33 replies to this topic

[bluemoon]

Leonard Guarente gave a short talk on Eysium Basis recently. He told the audience that last years' Basis 120 person trial provided two important end points - safety and the raising of NAD+ and that six more trials are in recruitment or planning stages. That's great, but once again he didn't say anything about the Basis trial already completed that tested blood pressure, heart rate, lipid levels, glucose levels, walking endurance and sleep patterns.   Guarente added Elysium is also setting up trials for new compounds and says that the hard part is getting a good source of the compounds. 

 

 

Begins at 3:35

[Oakman]

The more he talks, the less impressed I am of what he says, and represents. He's more than willing to throw the entire supplement industry under the bus, except, of course, for his company, which is a special snowflake in the industry. Hummm....

[bluemoon]

The more he talks, the less impressed I am of what he says, and represents. He's more than willing to throw the entire supplement industry under the bus, except, of course, for his company, which is a special snowflake in the industry. Hummm....

 

Guarente has had at least two interviews and two talks where he doesn't mention detail about the 2016 eight week trial apart from saying there is no evidence for weight loss and that they are in the process of six more trials for Basis. I think as with Chromadex, Elysium isn't sure how to price Basis or at what dose yet and may not have a supplier of NR yet to replace ChromaDex if needed. 

 

Two years ago he said he took 250 mg of resveratrol a day despite now calling it "a lousy compound because it's unstable " so use pterostilbine instead.

[MikeDC]

The old trial data can be thrown away. Elysium basis no longer has Niagen. These people are cheaters and counterfeit criminals.

Elysium is shipping basis that is pure white. Niagen is brown as Nicotinamide Riboside chloo salt. So what is in basis is no longer Niagen.

For what it is worth, here is another exert from the note from Elysium: "While the specific Basis formulation and the amount of each ingredient have not changed, this new production process has allowed us to take an exceptional product and make it even purer. We also have eliminated color variations and can now provide a consistently white final product, as you may have seen with your most recent shipment. This reflects our ongoing commitment to being a trusted source for our customers by continually exceeding the highest standards in the industry."

[Michael]

The fact that Elysium is not using branded Niagen doesn't at all mean that their product is worthless. If they've found a supplier that can provide an alternative stable soluble salt, it should work exactly the same.

[MikeDC]

The fact that Elysium is not using branded Niagen doesn't at all mean that their product is worthless. If they've found a supplier that can provide an alternative stable soluble salt, it should work exactly the same.

You don't know what is in Basis now. They don't tell you the details. Even if it is perfectly good, it has no data. All studies of NR has used Niagen so far. Switching a proven source ingredient with an unknown source without informing the subscribers is unethical to say the least.

[Michael]

 

The fact that Elysium is not using branded Niagen doesn't at all mean that their product is worthless. If they've found a supplier that can provide an alternative stable soluble salt, it should work exactly the same.

You don't know what is in Basis now. They don't tell you the details.

Agreed — I don't. Hence, "If."
 

Even if it is perfectly good, it has no data. All studies of NR has used Niagen so far. Switching a proven source ingredient with an unknown source without informing the subscribers is unethical to say the least.

They have informed subscribers: you've just quoted them doing so . IAC, NR doesn't work because of a logo or synthesis process, and it's not a botanical or a "proprietary blend:" it's a defined, single chemical entity. NR is NR, just like vitamin C  is vitamin C is vitamin C and table salt is table salt is NaCl. Now, it's of course possible that they're using road salt instead of NR, or that their material is highly hygroscopic and thus unstable, or that they have poor QC. But "If they've found a supplier that can provide an alternative stable soluble [NR] salt, it should work exactly the same."

Edited by Michael, 31 July 2017 - 06:21 PM.

[MikeDC]

I don't think they did. They responded to questions. It is unlikely to be a salt since ChromaDex owns the patents to make NR salt. Nobody knows how the NR in Basis behaves in the absorption process. It could disintegrate completely or only 10% is absorbed.

[stefan_001]

Agree something stinks with Elysium Health and they are not informing consumers. On their product website they blatantly state the product is under the Dartmouth College IPR, that looks like deception:

https://www.elysiumh...upplement-facts

Protected under U.S. Patent Numbers:
8,197,807 / 8,383,086 / 8,524,782 / 8,133,917 / 8,252,845
Elysium Health™ is a trademark of Elysium Health, Inc.

 

Also if they have developed a new variant of NR salt then should they do as they say on their website:

"'We conduct rigorous safety studies for a new dietary ingredient (NDI) submission to the FDA. The Federal Food, Drug, and Cosmetic Act (FD&C) requires that we submit studies to demonstrate the safety of “new dietary ingredients.”

