18 replies to this topic

[Kevin Johnson]

Hi, I am new to this site an do not want anyone to assume this as spam or selling, but as soliciting responce and advise (this will be long). Honsest disclosure, I am putting this up becasue I am considering selling premixed c60 and doing it a little more aggressively than curreltly done. If you consider responding and giving advise, please read the full post and understand my questions and points. I have looked at several sites selling pre-mixed c60-EVOO and find it funny one says that their product is formulated for an adult size individual but in no means be recommended for use by people (hint hint). They go on to say that they can't sell it to people becasue the FDA will shut them down and jail them.

However, c60 isn't really regulated yet and being that it is a form of carbon (like activated charcol but yes, much different) and EVOO is a food product, should fall under the Dietary Supplement Health and Education Act, and the only real standard be that the product be "safe" and that the labeling and advertisement be, well, honest i guess is the best way to put it.

Several studies have been conducted with animals and all have concluded that c60 is not "toxic" and that levels of c60 given to the animals in the studies were not "toxic levels". However, I find it amazing that rats and Large Mouth Bass were given doses as high as 500mg/kg, which I think is extremely high. One study administered c60 via arisol at 2.2mg/m3 but I didn't catch just how much was taken up by the rats. Yet also, in all the studies, the production and/or delivery was adminstered with a chemical process or via water soluable c60 which is not as stable as the currently available purified c60 (at 99.95%).

As you see, several sites selling the product sell .8mg/ml mix or 1.5mg daily intake as 45mg in 50ml EVOO for daily dose.

As for the "is your product safe" issue, I think that providing c60EVOO at the rate of between 1.5 - 3 mg daily (given a 10day dissipation rate) will give a mean serum level between 15 - 30 mg total for avg body weight of 85KG. This much different than the 10/100/300/500mg/kg testing done on animals and I think at this time would be a consensus that that level would not be toxic by any means and given the low content level, and being all of the test done and even the "at home" testing being done now, would be at least as safe as asperin (which the FDA wouldn't approve these days if it were submitted). Seeing everything I have doing my research, I don't really see any adverse results and in the original 1985 rat study, they autopsied the rats and found no adverse effects with much higher mg/kg dosage than what will be marketed for human use.

I know that the "base comment" will be there is no real realiable information or results. There is real interest however. Being basically carbon and EVOO, realistically, at a solution of 1.5 - 3 mg daily, I can't really see any major systematic differences between activated charcol and C60, however, being a nano particulate, can get places C7h4O cannot possibly leading to cellular differnces. My thought process is the only real concern and question as to C60's benefits and risks come primarily due to it's particulate size over ther carbon forms.

So what it comes down to is my willingness to stand up to question over safety becasue I don't think there is really any evidence that there are any toxic or negative effects at the mean serum rate that would be adminstered in a commercial application. I know a lot of people on this site have been following it and may have seen some results I have missed. Sure at 500mg/kg there may be adverse effects with anything. Has anyone seen any reporting at a more realistic dosage rate?

Thoughts/responces?

[pleb]

whilst C60 oo is legal now and not banned or controlled that may not be the case in the future,
and if you have put anything on a label or in print that it could or can be consumed by members of the public,,
you can be pretty sure that those words will come back and bite your ass if it is either banned or becomes subject to testing in a couple of years time,,
you can be sure that the authorities will use those words against you, that's why others selling it choose their words carefully,

[zorba990]

My plan is DIY. Buy 99.95% from SES, crush it up and add to green bariani pre-harvest when it is available. Then shake. Cost per liter should be under $100 at 500mg per liter. Of course crushing the C60 might enable as much as 1000mg per liter which would be much more convenient and cost about $150.00.

In any case, if I were to buy it completed, I'd be looking, long term, for something in the same price range with same quality of low temperature, raw, organic, high polyphenol oil.

https://sesres.com/Fullerene.asp
http://www.barianioliveoil.com

[pleb]

I'm also going down the DIY route as i'm moving to Mex and it would be easier and cheaper for me to do that once i am out there,

[niner]

Thoughts/responces?

Thanks for your candor and transparency.

