Food for thought
29 August 2010 By Susan Mitchell Take a walk down the aisle of your local supermarket any time soon, and you’re certain to see an array of claims plastered over the packaging of everything from smoothies to raisins, spreads and cereal
Cereals promise to help you ‘‘lose more weight’’.
Fruit drinks claim ‘‘energy-releasing B-vitamins’’.
Raisins boast antioxidants that ‘‘can slow the effects of ageing’’.
Spreads are enhanced with cholesterol busting additives, while yoghurts will help rebalance your gut.
Demand has shot up for ‘functional foods’ - products said to improve health or protect against disease.
The shelves are laden with foods that promise much more than a simple meal or snack, along with vitamins and supplements that claim to counteract a poor diet.
Where consumers go, regulators typically follow, and pressure from consumer groups was one of the factors that resulted in the European Union turning its attention to the vast array of health claims bombarding consumers.
In December 2006, the EU introduced legislation which means that each of the many thousands of health claims made by food companies in the union’s jurisdiction has to be backed up with scientific evidence.
‘‘There was a feeling that, for some claims, the proof was not obvious.
Manufacturers understand that when they make health claims, they sell.
Over the last 15 years, the number of health claims has grown, and the reason is because of the success of this type of marketing,” says Professor Albert Flynn, a professor in nutrition at University College Cork.
‘‘The problem was that in an unregulated market, competition could take the industry to a place where it was on thin ice.”
Margot Brennan of the Irish Nutrition and Dietetics Association says: ‘‘We need to remember that the reason this is all happening is to protect the consumer.
Ultimately, that is the main focus. In the long term, it will mean that consumers are getting what it says on the tin, as opposed to something that there is little or no evidence behind.”
The Nutrition and Health Claims Regulation was adopted ‘‘to ensure that consumers are not misled by unsubstantiated, exaggerated or untruthful claims about foodstuffs’’.
On the face of it, the EU’s stance hardly seems unfair or excessive, but testing the validity of the health claims made by food companies is taking time and generating controversy.
The legislation became law in summer 2007, but it is only in recent times - as the European Food Safety Authority (Efsa) begins to clear the backlog of claims submitted for evaluation - that its full impact has begun to become clear.
The regulation extends to a vast range of products, from multivitamins and slimming pills to margarine and yoghurt.
Dublin solicitor Maree Gallagher provides specialised legal and technical advice to the food, consumer, pharma and life sciences sector. She believes the Nutrition and Health Claims regulation is overly cumbersome for business.
She also argues that it is not entirely necessary, as legislation already existed to prevent companies misleading consumers.
The Food Safety Authority of Ireland takes a very different view. ‘‘Was the legislation necessary?
Yes, it absolutely was,” says Professor Alan Reilly, chief executive of the authority.
‘‘Essentially, all this prevents consumers from being misled by exaggerated or hoax health claims.
We are getting rid of rogue operators.
The vast majority in the industry were doing the right thing, but there were a number of ridiculous claims.
‘‘Some of them were well over the top.
There were claims that products would detoxify your system.
You would read that this food or that food would reduce heart disease.
They were fairly outrageous claims.”
But Gallagher believes the new legislation is more akin to what might be expected from pharmaceutical companies seeking approval for new drugs.
Professor Flynn, who also chairs Efsa’s expert panel on nutrition, acknowledges that the EU was ‘‘ambitious’ ’with the legislation.
‘‘It is strict legislation, but that is what the legislators decided. Efsa was told to give the highest level of scrutiny to all these claims.
That was the intention of the legislators,” he says.
Flynn believes the preceding legislation was relatively meaningless.
‘‘Legally, you could not mislead the consumer, but that said everything and it said nothing.
The problem was, it was impossible to enforce it.
The onus was on the enforcement authority to challenge the company and that was not easy,” he says.
According to Flynn, health claims were policed to a limited degree through advertising standards authorities before the EU enacted the present legislation.
‘‘If someone felt the claim you had made was untrue they could write to the Advertising Standards Authority and the authority could investigate the complaint.
If they said the company could not use the claim as it could not prove the claim, then there was an onus on the company to stop using it. It was not legally binding, but it did have some force,” he says.
Force, or muscle, is not something that Efsa is short of.
