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tween 80 warning posted on Biotivia site


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#1 bixbyte

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Posted 20 February 2009 - 05:47 AM


Urgent Health Alert Warning: A Resveratrol Supplement by revgenetics containing a compound called Tween is a possible health hazard.

Another day, another resveratrol scam. This latest one is not only irresponsible but may be hazardous to your health as well. A Florida based resveratrol reseller has begun adding the industrial chemical Polysorbate 80 to their product, which they call Nitro250. The company claims that this chemical, also known by the trade name Tween and Tween 80, increases bioavailability of the resveratrol contained in the company’s supplement. There is absolutely no evidence to support this claim. Tween is not intended to be used for this purpose and can be toxic at high doses easily consumed in such supplements. It is commonly used in industrial detergents, shampoos and degreasers and for the remediation of toxic wastes. There is no evidence that Tween in any way enhances resveratrol bio activity or any other beneficial property. Given its chemical properties there is no reason to believe that it would enhance resveratrol. It is an emulsifier whose function is to break down fats and grease. Resveratol is not a fat, although it is soluble in oil. Consequently Tween use in a supplement merely for marketing purposes is an outrageous and irresponsible violation of product safety and common sense. However the bigger issue is that Tween has been associated with severe side effects in humans.

Severe allergic reactions which have been associated with Polysorbate 80 (Tween) include: Rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue, blurred vision or vision changes; chest pain; confusion; fainting; fast or irregular heartbeat; flu-like symptoms (fever, chills, sore throat) one-sided weakness; pale skin color; seizures; redness, tenderness, or swelling of the calf; severe diarrhea, dizziness, headache, stomach pain, or vomiting; severe or persistent tiredness or weakness; slurred speech; sudden pain or numbness of an arm or leg; sudden shortness of breath; sudden trouble walking or loss of balance; swelling of the arms or legs; vision or speech problems; weight gain.

Other less severe adverse effects include: Constipation; cough; diarrhea; dizziness; headache; muscle, joint, back, or stomach pain; nausea or vomiting; pain, swelling, irritation, redness, or bruising at the injection site; unusual tiredness or weakness.

Studies have shown disturbing and potentially serious health effects related to Tween 80. The anti HPV vaccine Gardasil contains Polysorbate 80, which is linked to infertility in mice,” noted Dee Nicholson, National Communications Director for Freedom in Canadian Health Care. [Nov 2007] Sleight of Handling: More Merck Magic Tricks With HPV Vaccine By Christopher C. Barr

A study published in December, 2005 discovered that Tween 80 can cause anaphylaxis, a sometimes fatal reaction characterized by a sharp drop in blood pressure, hives, and breathing difficulties. Researchers concluded that the severe reaction was not a typical allergic response characterized by the combination of IgE antibodies and the release of histamines; it was caused by a serious disruption that had occurred within the immune system.

In another study neonatal female rats were injected ip (0.1 ml/rat) with Tween 80 in 1, 5 or 10 percent aqueous solution on days 4-7 after birth. Treatment with Tween 80 accelerated maturation, prolonged the oestrus cycle, and induced persistent vaginal oestrus. The relative weight of the uterus and ovaries was decreased relative to the untreated controls. Squamous cell metaplasia of the epithelial lining of the uterus and cytological changes in the uterus were indicative of chronic oestrogenic stimulation. Ovaries were without corpora lutea, and had degenerative follicles.” ~ PMID: 8473002. Female lab rats injected with Tween 80 developed impaired sexual organs as well as premature development of their sexual organs. Institute of Preventive and Clinical Medicine, Limbová, Bratislava.

Previous studies by Gajdova et al. have shown that polysorbate 80 (also known as Tween 80) administered by intraperitoneal injection to neonatal female rats on days 4-7 after birth produced estrogenic effects including earlier vaginal opening, prolongation of the estrus cycle and persistent vaginal estrus. Some of these effects were evident many weeks after cessation of administration of polysorbate 80.” [Gajdova et al - “Delayed effects of neonatal exposure to Tween 80 on female reproductive organs in rats.” Food Chem Toxicol 31(3):183-90 (1993) Institute of Preventive and Clinical Medicine.