It seems pretty clear that the short term toxicity of C60-oo is low. We've had reports of what sound like allergic responses in at least one human and two animals. There have been a couple reports of lung pain and one report of kidney pain. There have been a number of reports of increased sweating and transient pain or other sensation in extremities. There have been a couple reports of headache. Most of these reports occurred early on, and did not recur. There have been two or three reports of injuries from too much weight lifting. C60 suppresses muscle fatigue, so it's pretty easy to overdo it.

The problem with a claim of safety is that we know next to nothing about the long term safety of C60-oo. C60 is a reactive compound with some pretty profound effects in the body; it's not just another form of charcoal. It's very unlikely that we know all there is to know about the way in which the body uses free radicals, for example, radical mediated signalling is a relatively modern discovery. We have no idea what impact C60-oo would have on development. I would hesitate to give it to a non-adult, and use during pregnancy would be extremely ill-advised. Because the residence time of C60-oo in the body is so long, a woman could find herself pregnant with no way to eliminate C60-oo from her body.

If you're going to promote it more aggressively, that leads pretty quickly to health claims, and that is what really brings the FDA down on companies. I think a case could be made that c60 is a "natural product". It does, after all, exist in nature. I'm not familiar enough with the DSHEA to predict how that would go, but given the recent tone of the FDA, I wouldn't get my hopes up. The "natural product" claim is pretty dodgy, IMHO.

The community has now worked out a pretty cheap, simple and effective method for synthesizing C60-oo, which I would expect a lot of people to employ. It also means that the barrier to entry in the market is very low. I think there's a lot of room to compete on price while still producing a quality product, and we'd all like to see more competition in this space.

[d4shing]

Your question is essentially a legal one: Given that this product is not regulated as a drug, what sort of claims may I make about its health, safety and efficacy in marketing it to the public for human consumption?

I don't know the answer, but I do know that internet forums are a very poor place to solicit legal advice. Assuming you're in the US or another highly-regulated jurisdiction, hire a lawyer experienced in these matters (and don't expect it to be cheap).

[Kevin Johnson]

Thanks for the input guys. I'm thinking on 3 different levels here. 1. 45 to 60 MG in 30ml organic EVOO (1 month supply). It's is a low dose planed to be used long term but without a high mean serum level, I think a lot safer than putting out somthing in the 10mg/kg level. 2. Price point. I've seen C60 selling for $28.00 to $35, I can put it out for $14.99 witch will be a monthly supply. Some supplements are ranging in the $200 - $500 month range. TA-65 being one of them. 3. Yea I need to stroke the marketing more than "Don't take this; but it's formulated for human size" but not over hype it. I mean let's be real, the FDA can come to the conclusion it's marketed for human consumption, that doesn't really fool anyone. I think there are enough people out there interested in health that will look into it for the $15 price range. I really think that if health minded people start taking it and realize some health and energy effects as I have heard, it may grow. I plan to launch on eBay with the low price point, maybe as low as $13.99.

[Kevin Johnson]

And D4shing, it's not the legal stuff I'm interested in, it's the personal experience some of the people on this site that I want to solicit. I understand the FDA and the law. My main thoughts are in proving the product safe, the more people I know that have "experimented" with it (including myself), the more I can establish the absence of adverse effects. As a legal stance, I can't prove it safe, but can point to the lack of proven averse effects. On the same level, I don't want to put a product out that may be potentially harmful. I figured if I'm going to make it and take it, I might as well sell it.

[Andey]

Thanks for the input guys. I'm thinking on 3 different levels here. 1. 45 to 60 MG in 30ml organic EVOO (1 month supply). It's is a low dose planed to be used long term but without a high mean serum level, I think a lot safer than putting out somthing in the 10mg/kg level. 2. Price point. I've seen C60 selling for $28.00 to $35, I can put it out for $14.99 witch will be a monthly supply. Some supplements are ranging in the $200 - $500 month range. TA-65 being one of them. 3. Yea I need to stroke the marketing more than "Don't take this; but it's formulated for human size" but not over hype it. I mean let's be real, the FDA can come to the conclusion it's marketed for human consumption, that doesn't really fool anyone. I think there are enough people out there interested in health that will look into it for the $15 price range. I really think that if health minded people start taking it and realize some health and energy effects as I have heard, it may grow. I plan to launch on eBay with the low price point, maybe as low as $13.99.

