Will FDA’s “Grandfathered” Ingredients Rule Mean No More Real Vitamin E?

October 29, 2012
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Herbal supplementsSupplements not on an FDA “approved” list could disappear.

The NDI guidance interprets the rules for new supplements. After your protests got the first draft scrubbed, work on a second draft continues at FDA. A second meeting between FDA and “stakeholders”—mostly trade groups, with ANH-USA once again the only grassroots consumer group present—took place on October 16.

As we reported after the first meeting, the New Dietary Ingredients guidelines still pose a major threat. This is because FDA is trying to reaffirm the policies of the original guidance, particularly the elements that could remove huge numbers of supplements from the market.

Much of the meeting was dedicated to a discussion about how to create a list of “grandfathered” dietary ingredients (supplements). These supplements would have been sold prior to 1994, the year the underlying law, DSHEA, was passed and therefore would not require jumping through further regulatory hoops before being sold. The question was: what evidence would be required to show that a supplement was sold prior to 1994?

FDA says such a list won’t necessarily be final, and won’t be the only supplements allowed to be sold. But we could easily conceive of that being the outcome if left to the agency. We are also concerned that FDA wants to set the evidentiary bar so high that many supplements which were definitely sold prior to 1994 still won’t pass.

According to FDA, any of the following is sufficient to prove that a supplement was marketed before DSHEA was passed: an invoice, a bill of lading, a product label, or a catalog, provided it clearly indicates a date. But many companies don’t have this kind of documentation from eighteen years ago! For example, pyridoxamine (a B6 vitamin) was marketed before DSHEA, but no one in the industry has been able to provide the documentation required by FDA. Even signed affidavits from industry members have been inadequate in FDA’s eyes.

What if a dietary ingredient is, and has always been, in our food? Doesn’t that mean it was “marketed” before 1994? Not to the FDA. The supplement must have been separated out of the food, and sold for its own properties. Human beings have consumed the antioxidant resveratrol for millennia because it’s found naturally in the skin of grapes. But no one in the industry has yet been able to prove that resveratrol was marketed as a separate ingredient or was found on the label of a food or supplement before 1994.

The problem is a little different with P5P. P5P is the only form of vitamin B6 that the body can use directly. It’s produced naturally in the body: all other forms of B6, whether in food or in supplement form, must be converted to P5P first; without it we die. Most of us don’t get enough B6 in our diet, and some people lack the enzymes needed to convert pyridoxine into P5P.

There shouldn’t be any problem grandfathering P5P since there is no question that B6 was sold prior to 1994. But the FDA says no. If the form of B6 sold earlier was not P5P, if the label didn’t say P5P, they won’t grandfather it.

As we have previously reported, a drug company, Medicure Pharma, wants sole use of P5P and has petitioned the FDA to ban its use as a supplement entirely. Although Medicure has yet to market a drug made from P5P, it has already petitioned FDA to have the supplement banned now.

This idea of taking what we cannot live without and turning it into a controlled prescription drug is shocking. But this could only be the beginning. We are concerned this new “approved” list of supplements will be used by drug companies to knock out competition from other supplements effortlessly.

For a supplement to get on the grandfathered list, the FDA says it cannot be “chemically altered”—and the definition of that term was another bone of contention at the meeting. Many grandfathered ingredients, because they now go through different (and often safer) manufacturing processes than they did before 1994, could therefore be considered “chemically altered” by the FDA. So either supplement producers would have to revert to pre-DSHEA manufacturing processes, or else they would no longer be on the grandfathered list! Consumers would get the short end of the stick either way, but the FDA doesn’t care.

As we pointed out when the first draft of the guidance was issued, FDA’s stance is so extreme that a ripe apple would be considered “chemically altered” when compared to an unripe apple! Logic would suggest that the production process should not matter if the end ingredient is basically the same.

In all of this, FDA seems to be targeting new, improved, or technologically advanced supplements, presumably because they see them as potential competitors to drugs. If they keep cutting-edge supplements off the market, drug companies can also make big money by selling the older version of the supplement, as Pfizer does with its Centrum multivitamin that we discussed last week.

Here’s another example of why this question of a grandfathered list is so important. Vitamin E is a powerful antioxidant that prevents cell structure damage, boosts the immune system, reduces cholesterol, lowers the risk of developing cancer, thins the blood, helps skin repair itself, and even strengthens your hair. And everyone “knows” that vitamin E was sold prior to 1994. It currently appears on a trade association’s list of grandfathered dietary ingredients. However, this has not yet been vetted or approved by the FDA. If the proper documentation can’t be found, either vitamin E would be off the grandfathered list, or else some forms of E might be listed and others might not. This is important because different forms of the vitamin work very differently. Vitamin E in the form of mixed tocopherols may prevent breast cancer, among other benefits, whereas the common alpha-tocopherol form may not. Some researchers and integrative doctors actually warn against taking alpha-tocopherol alone because it may interfere with the body’s use of the other forms of vitamin E.

