ANH-USA to File Health Claim for Vitamin D—and It’s All Thanks to You! (Plus a Vitamin D Update)

January 18, 2011
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VitD

In addition to this exciting announcement, we have some troubling news to report: more conflicts of interest over the Institute of Medicine’s vitamin D report, and more evidence from a top Harvard expert that the IOM recommendations fly in the face of good science. What is really going on here?

First, the good news: Represented by famed attorney Jonathan Emord, the Alliance for Natural Health USA will be filing a Qualified Health Claim Petition with the FDA for vitamin D.

For many years, the US Food and Drug Administration held that health claims for foods or substances could only be made if there was Significant Scientific Agreement (SSA) about the claim. This is a standard which is almost impossible to reach in science.

Under pressure of court losses, the Agency finally relented. Its 2003 Consumer Health Information for Better Nutrition Initiative acknowledged that consumers benefit from more information on food labels concerning diet and health. As part of this initiative, the agency established interim procedures whereby “qualified” health claims can be made with a lower standard of scientific evidence, so long as the claims do not mislead consumers. These “qualified” health claims are often initiated by a petitioner—in this case, us.

It means that if the FDA accepts our petition, producers and sellers of vitamin D will be able to make certain specific claims about its ability to treat certain diseases or conditions.

We want to make it abundantly clear that we are able to file this petition only because of the generous financial support of our members. YOU are making things happen in a big way—and improving the lives of countless Americans. Thank you!

At the same time, we need to update you on the Institute of Medicine’s vitamin D report—the one that recommended such ridiculously low daily vitamin D allowances for most people. Dr. Walter Willett, one of the scientists who reviewed the IOM report but whose comments were never made public by the IOM (nor were the comments of any of the other reviewers), has published a summary of his concerns regarding vitamin D, calcium, and bone health. According to Dr. Willett, the randomized controlled trials (RCTs) studied by the IOM show that the daily dosage of vitamin D they recommended is too low to prevent the risk of bone fractures.

Please keep in mind that Dr. Willett, who teaches at Harvard, is probably the most famous nutritional scientist in the world. His comments will not be easily dismissed by the leaders of the Institute of Medicine. The IOM’s report was based almost solely on the effect of vitamin D on bone health; other health benefits were largely ignored. Now Dr. Willett says they didn’t even get the bone science right.

Before proceeding further, a quick chemistry lesson. Whether it is made in the skin or ingested, vitamin D3 (also called cholecalciferol) passes through the liver and becomes 25-hydroxycholecalciferol; this is usually abbreviated 25(OH)D. The level of 25(OH)D is measured in nanomoles per liter, or nmol/l.

Dr. Willett says that the IOM report suggestion that 50 nmol/l is sufficient is plainly contradicted by the IOM’s own data. The RCTs proved that the 50 nmol/l threshold “was insufficient for fracture or fall reduction.” By contrast, the International Osteoporosis Foundation’s analysis recommended a threshold of 75 nmol/l for optimal fall and fracture reduction, and recommended 800 to 1,000 IU of vitamin D per day for seniors age 60 years and older. And beyond the RCTs, there is compelling evidence that higher 25(OH)D blood serum levels can be effective in fighting colorectal cancer.

Tellingly, in their press conference about the IOM report, the authors admitted that the group initially chose 10,000 IU a day as an acceptable upper limit for vitamin D, then decided to reduce this to 4000 IU at the last moment—giving no indication why they made such a sudden and dramatic reversal, especially considering their own data contradicted those recommendations.

As we reported last month, one of the authors of the report, Dr. Glenville Jones—the one who openly pooh-poohed the idea that most people are vitamin D deficient—is an advisor for Cytochroma, a pharmaceutical company developing a synthetic drug version of vitamin D. Now we learn that he is also on the board of another drug company, Receptor Therapeutics, which has in the pipeline a drug called Onco-D102—an intravenous, high-dose vitamin D drug for the treatment of cancer. The drug is still in the preclinical stage. Could this obvious conflict of interest have anything to do with IOM’s recommendations which fly in the face of science?

