The Wall Street Journal's Matthew Dalton reports:
European scientific authorities Thursday rejected dozens of health claims made by food companies, in a sign of how tricky it will be for them to get some of their most popular claims past a European Union drive to bring scientific rigor to the health foods.
A panel of the European Food Safety Authority issued nearly a hundred opinions on health claims, about two-thirds of which were negative. The rejections included claims on special bacteria that are supposed to aid digestion and boost the immune system, beta carotene additives for sunscreen and shark cartilage for healthy joints.
The panel rejected two-thirds of the claims, and half of these were rejected because the substance in question wasn't adequately described, the EFSA said in a statement. The claims that were accepted related mainly to vitamins and minerals known to promote health, dietary fiber, fatty acids for lowering cholesterol and sugar-free gum that is good for the teeth.
The European Food Safety Authority (EFSA) has posted these opinions, and a survey of them shows an interesting regulatory model. Information online includes:
"General Function" health claims such as "calcium is good for your bones" are defined by article 13.1 of the Regulation. These claims are based on generally accepted scientific evidence. A consolidated list of these claims is currently being evaluated by EFSA.
"New function" health claims defined under Article 13.5 of the Regulation are based on new scientific evidence and/or for which protection of proprietary data is requested. They require applicants to provide scientific evidence substantiating the claim proposed for a specific product or substance.
Claims regarding disease risk reduction and child development or health. These kinds of claims, defined under Article 14 of the Regulation, require applicants to provide scientific evidence substantiating the claim proposed for a specific product or substance.
Criteria for setting nutrient profiles. Nutrient profiles are nutritional requirements that foods must respect in order to bear nutrition and health claims. Nutrient profiles are established by the European Commission and Member States.
I'd love to hear what ScienceBloggers think of the EFSA's process and work. The opinions are all online here!
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Damn good job! If such a procedure were followed in the US, it would be the end of the specious claims by such products as "Head on" and the ultimate demise of its woo-merchant manufacturer.
Problem is, I am not sure they "could" in the US. Years back some congress critter, of the same stripe as the current bozo that has direct ties to an agency promoting that, "fat/sugar isn't bad for you, but actually good since if helps prevent X, Y and Z", and several other idiocies, got a law passed that is the crux of the whole problem. That law says, in essence, "Food supplements do not need to be tested for effectiveness." And, sadly, that applies to *any* product into which such a "supplement" gets added.
In a related story:
Court rules against FTC in supplement ad case:
"It is not up to the FTC to decide what represents credible scientific backing for a claim. The agency must be reasonable and where diverse interpretations of scientific evidence represent differences of opinion rather than discredited positions, government policy must allow for that diversity instead of suppressing points of view it disagrees with."
This is an important legal victory for proponents of natural health.
I disapprove of health claims being allowed for foods with added phytosterols (aka plant sterols and stanols) or supplements containing these substances. Although phytosterols do lower LDL-cholesterol slightly, they have been never been shown to prevent heart attacks. A cause for concern is that, in the case of plant sterols, supplementation results in higher blood levels of plant sterols. Whether this is safe or not is not known. There is a rare genetic disease called sitosterolemia in which the patients have extremely high levels of plant sterols. This leads to accelerated atherosclerosis and premature heart disease. Whether the lower levels in people who take phytosterol supplements also promote atherosclerosis is unknown.
Weingartner, et al., Controversial role of plant sterol esters in the management of hypercholesterolaemia, European Heart Journal 2009 30(4):404-409.
@Jeff, what do you mean by "natural" health?
I find it kind of strange that some of us are highly critical of drug company representations (which are held to a high standard of safety and effectiveness), but supportive of "natural" producers of drugs (which are on a mere substantiation standard).
Many of these "natural" treatments are throwbacks to the patent medicine days.
@Anonymous: What do I mean by natural health? I mean improving health using supplements instead of drugs whenever possible or appropriate.
Take the example of proper bone health. The natural way would be to ensure adequate intake of protein, calcium, vitamin D, and magnesium, along with co-factor nutrients like zinc, boron, silica, manganese, vitamin C, vitamin K, and strontium.
