ANH-USA Wins Major Lawsuit on Qualified Health Claims

April 19, 2011
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ConstitutionWe took ’em to court—and we won! A federal court has found the FDA’s stance against vitamin health claims to be unconstitutional!

On April 13, the United States District Court for the District of Columbia held that the FDA’s denial of two health claims—which dealt with the ability of antioxidant vitamins to reduce the risk of cancer—was unconstitutional under the First Amendment.

ANH-USA, together with Durk Pearson and Sandy Shaw, sued the FDA for censoring antioxidant vitamin–cancer risk reduction claims after the agency denied multiple claims about the effectiveness of selenium and vitamins C and E in reducing cancer risk, and weakened and complicated other claims to the vanishing point. The plaintiffs were represented by Emord & Associates, a prominent constitutional law firm. You may recall that last October, Jonathan Emord successfully represented us against the FDA on the selenium claim. That win means that selenium supplements are now allowed to claim that “selenium may reduce the risk” of prostate, colon, bladder, or thyroid cancer.

“Qualified health claims” characterize the relationship between a substance and its ability to reduce the risk of a disease or health-related condition. They are permitted in relation to foods and supplements—a precedent established by the landmark decision of Pearson v. Shalala. Qualified health claims are a critical means toward communicating important health benefits of natural foods and dietary supplements otherwise forbidden by the FDA. Unfortunately, the FDA has consistently limited the information available to consumers about the real health benefits of food and supplements and routinely rejects all qualified health claims. This should come as no surprise, given that the FDA has worked shoulder-to-shoulder with the European Commission for well over a decade agreeing on ridiculously onerous guidelines for scientific substantiation of health claims internationally in the Codex Alimentarius. These requirements have been carbon-copied into EU law and some time next year will ban thousands of claims that have informed European citizens for years. We must stop trans-Atlantic European regulatory creep at all costs, and our biggest defense remains our precious First Amendment.

Although the District Court for the District of Columbia upheld FDA censorship of six other claims, the court ruled that the FDA violated the First Amendment when it prohibited two vitamin health claims and stated that it would allow them in a form reworded by the agency:

Vitamin C / gastric cancer claim: “Vitamin C may reduce the risk of gastric cancer.”

  • FDA had prohibited the claim, stating that it would only allow the following language to be used: “One weak study and one study with inconsistent results suggest that vitamin C supplements may reduce the risk of gastric cancer. Based on these studies, FDA concludes that it is highly uncertain that vitamin C supplements reduce the risk of gastric cancer.”

Vitamin E / bladder cancer claim: “Vitamin E may reduce the risk of bladder cancer.”

  • FDA had prohibited the claim, stating that it would only allow the following language to be used: “One small study suggests that vitamin E supplements may reduce the risk of bladder cancer. However, two small studies showed no reduction of risk. Based on these studies, FDA concludes that it is highly unlikely that vitamin E supplements reduce the risk of bladder cancer.”

The court held FDA’s rewording of the two claims unconstitutional under the First Amendment. FDA “has replaced plaintiffs’ claims entirely,” explained the court, and the qualifying the claim so completely “effectively negates any relationship between cancer risk and vitamin intake. The FDA’s rewording . . . makes it difficult to tell what the original health claims are and appears to disavow the FDA’s own conclusions that those claims are supported by credible evidence.”

The court reaffirmed Pearson v. Shalala against the FDA’s objections, holding that “where the evidence supporting a claim is inconclusive, the First Amendment permits the claim to be made; the FDA cannot require a disclaimer that simply swallows the claim.” The FDA has been ordered to revise its claim qualifications consistent with the court’s decision.

