“FDA Went Too Far,” Says Judge

March 20, 2012
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iStock_000003455183XSmallA court has stopped FDA’s latest attempt to censor food and supplement science. Action Alert!

An FDA disclaimer about green tea and the risk of cancer is so strongly worded that it “effectively negates” the manufacturer’s qualified health claim (QHC) and violates the First Amendment, according to US District Court Judge Vanessa L. Bryant.

QHCs enable companies to make a health claim about a substance in relation to a disease or condition when the supporting science fails to meet the FDA’s “significant scientific agreement” standard, so long as that health claim is “qualified” in such a way as to not mislead consumers. QHCs have been permitted in the US since the 1999 landmark case of Pearson v. Shalala (brought against the FDA by attorney Jonathan Emord on behalf of Durk Pearson and Sandy Shaw, ANH-USA, and others.

In practice, however, FDA rarely approves QHCs: the agency approved only twelve QHCs between 1999 and September 2010—and when they did, they usually created disclaimers that completely reversed the meaning of the claim. It was because of this that ANH-USA sued the FDA over its treatment of the QHC for selenium and cancer. And we were successful in creating a precedent that restricts FDA’s ability to infringe on the right to free speech, a right that is at least in part provided by QHCs.

Fleminger, Inc., sells green tea at TeaForHealth.com and discusses the science of antioxidants and the research on green tea’s anti-cancer properties. Fleminger first submitted a health claim petition to FDA in 2004. A year later, the FDA proposed two disclaimers that stated, in part, “FDA concludes that it is highly unlikely that green tea reduces the risk” of breast cancer or prostate cancer. Fleminger petitioned for an administrative review but it was denied.

In 2010, FDA sent a warning letter to Fleminger threatening to seize its products and insisting it use the exact language set forth in its qualified health claims. Shortly thereafter, however, FDA proposed a revised claim: “Green tea may reduce the risk of breast or prostate cancer. FDA does not agree that green tea may reduce the risk because there is very little scientific evidence for the claim.” This prompted Fleminger’s suit in the US District Court, asserting that FDA was making Fleminger “choose between speaking exactly as [FDA] wishes, remaining silent, or risking adverse action for its own commercial speech in violation of the First Amendment.”

Judge Bryant agreed with Fleminger: The FDA’s language “effectively negates the substance–disease relationship claim altogether….There are less burdensome ways in which the FDA could indicate in a short, succinct and accurate disclaimer that it has not approved the claim without nullifying the claim altogether.” FDA must now draft a new disclaimer statement.

Jonathan Emord found the ruling significant: “This is an important decision that adds to the landmark precedent of the Alliance for Natural Health USA v. Sebelius concerning the limits on FDA discretion in drafting health claim qualifications. Once again FDA is taken to task for using the disclaimer to promote its own agenda rather than constraining itself to a succinct and accurate qualification of the inconclusiveness of supporting science.”

Outside of QHCs, food and supplements are not allowed to speak of the specific health benefits of their products because the FDA takes the position that any such statement magically turns them into drugs. And, as drugs, they would have to go through exorbitantly expensive drug trials, a cost which the manufacturer could never recoup, since food and supplements are natural products and cannot be patented. Without a patent, anyone can sell them, so paying as much as a billion dollars for a drug trial is essentially money down the drain. This is the “Catch-22” we keep talking about.

The great thing about this ruling is that more people may get to learn about the cancer-fighting benefits of green tea. In 2005, UCLA researchers found that green tea extract targeted cancerous cells in the human bladder without harming healthy cells—and made it harder for the cancerous cells to become invasive and spread. And a 2009 study showed that three cups of tea per day reduced younger women’s risk of breast cancer by about 37 percent. Harvard Women’s Health Watch magazine noted that studies found an association between consuming green tea and a reduced risk for several cancers, including, skin, breast, lung, colon, esophageal, and bladder. Green tea has also been found effective in preventing and controlling CLL, a killer blood cancer.

Even under the best circumstances, QHCs are something of a stopgap measure because of the qualification language FDA is still able to use. A bill before Congress, the Free Speech About Science Act, would allow food and supplement manufacturers to cite legitimate peer-reviewed science without turning the product into a drug. The bill amends the appropriate sections of current law to allow the flow of legitimate scientific and educational information while still giving FDA and FTC the right to take action against misleading information and false and unsubstantiated claims.