Dr. Willett also reports that the IOM’s “safe upper limit” for calcium appears too high. He says that data supporting recommended calcium levels and bone health, especially in regard to hip bone density and fracture risk, is insufficient. There is also recent data on the possible adverse effects of calcium supplements on cardiovascular health and kidney stones—and with appropriate vitamin D supplementation, calcium recommendations should be adjusted downwards.

Regular Pulse readers already know that supplemental calcium should never be taken alone. It needs additional magnesium, vitamin D, omega–3 fatty acids, and vitamin K (in particular, vitamin K-2, which is especially important). Without these essential co-factors, the calcium may end up in our blood vessels or our heart, where it causes harm, rather than our bones, where it is needed. So long as these co-factors are taken as well, many studies have shown that added calcium plays an important role in building and maintaining bone mass—and also reduces the risk of colon cancer. Studies showing vitamin D’s effect on viruses such as the flu are less extensive but also persuasive. As we noted in an earlier article, one Japanese study found vitamin D much more effective at preventing the flu than vaccines.

The problem is, the government (not to mention the media) blindly accepts the IOM’s recommendations. And that blindness can be lethal—especially when government agencies have to come back later and say, “Whoops! We goofed!” The RDA for vitamin D has now been significantly raised, but it’s nowhere near as high as the science shows we need. The government recommends calcium, but still has no idea that it is dangerous without the necessary co-factors.

33 Responses to “ANH-USA to File Health Claim for Vitamin D—and It’s All Thanks to You! (Plus a Vitamin D Update)”

  1. Linda J. says:

    Thanks for such good information. I have long been advocating the use of Vitamin D at the 5,000 unit level. I think as consumers, we need to just take a look at what our government officials do as individuals. I find it interesting to note that Michelle Obama created an organic garden as one of her first actions after moving into the White House. We would do well to learn from that and start our own organic gardens. We need to find such items as alfalfa (to grow sprouts) and other organic seeds that will one day become obsolete and begin to store them safely. The government will not ever respond to the will of the people unless we use our pocket books to show them we are not playing. Sending emails and writing blogs are great, but our elected officials at this point will only respond when we use our dollars to make them listen.

    Start to buy organic foods in your super markets and the farmers, pesticide makers and other distribution channels for our food will begin to change. Anything less will only be useless, whining and soap box grandstanding. Our government, at the present time will not listen to politicians or consumers if they don’t follow the money. Where and how we spend our dollars is the only way that they will listen. Our votes elect our politicians, our politicians listen to whoever funds their campaigns. If corporations want us to buy their products, then we have to show them which products we are willing to buy. Short of that, nothing will change.

       1 likes

    • lillian shearer says:

      Valsick has received subsidies from the USDA over years for his “farmland”. The real revolving door on this particular issue is Michael Taylor (our food safety czar). He goes back and forth between Monsanto and the FDA regularly. He led the charge for GMO when he was in FDA; after senior positions at Monsanto. During one of his government positions he made sure Growth Hormone (created by Monsanto) could not be identified on a label. That was just overturned in the courts. It took years. What do you all bet he did not have an impact on the GMO alfalfa decision by Valsick.

         1 likes

  2. Donna Marquart says:

    Thanks for all you do regarding getting the facts out. It IS ALL about the money.

    Some years ago, my husband was taking quinine from time to time for night leg cramps. His doctor prescribed it. Nowadays, because of some “study” that reported that a number of people over a relatively long period of time supposedly died from taking quinine, it was banned in the U.S. After a good deal of searching for a source for quinine – because American doctors cannot prescribe it and pharmacies don’t have it (it is TOO dangerous !!!!!?????), he can get a synthetic form of quinine (some drug company holds the patent for it and it is not inexpensive) he spoke with someone who knew the REAL story – basically this pharmaceutical company has “cornered” the manufacture of this synthetic drug and had the real stuff outlawed, by producing this “study” that showed quinine was dangerous. It is a real pain to try to get something that works for him .

    On another topic, but very related to all the “science” about what is good for us INDIVIDUALS is this.