In a separate case, ANH-USA sued the FDA over good manufacturing practices (GMPs), operating requirements for dietary supplement manufacturers. Our concern has been that FDA is given authority to treat all GMP violations the same—which means that a paperwork violation carries the same penalties as selling food that harms the public: for both infractions, one is deemed to be selling “adulterated” products, with the same jail sentence. We said those regulations went beyond the statutory authority of the FDA to regulate dietary supplements—that they were unconstitutionally vague (in violation of the Fifth Amendment’s due process clause), arbitrary and capricious, and an abuse of the Administrative Procedure Act.

The judge in our GMP case, unfortunately, gave deference to FDA and its authority to regulate. This is another reason why the language in the Leahy bill is so troubling: it raises the penalty for “adulterating” a product to ten years in jail.

While we continue to make strides in the courtroom, the process is time-intensive, expensive, and—let’s face it—ridiculous. We should not have to sue the FDA to obtain the right to communicate every important piece of health-related information to consumers.

We need to pass the Free Speech about Science Act, which was introduced in Congress earlier this month. The Act would allow for the communication of legitimate scientific information to a health-conscious public more easily. If you haven’t already done so, please contact your senators and representatives and tell them how important this bill is!

16 Responses to “ANH-USA Wins Major Lawsuit on Qualified Health Claims”

  1. crystal says:

    much gratitude for the efforts made …. not many are willing to take the time and money to stand up … this gives me hope … change does not have to happen through war and killing … keep up the good work

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  2. DMills says:

    This is great news and a great victory over the corporate run, highly corrupt FDA. We also need the FDA to allow more qualified health claims for vitamin D. Optimal levels of vitamin D are so critical for so many facets of health and people need to know. The FDA would seek to hide this information and we cannot allow it!!

    Thanks for everything you all are doing for our health and freedom!!

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  3. Vicki Lockwood says:

    Congratulations to us. Of course, vitamins make a diference. When we used manure as a fertilizer, we were putting ALL the elements back into the soil for the plants to be able to take them in.Then, we ate broccoli, green beans, corn,cauliflower and got our vitamins and minerals from the plants.Now, manure is sold to the vitamin companies to sell back to YOU, in the form of bottles of individual vitamins, all the nutrients we used to get from our manure fertilized food. We are not better off. Gods plan was a circle. The animals provided for us and we provided for the animals. V.K.

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  4. marc says:

    A battle of wits and word play over the most obvious. I wonder if the defendants were on the verge of bursting out in laughter. What I don’t understand is the Constitution’s validity in the eyes of the parallel government. They obviously don’t care about it and may even use it to their own effect. Let’s hope a small battle has an effect in this war against life.

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  5. Claude says:

    great work guys. Hope we can beat the Codex as roundly!!! claude

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  6. Chris Johnson says:

    Are these claims by the FDA true?

    I have not investigated the matter, but if the suggested comments by the FDA are factually correct, I would absolutely agree with their conclusions.

    In medicine, evidence should meet a certain threshold before any claims should be issued whatsover.

    If the data is mixed or if there are only a few small studies, then no recommendation should be made.

    These are the proper standards of medicine and they protect us all.

    A small study demonstrating evidence of Vit E’s effectiveness in reducing risk of bladder cancer, when considered along side 2 inconclusive studies is not evidence of anything. The proper conclusion to draw is that Vit E shows some promise, but the data is insufficient to recommend its use at this time.

    I understand that doesn’t help supplement manufacturers make money and it doesn’t seem to help the cause of holistic medicine, but we should hold ourselves to the highest standards of medicine.

    Just because the cards are stacked against us doesn’t mean we should lower our standards. Just because Big Pharma manipulates research data to falsely demonstrate effectiveness and safety of their products doesn’t mean we should follow suit. All this does is give the public more ineffective treatments.

    If the data is robust, it will stand on its own.

    I’m no fan of the FDA or the medical-industrial complex, but it is hard for me to celebrate this ruling.