If you have not done so already, please contact Congress and ask your legislators to co-sponsor HR1364, the Free Speech about Science Act. If it passes, this bill has the potential to transform the healthcare field by educating the public about the real science behind natural health. It’s a small bill with vast potential leverage. Please take action today!

Take Action!

28 Responses to ““FDA Went Too Far,” Says Judge”

  1. Gisele Heinzle says:

    The software is high quality. This is the best bang for your business buck. It compresses data before sending to the storage site. We have logically backed up over 1TB of data but the actual storage is only 600GB (that’s real cost savings).

       0 likes

  2. D. says:

    People have been drinking green tea for eons. It should have nothing whatsoever to do with the controlling arm of the FDuh. Maybe some day some Judge will wake up and realize the over-reaching power the COURT SYSTEM has given the FDUh and the USDuh and many other guberment agencies (flophouses); but until they are taken off life support (lobbyists and kickback money) and jerk the power cord from the ABC agencies, we’re all hopelessly screwed.

       4 likes

  3. Linda Burger says:

    *I’ll look for an option to contact ANH with this question, as I doubt a ‘comment/reply’ will be seen.

    I’m a supporter of ANH, and admirer of Jonathan Emord & his work. A question related to the article on this page – it refers to ‘a bill before congress, The Free Speech About Science Act. Govtrack.us states that the bill [introduced in March of 2010] died, and wasn’t enacted.
    Searching for more recent versions of this bill, the latest I see is reference to a 2011 version.
    What’s the current status of this bill?
    Thanks, Linda

       1 likes

  4. Judith K says:

    What really ticks me off is the fact that while real nutrients cannot proclaim health benefits, the “phood” companies can claim all kinds of supposed “benefits.” Just one example: the ads for Honey Bunches of Oats that proclaim your kids will be mentally alert and perform well in school only if they consume their sugar and chemical laden product.

       10 likes

  5. Tony Isaacs says:

    Green tea is great stuff. Just be sure to find a green tea (preferably organic) that does not contain aluminum and I would also avoid green tea from Japan (by far the largest source) after the Fukushima disaster.

       1 likes

  6. ANH-USA and Flemminger are to be congratulated on this victory against excess FDA power. When companies and NGOs work together with expert legal advice, push back victories are possible.

       6 likes

  7. L.P. says:

    The FDA (Food & Death Administration) absolutely MUST be dismantled. This *Entity* of our corrupt United States Government has been given undue power, and with this, has abused ALL powers within itself.
    Dr. Gayle NEEDS to do her research on green tea and raise HER *Awareness*!!

       5 likes

  8. Patricia says:

    My biggest concern with signing something like this is that I am afraid of mainstream medicine taking over natural medicine and then we won’t be able to afford it.

       2 likes

  9. Laura Walls says:

    The Fascist Dictatorship Administration (and Sebelius) needs to be completely shut down and all of their Gestapo agents should be deported to Russia where they belong. The FDA considers human beings as government property and thereby can be regulated because we have adult stem cells that they classify as a drug. It is way past time to have a major revolution and remove these tyrants from our country, they just don’t get it, trying to make us slaves to thier control agenda due to their catastrophic inferiority complexes will only result in retaliation as they will be finding themselves peeing in a corner when the tables are turned.

       7 likes

  10. Dr Boraas says:

    Don’t know who this person called itself Dr Gayle in or why he/she is saying this.
    Green tea is being used as preventative and as part of pancreatic cancer treatments.
    It does not increase, but decrease the risk.

       3 likes

    • Laura Walls says:

      She is obvioulsy a follower of Immanual Kant, a progressive marxist and Bernard Shaw fan who believes people should stand before a committee to prove why they should be allowed to exist.

         2 likes

  11. shorebird says:

    This is another case demonstrating the power of money triumphing over common sense.

    The FDA has been going backwards for years, along the lines of a fascist organization bending over backwards to control every possible funding source at the expense of the general population for whom they are supposed to be looking out for. The FDA appears to have a long history now of approving flawed items tested only by the medical equipment manufacturers and new drugs based on manipulated reporting by Big Pharma. Clearly they have no shame for all the errors they continue to make. This was not the case years ago.

    How many more Americans will be harmed by their inaction, and left in the dark by their actions.
    For goodness sake, walnut growers cannot even say their nuts are heart healthy products, and cherry growers cannot claim that cherries are good for minimizing gout.