    NPR reported yesterday about an argument that is brewing about growing GM seed in the same valley as good, unmodified seed. The non GM seed grower argues that GM seed destroys the good stuff (I agree) Tom Vilsack – doesn’t/didn’t he work for Monsanto – or was on the board or something like that – see The World According to Monsanto and Mad Cowboy – Food, Inc. – documentaries about how our food is being tampered with by large CHEMICAL companies and it points out the revolving door of people who work for the chemical companies and then go on to government jobs and then back to the chemical companies I think they called it a revolving door. The farmer who grows the good seed said he may eventually be put out of business because no one from other countries will buy his seed because of the possibility of contamination of GM stuff. I don’t think this is a good idea of how the U.S can be in a global market to sell products. Are these chemical companies trying to take over the world?

       1 likes

  3. Gabriel ONWUKEME, says:

    Thanks a million for the update.

       1 likes

  4. Dave Philbin says:

    To Henry Lahore. The links you provide call for Vitamin A in the rediculous amount of 10000units! It is now a known science fact that large amounts of Vit. A will inhibit the body from absorbing Vitamin D3, so you are defeating the whole purpose. Other than that all the other information, though extreme, was inline with sound nutrition. (at this point of our knowledge)

       1 likes

  5. Henry Lahore says:

    A review of low-cost co-factors to take with Vitamin D and Calcium is at http://www.vitamindwiki.com/tiki-index.php?page_id=1270. Looked at over 100 suppliers – found both liquid solid co-factors for as little as 10 cents per day

       1 likes

  6. Henry Lahore says:

    Conflict of interest web page now have 5 panel members. Can you find more? http://www.vitamindwiki.com/tiki-index.php?page_id=1198

       0 likes

  7. janet says:

    It really never ends, does it? I have spent the past 5 years trying as hard as I can to keep my family healthy and in fact, return it to health. I’ve done this by a combination of dietary changes switching to “real” food away from processed and gmo’s plus supplement addition. We are healthy once again but it’s taxing to keep trying and know that the very people that we should be able to trust are those who are our worst enemies. It’s always about money, it’s never about what is right anymore. I am so discouraged.

       1 likes

  8. Cwolf88 says:

    I’m proud of ANH because you take action, vice lots of whining.

    Not sure there is a huge conspiracy; the simplest explanation is simple stupidity. Scientist X as one vote on the panel may work for other folks as long as it’s disclosed.

    I’m not sure what effect the DRI/RDA have. Afterall, who complies with them? They’re not linked to medical policy or treatment. The even bigger issue was even if they set the DRI/RDA at 2,000 iu, who would comply?

    The USDA/FDA sponsors are focused on food and menu planning (school lunches, military, food fortification, etc.).

    I think the strategic issue is that their paradigm is wrong.

    The USDA/FDA ask how much calcium do bones need at the population level (normed by age and gender). They do not ask what the bone system needs to be strong and healthy (impact exercise, 20 nutrients, an alkaline diet, etc.). Calcium will only help folks with inadequate calcium levels (which is why ‘blind dosing’ studies get odd results). Calcium by itself doesn’t make bones stronger in calcium replete folks.

    The USDA/FDA task to the IOM should be to set serum levels in balance based on function/health (not a statistically normal distribution) and define the Best Technical measurement (how many docs are using the wrong D test?).

    Focusing on dosages is misleading. If I take 2,000 iu D3/day(sun, lamp, or supplement) will my serum levels be healthy or effective? Impossible to say. D3 intake/uptake/utilization varies by latitude, lifestyle, age, genes, obesity, urban dwelling, diet, lifestyle, co-factors, etc. One shoe doesn’t fit all feet.

    “The problem is that we study one nutrient out of context. That’s the way we did research — one vitamin at a time, one mineral, one fat. It was always in a reductionist, narrowly focused way. But I learned that protein is not quite what we thought it was. We’ve distorted our diet seriously through the ages, and we have all the problems we have because of that distortion.

    What loomed large for me was that we shouldn’t be thinking in a linear way that A causes B. We should be thinking about how things work together. It’s a very complex biological system. The body is always trying to restore health every microsecond of our lives. How do we furnish the resources for the body to use? ” Dr. Campbell, Phd, The China Study

       2 likes

  9. Robaire says:

    ANH-USA lets get these finding on TV – PBS, and Radio like the Art Bell/Geo. Noorie broadcast on KFI in L. A. CA. 10PM to 2AM. This Radio broadcasts around the world with many high profile guest.