Tween is actually a synthetic chemical compound consisting of Polysorbate 80, also known as polyoxyethylene sorbitan, and various other chemical species. In the Sigma Aldrich chemicals catalog buyers are warned that Tween is “For laboratory use only. Not for drug, household or other uses.” The World Health Organisation also suggests that the compound is not safe for human consumption beyond “acceptable daily intake limits of 0-25 mg of polyoxyethylene sorbitan esters per kg body weight.”

Tween is a major component of industrial and household cleaners and degreasers.

The Clorox-made cleaning solution used by the iRobot Scooba floor-washing robot lists Tween 20 as one of its major ingredients on its MSDS. Tween variants are known as Tween 20,60, and 80 and are produced by several chemical companies, primarily in China.

Tween is commonly used in laboratory studies for the following purposes:

* to stabilize purified protein derivative (PPD) solution used in skin testing for tuberculosis exposure
* as a blocking agent in immunoassays, such as Western blots and ELISAs.
* as a solubilizing agent of membrane proteins.

The fact that a chemical has been used in food does not insure that it is safe and non toxic.

The chemicals bisphenol, aspartame, monosodium glutamate (MSG), potasium bromate, BHA and BHT and the artificial colourings brilliant blue and quinoline yellow, as well as many other chemical additives have been shown to have serious toxic or carcinogenic and mutagenic effects to humans but are still being used legally in foods in the US even though many other countries have banned their use in consumables. Even melanine is permitted in foods in small amounts. Tween 80 is used in some ice creams in the US however it is neither natural nor organic.

No Biotivia product contains any variant of Tween, Polysorbate or any other synthetic filler, additive, or chemical modifier. It is more costly and requires more sophisticated processing to produce supplements without chemical additives such as glidants, preservatives and fillers however Biotivia believes in producing a premium product that you can reply upon, not simply the cheapest one available. We do not take chances with your health. Chemical additives, particularily those with evidence of health hazards, are totally incompatible with supplements intended to enhance health and well being.

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Tags: FDA, resveratrol, Tween


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One must be very careful in selecting a resveratrol supplier. Since this compound has hit the mainstream press a flood of totally inexperienced and somewhat dodgy companies have sprung up selling this product, or what they claim is resveratrol. None of these companies, most of which have some form of resveratrol or longevity in their names, have a lab, quality control, scientists or pharmacists on board, or any history manufacturing health products of any type, let alone a complex product such as resveratrol.
The ConsumerLab did an evaluation of resveratrol brands recently which was open to all companies. In their independent lab tests they found that many products were basically worthless. For example Life Extension’s product had only 26% of the claimed resveratrol in their actual product. Revgenetics refused to provide a sample of their product to test at all.

The products which both passed the Consumer Lab tests and have doses of resveratrol recommended by the Harvard study published in the Journal Nature were Biotivia’s Bioforte and Transmax. Bioforte was also the lowest cost per mg of all products tested. The moral here is look before you leap.
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Comment by Biotivia (Who am I?) — January 10, 2009 @ 4:01 am

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http://www.biotivia....mful-to-humans/

#2 unglued

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Posted 20 February 2009 - 06:54 AM

The resveratrol sellers sure seem intent on warning consumers against each other's products.

For perspective, does anyone know how much Polysorbate 80 is one of the 250 mg resveratrol capsules compared to a tablespoon of ice cream, for those of us who might occasionally indulge in non-organic ice cream? Is there any reason for someone who hasn't suffered from any of those severe allergic reactions from consuming ice cream and other foods would need to fear the short-term health effects mentioned? I see it's a quote from the Wikipedia article (or vice versa), but that section has no citation to a primary source to back it up.

I did a Google search for *site:2OfMyFavoriteVitaminMerchants.com polysorbate-80* and found about 180 matches on each site, so given the number of supplement products I'm taking, I'm sure I was already consuming plenty of polysorbate 80 even before I tried the product in question. I'm more inclined to trust the FDA's judgment, underfunded as that agency may be, rather than warnings from commercial interests about the dangers of their competitor's products.

Does anyone know of a good reason to be concerned about this Generally Regarded As Safe ingredient being mixed with the Just Beginning To Be Studied For Safety In Humans supplement?

