Europe has rejected 95% of the health and nutrition claims under review. What does this mean for us?
The European Food Safety Authority (EFSA) evaluated 2,037 health claims—that is, statements that a nutrient or food contributes to or has a positive impact on a particular health condition—and authorized the use of only 241 of them. Most of the ones accepted were related to structure or function claims, such as “calcium contributes to normal muscle function.”
As we’ve reported previously, structure/function claims are statements that describe the role of a nutrient or dietary ingredient as it affects normal structure or function in humans. In the US, structure/function claims like “calcium builds strong bones” or “vitamin D boosts immune system function” are allowed, but one cannot legally cite the science showing that vitamin D prevents and treats the flu. The flu is considered a disease, so this is forbidden. With the EU’s list, we see the same censorship at work, only more so.
Claims that were rejected as being unacceptable included “(Cow’s) Milk products help support dental health. (Cow’s) Milk helps support the normal and healthy development of teeth. (Cow’s) Milk contributes to dental health” and “Vitamin D is needed for the normal/proper function of the thyroid. Vitamin D is needed for the proper regulation of blood calcium levels.”
Food and supplement products in the European Union must comply with this permitted list of health claims for use on food packaging, or else face prosecution for misleading marketing.
The EU created its Nutrition and Health Claims Regulation in 2006 to ensure that consumers were not misled by “unsubstantiated, exaggerated, or untruthful claims.” But we would ask: aren’t they misleading consumers into thinking that there aren’t benefits from food or dietary supplements, when the science overwhelmingly shows the opposite to be true? For example, we have the Harvard study that found a bioflavonoid in apples called rutin prevents clotting, and the studies indicating that medium chain triglycerides in coconut oil can prevent Alzheimer’s. But none of that would impress the EU unless a big company got behind it.
As ANH-International’s executive director, Robert Verkerk, noted on the BBC’s You and Yours program, some rules prevent you from claiming that fruit is beneficial, or that a diet rich in vegetables helps regulate body weight. Dr. Verkerk also said that big food companies, with their deep pockets, could play the system and claim health benefits for their food simply by inserting a small amount of an approved ingredient into a product.
As constitutional rights attorney Jonathan Emord points out, accurate health claims are a matter of safety. For example, the FDA would permit the following structure/function supplement claim: “This product supports healthy ranges of [blood sugar, blood pressure, or cholesterol]. But that doesn’t say enough. Someone on insulin should have clear information that a supplement could lower their blood sugar, in order to avoid a dangerous nutrient-drug interaction.
How will this new European regime of banning and forbidding affect American citizens? Potentially quite a lot. The EU is doing what the FDA wants to do and would do if it could. As it is, our system is not far behind the EU’s. For example, the current NDI draft guidance mirrors the EU’s Novel Food Regulation. The EU and the US have similar ways of determining “safe” upper levels of nutrient intake. And, as we reported last week, the EU is taking their anti-free speech position worldwide, insisting during Codex meetings that no language should be allowed indicating that food prevents disease, even in the case of nutrient deficiency illnesses.
This free speech issue is echoed in the POM Wonderful case, where the FDA attempted to bar a claim about the health benefits of pomegranate juice unless the company met a standard applicable only to drugs. As Jonathan Emord points out in a recent blog post, POM Wonderful’s court win could be reversed a month from now: the FTC has appealed the May 2012 ruling that POM’s structure/function claims don’t need to be supported by two random-controlled human clinical trials (RCTs). The final decision is expected on January 18. If the FTC wins, the two-RCT requirement could take effect in a little over a month.
What’s wrong with these trials? As we have noted many times, they are too expensive for most companies because the products ingredients are natural and cannot be patented. Without patents, there is no way to cover the exorbitant cost. The FTC and FDA know all this: they are just protecting drug companies, which in the case of the FDA pay much of the agency’s budget.
