Trading regulations and health foods

doi:10.1136/bmj.a2408

Published 25 November 2008, doi:10.1136/bmj.a2408
Cite this as: BMJ 2008;337:a2408

Editorials

Trading regulations and health foods

New legislation requires evidence for marketed health foods

The European Union promotes a free market economy in Europe;however, the pursuit of profit sometimes has to be curtailedif consumers are injured or deceived. For example, the unregulatedmarketing of certain foods may include claims about effectson health that deceive patients. The EU Directive on UnfairCommercial Practices, enforced in the United Kingdom in May2008,¹ was designed "to plug gaps in existing consumer protectionlegislation" and "to protect vulnerable consumers who are oftenthe target of unscrupulous traders." It obliges businesses notto mislead consumers,² and this includes health claims for servicesor products.

The distinction between medicines and foods is sometimes unclearwhen they are marketed for health reasons, and consumers canbe misled. Medicines are licensed in Europe only after stringentexperimental research to establish safety and efficacy. In theUK, this process is regulated by the Medicines and HealthcareProducts Regulatory Agency. Food products marketed for healthhave largely escaped these controls. The Joint Health ClaimsInitiative, which was set up in the UK to establish a code ofpractice for health claims on food, established a process fortheir evaluation on the basis that similar systematic evidencebases should be required to those for drugs. The EU regulationon nutrition and health claims for foods was adopted in 2006.All claims—such as "low fat," "high fibre," or "helpslower cholesterol"—are required to be clear, accurate,and substantiated, so that only products offering genuine healthor nutritional benefits could refer to these claims on theirlabels.³

It is already illegal under food labelling regulations (1996)to claim that food products can treat or prevent disease. However,huge numbers of such claims are still made, particularly forobesity (which is a disease—international classificationof diseases, 9th revision code 278).⁴ Many such claims are notovert or verbal. Using "implied claims" in brand names, andimages on packaging, they are positioned and promoted, by staffor "testimonials" on vendors’ websites, in such a waythat consumers are likely to be misled. Under the new regulations,products or services that falsely (without substantiation) claimor imply that they can improve health are now clearly illegal.Commercial practices considered unfair in all circumstancesare listed. Sponsored "advertorials," the use of images or soundsin editorial material in the media that fail to make their promotionalintent explicit to consumers, and misleading allusions to approvalor endorsement from professional or public bodies are specificallyprohibited.²

Misleading marketing is targeted at other vulnerable groupsof patients—for example, "diabetic" foods, which do notbenefit people with diabetes. However, unscrupulous tradingis most commonly linked to obesity. In 2000, $35bn (£22bn; ${euro}$ 28bn) was spent in the United States on weight loss products.Many of these products use false and unsubstantiated claims,enticing 7% of the entire population to buy them every year.⁵

Obesity is a serious disease that causes disability and shortenspeople’s lives.⁶ Its effect on quality of life is similarto that of rheumatoid arthritis or spinal cord injury,⁷ andit has enormous personal, healthcare, and social costs.⁸ Avoidingthe simple facts that losing body fat requires a lower energyintake than energy expenditure, and that obese people need toconsume more calories than if they were thinner are coupledwith frequent intentional misreporting⁹ and a willingness tospend huge amounts of money on ineffective, non-evidence based,treatments. Of hundreds of products on sale, only appropriatelydelivered diets and exercise, orlistat, sibutramine, and bariatricsurgery are safe, efficacious, and cost effective.¹⁰ ¹¹ Theremainder should not be marketed until we have evidence fortheir effectiveness and safety.⁴

With no requirement for research, these products have been hugelyprofitable. Ironically, well informed public denouncement ofthese medicines usually leads to increased sales. Products thatare investigated by advertising trading standards authoritiescan disappear and reappear with modified names, or in a differentcountry. Harmonised regulations across member states would helpthis.

Nothing justifies the commercial exploitation of vulnerablepatients with quack medicines. The new regulations provide goodlegislation to protect vulnerable consumers from misleading"health food" claims. They now need to be enforced proactivelyto help direct doctors and consumers towards safe, cost effective,and evidence based management of diseases. The regulations mayeven help with the bigger battle to prevent obesity, by prohibitingadvertisements across the EU that encourage children to buyenergy-dense products or to pester their parents to buy them.²

Cite this as: BMJ 2008;337:a2408

M E J Lean, professor of human nutrition

¹ Faculty of Medicine, University of Glasgow, Division of Developmental Medicine, Glasgow G31 2ER

lean{at}clinmed.gla.ac.uk

Competing interests: None declared.

Provenance and peer review: Commissioned based on an idea fromthe author; externally peer reviewed.

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