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FDA Went Too Far, Says Judge March 20, 2012 by ANH

Discussion in 'Action Alerts and Advocacy' started by ggingues, Mar 22, 2012.

  1. ggingues

    ggingues $10 gift code at iHerb GAS343 of $40

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    A court has stopped FDAs 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 manufacturers 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 FDAs 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 2010and 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 FDAs 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 teas 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 Flemingers 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 FDAs language effectively negates the substancedisease 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 cellsand 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 womens risk of breast cancer by about 37 percent. Harvard Womens 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. Its a small bill with vast potential leverage. Please take action today!

    http://www.anh-usa.org/fda-went-too-far/
    Jarod and CJB like this.
  2. ggingues

    ggingues $10 gift code at iHerb GAS343 of $40

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    thought a few people would be interested in this, seems like we should be very observant of what the FDA does!

    GG
  3. Waverunner

    Waverunner Senior Member

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    Very interesting, thanks. Government intervention is a huge problem although people don't recognize it. Government claims to protect us but at the same time it prevents new companies and smart brains from entering the market, it prevents competition in the pharma field and as a result of this it causes millions of death and lots of suffering. Personal and economic freedom create welfare, nothing else.
    ggingues and WillowJ like this.
  4. mellster

    mellster Marco

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    Agree - thanks for posting this. Wish they would keep their filthy noses out of other people's business.
    ggingues likes this.
  5. Sallysblooms

    Sallysblooms P.O.T.S. now SO MUCH BETTER!

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    Yes, I am on several sites that keep track of those goofballs.
  6. Jarod

    Jarod Senior Member

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    WooT! Goofballs is right!

    :balloons:

    Keep the good news coming, and pray the masses wake up fast enough to stop all the goofballs!!!! :victory:
    ggingues likes this.
  7. HowToEscape?

    HowToEscape? Senior Member

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    Well.... broadly, most health claims for supplements and superfoods turn out to be BS.

    Fresh foods, particularly fruits and vegetables of various colors and spices turn out to have health promoting properties. That's not news. Packaging a low grade of said foods with elaborate health claims and adding a significant markup is an old business, see pomegranate juice (far better to just eat a fresh pomegranate), antioxidants (too much interferes with basic body processes... fresh food has the right amounts), weight loss tea and on.

    It's not difficult to find or fund a scientific study that shows benefits of some substance in isolation. Chocolate, beer, noni juice, red meat, tomatoes, blackberries and milk all have studies to show that some component of them is "good for you". Well, they're foods, which each have their benefits and detriments. What's likely to be better: a tomato from your back yard, or a "special" tomato, freeze-dried and powdered for four times the price from, say, tomatoesforhealth.com?

    I'm quite happy that hucksters are at least partly discouraged from pushing health claims on more or less anything that can be branded and fit into a box. Better for us to find out what your body needs as opposed to getting one's health knowledge (or BS) off the side of a box.
  8. Sallysblooms

    Sallysblooms P.O.T.S. now SO MUCH BETTER!

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    Mell, how do you really feel, hehe! I agree! KEEP AWAY, we have to protect our freedom!
  9. richvank

    richvank Senior Member

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    Bravo for Judge Bryant!

    Rich
  10. mellster

    mellster Marco

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    The problem with this attitude is that you basically let the government decide what is healthy and what is not and aside from not always being up to date with latest government-backed research the bigger issues are corruption and de-education/loss of critical thinking of the public. For example some pizza association got the government's ok to distribute pizza in school cafeterias and have it count as a "serving of vegetable(s)", meanwhile milk has been blocked for a while from some due to its "high fat content". Winners and losers are picked and usually the deepest pockets win the endorsements. In a free society and free market usually the "best" cures and "healthiest" foods succeed as only the result counts. Sure, BS health claims will always find some suckers, but in the grand scheme of things only the best products will prevail eventually. Most of today's "evil giants" often used as an argument for government intervention have been created and flourished due to government intervention in the first place by corrupting politicians with money bribes to un-level the playing field and suppress potentially better competitors with unfair legislation. If the government-knows-best theory would be correct every patient would have been cured by now through GET/CBT. Some limited government intervention can be helpful, but instead of barring too much (and potentially partially hyped) information they should rather focus on forcing full disclosure of ALL food vendor's ingredients, incl. GMO, artifical sweeteners, flavors and other hidden crap that might get you sick in the first place so that if you could have avoided it you would not even have to worry about hyped health claims from potential treatments.

