Under pressure of our court victory, the FDA is for the first time allowing reasonable “qualified health claims” for some supplements.
Despite numerous court decisions allowing supplement manufacturers and distributors to make qualified health claims about their products, the FDA has refused to allow them. The Agency has acted as if it were above the law. In June 2009, it 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.
In September 2009 we announced that famed attorney Jonathan Emord, representing ANH-USA, together with dietary supplement formulators Durk Pearson and Sandy Shaw and the Coalition to End FDA and FTC Censorship, filed three separate lawsuits against the FDA. The lawsuits sought to reverse the denial of qualified health claims for these supplements, and bring the Agency back into compliance with the law.
This past June, the US District Court of the District of Columbia ruled in our favor. The judge rendered a summary judgment—which means she felt the case was clear from the start: the FDA was indeed violating freedom of speech by saying that no cancer-related health claims about the selenium could be made unless the science was completely conclusive or unless ridiculous and misleading disclaimers were added to the message.
We are pleased to report that a settlement agreement with the FDA now allows selenium supplements to claim that “selenium may reduce the risk” of prostate, colon, bladder, or thyroid cancer. The statements must be followed with the disclaimer, “Scientific evidence concerning this claim is inconclusive. Based on its review, FDA does not agree that selenium may reduce the risk” of these cancers.
This is the largest number of dietary supplement/cancer-risk-reduction claims ever approved by the FDA. And the disclaimer statements they’re requiring are the shortest and clearest ever approved. Nutrition science, like science generally, is almost never completely conclusive, so it is unremarkable that the health claims are qualified as being inconclusive. And the last sentence of the disclaimer—that the FDA does not agree—reflects not scientific fact but rather FDA’s opinion, which in turn reflects the agency’s well-known anti-supplement, pro-drug bias. This is a big step forward.
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wonderful!!!!!!!!!!
Score one for the good guys.
I personally feel that the unholy trinity’s… FDA/Big Pharma/Big Ag ..control of Congress could become a huge political issue in 2012 with the Defenders of Freedom leading the way to victory.
Let’s turn “…FDA does not agree…” into a sign of merit.
I like this.
Bravo!….A ripple in the water, forever, changes the pattern of the sea. We must go forward and assert our individual right to choose the type of medical treatments and supplements that we believe will further our quality of life. Government, and its agencies, must never usurp the rights of the individual to what they believe is quality healthcare and treatment.
This is terrific!
it is truly sad that the fda, small letters intended, sticks up for the drug companies, yet wants to sue a supplement company if someone has a reaction to vitamin c. how many deaths have been attributed to adverse reactions with drugs?!? this is what our (alleged) government has become.
This is great !!!
So happy to hear we are changing our world !!!
We all are very powerfull individuals, and together we are even more powerfull !!!
Thanks for the email .
David
The people and the courts are waking up! Jonathon Emord is helping them awaken and is a true blessing to humanity. His books, The Rise of Tyranny and Global Censorship of Health Information should be in every freedom lovers library.
We need to get the Food, Drug and Cosmetic Act’s definition of drug amended. It needs specific wording that natural substances, and particularly food and food supplements, are not drugs.
Hey Jonathon, can you introduce that legislation with Ron Paul?
right on… but purveyors of supplements ought to add, ‘and, as usual, the FDA has its collective head up its ass.’ they are just SUCH whores.
yippee…thanks for persevering.
Great news! Let’s keep the pressure on!! “Truth will out”
Amen!! thanks to all for great victory… the next big bubble to break will be traditional health with natural medicine will become biggest new industry… cheers!!!
Although this is good news, overall, we are totally missing the point in regards to isolated supplements. The research is clear. Single nutrient therapies, unless a person is diagnosed as deficient, do NOT help reduce risk of disease. It is selenium, in it’s whole food form, that will help reduce the risk of cancer. It is vitamin C in oranges, peppers, kiwi, etc, that helps to reduce the risk of cancer. It is NOT vitamin C alone.
There is no magic bullet. It is the totality of the diet, consisting of whole foods, that is most protective.
To Diane McCall: No one said there was a magic bullet. But supplements such as Vitamin D3 are essential to health. I live in the far north and our sunshine is limited. Without supplements of D3, I would be truly lacking. I eat foods which contain D3, but there aren’t all that many involved, and I do not eat fish. Just never was a favorite food.
The point is, if we want totality from the fda, that’s exactly what we’ll get if we don’t take a stand on all supplements. You can’t single things out.
The main reason the fda is up to their usual tricks here is because, IMPO, Vitamin C is being used in the form of IV therapy for cancer and a few other diseases — and having some unqualified success. The fda can’t HAVE that, you see. So they want blanket coverage of one thing to apply to all things. WE (the public) can’t let that happen. You can argue until the cows come home, but supplments, as single nutrient or whatever, are important in their own right.
Now to support POM Wonderful in their efforts to fight the FDA and FTC restrictions on educating the public about the health benefits of foods!
Having worked closely with Jonathan in the past on Congressman Ron Paul’s Health Freedom Protection Act, personally met with members of Congress in DC and their staffers alongside Jonathan and his staff, and attended conferences with Jonathan to help promote the Health Freedom agenda, I can tell you that precious little in this world is more gratifying than scoring a victory against the enemies of Health Freedom. Bravo again Jonathan!