 

What a joke as they obviously havent done an NDI. Would think Guarente had some professional pride left or then he is very sloppy. A science officer should not miss this. Either or this looks murky at best. Makes you wonder what they will do when they run out of Pterstilbene......

Edited by stefan_001, 31 July 2017 - 06:36 PM.

[MikeDC]

Elysium health acts like a criminal organization.

[Michael]

Agree something stinks with Elysium Health and they are not informing consumers. On their product website they blatantly state the product is under the Dartmouth College IPR, that looks like deception:
https://www.elysiumh...upplement-facts
Protected under U.S. Patent Numbers:
8,197,807 / 8,383,086 / 8,524,782 / 8,133,917 / 8,252,845

Well, they should certainly get that fixed. I suspect that's neglect rather than an attempt to deceive.
 

Also if they have developed a new variant of NR salt then should they do as they say on their website:
"'We conduct rigorous safety studies for a new dietary ingredient (NDI) submission to the FDA. The Federal Food, Drug, and Cosmetic Act (FD&C) requires that we submit studies to demonstrate the safety of “new dietary ingredients.”

What a joke as they obviously havent done an NDI. Would think Guarente had some professional pride left or then he is very sloppy. A science officer should not miss this. Either or this looks murky at best.

AFAICS you don't require an NDI for a new salt of the same ingredient: it isn't a "new" dietary ingredient (again, it's a defined chemical entity). Current FDA Draft Guidance says:
 

Is an NDI notification required for a dietary supplement containing an NDI if the supplement contains only dietary ingredients that have been present in the food supply as articles used for food in a form in which the food has not been chemically altered?

No, an NDI notification would not be required in this situation because of the exception to the notification requirement for dietary supplements that contain only dietary ingredients that have been present in the food supply as articles used for food in a form in which the food has not been chemically altered (21 U.S.C. 350b(a)(1)). See questions IV.B.4 and IV.B.5 for FDA’s view on what “chemically altered” means ...

In general, FDA considers a process that does not result in chemical alteration to mean a process that: (1) involves an ingredient composed of one single raw material, or derived from a single raw material using a manufacturing process that involves only physical steps (e.g., water extraction and condensation); and (2) does not involve attempts to selectively increase the concentration of particular active ingredients or cause a chemical reaction (other than esterification) that would modify the covalent bonds of any substance in the original material. This type of process is unlikely to affect the safety profile of the ingredient in question or of dietary supplements containing the ingredient....

5. What processes for manufacturing a dietary ingredient from an article of[font=times] food present in the food supply do not result in chemical alteration?

As set forth in the Congressional Statement of Agreement between the House and Senate sponsors of DSHEA, “[T]he term ‘‘chemically altered’ does not include the following physical modifications: minor loss of volatile components, dehydration, lyoph[i]lization, milling, tincture or solution in water, slurry, a powder, or solid in suspension.” [24] FDA considers this list to represent examples of manufacturing processes that do not involve chemical alteration, but not necessarily a complete list of such processes. FDA views “chemical alteration” specifically within the context of section 413(a)(1) of the FD&C Act, which creates an exemption from the NDI notification requirement for NDIs that have been “present in the food supply” as “article[s] used for food in a form in which the food has not been chemically altered.” ...

4. What are examples of processes that chemically alter an article of food[font=times] present in the food supply?

Below are some examples of processes that FDA would likely consider to involve chemical alteration. These processes would also be likely to affect the safety profile of a dietary ingredient. The examples below are intended only for the purpose of illustration and are not a comprehensive list of processes that result in chemical alteration. See question IV.B.5 for further discussion on chemical alteration.

 

• A process that makes or breaks chemical bonds, unless the bonds created by the process are reversed when the ingredient is dissolved in water (e.g., creation of a soluble salt) or during ingestion.

a

[stefan_001]

Perhaps but If they are not using niagen as basis I wonder how they can meet (1) below:

In general, FDA considers a process that does not result in chemical alteration to mean a process that: (1) involves an ingredient composed of one single raw material, or derived from a single raw material using a manufacturing process that involves only physical steps (e.g., water extraction and condensation); and (2) does not involve attempts to selectively increase the concentration of particular active ingredients or cause a chemical reaction (other than esterification) that would modify the covalent bonds of any substance in the original material. This type of process is unlikely to affect the safety profile of the ingredient in question or of dietary supplements containing the ingredient....

But okay I am not an expert on this regulation. In any case it appears Elysium is not having transparency high in their ethics.

Edited by stefan_001, 31 July 2017 - 07:47 PM.

[Michael]

Perhaps but If they are not using niagen as basis I wonder how they can meet (1) below:
 

In general, FDA considers a process that does not result in chemical alteration to mean a process that: (1) involves an ingredient composed of one single raw material, or derived from a single raw material using a manufacturing process that involves only physical steps (e.g., water extraction and condensation); and (2) does not involve attempts to selectively increase the concentration of particular active ingredients or cause a chemical reaction (other than esterification) that would modify the covalent bonds of any substance in the original material. This type of process is unlikely to affect the safety profile of the ingredient in question or of dietary supplements containing the ingredient....

