/NADH.jpg) no-repeat center center;background-size: contain;">

What is Nicotinamide Adenine Dinucleotide?

Nicotinamide adenine dinucleotide (NAD) is a coenzyme found in all living cells. It is a dinucleotide, which means that it consists of two nucleotides joined through their phosphate groups. One nucleotide contains an adenine base, and the other contains nicotinamide.
Read More

[Daniel Cooper]

The FDA is far more about protecting the interests of drug companies than it is about protecting the public interest. This has been true for a long time now. Perhaps since its inception.

[Phoebus]

Keep telling y'all Sinclair is a snake, no one want to hear it 

 

 

 

originally banned due to lobbying from Dr David Sinclair's company, Metro International Biotech, so that they can sell their own proprietary blend of NMN called MIB-626

 

https://twitter.com/...612525056884736

[Phoebus]

 

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.

Metro International Biotech suggested to FDA that drug preclusion applies to its article under investigation. “As a company that has instituted publicly available clinical trials on β-NMN, we request that FDA take the preclusion provision of section 201(ff) of the Federal Food, Drug and Cosmetic Act seriously,” Michael A. Willis, Ph.D., corporate counsel to Metro International Biotech, wrote to FDA in Dec. 1, 2021 comments.

https://www.naturalp...ugs-supplements

 

Metro Biotech = David sinclair. 

 

can we now all admit Sinclair is, and always has been, about the money? 

 

 

[Hebbeh]

can we now all admit Sinclair is, and always has been, about the money? 

 

Why wouldn't he?  After all, it's just good business.  Isn't it the capitalist way?  We can cite similar examples throughout the capitalist system.  Wouldn't we all want the money?  Can't get rich being Mr. Nice Guy.  Nothing new here.

[TheFountain]

liposomal nmn at least is already back ordered to Dec 20.  They just got it restocked on Nov 7

I just got some of that, the pump version actually. 

 

I also have some of the sublingual powder. But this has me wanting to stock some more. 

[ambivalent]

Why wouldn't he?  After all, it's just good business.  Isn't it the capitalist way?  We can cite similar examples throughout the capitalist system.  Wouldn't we all want the money?  Can't get rich being Mr. Nice Guy.  Nothing new here.

 

Why wouldn't he? Well he would if altruistic, as he has often claimed to be. I seem to remember him saying that he would offer those governments that recognised aging as a disease redictions in the cost of therapies, to treat their population. 

 

That we can easily cite examples of greed triumphing over benevolence isn't validating and we can find counter examples.

 

I suspect he will have given himself some greater good moral license, but this is the compound he takes and more than tacitly recommends everyone else do.

Edited by ambivalent, 17 November 2022 - 05:35 PM.

[kurdishfella]

Time to move to Russia. At least they don't ban everything and make everything harder.

[Daniel Cooper]

Time to move to Russia. At least they don't ban everything and make everything harder.

 

Da, and can make glorious contribution by serving as cannon fodder for special military operation.

[TheFountain]

Time to move to Russia. At least they don't ban everything and make everything harder.

Nah they only invade peaceful nations and elect communist dictators.

[kurdishfella]

I feel like the freedom there is better in some ways.

Edited by kurdishfella, 18 November 2022 - 10:36 PM.

[TheFountain]

I just paid for a 7 month supply of NMN powder. 

 

FUCK the FDA!!!!!

 

They take away everything good. 

 

Even Pyridoxamine which Lifelink used to sell and was a very helpful A1C reducing supplement. 

 

Shocked they haven't tried to fuck with Berberine yet.

[kurdishfella]

Next theyll come here. Please don't let them come to this forum and control this site as well and remove posts from being made. Has anyone archived or backed up this site somewhere else?

Edited by kurdishfella, 19 November 2022 - 08:59 PM.

[Rocket]

I just paid for a 7 month supply of NMN powder.

FUCK the FDA!!!!!

They take away everything good.

Even Pyridoxamine which Lifelink used to sell and was a very helpful A1C reducing supplement.

Shocked they haven't tried to fuck with Berberine yet.

Just like they took away the cure for the cold... Original formulation of zicam with intranasal zinc

Have you all seen the new PRESCRIPTION fish oil pills?

FDA is evil

Edited by Rocket, 26 November 2022 - 02:09 AM.

[Anthony_Loera]

Gentlemen and Gentleladies,

 

I am working with some people to find clarification and possibly a resolution on this issue. I can say that there is a growing group of people that are coming together to solve this. To that effect (and if you want to help), please reach out to the companies you have purchased NMN from and ask if any seller has been denied a "certification of free sale" for an NMN product by the FDA or have been denied an "export certificate" for an NMN product by the FDA.

 

While I can't discuss what is happening at this time, this may become important in the near future.