The conventional treatment for weak bones is biphosphonate drugs (Fosomax, Boniva), which have potentially serious side-effects, including a higher risk of atrial fibrilation. The FDA has issued a warning about severe pain with Osteoporosis Drugs:
Jeff, ***any*** treatment has side effects, if its capable of working at all. Why? Because drugs are drugs are drugs. You can poison yourself with too much of just about anything, including vitamins. Oh, and to be clear, the general trend, as stated in more than one article I have read, is to question whether or not increased vitamin intake has any real positive impact at all, save in those who are just not getting enough in the first place, and most people in the US **are**. The "take all this stuff and it will help your bones" people are basing this one what, the long line of people telling us that more vitamin pills are better, because we are losing them in foods? Foods that, according to, again, other valid studies, show no real difference between the "new" multi-billion dollar, over priced, "organic" foods, and the stuff you get everyplace else. Mind, this is hardly a surprise, plants need the same nutrients to grow, regardless of *where* they get them. Growing them non-organicly doesn't magically introduce some fantasy ingredients that make them grow without taking in the same *identical* levels of nutrients. In fact, if anything, you might get better amounts, if they nonsense was correct, with non-organic, since organics rely on natural fertilizers, and there is **no guarantee** that the animals that comes from won't have nutrient deficiencies in their own diet, which would extend "to" the fertilizers.
But, that isn't the only issue. Another critical issue is that the same people serving up "natural health", also serve up the whole herbal supplement BS, and a) 80% of the stuff has never been shown, in real tests, to have the effect it claims, b) another 10% of it has active ingredients that do the **exact opposite** of what is claimed, and the 10% that do have the correct active ingredients usually have it in levels that only believers in homeopathy would find significant. I.e., if you need, say 1,000mg of something for a heart condition, your "herb" might contain 0.1mg of it, and you would have to eat 50 pounds of the stuff to get the recommended medical doses.
Supplements are basically bullshit, if they where not, we would have never *invented* the medical industry, instead of moving away from the use of them in the first place. And, this gives me the biggest laugh, you won't find one single herbalist or "natural health" expert selling extracts from plants that still ***are*** used by the medical industry in the same dosages. Lilacs for example contain a chemical in high enough concentration you *can* use them to treat specific heart conditions, and they have been used for this since Galen, during the bloody Roman empire, yet, somehow, the "natural health" people don't have a single fracking clue that this natural product exists, and that it does work. The only difference between the original and the modern use - modern use makes the active ingredient in a lab, so they know the "precise" dosage, while plants, as I pointed out before with the organic vs. carefully supplied with nutrients artificially issue, change they amount they produce year by year, and even based on what season you picked them, and/or how you dried them.
"Natural Health" people are selling snake oil, and they are no different in principle than the right wing funded ad campaigns recently starting to run advocating things like skin cancer not being caused by sun exposure, and fat from cheeseburgers being "good for you", brought to you by the same people which once, and still, try to run ads claiming, "Cigarette smoke doesn't actually cause cancer."
But what is the natural/unnatural distinction between supplements and drugs? Many drugs are natural, many have side effects, etc. Supplements, even natural ones, can be toxic.
Frankly, Jeff, if you're well, you should be able to subsist quite well without any form of supplementation so long as you have a balanced diet (which is not as difficult as the makers of supplements would have you believe) and get sufficient exercise.
If you're not well, why would you trust that people running a multibillion dollar industry of supplements and assorted unregulated snake-oils would provide better results than the recommendations of your personal physician, and this doctor's pharmacopeia of heavily regulated and carefully studied medications? Because there's a big conspiracy?
Sounds like the conspiracy is on the wrong side there, bub.
Dangit, easily distraced today.
What I MEANT to say was YAY EFSA!
Anonymous: "if you need, say 1,000mg of something for a heart condition, your "herb" might contain 0.1mg of it, and you would have to eat 50 pounds of the stuff to get the recommended medical doses."
Exactly right. This is why standardized extracts are the only reliable way to buy plant-based products. Examples:
1. Green Tea extract: "(Camellia sinensis) (leaf) (standardized extract)[min. 98% total polyphenols, 80% total catechines, and 50% EGCg (Epigallocatechin Gallate) (200 mg)]"
2. Grape Seed Extract: "(Vitis vinifera) (min. 90% Total Polyphenols)
3. Pomegranate Extract: "(Punica granatum) extract (fruit) [std. to 30% punicalagins (120 mg)]"
Anonymous seems to assume supplements and drugs have equal risks. There are definite risks with supplements adulterated with steroids or other drugs. These are illegal products which involve criminal charges and penalties, whenever the FDA chooses to go after them. Fortunately these constitute a very small percentage of the market. When it comes to legal dietary supplements, the FDA's Adverse Event Reporting system tells the story:
In 2008 the FDA received a total of 1,080 AERs concerning dietary supplements. During that same year the FDA received 526,000 AERs concerning drugs and biologic products. Considering billions of bottles are sold annually, supplements have an excellent track record of safety.