 

I think that's quite clear: again, assuming that their new material a legit stable NR salt, it would be "an ingredient composed of one single raw material". #1 covered. No covalent bonds would be broken, and they're saying forming salts doesn't count as a chemical modification so long as they're "reversed when the ingredient is dissolved in water (e.g., creation of a soluble salt) or during ingestion" (as, indeed, it shouldn't).

[stefan_001]

Perhaps but If they are not using niagen as basis I wonder how they can meet (1) below:

In general, FDA considers a process that does not result in chemical alteration to mean a process that: (1) involves an ingredient composed of one single raw material, or derived from a single raw material using a manufacturing process that involves only physical steps (e.g., water extraction and condensation); and (2) does not involve attempts to selectively increase the concentration of particular active ingredients or cause a chemical reaction (other than esterification) that would modify the covalent bonds of any substance in the original material. This type of process is unlikely to affect the safety profile of the ingredient in question or of dietary supplements containing the ingredient....

I think that's quite clear: again, assuming that their new material a legit stable NR salt, it would be "an ingredient composed of one single raw material". #1 covered. No covalent bonds would be broken, and they're saying forming salts doesn't count as a chemical modification so long as they're "reversed when the ingredient is dissolved in water (e.g., creation of a soluble salt) or during ingestion" (as, indeed, it shouldn't).

I was reading it differently, but again I am not familiar with these regulations. Why do you think Chromadex did an NDI for Niagen and why would a new "Niagen" not require it?

Edited by stefan_001, 31 July 2017 - 08:36 PM.

[Oakman]

...

Edited by Oakman, 31 July 2017 - 09:59 PM.

[MikeDC]

I believe what is inside Basis was either manufactured using a new process that is different from ChromaDex, thus chemical bonds were created or changed, or they used ChromaDex's process to create Niagen and then alter it. The first case require NDI and the second infringing on ChromaDex's patent.

[MikeDC]

If it is a new process, a patent would have been filed already. My best guess is a Chinese manufacturer copied the ChromaDex process and replaced Chloride with fluoride or bromide which still violate the patent.

[Michael]

I was reading [the FDA guidance] differently, but again I am not familiar with these regulations. Why do you think Chromadex did an NDI for Niagen and why would a new "Niagen" not require it?

 
CDXC needed it because when they introduced NR, it was literally a "New Dietary Ingredient:" it had not been in supplements prior to the 1994 "grandfather." This is clear in DSHEA, and even more pointedly in the Draft Guidance: "Unless the ingredient was marketed as a dietary ingredient for use in or as a dietary supplement prior to October 15, 1994, it is an NDI."

But now that NR has passed NDI and is in supplements, it's no longer a "New Dietary Ingredient:" NR is NR is NR, and anyone else can sell it as a supplement. The raw material source doesn't matter, so long as it hasn't undergone chemical modification — by which they include modification of covalent bonds, but exclude the introduction of new salts. (Imagine the uproar if every new supplier of vitamin C or salt of B6 needed a whole new NDI ...!).
 

I believe what is inside Basis was either manufactured using a new process that is different from ChromaDex, thus chemical bonds were created or changed, or they used ChromaDex's process to create Niagen and then alter it. The first case require NDI and the second infringing on ChromaDex's patent. ... My best guess is a Chinese manufacturer copied the ChromaDex process and replaced Chloride with fluoride or bromide which still violate the patent.

 
See above on the NDI. And as I pointed out yesterday, Elysium is challenging Dartmouth's NR patents (which Chromadex licenses).
 

If it is a new process, a patent would have been filed already.

 

Possibly — though the crisis of having been cut off by CDXC might, hypothetically, have led them to rush to sale prior even to completing a patent application. However, I suspect (again) that they just have a new salt, and are expecting the patent to fall. They may think they have nothing to lose, either way: without a supply of NR, they have no basis for Basis.

[MikeDC]

The Niagen NDI was for Nicotinamide Riboside Chloride. It is not for NR even though people reference it that way.

[stefan_001]

 

I was reading [the FDA guidance] differently, but again I am not familiar with these regulations. Why do you think Chromadex did an NDI for Niagen and why would a new "Niagen" not require it?

 
CDXC needed it because when they introduced NR, it was literally a "New Dietary Ingredient:" it had not been in supplements prior to the 1994 "grandfather." This is clear in DSHEA, and even more pointedly in the Draft Guidance: "Unless the ingredient was marketed as a dietary ingredient for use in or as a dietary supplement prior to October 15, 1994, it is an NDI."