Unfortunately, this information has been buried by the media. All of the research on vitamin E that the media has been reporting—and badmouthing—has used alpha-tocopherols instead of mixed tocopherols, as Dr. Jonathan Wright points out in the current issue of his Nutrition and Healing newsletter.

We are pleased that the FDA is including stakeholders at the NDI guidance redraft meetings. We are pleased that consumers were included by inviting us. But there are reasons to be very watchful. We don’t want a grandfathered list that will not only exclude many supplements actually sold before 1994, but will also make it easier to reject all newer supplements. With vigilance and your help, we won’t let that happen.


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34 Responses to “Will FDA’s “Grandfathered” Ingredients Rule Mean No More Real Vitamin E?”

  1. Wayne Robey says:

    Although I agree that there is a problem with the regulations regarding New Dietary Ingredients, this does not appear to be a problem with vitamin E. A quick look at old catalogs shows Puritan’s Pride catalog 251 (sale ends Sept. 16, 1993) Products 440, 450, 453, 460, 463, 465, 2640, 2643, 551, 550, 553 have the description “The following E-COMPLEX softgel contains natural Vitamin E…from mixed tocopherols concentrate, derived from natural vegetable oils. E-Complex provides the essential D-alpha plus beta, gamma, delta tocopherols.” When I inquired about the quantity of the individual components, I was given numbers but they were so small that I considered this to be an advertising gimmick. The Nutrition Warehouse SEP94 catalog lists item 1103 as “Super E Mixed Tocopherols COMPLEX Alpha, Beta, Delta & Gamma”. I think the first mass market supplier to list the individual tocopherols with useful quantities was Carotec. It was called “The E” but I don’t know when it was introduced. Eastman Kodak supplied the ingredients. I see the Jan 1979 organic chemicals catalog only lists d-alpha-tocopherol and d-gamma-tocopherol.

       0 likes

  2. bltw says:

    The FDA & Big Pharma are a legalized mafia.

       2 likes

  3. Tim Wallace says:

    All Vitamins, be they before or after 1994 should not be under the consideration of the FDA. They are vital to the health of mankind and in that respect should not be controlled by any government agency except for quality.
    The FDA and many of the so called government agency are in no way independent. No government agency should be allowed to employ anyone that has been previously employed by the type of company that they are supposedly overseeing. All present employees of government agencies like the FDA and USDA, that have previously been employed by any corporation that is regulated by such agency should be summarily be dismissed without notice or compensation.
    Lobbying of such agencies by corporations that can or should be regulated by such government agencies should be made a felony, punishably by penal fines and imprisonment in county or state prisons of all employees engaged in such lobbying, together with the employees of the lobby companies.
    Corruption in any form should be wiped out as soon as possible

       3 likes

  4. Pat says:

    This will just make the black market or ordering from, say, Canada happen that much quicker. Hate that another country would get our money though.

       0 likes

    • Darlene says:

      Anyone who trusts the FDA to do the right thing needs to read articles such as this. The FDA is Big Pharma’s puppet and mouthpiece.

         1 likes

  5. Bill Bledsoe says:

    My opinion: This issue is not just about the tyrannical ‘government’ in DC…..it is also about
    colussion of corporate greediness with the government. How’s this: The two groups decide
    that classifying the supplements/vitamins as illegal (banned), will drive it underground, and
    the corporations/pharmaceuticals (as in Medicure Pharma) will reap a windfall. After all, many
    corporations pay the campaign bills for politicians. Such ‘conspiratorial’ actions by two or more
    entities (government and corporation) has been in vogue for many years. Which means that
    “We the People” have to rise up and take back the federal government gone mad.

       0 likes

  6. Rebecca P says:

    Is there anyway we can abolish the FDA and all bureaucratic, greedy, kick-back infested, regulating bodies of the same ilk…?? Then maybe (???) find some way to PROPERLY legislate to protect the PEOPLE and their freedom of choice!! Just wondering… OR do I have to defect to another country, where they care about the well-being of their people??

       7 likes

    • Lou says:

      The simple brutal truth is the FDA, CDC and HHS are implementing the UN Agenda 21 depopulation mandate. They are doing this with the full permission and approval of the highest levels of US and World politics. That is why NOTHING ever changes and grows worse. Think of all the major health “problems” we have in the US; ALL of them have relatively easy solutions. These solutions are not politically possible. When enough of us understand this BASIC problem change is possible.

