Trading regulations and health foods

The European Union promotes a free market economy in Europe; however, the pursuit of profit sometimes has to be curtailed if consumers are injured or deceived. For example, the unregulated marketing of certain foods may include claims about effects on health that deceive patients. The EU Directive on Unfair Commercial Practices, enforced in the United Kingdom in May 2008,1 was designed “to plug gaps in existing consumer protection legislation” and “to protect vulnerable consumers who are often the target of unscrupulous traders.” It obliges businesses not to mislead consumers,2 and this includes health claims for services or products.

The distinction between medicines and foods is sometimes unclear when they are marketed for health reasons, and consumers can be misled. Medicines are licensed in Europe only after stringent experimental research to establish safety and efficacy. In the UK, this process is regulated by the Medicines and Healthcare Products Regulatory Agency. Food products marketed for health have largely escaped these controls. The Joint Health Claims Initiative, which was set up in the UK to establish a code of practice for health claims on food, established a process for their evaluation on the basis that similar systematic evidence bases should be required to those for drugs. The EU regulation on nutrition and health claims for foods was adopted in 2006. All claims—such as “low fat,” “high fibre,” or “helps lower cholesterol”—are required to be clear, accurate, and substantiated, so that only products offering genuine health or nutritional benefits could refer to these claims on their labels.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 for obesity (which is a disease—international classification of diseases, 9th revision code 278).4 Many such claims are not overt or verbal. Using “implied claims” in brand names, and images on packaging, they are positioned and promoted, by staff or “testimonials” on vendors’ websites, in such a way that consumers are likely to be misled. Under the new regulations, products or services that falsely (without substantiation) claim or imply that they can improve health are now clearly illegal. Commercial practices considered unfair in all circumstances are listed. Sponsored “advertorials,” the use of images or sounds in editorial material in the media that fail to make their promotional intent explicit to consumers, and misleading allusions to approval or endorsement from professional or public bodies are specifically prohibited.2

Misleading marketing is targeted at other vulnerable groups of patients—for example, “diabetic” foods, which do not benefit people with diabetes. However, unscrupulous trading is most commonly linked to obesity. In 2000, $35bn (£22bn; €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 shortens people’s lives.6 Its effect on quality of life is similar to that of rheumatoid arthritis or spinal cord injury,7 and it has enormous personal, healthcare, and social costs.8 Avoiding the simple facts that losing body fat requires a lower energy intake than energy expenditure, and that obese people need to consume more calories than if they were thinner are coupled with frequent intentional misreporting9 and a willingness to spend huge amounts of money on ineffective, non-evidence based, treatments. Of hundreds of products on sale, only appropriately delivered diets and exercise, orlistat, sibutramine, and bariatric surgery are safe, efficacious, and cost effective.10 11 The remainder should not be marketed until we have evidence for their effectiveness and safety.4

With no requirement for research, these products have been hugely profitable. Ironically, well informed public denouncement of these medicines usually leads to increased sales. Products that are investigated by advertising trading standards authorities can disappear and reappear with modified names, or in a different country. Harmonised regulations across member states would help this.

Nothing justifies the commercial exploitation of vulnerable patients with quack medicines. The new regulations provide good legislation to protect vulnerable consumers from misleading “health food” claims. They now need to be enforced proactively to help direct doctors and consumers towards safe, cost effective, and evidence based management of diseases. The regulations may even help with the bigger battle to prevent obesity, by prohibiting advertisements across the EU that encourage children to buy energy-dense products or to pester their parents to buy them.2