Questions About Vitamin E Safety

Question: Don't recent studies show that vitamin E may be fatal to its users?

Answer: There is no evidence to support the claim that taking vitamin E could be fatal. Even though it has been totally refuted and discredited by the research community, Edgar Miller's vitamin E meta-analysis* that claimed vitamin E increases all-cause mortality is still being pushed by the media. Since November (2004) when the meta-analysis was released, new reports, rehashing false information about vitamin E being harmful, have continued to surface to this day. While we will not go into all the details about this issue, here are a few key points:

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 Only 1 of the 19 studies used in the meta-analysis showed any statistically significant increase in all-cause mortality.
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 Not a single studied included in the meta-analysis used the natural vitamin E complex.
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 Blatant Bias: Miller excluded any vitamin E study with fewer than 10 deaths (this fact alone confounds his results).
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 The subjects in the meta-analysis were already sick, yet the authors try to apply their conclusions to the general population.
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This meta-analysis has been systematically rejected by every major research authority.

To encapsulate the feelings of research professionals we present the following four doctors from Walter Reed Army Medical School, who's response to the meta-analysis was published in the Annals of Internal Medicine. They said:

"Although we read Miller and colleagues' article with interest, we question their conclusions regarding high-dose vitamin E"

"..we found a suggestion of publication bias.."

"They also excluded trials with fewer than 10 deaths...and this in particular, would tend to bias the results toward a finding of harm."

"In summary, we have trouble accepting Miller and colleagues' conclusions regarding high-dose vitamin E because of the statistical methods used and the lack of controlling for study quality and publication or selection bias. We contend that correction of any one of these factors could negate the marginally significant results."

"...telling our patients that vitamin E may be harmful seems premature."

Kent J. DeZee, MD, MPH
William Shimeall, MD, MPH MD,MPH
Kevin Douglas, MD
Jeffrey L. Jackson, MD, MPH
Walter Reed Army Medical Center

Question: Are Vitamin E supplements dangerous?

Answer: Although not covered by the media, the most recent study* on the safety of vitamin E and C found that both were safe.

*Vitamin E and C are safe across a broad range of intakes. Am J Clin Nutr 2005;81:736-45.

After extensive review of the available data, including the recent negative studies, 14 prominent researchers declared that, "Evidence of bleeding effects and other potential adverse effects of high vitamin E intakes in humans is not convincing.'

The researchers went on further to state that, "Furthermore, most of the studies with negative results used [synthetic] all-rac-tocopherol and not [natural] RRR-tocopherol at doses that are not anti-inflammatory (<800 IU/d)."

The researchers also pointed out that in 20 clinical trials involving at least 80,000 subjects with administered doses of up to 3,200 I.U. daily, there were no reported side-effects.

*Miller ER 3rd, Pastor-Barriuso R, Dalal D, Riemersma RA, Appel LJ, Guallar E. Meta-analysis: high-dosage vitamin E supplementation may increase all-cause mortality. Ann Intern Med. 2005;142:37-46. [PMID: 15537682]

Question: What about dosage, is any dosage above 400 I.U. harmful?

Answer: While studies using the synthetic or esterified form of vitamin E may suggest harmful effects associated with higher doses, there has been no such correlation with the natural vitamin E complex.

A toxicology report* that reviewed 216 separate studies of high dose vitamin E showed that, "In trials on over 9,000 cases with administered doses of up to 3,000 I.U. daily for up to eleven years (and 55,000 I.U. daily for five months in a few subjects) no side effects were reported."

Dr. Atkins, of the famed Atkins Diet®, said in his book Vita-Nutrient Solution that, "Doses of vitamin E up to 3,200 I.U. per day are very safe."

Also, the vitamin E pioneer, Dr Evan Shute, stated that, "A correct dose for a person is anything he can tolerate. I have my wife taking 3,200 units a day. I take 2,400 units my self."

It is interesting to note that the government’s own research suggests that the UL (upper level) for natural vitamin E is 1,600 I.U. The UL's were designed, "to protect the most sensitive individuals in the general population."

Furthermore, many of vitamin E's greatest benefits are dose dependant, requiring a minimum of 800-1200 I.U.

Remember, while the synthetic forms of vitamin E have been shown in some studies to have dangerous side effects, the natural vitamin E complex is safe and effective.

Question: Don't Americans get plenty of vitamin E in their diets?

Answer: The recent report from the Dietary Guide-lines Advisory Committee concluded that nearly all Americans fall short in their RDA intake of vitamin E. That being said, many researchers believe that the current RDA levels for vitamin E (15 mg a day) are a travesty and point out that the current RDA is based on deficiency symptoms instead of disease prevention.

Below is a graph of the RDA (Recommended Daily Allowance), EAR (Estimated Average Requirement for half the population), and the actual levels of vitamin E in men and women (seen in yellow).


97.6% of women and 92% of men do not meet
even the EAR of 12 mg of vitamin E.

Yet people across the U.S. are being persuaded to stop taking vitamin E.

EVERYONE SHOULD BE TAKING UNIQUE E®!

*Toxicology Report: Kappus H, Diplock AT. Tolerance and safety of vitamin E: a lexicological position report. Free Radic Biol Med 1992;13:55—74.