    ggingues, Waverunner and Sallysblooms like this.
  11. Waverunner

    Waverunner Senior Member

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    Sorry but I would like to decide myself what is BS and what's not. People like you don't understand that as long as you give up personal liberty for "more" security you will always end up with less security, less wealth and lobbyists all over politicians, who then decide what is good for you and what is bad. Moreover you neglect the fact that there are people with fructose malabsorption or whatever, who are not able to eat normal fruits or vegetables. Supplements are an alternative for them. Unless you have the same problems, you should care about something else.
    Sallysblooms likes this.
  12. alex3619

    alex3619 Senior Member

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    Hi, there is a flip side to this story that is also scary. Its been mandated to supplement foods with folic acid. Folic acid is a methyl folate equivalent. Its been used to mass supplement the population by spraying on practically all grain products. Its also fed to pregnant women, and is in most multivitamins and B complex, including those prescribed by doctors.

    The problem is four out of five post-menopausal women can't properly metabolize it (actually 78%, and I dont have figures for the rest of the population). It accumulates. It gives a false folate reading in the blood - things look normal. However it is now tentatively linked to cancer, dementia and immune deficits, especially in NK cells (the same deficit that is in ME). These studies are relatively recent (the last few years) and we urgently need more research - we as in 80% of the population. We fortified with folate to stop spina bifida - pretty well all grain products, even rice. Now it might be the case (and requires urgent research) that its a risk factor in many of the rapidly growing diseases in society.

    Yet folic acid supplementation still has government stamps of approval.

    The worst thing is that synthetic folate may suppress natural folate metabolism via competitive inhibition. Guess what symptoms you get when this happens? Look at autism or CFS for example. I am not saying this is proven, I am saying that even things with a stamp of approval might be a real problem. Furthermore presumed homeostatic mechanisms might not kick into to increase methylation cycle activity because we sense we have enough folate - wrongly.

    This issue is due to folic acid NOT being a vitamin. Its a vitamin precursor. A similar thing happens with alpha tocopherol. Its a very low bioavailable form of vitamin E. It can compete with the other forms from food and actually LOWER vitamin E effects. My suspicion is that we have to stop using vitamin precursors, all of them, and only supplement with actual vitamins. One possible exception to this is beta carotene, because vitamin A is toxic at relatively low levels.

    Another case that the FDA issue will impact is CoEnzyme Q10. Young people can easily make it from vegetable CoQ9, at least most can (I have not heard of a polymorphism that prevents this, I suspect its lethal and so does not appear). However from about age 30 the enzymatic abilty to convert CoQ9 declines. It keeps declining. You convert very little with age. So from about age 30 we need to supplement in diet if we want to keep antioxidant capacity and energy production at high levels. The alternative is to eat beef hearts ... lots of them. Heart muscle is high in Coenzyme Q10. Please note that this will be partially preventative versus heart failure in older age as well.

    Repeat this story for how many other vitamins?

    Now minerals are another matter. They are easily toxic in excess and need to be carefully considered in all cases. The toxicity to optimal ratio is typically very small. A little is good. More is better. Slightly more than that is dangerous.

    This is not a simple debate. The FDA putting a blanket ban on this is a bad idea. It needs to be more considered, more detailed. There are already strict limits on claims from super foods etc. I think, at least in many countries. We may not need to do more, just enforce them by prosecuting those making over the top claims. Increasing enforcement in existing laws instead of blanket bans would be a good start.

    Bye, Alex
  13. HowToEscape?

    HowToEscape? Senior Member

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    "People like you don't understand that as long as you give up personal liberty for "more" security you will always end up with less security"

    I said or implied nothing of the kind.

    I believe that we ought to be free to purchase whatever supplements or nutrients can be sold with a reasonable though not total assurance of safety. What I address is a limit on what claims can be printed on a package; if you want to market something as a drug then have the proof to back it up. Otherwise get one's sales from an informed consumer who has made their own decision of what supplement they wish to use.

    People are accustomed to regulations on the claims that can be made for drugs and have come to rely them. That is, if a box of something at the pharmacy claims to quell stomach upset, people believe that it has been tested and found to work well enough and be highly unlikely to cause major harm. That system does get abused, but it's far from what existed before the FDA. Now if we allow a separate category of information, where the maker can print whatever they please on a package or advertise as such on infomercials quite a few people will be fooled, thinking "they couldn't possibly get away with telling me this stuff shrinks cancers 80% if it's really zero or 8%".