      Not until.

         0 likes

      • Darlene says:

        Lou, your comment hit home with me. I used to wonder,did AIDS just fall out the sky one day? Of course the answer is no. According to Dr. Len Horowitz (Emerging Viruses: Aids, Ebola and Vaccines), AIDS was created, on purpose, in laboratories. You’ll never guess who was behind it’s developement. Incidently, I found the video at Netflix.

        And consider Dr. Max Gerson, how he was villified, and eventually murdered, for curing cancer.

        Nothing will ever change until the public demands change.

           0 likes

  7. dez says:

    Hopefully Obama will be defeated and the slimy character he appointed head of of the FDA will be replaced. Also his appointees to the USDA, EPA and NLRB.

       2 likes

    • Kay Lang says:

      The FDA has been a major problem way before Obama hit the scene. For many years the FDA has been in bed with Big Pharm et al. And no way will the conservatives step on the toes of a huge money gorging corporation like Big Pharm. We do need the FDA, but only an honest FDA that does the job that they are suppose to do—monitoring things like our food supply such as genetically modified foods, msg, aspartame, partially hydrogenated oils…We should have thousands of emails going to our Representatives and Senators more frequently than we do.

         3 likes

    • Margie says:

      This has nothing to do with President Obama and I resent your bringing slimy political allegations into this discussion. And if you feel necessary to respond I will go into detail about what the other candidate for office would do. Trust me, it isn’t pretty.

         1 likes

    • Helen says:

      I agree with your assessment of Obama’s pick for head of the FDA but do you really believe Romney’s would be any better? Romney’s choice will be even more industry slanted in his belief that everything needs to be privatized.

         0 likes

      • davea0511 says:

        dez didn’t say Obama was slimy … just that he appointed a slimy character to the FDA. Regardless whether Romney would be any better (a worthy point of contention) doesn’t change the fact that the FDA has become significantly worse on his watch … enough so that I’d say dez is justified in hoping that a change couldn’t be worse than what we already have. Isn’t that the platform Obama ran on 4 years ago? Change … it has not been for the better these last 4 years regarding the FDA’s collusion with Big Pharma. Romney’s track record regarding corporate profits at the expense of the little guy should give the voter pause as well though. I’m just saying … don’t shoot the messenger.

           0 likes

  8. Lou says:

    Here are some results of FDA, HHS, CDC et al policy.

    http://www.youtube.com/watch?v=K7_e_4AOsFo

       0 likes

  9. Doris says:

    Write your congressman and tell them you are tired of having to go through this (it seems weekly) to ask them to vote against another bill to protect us from the FDA. Big Pharm is running scared. There are too many of us that are too educated on knowing how to take care of our health without their drugs, and the number is growing. Their only defense is to ban the supplements that we use to do it with. We have got to write letters and stop the FDA. We simply do not need them. Let the pharma protect themselves by not putting the killer drugs on the market. If they must be used make sure the warnings are large enought print to read and then let the consumer beware.

       4 likes

  10. Ignatius Turchi says:

    The F’ing DA is pulling the same stuff with P5P as they did with pyridoxamine. See the Life Extension website and search for pyridoxamine

       1 likes

  11. Ignatius Turchi says:

    The F’ing DA is doing the same thing with P5P as they did with pyridoxamine.

       1 likes

  12. Lou says:

    Clearly there is NO way to live with the FDA. Any agency that gladly approves the toxic GMO garbage as food but prohibits the natural chemicals found in our bodies as supplements is out to induce disease and death in the people it is supposed to be protecting.

    Please pass this on.

       10 likes

  13. Carol Leman says:

    I am concerned this new “approved” list of supplements will be used by drug companies to knock out competition from other supplements effortlessly.
    Stop the attacks on products whose only sin is that they cannot be pattented for monetary expolitation.

       7 likes

  14. jo nelson says:

    Why don’t you pay more attention to the real killers—pharmaceutical drugs that kill more people every year and stay away from harmless supplements?It’s all about money and profit isn’t it…not health. This is shameful.

       9 likes

  15. Peter Lindquist says:

    Is this mostly smoke? Or is the real fire in the vitamins that drug companies sell, After buying out major and minor vitamin companies, Drug companies now control what is actually in and or on your vitamins,
    FDC Red#40 has invaded some very popular vitamins, inside and out! Also ad blue lake in its many forms now showing up in and or on your vitamins, Alzheimer’s is unavoidable with these in a daily dose that now are in or on your supplement in doses far exceeding a package of hot dogs or a half a box of breakfast cereal!