You can contact me by email, or provide my email to the company so that they can contact me: anthony(at)revgenetics(dot)com

 

I will hold all emails from competitors and people who want to help, as confidential. 

 

Thank you

Anthony

[Anthony_Loera]

Quick update:

 

Yesterday one of the main Dietary supplement associations in Washington DC and a group of interested parties, including myself had a call with the Director of the FDA Cara Welch and other FDA reps regarding this item.

 

I have not asked for permission of the parties, so I cannot provide the information of who was there at this time. However, I assume a summary of the meeting will be provided to many in the industry by tomorrow evening. While this is not resolved at this time, steps have been taken to move forward. The D.C. based Dietary Supplement Association and our group will continue with an open line of communication moving the needle towards a resolution. While there was no change at the end of the meet, the FDA did agree to evaluate and look at advertisements in 2021 or earlier where NMN was in a food or sold as a food.

 

If you have purchased NMN in any type of food or quasi-food, such as a drink or gummies, etc. Please email me, as it may pave one of the directions of resolution.

 

Of course any emails, ads, etc. that we can provide can be used down the road. Please save these, take a picture, screenshot, etc. You can email to me so that I can collect them at this time, and provide them when and if they are needed. You can contact me by email, or provide my email to the company so that they can contact me: anthony(at)revgenetics(dot)com

 

I will hold all emails from competitors and people who want to help, as confidential. 

 

Thank you

Anthony

Edited by Anthony_Loera, 02 December 2022 - 02:14 AM.

[Anthony_Loera]

Update: 12/06/2022

 

If NMN, CBD and NAC matters to you, consider registering with the NPA to get updates by email.

 

Today the NPA (Natural Products Association) who met the FDA Director Cara Welch

along with our group I mentioned in my previous posts, has published their article here

about the meeting:

 

https://www.naturalp...-ingredient-nmn

 

On Wednesday, Nov. 30, representatives from the Natural Products Association (NPA) met with four FDA officials in response to a recent determination by regulators that an anti-aging ingredient, β-NMN (beta-nicotinamide mononucleotide), cannot be marketed in dietary supplements due to its earlier investigation as a pharmaceutical drug.

 

The next day, NPA CEO and President Dan Fabricant requested FDA open a docket on NMN to allow stakeholders to submit information and comments to the agency on the presence of the ingredient in food and supplements.

 

Cara Welch, who oversees FDA’s Office of Dietary Supplement Programs (ODSP), advised Fabricant in an email that her agency would review and respond to NPA’s request.

 

In an interview last week following the meeting, Fabricant said he and NPA’s outside counsel, Kevin Bell, “made a few key points” during the 50-minute conference call with FDA officials, who included Welch and two other representatives from ODSP, as well as a lawyer from the Office of Chief Counsel, Louisa Nickerson. Several industry stakeholders also joined the conference call, including Now Health Group CEO Jim Emme, an NPA board member.

 

During the meeting, Fabricant recollected, he said NMN poses no safety issues, and he challenged FDA on its legal interpretation of a section in U.S. law that prohibits ingredients in dietary supplements if they have been authorized for investigation as a new drug and the subject of substantial clinical investigations that have been instituted and made public.

 

According to FDA, the prohibition doesn’t apply if the ingredient or “article" was lawfully marketed as a food or dietary supplement before it was authorized for investigation as a new drug.

 

NPA has shared documents with FDA that may have relevance to the analysis above. The materials include a few patents related to NMN in food and supplements, as well as a company’s announcement four years ago that its ingredient was self-affirmed GRAS (generally recognized as safe).

The December 2018 announcement by Nutraland USA suggested an intent to sell NMN as a food—perhaps before the ingredient was authorized for investigation as a new drug.

 

According to its website, Nutraland USA was incorporated in California in 2011, the company has an R&D center and manufacturing facility at its joint venture in China, and its roots date back to the 1990s when its “key team members started working in the nutraceutical industry.”

 

The company did not respond to two emails and a message delivered through its website for this story. Fabricant said he had not spoken with Nutraland USA, but he planned to.

 

What does NPA’s leader find “most troubling” about the NMN dilemma? That FDA concluded NMN is excluded from supplements without first checking if stakeholders in the natural products industry had evidence relevant to its determination, according to Fabricant, who oversaw FDA's Division of Dietary Supplement Programs from 2011 until 2014.

 

Industry stakeholders also have expressed frustration that FDA changed its position concerning the legality of NMN in dietary supplements.

 

In May, for example, FDA acknowledged without objection a new dietary ingredient notification (NDIN) for NMM, clearing a path for the ingredient to be marketed lawfully in supplements.

 

The agency changed its position after making the association between an article authorized for investigation as a new drug—called MIB-626—and NMN.