       1 likes

  10. Ogre says:

    Make your representatives aware that you and many others are aware of the situation and you will vote for the party that decides to take on these issues in 2012. Its time to bring the “Evil Triad” to heel. (Big Ag, Big Pharma, Big Med, with the FDA in the center.)

       1 likes

  11. Julianne says:

    Ive said it before and I’ll say it over and over again. Nobody has the right to tell me
    what I can and can’t put in my body but me. Leave all vitamins & other suppliments
    alone.

       1 likes

    • Tommy says:

      Yes, and I wish they would stop adding vitamins to products such as milk. The brand says organic for example and I look and sure enough they added Vit D to it.

         0 likes

  12. Colleen says:

    Thank you for standing up to these impoirtant issues, and bring them to our attention. I have taken vitamins faithfuly for over 40 years and have never had problems from taking them.
    I don’t like it when these people who know nothing about it steps in to take over and ban vitamins. Just because one person might have a problem with a vitamin, doesn’t mean we all do. There are people who may have problems with prescribed and over-the-counter medications and foods, but why the heck do we all have to suffer? Those people can just stop intaking them. I wish the Food and Drugs would worry more about all the bad meats, eggs and other foods that have been recalled. Plus even the booster shots for the flu that caused major illnesses.That’s where they should be focusing and finding ways to prevent these tragic events from happening again.

       1 likes

  13. Deb says:

    Some people may be confused by your measurement of vitamin D levels in nmol/l. My lab results were in ng/ml. The ratio between the two units is 2.5. So your reference to 50 nmol/l equates to 20 ng/ml. Dr John Cannell (at vitamindcouncil.org) says the minimum healthy level is 50 ng/ml, which is 125 nmol/l. My doctor wants my level to be 80 ng/ml.

       0 likes

  14. Pristine says:

    I wish I could see this backlash grow and I do believe in time it will. Until then ANH is an important resource that will certainly get my support. Thanks for your hard work!

       0 likes

  15. B Cause says:

    Another consideration that has appaently been important in making the RDA recommendations is that the higher the values for any vitamin or mineral (although scietifically sound) the more people will be eligable for puplic assistance and food stamps. This is a major budget item for the country although outside of the budget since it is an entitlement.

       0 likes

  16. William Cloud says:

    May I add my thanks to your efforts. I read widely on the subject of nutrition and find the internet a rich source of reporting on current research. Your writings are clear and accurate. Thank you!

       0 likes

  17. kacy says:

    People have to be cautious of all fat soluble vitamins they are hard on the liver. I’m not saying don’t take vitamin D just be cautious.

       0 likes

  18. Fletcher Millmore says:

    This is good, however it is another one shot “death of a million cuts” endeavor.
    What if anything is happening with the “free speech about science” legislation?
    And how can we attack the IOM itself and any and all other bureaucracies that control free speech and real information?
    Reading a few IOM reports shows that they are astonishingly clueless, such as the currently up for comment USDA school lunch guidelines. Note that the new WIC regulations also are preaching and in effect LEGISLATING the stupid and dangerous diabetes producing “low fat low salt” nonsense, on the basis of IOM reports.
    See: http://www.fns.usda.gov/cga/PressReleases/2011/0010.htm

    It is my opinion that any study, review, collaboration etc that is used to set public policy or that is paid for by taxpayers MUST be made freely and completely available to those affected – the American Citizen. This includes all information re the actual interests of the participants. This has been going in for a long time, see the story of the Salt Institute trying to get publicly funded studies released as required by law.
    I think that this matter is the most important single item that could help to control these people.

