The Alliance For Natural Health

FDA Flubs Again on Vitamin E, Stubbornly Clinging to Outdated Science

29

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 In its proposed changes to labeling rules, the FDA has once again refused to update its unscientific, completely outdated view.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.

Take-Action11

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!

Take-Action11

Share.
  • Dianne Williams

    The FDA isn’t ignorant of Vitamin E – it is ignoring it because it’s in the pocket of Big Pharma. The FDA has demonstrated time and again that it has little interest in protecting/promoting the health of the average citizen – it is only interested in protecting/promoting the cash health of the drug companies that pay them.

  • Himavat Ishaya

    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.
    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, it is best to not ignore the all-important gamma-tocopherol form of vitamin E, 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…

  • Linda Ethridge

    I use supplements daily. These are the things that are keeping me healthy at the age of 57. I will not be using the ACA nor my insurance at work due to the cost of going to the doctor. I watched my mother die because of doctors prescribing medicines that have side affects then would prescribe other medicines to cover that. Our food source is not supplying the nutrients that our bodies need. If you give the body what it needs it will heal it’s self. I am begging you to update your research, which we all know changes just about everyday.

    Kind regards,
    Linda Ethridge
    Corpus Christi, TX

  • Zeneta Kertis

    Please leave our supplements along, vitamin E is very important we do not need you people to start messing around and destroying or depleting our vitamins.

  • Drew Pecoraro

    Please do not take away Vitamin E, especially on information that is clearly outdated.

  • Suzanne Hachey

    please fix Vitimen E classification, get it right!!!!

  • Coby Lyons

    Please make your policies on supplements, Vitamin E in this case, reflect what is known scientifically with up-to-date information and understanding. 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. It is time to recognize and request labeling of the other forms of Vitamin E which has a multitude of beneficial properties. Don’t endanger society with misinformation when you are the agency that is supposed to protect the consumer.

    Thank you for your consideration of this matter

  • Bonnie Johnston

    Please recognize other forms of vitamin E when labeling supplements containing natural E complex. Other forms of E besides alpha-tocopherol have been found to be biologically active and beneficial in a number of ways.

  • As a past teacher of physiology with an emphasis on nutrition I know that the science is always improving. Change, sometimes radical, seems to be analogous to punctuated equilibrium, inasmuch as things stay the same for a while then new knowledge drives rapid change. Forgive the effort at comparisons but supplements, while sometimes toxic or unnecessary, seem to give the greatest benefit when balanced and complemented by other compounds and substances working in synergy with the complexes of other supplements. Folate and vitamin E, folate in particular, seem to be insufficiently present in the average diet.

  • Lee Johnson

    What is the motivation for the FDA’s unfounded and flawed declaration denying the undeniable benefits of Vitamin E? The general public is well aware of the manipulative pharmaceutical firms greed, and denial of the benefits of OTC drugs, that eat into their profits.

  • Lanette Larson

    PLEASE LABEL ALL VITAMINS IN LYMENS TERMS — I have taken Vita E for over 45 years, for fibrocystic breasts. I know Vita E is not a water soluble vitamin. Too much can become toxic in a human body and can be very dangerous. WE NEED TO KNOW WHAT/HOW TO READ THE PROPER INGREDIENTS

  • Scott D Morrow

    This article is fantastic! Even the red palm oil merchants fail to fully cover the full spectrum of complex vitamin E. Thank you for educating whomever received this message. I enjoy supplementing organic, fair trade, red palm oil daily as a natural, complete source of vitamin E complex, carotenoids and medium chain fatty acids. Forget synthetic supplements and always go with whole raw organic foods for your nutrition…..OH, the FDA is a w—- for the convicted felon drug monopolies.

  • Colleen Satterfield

    Please revise the new units of measurement for vitamin E into something we all can understand. Also reconsider the potency issue as there are many who ‘s health depends on taking supplements that help the body to heal. Thank You

  • Susan Mann

    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).

  • Durk Pearson

    I think that it is far too charitable to attribute the FDA’s position on vitamin E labeling to ignorance.

    Why?

    Lets start by taking a look at what the National Library of Medicine has indexed on gamma tocopherol:
    http://www.ncbi.nlm.nih.gov/pubmed/?term=gamma+tocopherol

    Hmmmmm…. That is 2046 published peer reviewed scientific papers concerning gamma tocopherol, which is especially valuable for its high activity against the strong oxidant peroxynitrite – among a lot of other reasons.

    How about delta tocopherol:
    http://www.ncbi.nlm.nih.gov/pubmed/?term=delta+tocopherol
    314 scientific papers

    What about tocotrienols?
    http://www.ncbi.nlm.nih.gov/pubmed/?term=tocotrienol
    1037 more,

    Does this really look like mere ignorance???