    The rule currently allows a marketer to print their claims, disallows those found to be false or misleading and adds an FDA statement informing people whether or not the item has been though a quite difficult and expensive qualification process. Most importantly it allows one to purchase supplements that might be useful or essential for some individuals where there is no patentable (and expensive) invention and thus no means to pay for FDA mandated trials. That includes us, for whom there are and probably will not be safe and effective prescription drugs developed. Is is really an unbearable burden if you are confronted with a disclaimer to the effect that the FDA knows not of your preferred supplement and you are on your own to make a final determination of whether it's good for you?

    I said nothing about banning supplements of any kind. Generally I think they should be permitted, though radium, ebola or marble dust capsules and the like don't need to be freely available. Someone out there ferevently believes in each of those; in a truly free market they would be available. There's a well known paper proving that radiation levels many times higher than background are good for you, yet I still stubbornly refuse to countenance a bottle of radium pills marked as curative. You can "prove" a lot of things if the proof swings on the gullibility of the listener.
    Advertising hype in drug and quasi-drug marketing needs to be restricted.

    I use quite a few supplements myself, all of which have either no health claims printed on the package or have the supposedly onerous FDA disclaimer. Neither the extra ink nor the lack of it has made those supplements less effective, or (sadly) more so.
  14. HowToEscape?

    HowToEscape? Senior Member

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    Sounds like a good argument for minimal intervention:

    We should have almost no additives required to be added in food, well intentioned or not. Folate sounds rather like one of the supplements, only here the government is acting as a musclebound marketer of the stuff, with no choice or information given to the consumer. Better to state "we think the stuff is good for you, and we allow it to be added to food *with labeling*. You'd then see boxes of stuff marked as having "essential folate boost!" alongside others marked "no artificial vitamins!". Wasteful, but at least admitting choice.

    Once in a rare while widespread supplementation makes sense. Iodized salt is the default if you just grab salt off the shelf but isn't mandated. It's also labelled so that you could (in your own kitchen at least) avoid it. After many years it seems have worked out well. But because one such thing works does not mean that more like it are justified; I'd rather get my vitamin D from the sun or pick my own supplement than to have a mandatory additive to my food.

    Unless I have misunderstood the OP's issue isn't about banning any supplement, only the FDA's printing of a disclaimer after a marketer's claim. Hard to get too worked up about the latter.
  15. Waverunner

    Waverunner Senior Member

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    @HowToEscape:

    I agree that there are many false claims and there is lots of fraud with supplements. Just yesterday I read about Allicin in garlic supplements, which, when not enteric coated gets deactivated by stomach acid, so nothing reaches the intestine. I'm not sure however how to prevent this or if this should be prevented at all. High transparency would be very nice. Maybe the producers should be forced to show studies on their homepages that back up or contradict what they claim so the customer himself can decide if he takes it or not.
  16. alex3619

    alex3619 Senior Member

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    Hi, my comments about bans was because there has been repeated moves over the last several years to limit or ban supplements, both in the USA and Australia. So far it has not gained much momentum except in Europe. Its a bad idea. Instead of banning, or limiting, or restricting, they should go after the charlatans and put them out of business. This is about enforcing laws we already have, not introducing unnecessary ones.

    However in Australia, for example, quite a few natural supplements have been highly restricted. This is not about blanket broad restrictions, they are doing it in a targeted way (melatonin for example). Recently high dose potassium supplements became restricted to prescription only. This is not too bad because at least you can go to a doctor and get a script. However, this is a disincentive because now to buy potassium you have a doctors visit and a shopping trip, with a lot of costs involved. If this becomes a trend it would be a great concern.

    Bye, Alex
  17. mellster

    mellster Marco

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    Don't forget that research is a moving target as well and some claims can prove valid or invalid at a later stage, IMO an FDA disclaimer (and a minimum of warning labels where appropriate) that they don't endorse those claims is suffcient for everything. No need to put people out of business or in jail - by that token you could jail any hypnotherapist, psychotherapist or energy healer. If it helps one person that's fine with me.
  18. Sallysblooms

    Sallysblooms P.O.T.S. now SO MUCH BETTER!

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    Being a nanny state helps no one. People need to take responsiblity and research what will help, find the best integrative doctors and have the freedom to do all they can to keep from taking medicine that does not even help and usually harms.
  19. Waverunner

    Waverunner Senior Member

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    True. It's funny that we are allowed to buy anything at all, for example battery acid. We can buy battery acid everywhere. If someone would claim that battery acid is healthy for us, he could be charged in front of court. In this case government takes no measure to prevent battery acid from reaching the market. On the other side they ban supplements right of the start. This is ridiculous.
  20. mellster

    mellster Marco

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