       0 likes

  19. Marilyn says:

    Thank you for the update. It appears the bottom line is greed-money and need to have one pharma company rule. Aside from this factor, Vitamins C and D in degrees of dosages are essentials for various body functions. We know that our plastic and out-dated foods do not give us the nurtritional amounts needed so supplements are in order. I spend my bucks on staying well instead of paying doctors to cure illnesses. It’s called, “Quality of life.” I agree that vitamins need other essential co-factors to do the job. I also believe that chelated vitamins are the best vitamins available. In other words, supplements do not immediately pass through the system into the bladder.

       0 likes

  20. Vic3 says:

    The FDA has approved a request by BioStratum to disallow any other company from putting out Vitamin D as pyridoxamine, considered by some as the best kind of ‘D’. This should be stopped. A single company intending to make a prescription version of the D vitamin and being allowed to ‘own’ the vitamin is wrong.

       0 likes

  21. Alan8 says:

    This is just one of many symptoms that corporate interests have taken over (”captured”) government agencies that we depend on to protect us. These corporations are required BY LAW to maximize profits for their investors.

    They oppose and sabotage anything that is a threat to these profits, and their virtually unlimited resources give them a clout that can’t be matched by ordinary citizens.

    We’ve seen this merger between corporations and government before, in pre-world-war-II Italy and Germany: It’s called “fascism”.

       0 likes

    • Bobbalu525 says:

      They oppose and sabotage anything that is a threat to these profits, and their virtually unlimited resources give them a clout that can’t be matched by ordinary citizens.

      We’ve seen this merger between corporations and government before, in pre-world-war-II Italy and Germany: It’s called “fascism”……I totally agree. Until we the people have the wherewithal to to get these money hungry idiots OUT OF OFFICE AND KEEP THEM OUT, there will w no end to this.

         0 likes

    • Bethany Ogdon says:

      Absolutely.

         0 likes

    • Evan Eberhardt says:

      America is too diverse to fall under fascism. However, it does display signs of an oligarchy (a corporatocracy to be specific). This is made abundantly clear by how many government bodies have been ‘captured,’ as you mentioned, and thus do the bidding of corporations and not the public. I have come to the conclusion that any attempt to correct these institutions is typically an exercise in futility; our efforts would be better spent dismantling them all together (limiting government will limit corruption automatically). It will be very hard to ever defeat these tyrannical companies as long as regulatory bodies are given power to restrain our personal liberties.

         0 likes

      • Don Gropp says:

        I would agree that Americans are “too diverse to fall under the control of fascism,” however, due to military/government/corporate secrets, combined with public ignorance, we have fallen under the control of a tryannical government; controlling and increasingly oppressive. The people are simply means, or objects. Even so, I absolutely believe that when good people band together, good will win. It always has.

        As Dr. Linus Pauling once musingly asked his host, “Do you know how hard it is to convince someone about a new idea?”
        ‘A Lifelong Quest for Peace: A Dialogue’

           0 likes

    • fallingman says:

      You got it, pal. Excellent comment.

      I might humbly suggest that, while you are 100% correct, we might be better served to call it “corporatism,” because the average clueless American thinks of gangs of brown shirted thugs massing in the street, the SS, and the like when they hear the word “fascism.”

      Our current day fascists depend, instead, primarily on the use of media propaganda and large cash “donations.”

      Nothing wrong with corporations, per se, but when they use the coercive power of the government to protect, defend, promote, and enrich themselves … and attack their rivals … that’s dirty pool.

      Notice how often “government/business partnership” is offered as a good thing. The hell. It’s an abomination.

         0 likes

  22. And thank YOU, ANH for your diligence and informative web presence!

       0 likes

    • Karmal says:

      How the big drug and insurance corporations, along with their pet politicians Washington, love to gloat about the “free market” system–that is, until the public wields the free market in a way that’s not in such corporations’ vested interests.Then said corporations can’t scurry and slither fast enough to skew the FDA rules in their favor at rates only they can price gouge. If we can take down the big cigarette companies, and stop Big Credit compannies from their unethical lending practices, surely Big Pharma and Big Oil are next on the hit list. If it were allowed, I’d simply pay into the French, British or Canadian system. If those who worrship the free market think it so wonderful, then they’d have no right to complain. Provide a better system at a lower price and they’d have nothing to worry about even if one could shop for alternative health insurance anywhere in the world.

         0 likes

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