You cannot dissolve more then 0.8 - 0.9 mg per ml, so month supply must be around 50 ml.
Think about consider larger volumes - it will lower costs for bottles and packaging both for you and buyers. Maybe 250ml or 0.5l could be a sweet spot.
You also need a montly volume product for newcamers but after first buy they will definatly thinking about larger buys.
Also important to give comfortable and accurate daily dosage tool. For example a pipette in SV bottles is messy, I could not find way to fill it properly )

[niner]

The best way to be favorably received in this community is to be take the steps that are needed to create a quality product, and be open and transparent about it. For example, you should use a high grade C60 from a quality company. I like the 99.95% grade from SES because they use a vacuum oven in the final processing steps, which should result in the lowest amount of solvent residue of any grade. I don't really want to be consuming toluene. Showing us a receipt for a large purchase of your c60 would be the sort of transparency that I'm talking about. We like to see Certificates of Analysis. (CoA's) The "industry standard" is vacuum filtration at 0.2 microns or so, which would be an important step for something that you're going to sell. Centrifugation is pointless and unnecessary, unless you can provide more than a million g's, which is what it would take to settle particles smaller than 0.2 microns in a fluid of the viscosity of olive oil. I do not believe that a top quality, high polyphenol olive oil is needed. That should be sitting on people's kitchen table, and they should be using a couple tablespoons a day, but the 1-3 ml they'll get from normal dosing of c60-oo isn't going to make a difference. Something along the lines of Philipo Berrio from Costco is more than enough. (There's no evidence, nor is there known chemistry that says polyphenols are involved in the active agent. That doesn't mean oo polyphenols aren't good for you- they certainly are.)

Are you familiar with GMP standards? That's what the FDA would like to see, and what I'd like to see for supplements that I use. Full GMP is overkill, but it would be nice to know that it wasn't produced in a dusty garage.

[tintinet]

WRT olive oil, Trader Joe's California Estate was one of the best tested by Consumer Reports recently.

[Kevin Johnson]

Hi Niner, thanks for the advise. I definately am looking to SES as the supplier. Also, I figure the people here are making their own, I was looking more for experiences in dealing with the C60 more than customers here. I'll have to look up GMP. I was an Operations manager for a large clinical lab for 10 years and am used to dealing with high level clinical processes. I definately want an independant lab to so a composition analysis test on my product before sale. Thats as much for a legal safegaurd as well as me knowing that I'm getting what I am told I am getting in both the C60 and quality of OO.

[Andey]

I like the 99.95% grade from SES because they use a vacuum oven in the final processing steps, which should result in the lowest amount of solvent residue of any grade. I don't really want to be consuming toluene.

I think nothing wrong if different purity solutions would be available at the same time for different price. )
Personally I see very little potentional harm in few micrograms of reagent that I consume with less purified but much cheaper product.

[Kevin Johnson]

The cost difference between 99.9 and 99.5 at 5g is $100. To me, it's worth the cost. If it were double or something, sure. But for a better product at such a low price I might as well use the better stuff. In production it's $1.08 per bottle for 99.9 and $1.89 per bottle for 99.95 oven baked and vaccum packed. I'd rather not have questions or problems.

[pleb]

as far as toxicity levels and how safe toluene is when ingested, i found the following, and after reading this my own thoughts at least for DIY are that the cheaper raw C60 would not be a problem as the limit for drinking water which i assume most people would consume in much larger amounts over a short period of time compared to a litre of C60 which perhaps would last 6 months to a year ? price and choice wise a lot depends on how much you are spending each week on other supplements

and for those that want to check there are phone and address's included,




Has the federal government made recommendations to protect human health?

EPA has set a limit of 1 milligram per liter of drinking water (1 mg/L).
Discharges, releases, or spills of more than 1,000 pounds of toluene must be reported to the National Response Center.
The Occupational Safety and Health Administration has set a limit of 200 parts toluene per million of workplace air (200 ppm).
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References

Agency for Toxic Substances and Disease Registry (ATSDR). 2000. Toxicological Profile for Toluene. Update. Atlanta, GA: U.S. Department of Health and Human Services, Public Health Service.
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Where can I get more information?