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#3 maxwatt

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Posted 20 February 2009 - 10:49 AM

FOOD RESOURCE
COLLEGE OF HEALTH AND HUMAN SCIENCES, OREGON STATE UNIVERSITY
Polysorbate80 -- An emulsifying agent for special dietary products and pharmaceuticals, a defoamer in yeast production, and a chewing gum plasticizer. An unintentionally administered daily dose of 19.2 grams per kilogram of body weight for 2 days to a 4-month-old baby caused no harm except loose stools.

I do wonder why Sirtris chose HPMC with DOSS over Tween 80 (polysorbate-80) for their resveratrol formulation.

#4 Anthony_Loera

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Posted 20 February 2009 - 01:56 PM

Yes,

Many CoQ10 products already have Tween 80.
This comes from Consumer Labs, that has passed them as good products without issues.

The Article doesn't mention that Consumer Labs only tested their product once back in 2007, and did not state that they were the best.
We test every batch, while they maintain one batch in 2007 is enough for people to consider them.

A

#5 maxwatt

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Posted 20 February 2009 - 02:57 PM

Yes,

Many CoQ10 products already have Tween 80.
This comes from Consumer Labs, that has passed them as good products without issues.

The Article doesn't mention that Consumer Labs only tested their product once back in 2007, and did not state that they were the best.
We test every batch, while they maintain one batch in 2007 is enough for people to consider them.

A


How come James uses your product name on his website but threatens to sue you if you use his product name in your comparative price list?

#6 Anthony_Loera

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Posted 20 February 2009 - 03:47 PM

The same reason James says Dr. Maroon's choice of resvertrol is Bioforte on his homepage, while at the same time Dr. Maroon states he has endorsed no resveratrol product to date.

(Yes, I have an email from the good Dr.)

However because James is using our trademark without our permission, I will be talking to his hosting provider soon.

A

#7 niner

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Posted 20 February 2009 - 09:39 PM

The same reason James says Dr. Maroon's choice of resvertrol is Bioforte on his homepage, while at the same time Dr. Maroon states he has endorsed no resveratrol product to date.

In a like fashion, James still continues to claim that David Sinclair and various other resveratrol researchers use "Transmax" (a Biotivia tradename) in their research. These are falsehoods. The misleading tract on Tween is just another in a long string of ethical problems.

#8 Anthony_Loera

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Posted 20 February 2009 - 10:56 PM

Hi Maxwatt,

After contacting his hosting provider (Rackspace.com), they have changed the story on their website.
The article in it's original form does not exist anymore.

I hope Dr. Maroon and Dr. Oz contact him about the claims on his homepage.

If anyone knows Dr. Oz's email, pass it along. I will simply email him to verify claims as well. If it turns out Dr. Oz does prefer his product, I will certainly tell everyone here.

A

Edited by Anthony_Loera, 20 February 2009 - 10:58 PM.


#9 2tender

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Posted 20 February 2009 - 11:58 PM

Well its certainly food for thought, but, would a supplement company knowingly put a potentially harmful ingredient in their product? They would not be in business long nor would their product sell. Thats what seems to be the issue, sales, or lack thereof. Im interested in taking a Resveratrol product that is tolerable and effective, what works for me may not work for someone else. Its good that there are several companies vying for the market, it essentially makes for better product and wiser, healthier, consumers. I know what products have worked for me and thats what I will continue with. Sure, Im interested in what brands popular Doctors use, it may even influence what I purchase. Whether I would continue with that product is based on my subjective experience.

Edited by 2tender, 21 February 2009 - 12:09 AM.


#10 Anthony_Loera

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Posted 24 February 2009 - 06:22 PM

I hope Dr. Maroon and Dr. Oz contact him about the claims on his homepage.


Apparently something has happened as the main webpage does not have this posted anymore, luckily I have a PDF of it for reference.

Niner, do you know where transmax is mentioned for Dr. Sinclair? I would like to get a copy of that as well...
If someone has the old yahoo resveratrol posts where this is discussed, please PM me.

A

Edited by Anthony_Loera, 24 February 2009 - 06:24 PM.


#11 niner

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Posted 24 February 2009 - 06:35 PM

Its good that there are several companies vying for the market, it essentially makes for better product and wiser, healthier, consumers.

Well, competition is good, but if some of those companies are lying to consumers, I'm not so sure it makes us wiser.

Niner, do you know where transmax is mentioned for Dr. Sinclair? I would like to get a copy of that as well...