This is a reminder why the Free Speech About Science Act (FSAS) is so important. It will enable food and supplement companies to cite scientific evidence of benefits. It will ensure that free speech about science will be preserved, even while regulators and politicians such as Senator Dick Durbin and Congressman Henry Waxman try to bring EU regulations to the US.
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Keep up the good work. This is important!
I will contact Sen. Durbin and Rep. Waxman on this issue.
Keep up the good work.
Sincerely,
Pete Whelan
Right, we can not let this happen! We just have to forge ahead, forever and ever it seems, these people are relentless and all for Greed, they don’t care if they kill us..as long as it makes them billionairs’…they will never quit trying to incapacitate us, and we are not going to let that happen.
I’m ever so grateful for a place like you, to hold us strong.
Thank You.
Will they eventually remove books concerning vitamins and herbs that relay these remedies used throughout history? That would totally destroy all historical information. That would be a tragedy.
Isn’t that kind of what happened historically in the Western world when Rome fell? And the barbarians took over? The Dark Ages? And much of the written knowledge that had been written by the Greeks, the Jews, the Arabs was hidden? because it was being neglected and destroyed?
Please keep our civil liberties ! We have given up way to much already . We need to lead the world by example not conformity ! This great country is crumbling and we are allowing everybody else to have a part in it !!! It is time we stop it and turn it around . Our forefathers did not intend to die in vain because of human greed ! After all who is going tog be left tog enjoy it if we keep wiping ourselves out . The human body is Biological and we are allowing to just shove more and more chemicals into us everyday – the insanity has to stop and now is the perfect time to start , so please everybody stand together if you believe in free will!,,,,!!!!!!
How can we protect ourselves from the Government turning over to the EU (and possibly the UN) yet another infringement on our liberties in this country of ours?
Amazing positioning, with rising cancer, heart disease and autism rates in all developed and developing nations, that any group of bureaucrats would take such a short-sighted legal position over labeling of whole foods.
I happen to agree that after a certain age, drinking cows milk may not be a healthful, milk may actually interfere with building strong bones and may even be assisting cancer growth…but it would be a lot nicer to have more research to back up these concepts. Better still, it would be helpful if some organization could put their money and time into whole foods, instead of relying so heavily on big pockets from Big Ag or Big Pharma, who appear to be preying on the unsuspecting.
After we learned that “heart healthy” Honey Nuts Cheerios has 4 tsp sugar in each serving, it makes you wonder what the heck is being foisted on average citizens and the next generation of children.
Threre is concrete proof that supliments such as dark green leafy vegetable and coconut oil are beneficial in the prevention of Cancer and Alzheimer’s…..To restrict free speech in America is unconstitutional….
Senator Dick Durbin and Congressman Henry Waxman should not be permitted to impose their Draconian measures in this country….
There are millions of us who know that decent nutrition PREVENTS DISEASE….AND
therein lies the problem….. Government in league with Drug companies want to impose the standards that governm our daily lives….
This is wrong. Thank you for taking the time to read and listen…
Sincerely, Carol Sereix
EU anti-speech- Not For Americans. Americans are doing just fine labeling vitamins, minerals, etc.,and we don’t need any more regulations that destroy good health. If Eu people accept all of the rules and don’t want to have freedom of speech, so be it. NOT IN AMERICA!
DOnt ya think that the gov’t needs to stay the heck out of our food supply and our lives period!
Our best hope for healthy food is to educate ourselves and not rely on labels. There are other labeling travesties. For example, honey can contain up to 5% corn syrup and still be called “pure honey.” There are people very allergic to corn who have to buy only familiar brands of honey. Labeling can claim “natural” but there is no definition and it can mean whatever the company wants it to mean — and usually it means chemically similar to substances occurring in nature. However, the impurities in a synthetic substance are quite different from the impurities in a natural substance. The former may be toxic and the latter are unlikely to be toxic. The whole hydrogenated oil industry is based on the implication that animal fat is bad — “contains no animal fat.” When this industry began, there was no evidence that animal fat was bad and the substitute was hydrogenated cotton seed oil. Cotton-growing is the number 1 pesticide use. The best argument against animal fat is that it is higher on the food chain and likely contains endocrine-disrupting substances. See the recent youtube videooo by Theo Colburn.