But now that NR has passed NDI and is in supplements, it's no longer a "New Dietary Ingredient:" NR is NR is NR, and anyone else can sell it as a supplement. The raw material source doesn't matter, so long as it hasn't undergone chemical modification — by which they include modification of covalent bonds, but exclude the introduction of new salts. (Imagine the uproar if every new supplier of vitamin C or salt of B6 needed a whole new NDI ...!).
 

I believe what is inside Basis was either manufactured using a new process that is different from ChromaDex, thus chemical bonds were created or changed, or they used ChromaDex's process to create Niagen and then alter it. The first case require NDI and the second infringing on ChromaDex's patent. ... My best guess is a Chinese manufacturer copied the ChromaDex process and replaced Chloride with fluoride or bromide which still violate the patent.

 
See above on the NDI. And as I pointed out yesterday, Elysium is challenging Dartmouth's NR patents (which Chromadex licenses).
 

If it is a new process, a patent would have been filed already.

 

Possibly — though the crisis of having been cut off by CDXC might, hypothetically, have led them to rush to sale prior even to completing a patent application. However, I suspect (again) that they just have a new salt, and are expecting the patent to fall. They may think they have nothing to lose, either way: without a supply of NR, they have no basis for Basis.

 

 

Ok thanks for explaining the NDI. I am believing also that Elysium is selling a new salt. I am not sure are they counting on the patent to fall. I think its a stalling tactic, you stretch the procedures for years and try to avoid injunction untill there is a legal alternative product they can sell down the road or reach a new agreement with Chromadex. Once they have secured that they will go for a settlement for the intervening period. I would expect Chromadex to consider filing an injunction against the manufacturer of the "Niagen" copy. If the manufacturer is Chinese I would expect an import injunction to be granted before any patent invalidation process is completed.
 

Edited by stefan_001, 01 August 2017 - 09:29 AM.

[stefan_001]

Looking at the open jobs at Elysium Health we should not expect too much science:

https://angel.co/elysium-health/jobs

Good they are trying to hire a general counsel, perhaps that will improve their behavior.

[MikeDC]

Elysium CEO must have contracted mad-dog disease. Unreal.

[able]

I find their attitude extremely arrogant, offensive, and deceptive.  For example, this quote:

 

"Elysium is building the world's first direct-to-consumer health science company. Using new technologies, we can now impact wellness at an unprecedented scale"

 

How are they the first?  And the only thing they have done so far is taken 2 supplements made by Chromadex, and put in a capsule.  

Edited by able, 04 August 2017 - 10:27 PM.

[bluemoon]

 "How is Elysium the first?"

 

Can you name another company?

 

 

[able]

Thorne Research, Life Extension, dozens more I'm sure that put some science behind their products, and are dtc.

 

I understand Elysium is  claiming to be "more scientific", but don't see any evidence  so far that they are anything more than a good marketing scheme with their list of nobel scientists "advisors".

 

It just irritates me how they misrepresent their role in developing Basis.

Edited by able, 05 August 2017 - 12:47 AM.

[bluemoon]

Thorne Research, Life Extension, dozens more I'm sure that put some science behind their products, and are dtc.

 

I understand Elysium is  claiming to be "more scientific", but don't see any evidence  so far that they are anything more than a good marketing scheme with their list of nobel scientists "advisors".

 

It just irritates me how they misrepresent their role in developing Basis.

 

Thorne isn't direct to consumer yet is it?  How does Life Extension  "put some science behind their products"?  

 

  

[able]

Sure, I've purchased direct from https://www.thorne.com for years now.

[stefan_001]

 

If it is a new process, a patent would have been filed already.

 

Possibly — though the crisis of having been cut off by CDXC might, hypothetically, have led them to rush to sale prior even to completing a patent application. However, I suspect (again) that they just have a new salt, and are expecting the patent to fall. They may think they have nothing to lose, either way: without a supply of NR, they have no basis for Basis.

 

 

Ok thanks for explaining the NDI. I am believing also that Elysium is selling a new salt. I am not sure are they counting on the patent to fall. I think its a stalling tactic, you stretch the procedures for years and try to avoid injunction untill there is a legal alternative product they can sell down the road or reach a new agreement with Chromadex. Once they have secured that they will go for a settlement for the intervening period. I would expect Chromadex to consider filing an injunction against the manufacturer of the "Niagen" copy. If the manufacturer is Chinese I would expect an import injunction to be granted before any patent invalidation process is completed.
 

 

 

Btw perhaps there could be the option that Chromadex and Elysium settled....from the personal experiences thread I noticed Nate reporting that HPN Niagen is more white recently....A bit too much coincidence here?

 

[MikeDC]

I thought he said less white.

[stefan_001]

I thought he said less white.

You are right, I wrongly read it. Back to NR wars then.