If you google sinclair transmax, you can find a lot of sock puppetry on various sites.

#12 Anthony_Loera

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Posted 25 February 2009 - 12:28 AM

I don't see the "Albert Einstein College of Medicine" regarding trials and the IND anymore on the home page.

I emailed them just to verify if the claims were true regarding the trials and IND, and I have a reply from them letting me know they would contact the company about the claims. If a claim is mentioned in marketing, it is not disparaging to contact a third party for verification when you can.

This is simply the truth or facts gathered about claims after receiving emails from folks, it is not disparagement.

A

#13 Anthony_Loera

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Posted 11 May 2009 - 09:38 PM

Its good that there are several companies vying for the market, it essentially makes for better product and wiser, healthier, consumers.

Well, competition is good, but if some of those companies are lying to consumers, I'm not so sure it makes us wiser.

Niner, do you know where transmax is mentioned for Dr. Sinclair? I would like to get a copy of that as well...

If you google sinclair transmax, you can find a lot of sock puppetry on various sites.


Found it:

http://digg.com/heal...38440#c20638440

A

#14 nancyd

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Posted 11 May 2009 - 09:44 PM

Yes,

Many CoQ10 products already have Tween 80.
This comes from Consumer Labs, that has passed them as good products without issues.

The Article doesn't mention that Consumer Labs only tested their product once back in 2007, and did not state that they were the best.
We test every batch, while they maintain one batch in 2007 is enough for people to consider them.

A



Just curious which CoQ10 brands use Tween 80? I haven't noticed this ingredient in the various brands I've tried over the years.

Edited by nancyd, 11 May 2009 - 09:45 PM.


#15 Anthony_Loera

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Posted 12 May 2009 - 12:41 PM

Yes,

Many CoQ10 products already have Tween 80.
This comes from Consumer Labs, that has passed them as good products without issues.

The Article doesn't mention that Consumer Labs only tested their product once back in 2007, and did not state that they were the best.
We test every batch, while they maintain one batch in 2007 is enough for people to consider them.

A



Just curious which CoQ10 brands use Tween 80? I haven't noticed this ingredient in the various brands I've tried over the years.



You can do a google search and find them or sign up with consumer labs, as they have mentioned polysorbate 80 in January 2009 under "Bioavailability" in their latest tests:

http://www.nutraingr...es-quality-test

Product tester Consumerlab.com has found most coenzyme Q10 dietary supplements – best known to benefit heart health – do exactly what they say on the tin.

But it noted what products said on their respective tins, or bottles or blisterpacks, varied greatly as CoQ10 dosage levels ranged from 22mg to 600mg – a significant discrepancy for a supplement with known bioavailability issues.

The research follows earlier ConsumerLab.com surveys in 2000 and 2004 that found not all CoQ10 supplements met their label claims, although the last test – in 2006 – found all products were above board.

In the current examination only one of the products failed to meet its stated label amount.

That product – Healthy America Coenzyme Q10 – contained only 86.7 percent of its labeled amount of 150mg of CoQ10 per soft gel. This claim was made despite the existence of a quality guarantee and cGMP claim that suggested it was made according to the Food and Drug Administration’s good manufacturing practices (GMPs) for dietary supplements.

Consumerlab tested 39 CoQ10, or ubiquinol, products – 20 of which it selected independently. The others were submitted by their manufacturers and one additional product passed because it was very similar to one that passed but sold under another brand name.

Brands tested included Andrew Lessman, Berkley & Jensen, Carlson, New Chapter, Twin Lab and USANA.

Bioavailability

Forms tested included soft gels and chewable tablets and Consumerlab suggested CoQ10 was best absorbed when accompanied by fats or oils that may be present in the digestive tract (especially during meal times). This may make it more absorbable if fats and oils are present at the time of consumption, as may be the case in a soft gel.

Such oils include rice bran oil, soybean oil, sunflower oil, vitamin E, and medium chain triglycerides.
CoQ10 that has been solubilized with polysorbate 80 or formulated as water-soluble beadlets can offer improved absorption, Consumerlab said.

“CoQ10 found in most supplements is in the oxidized state (ubiquinone), but once in the body it readily goes into the reduced state (ubiquinol), which is its active, antioxidant form,” Consumerlab wrote.

CoQ10 comes in two dominant forms – synthetic and fermented. Most material is fermented because the process is cheaper.