Unfortunately, GMO’s are sprayed with pestisides that are contaminated with 1,4 dioxane. This substance disrupts the intire endocrine system and is a cancer causing agent. Our government has known about the 1,4 dioxane contamination since 1989.
There is a new book out saying the one thing to avoid to save your heart is sugar and not animal fat. I happen to agree. I have almost no plaque in my system and am in my mid fifties. I do eat organically grown beef.
The way to solve the FDA’s conflict of interest is to make sure ALL of their funding comes out of general revenue and ALL fees or fines goes into the general tax take.
I study the various chronic diseases and disorders as influenced by nutrition. The claim that I make relates to all of the non-communicable diseases that have historically been prevented and in many cases cured by having a complete diet. The adequacy for a complete or adequate diet is based upon the composition of healthy animals including humans. A simple comparison of the composition of the body to the nutrients available in a particular diet identifies the deficiencies and thus my claim is that a dietary supplement or dietary change “will eliminate the deficiencies that have been confirmed to relate to the basic causes for the various chronic diseases.”
To deny the truth of nutrition through regulation will only increase the need for more diagnosis, therapy, medications and bring additional burdens on those affected as in pain, suffering, and financial loss.
Isn’t that what the big pharmaceutical industry CEO’s and shareholders want? more PROFIT$ ?
I think both sides make good points , I would feel much healthier eating German Ham than American Spam.
However the EU and big Pharma does want to monopolize and monetize these phyto-nutrients and we do have to stop them from taking our nutricuticals not to mention the thousands of compounds recently SCHEDULED in fact or defacto.analogue interpretation left to the whim a judge appointed from ON HIGH>
GOD BLESS AMERICA
Einstein said “the future of medicine is prevention”.
That was quite some time ago but I think THAT future is moving further and further from reach.
The front of the label is advertising and it should be labeled as such. The back of the label is nutrition content and ingredients and should be properly and completely labeled. The company should not be allowed to make any claims on the front so no writing other than weight of product.
If they are required to be honest on the back they are going to need more room “natural flavorings” is what exactly? Every label should have a phone number so the consumer can call and double check things from the store. Vegetarian Safe, Vegan Safe, Halal, Heart Healthy, Low Sodium must be according to those health organizations not compared to their even unhealthier versions. Other countries have symbols for the vegetarian, vegans. It is required in India and Thailand.
Stop misleading people. The company can advertise elsewhere but not on the product.
A government that borrows $0.47 of every dollar it spends is corrupt at its core. If it can engage in “takings” via inflation (currency devaluation), rising taxes, and other forms of confiscation without due process, what chance does freedom of speech regarding health choices have? Regardless of the FDA’s peculiar version of cooptation by drug companies, an electorate that affirms 17% of the economy being taken over by an virtually ad hoc and inevitably hostile bureacracy is unlikely to nudge or negotiate the FDA to a sane and responsible position. Until we embrace substantially smaller Government, say 30% smaller, we can only fight holding actions until such time as this one blows up or is cut to size. Durbin and Waxman are uber liberal Democrats….all those they caucus with and who elevate them to Committee power are liberal Democrats. There is nothing progressive about the “progessives”. They only respect blunt politcal power because that is all they are interested in acqiring and using. Read and learn what you can now, store that knowledge as it will soon be relegated to a oral tradition somewhere in the ditch of the Information Age. Sad, sad, sad.
seems the foxes are paid to watch the chicken coop!