 

“When the FDA initially reviewed NDI notifications relating to NMN, NMN was not clearly identified as an article that was authorized for investigation, i.e. MIB-626,” an FDA spokesperson said in a Nov. 10 email. “Once the FDA was made aware of the connection between NMN and MIB-626, we concluded NMN is, in fact, excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(ii) of the FD&C [Food, Drug & Cosmetic] Act.”

 

Massachusetts-based Metro International Biotech has been studying MIB-626, or NMN, to treat such medical conditions as Alzheimer’s and Friedreich's Ataxia, a rare disease the National Institutes of Health says causes progressive nerve system damage and movement problems.

 

David Livingston, president and CEO of Metro International Biotech, previously declined to comment on FDA’s conclusions in letters to ingredient suppliers that NMN is excluded from the definition of a dietary supplement.

 

A recent FDA letter on NMN, Livingston said in a Nov. 10 email, “speaks for itself, and of course we will abide by their adjudication on this matter.”

 

The rational for FDA’s NMN determination, including analysis of several related legal issues, is articulated in a Nov. 4 letter to Inner Mongolia Kingdomway Pharmaceutical Limited (Kingdomway).

 

“Now, we have to provide all this other information when FDA didn’t look,” Fabricant said in the phone interview, where he was joined by Bell, outside counsel to NPA and a partner with Arnall Golden Gregory LLP. “Where does that come from in the statute?”

 

As for the materials NPA sent to FDA in advance of the meeting, FDA shared it had not closely reviewed the information and “couldn’t speak to much of it,” according to Bell.

 

The lawyer said he asked FDA officials if any of the information forwarded to FDA was helpful or not helpful. Bell said Welch responded it would need evidence NMN was lawfully marketed as a food or supplement prior to the date the ingredient was authorized for investigation as a new drug, which FDA does not publicly disclose.

 

“Unfortunately, there’s nothing very surprising that comes from these [FDA meetings] because they don’t commit to anything,” said Bell, who represented NPA in a lawsuit against FDA relating to FDA’s determination that NAC (N-acetyl-L-cysteine) is excluded from the definition of a dietary supplement due to its approval as a drug in 1963. That lawsuit was recently voluntarily dismissed after FDA issued a policy of “enforcement discretion,” providing an avenue for brands to continue to sell NAC supplements in the U.S.

 

FDA did not respond to specific questions for this article about the substance of the meeting last week with NPA or whether it would open a docket in response to NPA’s request. FDA also did not comment on its response to information shared with the agency, including the self-affirmed GRAS announcement in 2018.

 

However, the agency issued a statement in response to several questions from Natural Products Insider.

 

“The FDA has communicated with various groups in recent weeks regarding the conclusion that NMN is excluded from the definition of dietary supplement, as described in the November 4, 2022 letter,” an FDA spokesperson said in an email. “We are aware that industry stakeholders are interested in understanding more about the FDA’s position as well as learning what information would be relevant to revisiting this conclusion. We refer interested parties to the explanation in the November 4, 2022, letter. The FDA values the input we receive from all stakeholders and will review the information provided to us.”

 

NMN is still being widely sold on the internet. One brand said it believed NMN is a supplement and that such a position is shared by leading industry trade associations.

 

NMN “has been safely studied as a supplement since 2017, which predates its research in other areas, and we plan to continue offering it to our customers,” said the company, which spoke on condition of anonymity so it could speak freely without unwanted attention from FDA.

 

FDA did not reveal whether it intends to take enforcement action against brands that continue to sell NMN in dietary supplement products. The agency, however, reiterated NMN may not be marketed in or as a dietary supplement.

 

“If the FDA determines that a product labeled as a dietary supplement is unsafe or otherwise violates the law, the agency takes action as appropriate, based on public health priorities and available resources,” the FDA spokesperson said. “We are committed to working collaboratively with all of our stakeholders to help ensure dietary supplements are safe, produced in conformity with current good manufacturing practices and accurately labeled.”

[Daniel Cooper]

Update: 12/06/2022

 

If NMN, CBD and NAC matters to you, consider registering with the NPA to get updates by email.

 

Today the NPA (Natural Products Association) who met the FDA Director Cara Welch

along with our group I mentioned in my previous posts, has published their article here

about the meeting:

 

https://www.naturalp...-ingredient-nmn

 

On Wednesday, Nov. 30, representatives from the Natural Products Association (NPA) met with four FDA officials in response to a recent determination by regulators that an anti-aging ingredient, β-NMN (beta-nicotinamide mononucleotide), cannot be marketed in dietary supplements due to its earlier investigation as a pharmaceutical drug.

 

 

Anthony - do you know when β-NMN was investigated as a drug, who holds the patent and when that patent was granted?