Dosages

CoQ10 is often taken – especially in the US- in conjunction with statin drugs which deplete the body’s natural CoQ10 reserves. Typical doses in this area are 100-200mg, although some medical professionals recommend doses up to 600mg.

Daily doses for other ailments include 300mg to help prevent migraines (although it may take three months to become effective); Parkinson's (300 to 1200 mg); hypertension (120 to 200 mg); angina (150 mg); for reducing the likelihood of future heart problems in people who've had a first heart attack (120 mg); HIV/AIDS (200 mg); muscular dystrophy (100 mg); mitochondrial encephalomyopathies (150 to 160 mg); increasing sperm motility (200 mg); increasing ubiquinol ratios in children with trisomy 21 (10 mg of ubiquinol (liquid form) per kilogram of body weight).


Edited by Anthony_Loera, 12 May 2009 - 12:42 PM.


#16 2tender

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Posted 13 May 2009 - 11:33 AM

Is there more Tween 80 in a bowl of ice cream than there is in one Nitro capsule? Why has this become an "issue" in terms of supplementation? Its been in other supplements for years.

#17 Anthony_Loera

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Posted 13 May 2009 - 01:42 PM

To sum up...

There are no issues, CoQ10 and many other products in your local supermarket have polysorbate 80, including ice cream.
Consumer Labs is fine with polysorbate 80 in products. As you can see Consumer Labs even states that polysorbate 80 will allow for greater absorption in the CoQ10 products they have tested.

So there is no secret that polysorbate is in CoQ10, and other products to increase absorption, and that it is used by supplement companies as well as food companies around the world for different purposes.

We are not the first to use it to create a better product, and we certainly will not be the last.

Cheers
A

#18 HOTCells

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Posted 14 May 2009 - 04:08 PM

Anthony, beings ice cream has Polysorbate 80, would taking reveratrol powder with an ice cream increase resveratrol absorption?


To sum up...

There are no issues, CoQ10 and many other products in your local supermarket have polysorbate 80, including ice cream.
Consumer Labs is fine with polysorbate 80 in products. As you can see Consumer Labs even states that polysorbate 80 will allow for greater absorption in the CoQ10 products they have tested.

So there is no secret that polysorbate is in CoQ10, and other products to increase absorption, and that it is used by supplement companies as well as food companies around the world for different purposes.

We are not the first to use it to create a better product, and we certainly will not be the last.

Cheers
A



#19 Anthony_Loera

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Posted 14 May 2009 - 06:51 PM

Any method of dispersion or emulsion should help increase absorption.

However, the Sirtris charts did not test ice cream, so we have no way to see what increase in absorption the beta-lactoglobulin in the ice cream and small amount of polysorbate 80, would have.

Cheers
A

#20 2tender

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Posted 14 May 2009 - 06:56 PM

Is there more polysorbate 80 in a capsule of Nitro 250, than there is in a bowl of ice cream?

#21 maxwatt

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Posted 14 May 2009 - 08:01 PM

Is there more polysorbate 80 in a capsule of Nitro 250, than there is in a bowl of ice cream?


If anyone using Nitro250 has a scale that measures 10ths of gram, please weigh a nitro 250 capsule. We know there's 250 mg of resveratrol in it, and the capsule should weigh 10 mg. My guess is that there are approximately 250 mg of Tween 80 in a capsule, though it could be less, especially if other ingredients are noted on the label. I believe 250 mg is an upper bound. The WHO has set the upper limit for long-term daily ingestion of Tween80 at 1725 mg for a 70 kg man, with a considerable safety margin. I would think taking up to seven caps of Nitro250 a day won't be a problem for anyone.

On could also mix 98% resveratrol into ice cream as it melts, even if there is no polysorbate 80 in the ice cream. Milk is an emulsifier, and resveratrol powder dissolves in milk or in melted ice cream. I've done this. It probably results in increased serum levels with a given dose, though you might get fat.

Edited by maxwatt, 14 May 2009 - 08:03 PM.


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#22 2tender

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Posted 15 May 2009 - 12:50 AM

Thanks for the educated estimate, the point is that the Tween 80 is probably harmless in the amounts per capsule. This is a less noxious emulsifier than D-limonene, which has fallen out of use, fortunately.




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