The UK experience illustrates what can happen when companies are permitted to make claims for functional foods without prior government approval. Recently, for example, SmithKline Beecham (SB) began promoting a juice drink called Ribena Tooth Kind. The product contains added calcium carbonate and claims that the product does not encourage tooth decay nor promote tooth erosion. The product carries the endorsement of the British Dental Association (BDA).

Action and Information on Sugars (AIS), a voluntary network of health professionals, academics, and researchers concerned with the consumption of sugars and public health has challenged the tooth decay prevention claim. The group claims that when tested under the most widely-respected method used to detect the rise and fall in product acidity, the product has been shown to have cariogenic potential. In addition, the group alleges conflict of interest between the BDA’s accreditation panel and SB. According to AIS, two of the four members of the BDA panel that conducted research on the product were under contract from SB.⁽¹⁵⁵⁾ AIS has, therefore, requested that the Advertising Standards Authority prohibit the use of the tooth decay prevention claim and that the trading standards officers in the London Borough of Hounslow (SB’s "home authority") require SB to remove the claim from product labels.

The ASA, a "self-regulatory" body established by advertisers, agencies, and publishers, has been recognized de facto by successive UK governments as the regulatory authority for print advertising. For the last four years, it has on average upheld one complaint a month against functional foods, like Ribena and food supplements incorporating similar functional ingredients.

An ASA report released in July 1998 on Health and Beauty Ads appearing in the UK concluded that "advertisements for vitamins and supplements raised several issues and contained a high number of problem claims." The group found 35% of vitamin and supplement product ads to be unacceptable. It also found a number of advertisements for products that should have been licensed as medicines, but were not.⁽¹⁵⁶⁾

Products and claims that the ASA has found misleading include:

• Kellogg’s All-Bran Cereal — Kellogg had promoted the cereal as "detox in a box."⁽¹⁵⁷⁾
• Kellogg’s Special K— promoted as a slimming productwhen it contained the same number of calories as Kellogg’s Corn Flakes and double the sugar.⁽¹⁵⁸⁾
• MD Foods Pact — a yellow-fat spread containing fish oil. ASA found that there was insufficient evidence that the product benefitted the heart, as the ad implied.⁽¹⁵⁹⁾

• MD Foods Gaio Soya Yoghurt containing Causido culture — which the manufacturer claimed would reduce cholesterol levels.⁽¹⁶⁰⁾ The ASA concluded that the claims were unsupported by scientific evidence and that graphs promoting the product exaggerated the effects.⁽¹⁶¹⁾

Generally, the ASA only acts when it receives a complaint. Furthermore, ASA decisions do not have a binding effect on manufacturers and do not prevent them from repeating the misleading claim because the ASA has rather limited sanctions it can take against companies who ignore its rulings and does not undertake legal prosecutions against companies. And importantly for the marketing of functional foods, the ASA’s remit does not cover ads in journals directed at health professionals. Nonetheless, in the absence of comprehensive legislation, the ASA’s rules provide one standard against which to assess claims. As a result, the Authority has become the most active organization in curbing the excesses of health claims about functional products. In the longer term, however, when many more functional foods come to market, such a reactive, self-regulatory body is an inadequate means of protecting consumers from misleading advertising claims.⁽¹⁶²⁾

Responsibility for claims made on product labels rests with the MCA for drugs and the local TSOs for foods. The result is an abundance of misleading claims caused by unclear legal requirements, lack of enforcement, and the absence of a mandatory government approval scheme for health claims.

In light of the limited government oversight of both labeling and advertising claims, it is not surprising that numerous food products misleadingly imply that they can prevent disease or improve health. For example, MD Foods’ claimed in ads for both its Pact Yoghurt with added folic acid and its Pact fat spread with Omega-3 oil that the products "may help reduce the risk of heart disease."⁽¹⁶³⁾ Also, the packaging for the margarine spread was in the shape of a heart. In the U.S., the presence of a heart or the use of heart-shaped packaging would constitute a health claim requiring pre-market approval. The ASA upheld complaints against MD on seven grounds, including that the claim was unsubstantiated, misleading and an illegal medicinal claim because of the reference to heart disease.⁽¹⁶⁴⁾

The entire Pact range was subsequently withdrawn. But, a white bread with added Omega oil is still on the market, despite claiming that it "may influence the fats in the blood in a way that is healthier for the heart."⁽¹⁶⁵⁾ The product label contains pictures of hearts, as well as a product logo containing the words "heart watch." Speakers of plain English, ignorant of regulatory jargon, may think that the Pact and white bread claims are saying the same thing in different ways. And many fluent specialists would agree, seeing the bread claim as an "implied medicinal claim," which is also forbidden. But, in the rules of the game currently prevailing in the UK, this is treated as an acceptable "health maintenance" claim rather than an illegal "disease prevention" claim.

B. Some Claims are Made for Products with Unhealthful Ingredients.

In some cases, claims are misleading because the purported benefit may not be easily obtained from the product as it is actually consumed. For example, Ribena justified the addition of soluble fiber to a soft drink (Ribena Juice ’n’ Fibre) by referring to reports that document the benefits of consuming dietary fiber in foods that naturally contain fiber. The promotion of soft drinks containing added fiber undermines the attempts of health educators to encourage the consumption of whole grain cereals and breads. In addition, consumers may be left with the impression that it is not possible to obtain sufficient amounts of fiber without buying beverages such as Ribena.

Some functional ingredients are present in foods high in fat, saturated fat, sugar or salt and are promoted as beneficial to health, when, in fact, such foods should be restricted to only a small part of the diet. For example, a high sugar spread for bread, Robertson’s Toffee Treat, is promoted as a source of calcium. Sweetened drinks such as fruit-flavored beverages are promoted as containing essential vitamins.

Other functional foods may pose potential safety concerns because they contain high levels of nutrients that can cause harm, yet are promoted as healthful without adequate qualifications. For example, vitamin A is added to some products and is promoted in a manner that could encourage consumption at levels that could increase the risk of birth defects.⁽¹⁶⁶⁾ Similarly, although there is no evidence of a protein deficiency problem in the UK, many products are promoted as high in protein, despite concern that excessive protein consumption is associated with bone demineralization and renal function deterioration in patients with renal disease.⁽¹⁶⁷⁾