Sorry. Stupid thing had me logged out, but insisted I was still logged in.
Zinc - perfect example. Its a nerve toxin. Virtually ***any*** quantity at all, if exposed directly to nerves will damage or destroy them. One of the most common "recent" woo medicines, from the "health food" people, Zicam, had a nasal version. Nearly everyone that took it suffered irreparable nerve damage to their sinuses, the only part of the body where nerves are directly exposed to the outside world (the reason being that its nerve cells that let you 'smell', and they are directly exposed to the air inside the nose). Its also why taking certain drugs, intended to reach the brain fast, is quicker and has a bigger "wham" when taken that way.
If it has *any* effect on the body at all, it qualifies as a drug, when complex. What makes most supplements not qualify are two, and only two, things - 1) most are considered simple, like vitamins, and 2) some congress person, decades ago, before we knew how, when, and in what doses, most of them are toxic, convinced the rest of congress that, "Its natural, so safe, unlike them drugs, so lets no regulate it." This was a bloody stupid mistake, and we have been paying the price with an industry selling "supplements", which, due to paranoia, cluelessness, and just bloody stupidity, in some cases, is rapidly becoming a "bigger" industry that big Pharma, and which is 100% unregulated, and who have, do, and continue, to lie, knowing that, as long as they print the magic words, "This product is not intended to treat or cure any disease.", their pushers, and even their TV ads, can promote the exact opposite all they want, and short of killing someone, they won't ever get called on it.
Enzyte, as another example, **was** sued, by 5 states, *and* a group of people that claimed they lied. The courts concluded that, "Yes, they did lie." It went off the market for like what, a week maybe? Just long enough for them to clean up the obvious labeling and other legal issues that they *did* get in trouble for, and bingo.. there is smiling Bob again, right back pushing pure BS. Same with "Airborne". Sued by multiple people, determined to have a) never been tested, b) that the place they claimed tested it doesn't even exist, c) that it was invented *purely* by the altie medicine people, not a school teacher, and d) it doesn't do anything. Result.. They where allowed to sell what was left in stock, after which they had to, "change the packaging, to remove misleading information, or stop selling it." So.. what the heck are the new labels supposed to have, an ingredient list? Its the only claim made on the packaging that wasn't total and complete bull.
Or, lets put it another way. Big pharma probably makes a billion a year, but then has to spend 50% of that on new research, and another 25% on making sure the contents are "accurate", and examining claims of problems with the drugs, as well as advertising and other expenses, and 10% **making** the stuff in a high tech lab, wit hvery careful controls. "Health food" people probably make the same billion each year. 10% of their money go into advertising, 5% into making the stuff (or buying it, without safeguards, tests, or requirements that testing be done, from some place like China), maybe 5% is spent lobbying fools to encourage its continued use, and application, along side read medications, and the rest.. all lands in someone's pocket. They don't have labs, they don't do research, they often don't even make their own product, but buy it from other countries, they do **no** research, other than the sort where you go around and ask, "Did you feel better taking this?", and, there is no legal requirement for them to "do" any real research, any testing, or verify that their suppliers did so, nor any legal grounds for the FDA, or anyone else, to test it either.
Yeah. I really got to go with the people without any regulation or rules, who are making 50 times the profit, off selling the same amount of product as "big pharma"...
Is it always the case in recent years that Europe takes the path of reason based policy, while the United States drowns in political, and religious speculation? The problem is, as others here have said, it seems hard for Americans to follow Europe in anything. It seems to be a matter of pride. Instead we need to react as a matter of pragmatism and responsibility.
@6 - 'Many of these "natural" treatments are throwbacks to the patent medicine days.'
No lie. I'm acquainted with this person who is busily building a business flogging this concoction, which I will not describe, save to say that it's pretty harmless and smells ok. Cures everything, apparently.
The lady honestly believes in this stuff, and is frankly not too bright. But has a lot of energy and determination. I think the word "domineering" would not be entirely wrong, although perhaps it goes a little far. Or then again, maybe not.
Anyway. That's what you're up against.
No side effects right????