EFSA rules probiotic health claims unproven

October 22, 2010

According to the Guardian, the food industry’s probiotics sector was called in to question today by a new European ruling that its health claims are unsupported by sound science. The European Food Safety Authority (EFSA) posted its formal assessment of the merit of 808 health claims, including widely used assertions that probiotic products boost the immune system. The claims were submitted to the EFSA by the food industry and member states.

The EFSA’s panel of independent scientists concluded that the evidence the industry had submitted to support its claims that various food additives could strengthen the body’s defenses, improve immune function, and reduce gut problems were either so general as to be inadmissible, or could not be shown to have the claimed effect.

In a separate ruling, the panel examined a dossier of 12 studies submitted by Yakult for its proprietary strain of probiotic bacteria, Lactobacillus casei shirota. The panel found that all were inadequate to support the company’s claim that its products maintained immune defenses against the common cold.

The gradual introduction of new EU regulations was finally agreed on in 2007 as a result of pressure from consumer groups. They wanted food companies to be prevented from using health claims to sell products unless they had proved them first, and unless the products were deemed healthy enough overall to warrant claims of benefits. Under the new rules, member states were asked to submit health claims from manufacturers, along with dossiers of scientific evidence, for independent assessment by the EFSA.

Britain’s Food Standards Agency (FSA) collected more than 4,000 claims from the UK industry; across Europe, some 44,000 claims were submitted. EFSA scientists, who were taken by surprise by the volume of claims, whittled these down to 4,000 for detailed assessment.

The opinions published Oct. 19 were the latest in a series of rulings. The EFSA had already published five opinions on claims relating to probiotics, all negative, although a spokeswoman said EFSA scientists “avoid using the term probiotics,” since it has no proper scientific meaning.

The new EFSA rulings represent a serious blow to the food industry, which has invested heavily in new, so-called functional foods such as probiotics. These typically sell for high margins, and enable manufacturers to differentiate their products from those of competitors in a crowded market. The EFSA did give some health claims favorable rulings, but they relate to vitamins and minerals for which the effects have long been known, such as the ability of iron to relieve anemia.

The industry has complained that EFSA is applying excessively rigorous scientific standards when assessing the new claims. It has asked for a series of meetings to discuss the criteria. Yakult issued a statement saying its rejected claim was just one aspect of its research. “The claim was supported by well-designed, double-blind, placebo-controlled human studies,” it said. “In response to the EFSA opinion, the company wishes to discuss the evaluation process and this outcome with EFSA. With the benefit of further guidance, the company anticipates a positive EFSA opinion in due course.”

Guardian article

EFSA Yakult opinion