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FDA Flubs Again on Vitamin E, Stubbornly Clinging to Outdated Science

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FDA Clings to False Science The FDA’s ignorance of vitamin E could create serious risks for consumers. This is on top of other parts of the FDA’s proposed new labeling rules that aim to ban the natural form of folate (vitamin B9), and result in less potent supplements. URGENT Action Alerts!
In our last issue, we told you how the FDA needs a lesson in supplement science. This week, we share why the agency’s staff might need instruction in basic arithmetic, too.
Although there are eight different compounds that make up vitamin E—four tocopherols (alpha, beta, delta, and gamma) and four tocotrienols (alpha, beta, delta, and gamma)—the FDA has traditionally only recognized one form, alpha-tocopherol, as biologically active. In its proposed changes to labeling rules, the FDA has once again refused to update its unscientific, completely outdated view.
So, the agency’s “logic” runs like this: any amount of seven of the eight forms of vitamin E—even 1 million units—equals zero, zip, nada vitamin E.
While this may sound like a joke, the consequences are far from funny.
The FDA’s thinking originates from the antiquated idea that vitamin E is only good for one thing: preventing infertility—in rats, mind you. Since alpha-tocopherol is the best at this, it’s the only form considered to be “active” by the FDA. This is why the FDA’s current unit of measurement for vitamin E, International Units (IU), reflects how much alpha-tocopherol is needed to prevent fetal resorption in vitamin E-deficient rats.
But of course, we know now that complete vitamin E is good for far more than fertility. Vitamin E is not only necessary to life, but is a big-time antioxidant, immune system booster, blood clot preventer, and vessel dilator, among other functions known and unknown. It’s also an extremely complex nutrient: how it affects your body, as well as your gene expression, depends on whether it’s natural or synthetic, what form it’s taken in, how those forms are mixed (or not) with each other, and what your vitamin E status is in the first place.
Importantly, natural vitamin E is much more potent than its synthetic cousin. People need 50% more synthetic dl-alpha-tocopherol to obtain the same amount of the nutrient as they would from the natural equivalent (d-alpha-tocopherol).
Although vitamin E occurs naturally in nuts, some greens, and oils, most of what’s in dietary supplements is synthetic dl-alpha-tocopherol (when reading supplement labels, remember that dl equals synthetic). We also worry that when dl-alpha-tocopherol is synthesized, it produces eight isomers—seven of which are completely uncontrolled and random byproducts of a chemical process.
In addition, to ignore the all-important gamma-tocopherol form of vitamin E is nothing short of negligent, given what’s known about the science. This form is not only the most common form in foods, it’s also the most important antioxidant tocopherol.
Tocopherols and tocotrienols have different molecular structures: tocopherols have a long tail with no double bonds, while tocotrienols have a short tail with three double bonds. Naturally—in the healthiest diets—the tocopherols are ingested in larger amounts than the tocotrienols, and this ratio is often preserved for good reason in supplements delivering full-spectrum vitamin E. Tocotrienols’ “shape” gives them great mobility in your body (they can pass through cell membranes more easily), and greater anti-oxidative effects.
According to the Life Extension Foundation, tocotrienols can provide anti-aging benefits and reduce the risk of stroke. Tocotrienols are among the most useful nutrients for preventing neurodegeneration of the brain, a key factor for Alzheimer’s and dementia. Additionally, animal studies on tocotrienols show that they can inhibit breast, prostate, pancreas, skin, lung, liver, and colon cancer. Men take note: some of them may have a positive effect on hair loss.
Emerging science indicates that gamma-tocotrienol may actually be the most active form of vitamin E (remember—according to the FDA, this version of vitamin E is completely inactive). As Dr. Barry Tan, one of the leading experts on vitamin E, told Whole Foods Magazine, delta- and gamma- tocotrienols are “without exception” the most potent forms of vitamin E. No matter what the most active forms are, vitamin E supplements work best when consumed in a mixture of all eight forms (look for “full spectrum of mixed tocotrienols and tocopherols” on supplement labels). In fact, there’s evidence that mixed vitamin E can reverse arteriosclerosis (the thickening and calcification of the arterial walls).
It’s best to avoid supplementing with alpha-tocopherol alone—it can interfere with your body’s use of gamma-tocopherol, and may even increase the risk of certain cancers (hence, the “Vitamin E Causes Cancer!” headlines).
The FDA could have partially redeemed its disastrous labeling proposal by updating the units of measurement for vitamin E in a way that encouraged use of forms other than alpha-tocopherol. We do agree that they should transition from IU to milligrams (mg). And they are proposing to account for the fact that natural vitamin E is much more bioavailable than synthetic vitamin E. However, the proposed new rules still consider alpha-tocopherol to be the only active form of vitamin E. Instead, the FDA’s new unit of measurement should consider all eight forms of vitamin E, with specific conversion factors for each. The unit for total vitamin E on the label would be in milligrams, but with all the different forms and their relative amounts expressed to give citizens (and practitioners) a clear view of what was being consumed.
Consumers who are new to supplementation may be confused and harmed by thinking they should just supplement with alpha-tocopherol, because it suggests it’s the “only” important or active form of E. Furthermore, it’s unclear whether or not dietary supplement producers who include other forms of vitamin E beyond alpha-tocopherol can even say so in the Supplement Facts label—the most experienced supplement consumer may simply be left in the dark.
The agency’s persistence in clinging to completely outdated supplement science is misleading, and could very well be dangerous. Will they next insist that the world is flat? This is why we think supplements need their own regulatory agency under Health and Human Services. The FDA is not only unaware of supplement science—it has many of its salaries paid by drug companies and perhaps, for this reason, is pro-drugs and anti-supplements.
The FDA’s newly proposed “labeling” rules are one of the biggest challenges to supplement access we’ve seen in this decade. In one fell swoop, the FDA plans to ban a B vitamin vital to life, dumb down supplement potency, and hurt consumers by obscuring the basic facts about supplementation. Please take action now, before it’s too late.
Action Alert! The FDA’s labeling changes show a poor understanding of supplement science, will confuse consumers, and could endanger the long-term health of Americans, most of whom are teetering on the edge of one form of nutritional deficiency or another. Write to the FDA TODAY, and ask the agency to revise its new units of measurement for vitamin E.


Even if you’ve already taken action on the FDA’s folate ban, please do so again. This is one battle we can’t afford to lose!


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