If you have questions or concerns, please contact your community or state health or environmental quality department or:
For more information, contact:
Agency for Toxic Substances and Disease Registry
Division of Toxicology and Environmental Medicine
1600 Clifton Road NE, Mailstop F-62
Atlanta, GA 30333
Phone: 1-800-CDC-INFO · 888-232-6348 (TTY)
Fax: 1-770-488-4178
Email: <a href="mailto:cdcinfo@cdc.gov">cdcinfo@cdc.gov
ATSDR can also tell you the location of occupational and environmental health clinics. These clinics specialize in recognizing, evaluating, and treating illnesses resulting from exposure to hazardous substances.
Information line and technical assistance:
Phone: 888-422-8737
FAX: (770)-488-4178
To order toxicological profiles, contact:
National Technical Information Service
5285 Port Royal Road
Springfield, VA 22161
Phone: 800-553-6847 or 703-605-6000
Is there potential for toluene to build-up or accumulate in my body?

Toluene is readily absorbed by inhalation, ingestion and through the skin.
Inhaled toluene appears quickly in the brain fat (lipid) where it is rapidly eliminated. The half-life in human adipose tissue is 0.5-2.7 days. Toluene is removed rapidly from the blood. It is metabolized in the liver where it is converted via several steps primarily to hippuric acid, which is excreted in the urine. A small amount of toluene is also exhaled unchanged. Toluene has been identified in human milk.

[somecallmetim]

I think a case could be made that c60 is a "natural product". It does, after all, exist in nature.

I'm not so sure that the synthesized version of c60 is the same as the c60 found in nature ie. Shungite. When I get some time, I will post a new thread on this. Let's just say Kroto & son won't be happy when I do.

Edited by somecallmetim, 19 October 2012 - 04:13 AM.

[Anthony_Loera]

The cost difference between 99.9 and 99.5 at 5g is $100. To me, it's worth the cost. If it were double or something, sure. But for a better product at such a low price I might as well use the better stuff. In production it's $1.08 per bottle for 99.9 and $1.89 per bottle for 99.95 oven baked and vaccum packed. I'd rather not have questions or problems.

What amount of oil are you using in each bottle, and how much C60 are you dissolving in the oil?

As for testing, let me know what lab you use, and if you will be testing the C60 before tou dissolve it, or is your goal to test the amount of C60 in your product after it is dissolved in oil.

Cheers
A

[smithx]

It's very unlikely that we know all there is to know about the way in which the body uses free radicals, for example, radical mediated signalling is a relatively modern discovery. We have no idea what impact C60-oo would have on development. I would hesitate to give it to a non-adult, and use during pregnancy would be extremely ill-advised. Because the residence time of C60-oo in the body is so long, a woman could find herself pregnant with no way to eliminate C60-oo from her body.

These are very good points, especially considering the studies which found that exercise did not produce the same kinds of strength gains and muscle building if people had taken antioxidants prior to their workouts. A really perfect antioxidant, in sufficient quantity in the body, would undoubtedly prove fatal.

So I do think the lower dosing is prudent, and would be concerned about women of childbearing age taking the stuff, at least until we have good animal studies which include studying the birth rates, birth weights, and general condition of the progeny. In fact, to be really safe I'd want to see such studies continued for at least two generations, so we know that the children of C60 dosed individuals' children are also unaffected.

[niner]

I think a case could be made that c60 is a "natural product". It does, after all, exist in nature.

I'm not so sure that the synthesized version of c60 is the same as the c60 found in nature ie. Shungite. When I get some time, I will post a new thread on this. Let's just say Kroto & son won't be happy when I do.

I was thinking about the presence of C60 in soot and combustion byproducts in general. It's been found in cigarette smoke (a well known "natural product"...), for example, and would undoubtedly show up in wood fires, barbecues, etc. This suggests that there's a very long human history of exposure, albeit at very low levels.