EU member states submitted more than 44,000 ‘‘general function’’ health claims on the part of manufacturers.
They were whittled down to just over 4,500 claims for consideration by Efsa.
Of the claims assessed so far, the vast majority have been rejected, suggesting consumers have been swallowing rubbish for far too long.
‘‘In principle, if they cannot substantiate the claim, they have to take it off their packaging,” says Flynn. ‘‘That has already happened with some claims.
‘‘It is not quite automatic -we give advice to the EU Commission, which then makes the legal decision on the claim based on the scientific advice.
‘‘In some cases, the company has to stop using the claim within six months of that happening.”
Ocean Spray cranberry juice, Lipton black tea and some probiotic supplements are among the items whose claimed health benefits are scientifically unproven, according to Efsa.
Efsa did not back Ocean Spray’s suggestion that its cranberry juice could protect women against urinary infections.
Efsa also rejected an application from Unilever which claimed that drinking Lipton black tea makes people more alert.
The list is endless and some of the adjudications make for interesting reading.
They are available in full on the EU website (http://www.efsa.europa.eu/).
Take fish oil, for example.
Fish oil supplements are one of the bestselling food supplements in Ireland, while the global market is worth about $55 billion.
Pharmaceutical company Vifor Pharma submitted a claim to Efsa because it wanted to continue to claim that its Eye Q fish oil capsules improve working memory in children.
The company sent in references to six studies, a fact noted by Ben Goldacre, journalist and author of the Guardian newspaper’s Bad Science column.
Goldacre trawled through the submission and questioned why Vifor Pharma had only submitted six studies.
He claimed the company had told him back in 2006 that it had 20 positive studies showing that Eye Q improved school performance and behaviour in children.
‘‘If ever there was a time to roll out those well-conducted trials, in which thousands of children volunteered their bodies for experiment, surely it was now, for the EU?
Apparently not,” Goldacre wrote.
Two of the six studies submitted had been conducted on children with developmental coordination disorder and attention deficit hyperactivity disorder (ADHD) - not exactly mainstream - while three of the studies did not look at working memory at all.
The final study displayed a positive result for one sub-type of working memory, verbal working memory, that was tested with digit span.
Efsa ruled that the evidence was far from compelling.
Much of the scientific evidence companies have used to try to support their claims has been unimpressive.
At a stakeholder meeting in Parma last June, Efsa’s health claims unit chief, Juliane Kleiner, said the quality of the literature provided by applicants in the form of references to support claims had been ‘‘far from optimal’’.
Along with the expected references to clinical studies published in peer-reviewed academic journals, Efsa was presented with references from Wikipedia, press releases, dictionaries, the Bible and even a Royal Air Force Report.
Big business is seething.
The European Fruit Juice Association has complained about ‘‘a lack of transparency’’ from Efsa.
The International Margarine Association of the Countries of Europe contends that the process is imperfect.
One of the more vocal critics is Ioannis Misopoulos of the International Probiotics Association (see panel). ‘‘It can take three years to get these kinds of human studies together but, in the meantime, the claims are going to be wiped away.
The regulation is killing this industry, and the job losses are already being felt,” he told the BBC.
British company Power Health warned that if Efsa did not allow EU companies to make their claims, people would buy products from less regulated markets further afield.
‘‘People will probably start buying in from unregulated countries, especially via the internet, and we could well end up with customers less protected than they were right at the start of this process,” it said.
But while that argument might wash for vitamins and supplements, it is hard to imagine customers shipping in yoghurts from Belarus.
Some applications were clearly sub-standard, but the European Confederation of the Food and Drink Industries (CIAA) argues that insufficient guidance at the beginning of the process about what was required had also scuppered many applications.
In a presentation outlining the experience and expectations of the food industry in regard to the claims process, Mella Frewen, director general of the CIAA, said food companies had only become aware of the detailed requirements for submissions late into the process.
Frewen says the industry has concerns about the lack of transparency in the claims process, the failure to conduct a proper impact assessment, the lack of legal certainty over timelines, the controversial decision to publish claims in batches, and the general complexity of the process.
It has been claimed that smaller companies are being disadvantaged as they now have to fund expensive studies and trials to substantiate their claims. ‘‘In many ways, small companies have a disadvantage compared to bigger companies, but that is just a fact of life,” says Professor Flynn.