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    • ANH-USA says:

      The primary issue here is the large number of studies which the FDA does not “count” because they are not random-controlled trials on cancer patients. The nature of vitamins makes it such that this kind of study is often nonsensical and inappropriate. Vitamins are not drugs: they are not a novel substance introduced to the body to alter its chemistry and thereby attack a disease. Instead, the cancer-protective effects of vitamins are due to the fact that they are essential nutrients, deficiencies in which can promote illnesses like cancer. The biggest obstacle to completing RCTs with vitamins is the inability to truly create a “control” group, since you cannot guarantee the absence of a vitamin in a test subject the way you can guarantee the absence of a drug. Another obstacle, again because vitamins are not drugs but essential nutrients, is that vitamins work in synergy with a multitude of co-factors in your body. While ensuring adequate levels of vitamin E is essential to cancer prevention, the same is true of many other vitamins. A subject that has sufficient vitamin E but is deficient in other vitamins and co-factors will still experience heightened cancer risk, but that doesn’t mean they don’t need vitamin E to protect against cancer. It means they need everything else, too. The FDA throws out many non-random, non-controlled studies without even considering their evidence, which is how they reach the conclusions they state above.

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      • Amber Bergstein says:

        Great comment. Thank you

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        • Drina Brooke says:

          I want to add that it is *dangerous* to our freedom to allow the Feds to control what we say and don’t say.

          Whether or not they are right (I don’t think that they are fyi) is beside the point. Once the goverment says what we can or cannot say, we are doomed.

          Think about it.

          Free speech is the core issue here, not only the science and the naturopathics, which everybody has a right to access freely and knowing of the true health benefits.

          To hold the knowledge of these health benefits down is to knowingly and willfully keep the public sick and deprived of things that they need—for their health. I consider this a violent crime, it should be a felonly just like domestic violence and all the other physically violent crimes.

          Again think about it.

          I feel very strongly about this and will not take my words back. Not for anyone.

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  7. Jon says:

    Excellent info. I have acted on these. You may not have heard that Monsanto has “won” the tilte of most damaging corporation (not exact words) in a US poll of e-mail contacts by Corporate Accountability, the susccessor org to InFact, which launched the Nestle boycott against infant formula decades back. They even bet out BP for 2010, which was some feat! They got my vote! JD

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  8. Sean says:

    Thanks to Durk Pearson and Sandy Shaw; true “Americans” who have been fighting for freedom in more ways than one. I use many of the products these two scientists have invented, they are well manufactured and have excellent results. The research they have provided is a good source of information and explained in a way anyone with or without a degree in science can understand and the positive effects upon the human body. You can find their products on life-enhancement.com.
    It is truly amazing and sickening that more Americans don’t want FREEDOM. We do not need anyone like the FDA telling us how much or when to eat the right foods, or discounting the fact that humans have been ingesting vitamin E, C and selenium and other vitamins and minerals to avoid disease. Anyone with good judgment knows what a healthy intake of food and supplements are and how much your body needs to stay healthy. Humans have understand their own health long before the FDA and other dangerous agencies attempting to dictate our own lives. What’s worse is the FDA does nothing to stop the dangerous toxins produced by the major food manufacturers and the chemical additives they use in most food, which is causing poor health in this country. The FDA is incompetent, irresponsible and is not following any guidelines for healthy living.

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  9. Clay Young says:

    Go to popvox.com and vote your support of HR 1364. Just Google “popvox hr 1364″, click on the first hit.

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  10. JadeQueen says:

    Please consider writing congress about the Free Speech about Science Act. Cherry growers can’t talk about how cherries help arthritis. I am eating cherries as I write this.

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  11. Sandi says:

    Hurray! Hurray!
    I am planning to attend the hearing with Scientific Evidence from The Linus Paruling Institute and the MannaScience Organization Nobel Prize Winning Scinece and Clinical Trials.

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  12. Elsie Rimer says:

    Way to Go!!! Congratulations!!!!!!!!!!!! It’s about time some body put the FDA in their place. Their rules are the same as in a Socialist Country.

       0 likes

  13. Paul D says:

    I love it. Kepp up the good work!

       0 likes

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