    When will the FDA’s monetary funding aspect be subdued and common sense prevail again?

       9 likes

    • SmilingAhab says:

      When we get a congress that is not afraid to mercilessly crush department lobbying and the billions of fast cash that pours into the FDA, USDA and HHS from the very corporate conglomerate they supervise. And since the closest thing to social democrats we have in the USA is the CPC, we’re kinda screwed and money rules.

         3 likes

  12. Harvard Women’s Health Watch magazine noted that studies found an association between consuming green tea and a reduced risk for several cancers, including, skin, breast, lung, colon, esophageal, and bladder. Green tea has also been found effective in preventing and controlling CLL, a killer blood cancer.

    Food was put on this planet as our means for staying healthy long before pharmaceutical companies bought out the FDA. US citizens have a right to know that food can protect us from disease. Science is proof. The FDA is helping to bankrupt this country and is supporting ignorance.

       7 likes

    • SmilingAhab says:

      Or, rather, we grew up maintaining biotic heterostasis on what grows forth from the soil, not what Eddie Engineer can cook up in his autistic mind.

         1 likes

  13. Jan Lindner says:

    The FDA should stop working for Big Pharma.

    When high-ticket prescription drugs — whose side effects are generally delivered in unreadably small print or in a hushed, hurried voice — are subjected to the same excess of caution as natural supplements, THEN we might see some effective rules.

    There are VERY FEW natural substances generally used as supplements that have the litany of terrifying side effects that we see every single day in ads for prescription medicine.

    But then, I can grow a lot of my own herbs – and be assured that they haven’t been sprayed with poison — and Big Pharma doesn’t make a penny. I”m sure that makes them unhappy, but … sorry, making billionaires richer and happier is NOT my job.

       10 likes

    • SmilingAhab says:

      40 years of conservative shearing have left the FDA with so little to work with and so few barriers to private sources of funding that it was all but inevitable. They are also human. There’s blame to go around, but it falls mostly on the pharmaceuticals.

         3 likes

  14. k.stoute says:

    The FDA is the guard dogs for the giant food companies, Biotech companies and big pharma. I have no trust whatsoever is this organization anymore.
    Please sign my petition and pass on to others if you agree with it
    http://www.change.org/petitions/its-time-for-us-to-take-back-the-constitutional-rights-that-our-founding-fathers

       2 likes

    • SmilingAhab says:

      Our founding fathers also agreed on a sentiment: that government must be allowed to change and evolve to meet modern needs. While the FDA has long since been perverted in this regard, we need a watchdog with the power of the state behind it to stop shysters peddling snake oil or worse. Caveat emptor just doesn’t cut it. We need the FDA, but we need it to be what it originallly was – a gatekeeper whose responsibility was to ensure that non-food chemicals were not poisonous.

         4 likes

    • mrhjdez says:

      Looks like your petition has been confiscated. I wonder who and why. I think somebody is spying on us. Hope the get an eye full of truth.

         0 likes

  15. Paul says:

    We are supposed to have a REPRESENTATIVE government, and we need to keep reminding the members of congress that they are there to REPRESENT US, not rule us for the benefit of their fat-wallet campaign donors! Term limits for congress! If it’s good enough for the President, it’s good enough for congress!

       8 likes

    • SmilingAhab says:

      While it was conservative meddling and budget axes that weakened the gate, the relationship between the FDA and the pharmaceutical industry evolved fairly autonomously from Congress.

         1 likes

  16. Dr Gayle says:

    It is unfortunate however helpful tea may be, green tea is known to have a risk of pancratic cancer and little is being done to rewaise awareness.

       0 likes

    • Cheryl says:

      Without the citation of supportive references to back your statement, I find your comment lacking in credibility. However, do not be concerned, your job at the FDA is still safe.

         9 likes

    • Don Duca says:

      Dr Gayle, could you provide a link to the study that generated your information? I would very much like to see the protocols. I can then track the source of the study’s funding. I am sure that it would be telling. I do not take statements like this seriously unless they are backed with credible source reference, and neither should anyone else. Green tea has been in use therapeutically and as a daily beverage for thousands of years in Asia. I have never heard of any pancreatic cancer clusters from that very populous green tea drinking part of the world. Have you?

         4 likes

    • mrhjdez says:

      Dr Gayle Lying must pay very well to put your veracity on the line.

         0 likes

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