    Praise God! Truth will set you free

       4 likes

  16. Barranca Wren says:

    Please do not restrict the use of natural supplements!

       2 likes

    • fallingman says:

      I don’t mean to be harsh, but stop saying PLEASE and begging for what’s rightfully yours. The people who run the FDA and the people who control the FDA are domestic terrorists. Treat them as such. You don’t beg at their feet. You resist them.

      Organizations such as the Alliance for Natural Health and The Life Extension Foundation are doing just that. They deserve our support. There is strength in numbers. It may be enough to stop the worst of the abuses. But they have the guns. They also have the paid 8 hour a day jobs required to engage in full time persecution. We just have numbers and numbers might not be enough, as they don’t care what we think until the numbers and the negative feedback we generate become simply overwhelming.

      But regardless of how this turns out, never beg for what you have a natural right to that they have stolen from you. Don’t plead with terrorists. It’s unseemly and undignified.

      End the Fed! End the FDA! Nothing less will set us free.

         5 likes

  17. Carole says:

    How can we say we live in a free country when the FDA a government agency is determined to take away our very most basic freedoms. They are taking away our right to care for our own bodies, to determine what is right for us.

    It is also important to know, over 100,000 people a year die from the drugs approved by the FDA. Legally prescribed, properly taken drugs. That does not take into consideration all the people who are now addicted to prescription drugs.

    Hospitals and doctors are now the 6th highest cause of death in this country. How can we continue to allow these people and government agency’s to make the rules that kill us, that cause horrific side effets that cause unknown suffering. How can the government allow this to happen?

       6 likes

    • Margie says:

      We do need the FDA, but the battle against supplements has to stop. I am concerned that too many people are unaware of the options that they have to prescription drugs, but I am more concerned that those of us who use supplements to stay healthy may be robbed of our choice in picking supplements.
      The fox is guarding the henhouse and that has to stop. Scientists who have proven connections to big pharma are not appropriate choices to lead the agency. That permission given on the B6 supplement needs to be rescinded and supplements need to be allowed to be sold freely to the public.

      Congress can propose legislation at any time to protect supplements and disallow big pharma to have a monopoly on a supplement for any purpose including research. Who has a friendly congress person or senator that would be willing to sponsor such legislation?

         2 likes

  18. robert seaton says:

    If these things get passed,and they take our right to use suppiments away. I guess for the first time in my life i will have to become an OUTLAW. I WILL FIND A WAY TO GET THEM !!

       3 likes

  19. James Duffy says:

    It seems that the Federal Death Administration (oops … i mean, the Food and Drug Aministration) is on the payroll of Big Pharma. We should seriously consider whether the FDA is even necessary, inasmuch as it appears to consistently work against the welfare of the American people. Perhaps the elimination of the FDA would save lives.

       6 likes

  20. Thank-you ANH for looking out for the rest of us!

       2 likes

  21. Melodie Metje says:

    I want my freedom to choose to buy whatever supplement I want! Doctors told me that I had to live in excruciating pain for the rest of my life. Supplements gave me my life back.

    Give me my freedom of choice!

       6 likes

  22. Pauline Vega says:

    We have to pay attention to how vitamin and mineral supplements are portrayed. Because they cannot be patented in their natural form big pharma cannot make money off of them. If they tweak them just a little bit they can make millions and we loose all the the healthy goodness of them. This is happening on an international level as well. Take notice! This effects everyone young and old. Pretty soon Big Pharma and some multi- national companies will be able to say and worse- enforce laws stating all vitamins but the ones they lab create are bad for everyone. They are saying that now. They just do not have enough control to force supplements off the market- Yet!
    It is (very sadly) a fact about Big Pharma and some multi national companies- (think Monsanto, etc ) and has been for a very long time now. They want total control over our food supply and that means how they are “lab created” minus the vitamin and minerals. They can then “lab create” and then sell at higher cost the vitamin and mineral supplements that are missing from the food -and seeds they “lab create”. Sounds like a futurist story line from a book or movie. But it would be real and happening now…..

       4 likes

  23. Judith says:

    No artificial vitamins for me. How do we turn this mess around for the better? Thanks for letting us know

       2 likes

  24. Janice Lansel says:

    Leave our supplements ALONE! Gosh, I am trying to stay healthy & keep my family
    healthy & strong…. These supplements are all natural….God given. Leave them be
    so we can have a healthy nation. Hands off our natural supplements!

       2 likes

  25. Linda Rosencrantz says:

    Vutamin E is as important as sunshine in our lives who are you to tell us what we can take

       3 likes

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