  • Mark Thorson

    Tocopherols are common in normal human diets, while tocotrienols only occur at very low levels, which probably accounts for their recognition by the steroid and xenobiotic receptor (SXR) as a foreign molecule (xenobiotic). Why do you not mention the risk of SXR activation from the tocotrienols? Tocopherols have vitamin E activity but do not have this risk. I mentioned that in a comment to an earlier article you put on this website in February:

    With regard to vitamin E, you should also mention that tocotrienols are potentially hazardous to anyone taking a prescription drug. Unlike the tocopherols, the tocotrienols activate the steroid and xenobiotic receptor (SXR). Activating this receptor up-regulates the drug-metabolizing enyzme CYP3A4, which is the main enzyme that destroys drugs and other molecules not normally present in the human body (xenobiotics). Activating SXR also up-regulates P-glycoprotein, which is the main enzyme that transports drugs and other xenobiotics out of the body.

    http://www.ncbi.nlm.nih.gov/pubmed/15269186

    Organ rejection has been caused by natural supplements that activated SXR and diminished the effectiveness of the anti-rejection drug cyclosporine. Failure of birth control drugs has been caused by natural supplements that activated SXR. If you do not take any drug and never will, perhaps you would want to take an SXR-activating supplement to remove xenobiotics from your body. In that case, take St. John’s Wort, which is notorious as a very powerful SXR activator.

    On the other hand, if you might get cancer and want the anti-cancer drugs to be effective, you should not take SXR activators like the tocotrienols. P-glycoprotein was discovered during research to understand why cancer chemotherapy eventually fails — most anti-cancer drugs are potent SXR activators, and activation of SXR greatly diminishes their effectiveness after a year or two of treatment. You can satisfy all of your vitamin E needs from the tocopherols, which do not activate SXR at all.

    Some promoters of tocotrienols do not mention this very important risk. These people do not have your health and well-being at heart, only their own profits. You should only buy supplements from people who give you complete information, both positive and negative, so you can make your own informed decision about whether you should take SXR activators like tocotrienols, St. John’s wort, curcumin, and ginseng. The people who sell these supplements are aware of this…

  • Felicia Dale

    Your idea about labeling changes for vitamin E show a very poor understanding of supplement science, it will confuse consumers and could endanger the long =-term health of Americans most of whom are already seriously nutritionally compromised with one form or another of nutritional deficiency. Please reconsider revising your new units of measurement for vitamin E now!

  • Michelle Wells

    The ANH-USA has once again admirably reminded us that the FDA continues to cling to outdated information regarding supplements, which is misleading and possibly dangerous to consumers. The FDA’s outmoded views are evident in its proposed changes to continue recognizing only one form of Vitamin E, alpha-tocopherol, as biologically active, with limited usefulness in treating infertility. There are actually eight different compounds that make up vitamin E—four tocopherols (alpha, beta, delta, and gamma) and four tocotrienols (alpha, beta, delta, and gamma). Emerging science indicates that complete vitamin E (all eight forms) is good for far more than fertility. Full spectrum tocotrienols are not only necessary to life, but also serve as an important antioxidant, immune system booster, blood clot preventative, to name a few. In addition, complete Vitamin E provides useful nutrients for preventing degeneration of the brain. Even animal studies suggest that complete Vitamin E can inhibit breast, prostate, pancreas, skin, lung, liver, and colon cancer. However, the FDA’s latest changes in labeling will likely confuse consumers and could endanger the long-term health of Americans, many of whom are already on the edge of some form of nutritional deficiency. ANH-USA indicates that It is best to avoid supplementing with alpha-tocopherol alone, as it can interfere with the body’s use of gamma-tocopherol, and may even increase the risk of certain cancers (hence, the “Vitamin E Causes Cancer!” headlines). Thus, 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.

    Thank you, ANH-USA for such valuable information regarding the need to look toward full spectrum Vitamin E supplementation to assist us in maintaining good health.

  • alice Dudley

    It’s bad enough I lose my natural doctor to our government bureaucrats. Leave my natural vitamins alone.All these people seem to like to do is ruin our lives. Will they ever stay out of it?

  • Roger Batchelder

    This is not directly related to nutrition, but insufficient funds make it harder to buy healthy foods and
    supplements.
    We still have a Jobs Crisis in this country, despite the political propaganda. Compounding this
    problem is the refusal of politicians and media to even mention the obvious, proven answer to the
    Jobs Crisis- the WPA and CCC public works programs that gave relief to more than 10 million
    Americans during the depression of the 1930’s.
    Please sign the petition to revive the WPA and CCC, and also talk it up, whatever way you can,
    to break the silence about this proven solution. It could also do good for the environment, planting
    millions of trees, for example.
    http://www.petitions.moveon.org/sign/remember-fdr-wpaccc-jobs
    Thanks!

