CMAJ News

European industry fears regulations will scuttle market for health-promoting or disease-preventing foods

Published at www.cmaj.ca on June 17 Conference workshop on Fri- stantiate their health claims to the day to discuss strategies for weathering European Union member state of their he European probiotic food the storm. choice. That evidence was consoli- industry may be frozen out of “It’s a mess and we’re all trying to dated and passed along to the EFSA T the consumer market as a result work our way through it with little or no for evaluation. of new European Union nutrition and guidance from EFSA,” says Dr. Elinor After the EFSA rejected claims health regulations requiring proof that McCartney, director of Pen & Tec Con- regarding the gut, immunity and other health benefits accrue from health benefits of probiotics, adding live microorganisms the European Food and Feed such as lactic acid bacteria Cultures Association and yeasts to fermented prod- slammed the authority for ucts such as yogurt. failing to communicate The industry has long expectations or publish maintained that consumption guidelines on how much or of probiotics has a beneficial what type of evidence effi- effect on humans because cacy panels require. they inhibit the reproduction “We actually do not of pathogens that cause know how EFSA is evaluat- intestinal inflammatory dis- ing probiotic claims,” says eases, some forms of Caroline Herody, a represen- and urogenital infections. tative for both the associa- But regulations introduced tion and the Danish food- in 2007 to protect consumers production company against misleading or false Danisco, which makes advertising now require indus- excipients (inactive sub- try to submit all food and sup- stances which are carriers for plement health claims to the the active ingredients of a European Food Safety medication). Authority (EFSA) for scien- EFSA hasn’t been trans- tific evaluation prior to their parent with industry about use in the European Union, what they’re looking for, the world’s largest and most adds Dr. Gregor Reid, direc- advanced market for so-called tor of the Canadian “functional foods,” i.e., ones Research and Development which are said to have health- Centre for Probiotics. promoting or disease-prevent- “They’ve made it unneces- ing properties. sarily difficult for compa- The safety authority has nies to know what informa-

subsequently rejected wave Corp. Jupiterimages 2010 © tion to provide in order to after wave of probiotic health gain approval, and where claim dossiers. To date, it has Yogurt is the most common product into which live microorgan- there has been guidance it’s isms are added and then promoted as having health benefits. rejected every submitted invariably come too late.” claim. The industry says the In 2008, the European dossiers are often rejected on the basis sulting and chair of the regulatory work- Commission issued guidance that indi- of technicalities rather than a lack of shop. “They’re just throwing out claims. cated the authority would reject outright evidence. Once rejected, products must We’ve all been surprised by how rigid an any scientific health claims dossier that be withdrawn from the market within approach they’ve taken to probiotics.” didn’t contain human clinical data. six months, on pain of prose-cution. Under the new regulations, compa- The instructions came too late for Within that context, scientists and nies were asked to submit whatever many probiotic food companies who industry will meet at an International evidence they felt necessary to sub- were already in the process of submit-

CMAJ•AUGUST 10, 2010 • 182(11) E493 © 2010 Canadian Medical Association or its licensors News ting their claims, as human studies can gies. In those cases, the authority did that public confidence in probiotics is take three or more years to complete. not scrutinize the gut health, immunity based on true health benefits. EFSA’s insistence on evidence and other health benefit data contained “Food are not drugs … but the sci- derived from the gold standard of ran- in the dossiers. ence behind [probiotics] should be domized clinical trials is ill-suited to According to McCartney, EFSA’s sound in any case,” says Sanz. “This is demonstrating the supportive function failure to communicate its assessment contrasted with the previous situation in that live microorganisms play in human process has left many companies in which nothing was regulated and that is health, critics say. limbo, unwilling to develop new prod- why criteria seem to be so strict.” “Probiotics are not drugs and ucts or resubmit claims for fear of fur- EFSA is organizing a fall workshop they’re not nutrients: they fall some- ther rejection and adverse publicity. to address concerns about these criteria. where in between,” says McCartney. -based industry leader- Meanwhile, industry legal teams are “EFSA is taking a pharmaceutical has twice withdrawn health preparing court challenges. approach, but the standards of evi- claims applications for probiotic “There’s only two ways around dence that go along with that approach yogurts Activia and . EFSA in this situation: you either do are too high, particularly if we’re look- “There are serious financial and the work or you change the law,” says ing at healthy populations.” health implications to EFSA’s McCartney. “In the short term, indus- As it can take 10–15 years for a dis- approach,” says Reid. “If EFSA doesn’t try will have to reduce their claims to ease to develop, and the study partici- start communicating what they want, deal with simple things like improved pants are free of disease at the baseline, food companies will eventually give up fecal consistency, but obviously those it’s not surprising or particularly infor- on the expensive claims application claims won’t be amenable to creative mative to see no benefits after several process and, in turn, will likely give up marketing.” years of supplementation, she adds. on putting the money into researching Another alternative for companies is “It’s pulling probiotics out of context and selling probiotic products.” to resubmit rejected claims under dif- and treating them like drugs, which no The probiotic food market was esti- ferent articles of the health claims regu- one is claiming they are. It’s also not mated to be worth approximately €10 lations. But that would require them to taking into consideration nutrition sci- billion in 2008 and holds an estimated meet a higher standard of evidence. ence in its entirety.” 10% of the global functional food mar- The June 18 regulatory workshop But the absence of data from clinical ket, but the industry is only as strong as was part of the week-long International trials hasn’t been the only problem. its health claims. Scientific Conference on Probiotics and Many industry claims were made “EFSA is in danger of killing public Prebiotics held in Kosice, Slovakia. before companies realized that the confidence in probiotics, and that would “This really is an international issue, authority was requiring them to include mean a smaller health food industry in because the world looks to Europe as a strain characterization for all microor- Europe, reduced spending on research leader in probiotics,” Reid says. “I ganisms. That, in turn, led to many and development, jobs lost, billions of think it’s not unreasonable to expect to EFSA rejections on the grounds of dollars drained from the economy and see these kinds of regulations exported incomplete dossiers rather than insuffi- studies killed,” Reid says. “The worst elsewhere in the world.” cient evidence of efficacy. that could happen is if probiotics Canada currently doesn’t regulate Many claims were thrown out became no longer available and the con- what bugs can be called a probiotic or because EFSA deemed the strains were sumer was left with no options.” what health claims can be made about insufficiently characterized, says Dr. For its part, EFSA insists that hold- probiotic foods. — Lauren Vogel, CMAJ Yolanda Sanz, an EFSA panel expert ing probiotics to the gold standard of on nutrition, dietetic products and aller- clinical trials is necessary to guarantee DOI:10.1503/cmaj.109-3291

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