I comletely disagree with you,we are floated every day with countless claims that some Months or Years
later say there were not true. Eu has a very strict critiria on food that only can help us,it has nothing to do
with freedom but safety.As a person who spends a lot of time in Europa I can only vouch for there
system .
PLEASE STOP MISUSING THE WORD FREEDOM.
Theresa P NY
.
Fortunately for all lovers of freedom, the European Union will be dead soon; so, in all probability will the United States, and we won’t have to worry with anyone trying to tell us what we can or cannot supplement!
I wish that were true, however the big drug companies are no different than the mob and won’t allow anyone to compete against their profits. It’s always a case of following the money and sadly, we have far too many Congressmen who are without honor and will take a bribe in a heart beat.
I am ashamed to admit that I voted for Senator Durbin. This will never happen again! I will work diligently for his ouster in the next election. One can only wonder at his motives for supporting the big ($$$rich$$$) Pharma companies, against the good of the people.
Yes, Durbin is a so and so to be polite. Make sure you get rid of him next time around and you will be doing this country a great service!
It is in the general direction where the country is going: communism, where a few top elite enjoy the power and status while the people are paying the price, where freedom of speech and choices are discouraged and to the point of being forbidden. They have been dismantling the constitution. I sure hope people will wake up and see what is coming.
When the truth about nutrition is outlawed, uh, will it be criminal to be healthy? This action by the EU is the logical outgrowth of the access to scientific information, and the backlash from Big Pharma and Big Agriculture. These agencies are in the bag for business; they function as symbiotes with each other, and are parasitic and very toxic to the public.
We have been warned that the drug companies in conjunction with Congress and the FDA/AMA, may attempt to block the availability of beneficial nutrients so that the drug companies may get exclusive rights to sell them as drugs. And that they will be only available through the doctors by prescription. This big government control will squash free speech and access so that big Pharma, Congress, and doctors can make more money and decrease our ability to get natural, alternative treatments. DO NOT BE SILENT ON THIS SUBJECT!
FDA, EFSA, CDC, FTC, WHO, UN, …..All for a common cause….New World Order
“Double plus good I say”
We must remain ever vigilant ! There is too much malnutrition that is not recognized, not even by health professionals, and certainly not by the individual who is malnourished. We need a public program that educates us all about the more mild symptoms of malnourishment — from how we feel, to dull-appearing hair and skin.
Therefore it is our job to educate the general public to understand the benefits of nutrition and life style on the impact of a person’s overall well being and happiness. Once there are more awareness the landscape will be changed and people will vote these greedy short-sighted politicians out of office. But it will take the collective effort and unyielding passion for authentic life on this plant earth. I will start by spreading my ripple effect.
I previously contacted Sen. Durban via his website and it said that unless a writer was one of his constituents, the letter, note or email would not be forwarded by the site and no response would be given. I sent a letter anyhow, protesting his actions in trying to subvert the DSHEA ruling and trying to prevent our citizens from access to supplements, etc. I’m wondering what benefit he and
Sen. Waxman derive from their activities against nutritional supplements. So far, no one has published anything nefarious they could attribute to that pair, so we can be rid of them.
In my view, we must work to remove one and all of the FDA commissioners, expose the AMA for imposing their biased views upon doctors in order to work hand in glove with Big Pharma and lean on institutions of higher learning to properly educate medical students in nutrition.
At its most basic, the fuel for the body is food and without food: no vitamins or minerals. If you’re religious, consider that if God didn’t make it, it’s artificial and not made to nourish the body for survival. Period.
Has anyone considered that autism has to be coming from something fairly universal – not vaccines? How about our food, modified and full of unhealthy additives or the water supplies that are full of fluoride, a poison? My money is on fluoride. When I was in the health care field, we hardly ever heard the word ‘autism’. Now, it’s as common as blond hair or brown eyes. What gets me is that people like Durbin and Waxman think their dishonest and dangerous activities will never adversely affect their friends and relatives, because they’re insulated by money. We really need to use people power to put things right.