European Food Watchdog Slashes Dubious Health Claims

Does it work? Regulators have yet to decide whether Danone's Actimel "helps strengthen your body's natural defenses," as the company claimed.

Do antioxidants prevent premature aging?

BRUSSELS—Do antioxidants prevent premature aging? Do dried plums help maintain normal bowel function? Does lutein help your vision; does chewing sugarless gum pre-vent plaques; and does fermented whey improve gut health? The answers: No, no, no, no, and no, according to Europe's food safety watchdog, which on 25 February issued a scientific mass-verdict on more than 400 so-called health claims, the promises that food producers make on their labels and in advertisements. The opinions come from the European food Safety Authority (EFSA), based in Parma, Italy, which also rejected purported health benefits of certain peptides, honey, black and green teas, and a raft of other substances.

The decisions are the latest installment in a gargantuan and controversial effort by EFSA to validate more than 4000 health claims used by the food industry across the continent. More than a year behind schedule, the agency has more than 3000 claims to go but so far, it has rejected more than 80% of those it has looked at. The food industry may eventually have to stop using those claims.

Some hail the process, required by European Union (E.U.) legislation passed in 2006, as a timely new way to protect European consumers. "Finally, there's a bright scientific light on the somewhat shady world of food and supplements," says nutrition scientist Martijn Katan of the VU University in Amsterdam, the Netherlands. But many in the food industry and some academic researchers say that EFSA has put the scientific bar so high that it may stifle food research in the long run.

In the past decade, European companies have invested millions in so-called functional foods that they say offer health benefits; if EFSA rejects most of their claims, research on such products may lose its appeal. "I'm getting really worried about all the rejections," says Glenn Gibson, a food microbiologist at the University of Reading in the United Kingdom who studies probiotics, or "healthy bacteria" an area in which EFSA has so far rejected every claim it has reviewed. "My ultimate concern is that much of the food research in Europe will be lost." Some company representatives vented their frustration at EFSA at a meeting here last week organized by Cantox Health Sciences International, a company that helps food and supplement producers prepare their dossiers for the regulatory mill.

The high rejection rate is partly an arli fact of the way the regulation was set up a typical, tortured E.U. compromise. Member countries wanted to ensure an easy way through the process for food components already known to contribute to some function of the human body—such as vitamin C and iron. Under Article 13.1 of the regulation, such "function" claims can be filed with just a list of scientific references as evidence. But rather than "regulation-lite," Article 13.1 has become a graveyard of health claims. Except for cases that arc literally in the textbooks mostly vitamins and minerals EFSA found that there-was little consensus. Judging the claims was often "very difficult" because they were poorly stated and the literature cited was often incomplete or irrelevant, says nutrition scientist Albert Flynn of University College Cork in Ireland, the chair of the 21-member Panel on Dietetic Products, Nutrition and Allergies, which issues the rulings. Nigel Baldwin, a regulation specialist at Cantox, says the 13.1 procedure, forced upon EFSA by the E.U. bureaucracy, was flawed from the beginning.

There is another way through the maze. Applicants can make their arguments for a product in a full scientific dossier including a narrative about why they think it works and some products rejected in the first round may yet win approval by this path, says Flynn. But industry observers say that the EFSA panel is putting the bar very high here, too. The panel puts little stock in animal studies, for instance, and as for human data, it heavily favors randomized, controlled, blind clinical trials, which are far less common in nutrition than pharmaceutical research.

A big company recently stumbled, for example, even though it came with clinical data. On 4 February, EFSA rejected Danonc's claim that Immunofortis, a mixture of oligosaccharides added to infant formula, strengthens babies' immune systems. "There's 10 years of science behind this product," says Danone spokesperson Agnes Berthct-d'Anthonay; indeed, the company had 30 studies, including 25 with human data, to prove it. But the panel was unimpressed. Only one trial in 259 infants addressed the benefit directly, it concluded, but it had "considerable weaknesses": it wasn't clear how infections had been diagnosed, for instance. Danone is still awaiting a verdict on several other claims, including its probiotic drinks Actimel and Activia.

Katan disputes that the EFSA panel is particularly stringent. "This is not dracon-ian. It's just standard, mainstream science," he says. The industry's problem is that convincingly proving a benefit is extremely difficult. Because many ingredients can't be patented, the sector can't afford the kinds of large, rigorous studies that the pharmaceutical industry funds.

EFSA Senior Scientific Officer Julianc Kleiner also insists that the agency's scientific assessments aren't more demanding than, say, those of the U.S. Food and Drug Administration (FDA). But analysts point out that several features in the U.S. system make life easier for companies. As a result of a freedom of speech lawsuit, for instance, FDA also admits "qualified claims" for food products when there's some evidence but no scien-tific consensus. (A label could say, for instance, that there is "limited evidence" that a product may reduce the risk of disease.)The E.U. system doesn't allow that way out. It may be years before health claims actually start disappearing from labels andTV commercials, however. EFSA can't ban their use itself; that's up to the European Commission and the European Parliament, which have yet to decide what to do with most of the rejections. E.U. politicians are subject to intense lobbying by the industry to soften the blow, Katan says— "but I can't imagine that they'll throw all of these opinions in the garbage bin."