    • bMohr

      It will cost us even more, if we can’t have free, unfettered access to natural supplements and have to pay the exorbitant fees that the pharma co.s will require– copays, deductables and, not to mention, the full market rate hiked way up there by big pharma, when our doctor decides our need doesn’t meet clinical criteria, since we’re treating metabolic or, functional, disorders, and not frank pathologies. Man, this legislation is nothing short of conniving and evil to make us sicker and sicker as a nation.

  • Laurie in Florida

    This is the abbreviation for microgram (mcg) you wrote the abbreviation for milligram (mg) they are nowhere near the same. Making this story invalid. Now you must clarify which dosage amount you mean for this story to be valid in order for action to be taken.

    • Hi Laurie–Thanks for catching this! It is milligrams, which we’ve edited the article to reflect. Best, ANH-USA

  • Vernon Pope

    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.

  • I have been reading blogs… many people with the MTHFR gene disorder, which requires methylated supplements… have spent their life savings, had to sell homes, seeking help they never found until, gene testing became affordable.

    These people have suffered enough and do not deserve to be forced to pay for RX prices, when they have had such a difficult time. This country is so corrupt! Many drug companies have headquarters off shore and pay no tax to the USA.

    We are torturing our people with bad attitudes, generated in DC. The leaders have lost compassion, in their desire to take care of their handlers, instead of the people who need help.

    Jimmy Carter, recently said, ” There is no effective democracy in the United States”. Greed has taken it all. Apparently, the FDA is bought and sold.

    • Jerry T.

      Things in bottles are usually dead. Sprout you’re way out (of the bottle). Buy wheat germ instead.
      I wonder if there are people who take so many vitamins, they can’t eat?
      Theraputic values notwithstanding.
      As well noted in comments; We’re too poor to eat right, right. We are too poor of knowledge to eat right. I raise an autistic son. He is truly brilliant. He researched diet for his autism. We both eat a worlds worth of better. We find real food is cheaper. Unmolested things with engredients we can pronounce. Nothing bastardized, that is a huge no no for the autistic. HFC, Food coloring or mystery flavorings. We cook and bake scratch were we can. We do eat off diet on occassion, no harm. And no soda either.
      Educate. In this world, how can we not?
      My son is well known on line, he has his own server and is an amazing admin. He has all, well not all, of a 5th grade education, oops I mean schooling, that we battled our way through.
      If your going to wine, do it with cheeze. Let’s unbridle ourselves from the hype of our handlers.
      Vitamin E, wow, when hemp seed oil does the flesh healings so much better.
      Internal therapeutics, notwithstanding.

      • bMohr

        Hemp seed oil makes me high. I’d rather take a natural supplement.

  • Renrah

    no misunderstanding at all. The FDA is owned lock, stock and barrel by Big Pharma who will keep designing studies that result in a failure.

    Read a few of Dr. Sherry Rogers or Ben Goldacre’s books.

  • http://www(dot)ThePeoplesBranch(dot)org
    At the core of most political problems is one thing – SPECIAL INTEREST! The system doesn’t serve the people’s interest because it’s too busy serving special interest! The People’s Branch is a modern-day equivalent of the movement that added the Bill of Rights to the Constitution. It is a political movement that will make local, state and national government, more transparent, less corrupt, more accountable, less wasteful, more fair and just.

    The People’s Branch will create the ultimate check and balance upon most officials and public servants by letting the voters participate directly in government. With The People’s Branch the government remains a republic. Elected officials and public servants are still responsible to work for the people’s interest. Nothing essential is taken away from the present system. However, something very important and greatly needed is added! With The People’s Branch each elected official’s vote(s) concerning any matter can be changed by a majority vote of their constituents. Citizen voting will be voluntary and may be exercised by electronic means from home or office. The technology now exists that can implement this process. Remember, if you can bank online you can vote online? Citizens will only vote to Pass or Fail i.e. Approve or Disapprove their own elected official’s vote. If the majority Approve their elected official’s vote then that elected official’s vote remains unchanged. However, if a majority Disapprove their official’s vote then that vote is changed. By checking and balancing their own elected officials actions the people themselves become their own greatest champions for protecting their own interest and keeping government honest and fair.

    Only corrupt politicians, officials, and public servants fear this political movement because they know that if it succeeds then their power and control will come to an end.

    There’s never been a greater need for this political solution. But no one is saying it is going to be easy. Yet, neither was the Civil Rights movement or the Women’s Suffrage movement, etc., etc. So, why is it that even though everyone is for better government, the political solution that will systemically improve government at all levels by neutralizing special interest’s control, is yet to be implemented?

    The People’s Branch is a reasonable and non-violent way for the people to regain control of government from special interest.

    To take up this…