 

I'm guessing that the patent is long since expired (since no one selling NMN seems to be getting sued for patent infringement). That being the case if the FDA has it's way, no one will ever have legal access to this compound in the US. Why? Well, if no holds an enforceable patent no one is going to pay a few billion to get this compound through FDA approval, so it will never be sold as a prescription drug. The FDA will have engineered a situation where it's not a prescription drug, and it can't be sold as a supplement, therefore no one in the US will have access to it.

 

This is so par for the course for the FDA.

Edited by Daniel Cooper, 13 December 2022 - 09:19 PM.

[Anthony_Loera]

Hi Daniel,

 

I started writing this... and it come out longer than I imagined.

 

About the patents:

According to what I have heard from others, the patents state that NMN was a nutraceutical in specific claims. The patents bolster the fact that NMN was considered a dietary supplement long before the IND (investigational new drug) paperwork by Metro Biotech. (I can now say this, as many articles have come out talking about the pharma that seemed to be in the middle of it all)

 

Is "sinister" the appropriate word?

On the call with the FDA on November 30th, something more sinister appeared that I have not mentioned. The stance that the FDA is taking today allows any Biotech or Pharma to usurp many molecules in regular foods. Then take them over when the government considers them drugs in the future by filing some paperwork today.

 

Here was my understanding of the conversation (much of the following is paraphrased except what is in quotes):

When asked about how a university review board may require an IND of a molecule found, in, say.. a grape, before getting funding for a study. How this university IND study (to understand how the molecule gets metabolized and excreted by the body) may actually allow the molecules found in a grape to be considered drugs, simply because the molecules were studied before a food was sold WITHOUT a paper label stating the name of the molecule on it... would the FDA not have the power to go back and exclude all sorts of dietary supplements on the market, simply because the food sold was never LABELED to include a particular molecule that naturally exists in the food?

 

Cara stated, "this isn't about choosing to exclude something, but it was a factor of the dates presented to us."

 

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.

 

Initially, the Senior Council for the FDA, Louisa Nickerson, stated that what was being said was a straw man, as the current study was not on a PK study (pharmacokinetics) but on studies involving the treatment or prevention of disease. But when pushed, asking what's to stop somebody (i.e., Big Pharma) from filing IND paperwork now and then waiting 20 years after the fact to do substantial studies and exclude the dietary supplement from the market?

 

Louisa again stated that the specific decision taken was made appropriately, as no PK study was a factor,

but then said, "I am not saying it isn't a regulatory concern overall, but it's not relevant to what we are discussing this afternoon."

 

My concern is that in the future, we may play whack-o-mole for each ingredient or molecule in the dietary supplement area when some biotech claims they filed an IND (before a dietary supplement NDI was filed). The industry will start arguing again with the FDA... and on and on...

 

What we need is a solution. 

The best solution: is to demand a bill that will clear the way for foods (and the molecules within foods) not to become drugs based on paperwork like an IND but based on the molecule being changed from its natural state to a proprietary creation at the very least.

 

The low cost solution: that is dumb af, but may be easy to do for some people, is to simply sell conventional foods, with the molecules found in them, imprinted on the label. And if a new molecule is found, for a particular food, you would simply add it to the label and take a picture of the food, label and date of when it was sold on the market.

 

Why you may ask? Because the FDA regards conventional food labels as part of this "race to market" challenges when it comes to their regulations, and new dietary supplements.

 

Yes... If someone, somewhere was selling a conventional food (Say broccoli) which had a small label with a date, that said "Not a significant source of Nicotinamide mononucleotide" or "Contains nicotinamide mononucleotide" or has ingredients listed on the food, including "Nicotinamide Mononucleotide"... then imho (I am not a lawyer), the conventional food would win the race to market, allow for dietary supplements about 6 months after a conventional food is sold with the label, and basically allow some controls over big pharma IND's in the future. 

 

A reminder:

While we may know that NMN has always existed in broccoli, and that our bodies evolved over the last 300,000 years to absorb it

(as the SLC12A8 gene, the specific NMN transporter in our bodies, evolved to help transport NMN from the foods we eat)...

 

the FDA is simply blind to everything except their regulations and what a dated label, marketing, or ad says.

 

[ambivalent]

SInclair's response:

 

 

Pretty weak. He has always seemed to have oversold NMN. Below he mentions his dad of 82 acting like he is 30 and looking forward to the next 30 years. The scientist in him should instinctively throw caution of those statements, we don't as far as I know, have longevity data on raised NAD levels that would infer such a belief to be realistic. But he doesn't row on back those claims, sure he doesn't want to dampen his dad's ambitions - but he is, nevertheless, a very prominent scientist with a responsibility but seems to advance the unguarded claims of a salesman. And that, retrospectively, is what he appears as.

 

https://youtu.be/eaWWQfFQZfQ?t=460