‘‘Most of the claims that have been authorised don’t belong to any company at all. If you have a claim on calcium and bones, anyone can use it - every yoghurt manufacturer, big and small.
But a company with deep pockets could get a proprietary claim, which they could own for four or five years.
‘‘For example, a small UK company has invested in research into tomato extract and has shown that it can reduce blood clotting and help with blood thinning.
In general, big companies might have an advantage in that.”
Dr Alan Reilly says the response from Irish businesses has been mixed. ‘‘It can be difficult for small businesses to produce the dossiers. It can be economically prohibitive,” he says.
Next up, Reilly says, is more transparent food labelling.
In June, MEPs approved the Commission’s proposals that food labelling should contain mandatory nutritional information and guideline daily amounts (GDA) expressed in per-100g or 100ml values (see panel), but a clear majority rejected proposals for a traffic-light labelling system.
In a further victory for the big food companies, the parliament’s draft legislation bans individual member countries from adopting the traffic-light system even if they want to.
That traffic-light system would have obliged manufacturers to label their products with red, amber or green symbols to denote the amount of fat, saturated fat, salt and sugar per serving.
Research carried out for Which?, the British consumers’ association, and by scientists in Australia, showed that consumers found it far easier to identify healthy foods from the traffic-light system than from GDA labelling.
The difference was particularly marked for those from poorer socio-economic groups, who tend to suffer most from unhealthy diets.
While consumer organisations and health groups have been calling for mandatory colour-coding for products, business lobby groups argued that a traffic light system was dictatorial, overly simplistic and would demonise certain foods.
The lobbying campaigns on both sides came under the spotlight in June, when the non-governmental body Corporate Europe Observatory claimed that the food and drink industry had invested more than €1 billion in a lobby campaign that attempted to block an EU-wide traffic light labelling scheme.
‘‘Food industry lobbyists have bombarded MEPs with information about the labelling scheme, in the biggest lobbying campaign seen in Brussels in recent years,” the body asserted.
It cited an MEP who estimated that industry lobbyists managed to ‘‘drown out the message from public health campaigners on a scale of 100 to 1’’ ahead of the vote, as MEPs were bombarded with thousands of e-mails, letters, phone calls, reports, lectures and conferences.
The CIAA, representing food manufacturers, rejected the allegation, saying that the €1 billion figure was ‘‘quite simply unfounded and untrue’’.
Michael O’Shea, chief executive of the Irish Heart Foundation, challenged the food industry to focus its energies on reformulating products to be lower in fat, sugar and salt, rather than on opposing the traffic light food-labelling system.
The Irish Heart Foundation (IHF) points out that, in Ireland, over 60 per cent of adults are either overweight or obese.
While we have enjoyed years of reducing mortality from cardiovascular disease, ‘‘the obesity epidemic means that mortality and morbidity caused by heart disease and stroke will soon be on the increase once again’’, it says.
According to the IHF, surveys show that GDA labelling in isolation has been confusing and misleading.
The breakfast cereal giant Kellogg is one company which opposes the traffic light system, arguing that categorising foods according to the colours of traffic lights is ‘‘at best simplistic and at worst misleading’’.
‘‘Kellogg put nutrition labelling on its packs back in the 1930s.We believed consumers were ready for such information then, and we believe now that they are ready for the comprehensive but clear information given by a GDA label,” its director of corporate affairs, Paul Fitzsimmons, pointed out. Could this be the same firm which has been hauled up in the US by the Federal Trade Commission (FTC) and Drug Administration (FDA) for making false claims about its Rice Krispies?
Kellogg claimed that the cereal improved children’s health, but the FTC said that this claim was not backed up by scientific evidence.
Then, last year, the company was rapped on the knuckles about its Frosted Mini Wheats, which it was marketing as a food that could improve children’s attentiveness by 20 per cent.
The FTC was unimpressed. ‘‘We expect more from a great American company than making dubious claims - not once, but twice - that its cereals improve children’s health,” said FTC chairman Jon Leibowitz.
‘‘Next time, Kellogg needs to stop and think twice about the claims it’s making before rolling out a new ad campaign, so that parents can make the best choices for their children.”
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