While I agree with Diane’s assertion that the synergistic action of the elements in whole food (e.g, naturally occurring enzymes) is often necessary in order to derive maximum benefit from the target nutrient, let’s not forget that virtually all of the studies referenced in the published evidence noted here utilized what Diane refers to as “isolated supplements” — To quote Albert Einstein, “Like it or not, the science is what the science is.”
Rick and Einstein think scince is neutral, in the real world it is not.
Any scientist who has really earned his or her PhD should be able to set up a an experiment that will give the result wanted, that at the very least, can establish a cloud of uncertainty about any products effect on disease and health.
If you go to the imternet or even in medline you wil find many conficting studies. By insisting on unanimity, FDA maintains its right to instill fear and doubt in the public.
What is killing our industry and what exasperates the FDA is our tendency to mix information that is scientifically supported with that which is not. Pearson and Shaw have written at length on this issue.
There is evidence that increased consumption of fruits and vegetables reduces some cancers. There is evidence that vitamin C as a supplement reduces some cancers. There has been no study at all to show that “It is vitamin C in oranges, peppers, kiwi, etc, that helps to reduce the risk of cancer.”. If “oranges, peppers, kiwi, etc,” do reduce the risk of cancer, one would still need to determine what components of those foods are helpful or harmful before making such a claim.
Similarly, there has been no study that specifically shows “It is selenium, in it’s whole food form, that will help reduce the risk of cancer.” Indeed, Pearson and Shaw have recommended sodium selenite over selenomethionine because the latter can inappropriately substitute for normal methionine. Google for “selenium food toxicity”.
I was unable to find a single study that showed superiority of natural vitamin C over synthetic and doubt that any respected scientist would perform one. The claim that the same pure chemical would behave differently based on its distant source is absurd on its face and smacks of vitalism.
There is evidence supporting the superiority of mixed tocopherols over pure alpha tocopherol but none to recommend the natural d alpha form over the synthetic dl alpha form once one adjusts for dosage. If one were scientifically honest, one would recommend mixed tocotrienols over mixed tocopherols anyway.
The biggest issue regarding whole food claims is that it is difficult to do controlled studies on free-living humans and to standardize dosages from whole foods. Without unrealistically large sample sizes, the results will always be ambiguous. The vendors will always interpret them in their favor and the FDA or FTC will always claim the reverse.
While an isolated nutrient may not be as effective as that nutrient in combination with some or all od its whole food ingredients, the consumer has the right and ability to purchase a supplement that is made in accordance with those naturally occurring whole food sources and processed with a minimum of nutrient destroyng heat such as sun drying. Some quality supplement manufacturers such as Standard Process Laboratories are known to make these. But the ultimate choice should rest with the consumer, not FDA.
Thanks, to the great god, for protecting us from the legal criminals.
Both of us are very grateful for the absolutely essential and invaluable support of ANH-USA in these lawsuits. They couldn’t have happened without you. We are delighted to be plotting with you for the next attack on the FDA’s perennial denial of our Constitutional rights.
During the time before the landmark Pearson v. Shalala decision when the FDA was prohibiting all cardiovascular health claims for fish oil and its essential fatty acids, DHA and EPA, approximately 1,000,000 Americans died preventable unnecessary deaths from sudden death heart attacks. That is a death toll like one 9/11 attack per week every week for those seven years of litigation…
The victories won by the food supplement producers and supporters are good to know about. Well done and much more to be done. Good that the FDA is being reminded who is the employer – the people. So, now the FDA has to obey the law. So should we all.
However, the real problem is not Federal Agencies disobeying the law. That disobedience is, in itself, making a virtue of stupidity. This is strange behavior and destructive to America.
The real problem is greed. Let’s let our sons go onto the battle fields and sacrifice their lives while we cannot sacrifice twenty cents of profit. Note jobs moved out of America to other countries for profit and we look for someone to blame for the “job shortage.” Greed has successfully destroyed entire civilizations in the past and is now destroying America.
Are we getting what we deserve?
Well done, anh; and well asked, Laraine @October 6 at 1:12am. ANH should ask Ron Paul to get involved. His day may have finally come.
As for Robert Cruder’s comments about “the same pure chemical” – ie, vitamin C in this instance – not behaving differently “based on its distant source”, I would take exception to an otherwise valuable posting. I have seen chromatographs of both natural vitamin C – ie, as found in nature – and synthetic vitamin C as ascorbic acid, and there is indeed a difference. What difference does it make? One doesn’t know. But it’s not “absurd” to think there could be one. What with the likes of bioflavanoids, and such. Nature is more complex; and, well, natural.
Bravo ANH and Attorney Emord, along with formulators Pearson and Shaw! And thanks to “Stan” for sharing the information which indicates difference between “natural” and synthetic Vitamin C. according to chromatograph studies. With all due respect toward Robert Cruder’s concern for mixing “scientific” and non-scientifically supported information, I think we should be careful not to allow the tail to wag the dog.
While the use of the scientic method to explore and validate new knowledge has its merit, it is certainly not the only way to do so. Einstein and other greats in science often used the scientific method as a tool simply to validate what they already knew, through intuition and the use of common sense. My mentor and chemistry professor offered this quote: “The definition of a fool is one who requires proof of knowledge; the greater fool is he who provides it”. He did, however, have 4 PhD degrees in chemistry…
I’m so happy to read this. This is the type of info that needs to be given and not the poor misinformation that’s at the other blogs. I appreciate your sharing this.