United Kingdom—
Chaos Reigns Supreme

Regulatory Requirements
Japan—The Inventor of Functional Foods
United States—A Good System Gone Bad
United Kingdom—Chaos Reigns Supreme
        Regulatory Requirements
        Marketplace Implications and Consumer Impact

A.  Legal Requirements

Although specific legislation addressing functional foods does not exist in the United Kingdom, medicinal claims on foods are specifically prohibited. The UK, like the U.S., draws a dichotomy between food and medicines. Medicines must be licensed and must fulfill pre-market approval requirements to obtain such licenses (a narrow exception is made for herbal products that are minimally processed and do not make health claims).(124) "Medicinal products" have been defined as:

Any substance or combination of substances presented for treating or preventing disease in human beings or animals.

Any substance or combination of substances which may be administered to human beings or animals with a view to making a diagnosis or to restoring, correcting, or modifying physiological functions in human beings or animals. . . .(125)

Furthermore, the Food Safety Act of 1990 prohibits false or misleading advertising of food, and regulations interpreting the Act prohibit claims that "a food has the property of preventing, treating, or curing a human disease or any such reference to such a property."(126) These are called "medicinal claims" because they are only permitted for licensed medicines.

The Food Safety Act also prohibits the addition to food of any substance that renders it injurious to health and provides the basis for specific regulations controlling different categories of additives. Since Jan. 1, 1996, the use of most food additives in the UK has been controlled by three sets of regulations implementing harmonized EU rules. The labeling of any novel ingredients, including those which might be included in functional foods, is governed by the EU’s Novel Foods Regulation.(127)

Over the years, food manufacturers and enforcement authorities have liberalized their interpretations on the prohibition on medicinal claims on foods, but at the same time the UK and the EU have failed to establish regulations for permitting health claims in the absence of a medical license. Unlike the U.S., there is no regulatory system in the UK for pre-market government approval of claims linking a food component to the reduction in the risk of disease. The result has been confusion among both marketers and consumers alike.

It is important to note that the term "health claims" has different meanings in the U.S. and the UK. In the UK, the term "health claims" refers to claims that a food has a "specific health benefit."(128)

In most, but not all cases, these claims are equivalent to what is known as "structure/function" claims in the U.S.

One factor in the U.K. that complicates the regulation of functional foods is the fact that foods and drugs are regulated by separate government agencies. This is in contrast to the regulatory framework in the U.S. where one agency carries out the mandate of a single statutory scheme that encompasses both foods and drugs. In the UK, the Ministry of Agriculture, Fisheries and Food (MAFF) has authority to draft regulations for foods, with enforcement responsibilities delegated to local trading standards officers (TSO) (or environmental health departments of local authorities); drug regulation and enforcement, including labeling and advertising violations, is carried out by the Medicines Control Agency (MCA). Further complications arise because food claims in advertising are regulated by three different authorities, one each for television, radio and print media, all with differing rules, procedures, and legal status.

Stimulated by the arrival of functional foods, there have been several attempts in recent years, by various key players in the field, to make good the gaps in the regulatory framework for food claims. At the current time, none has produced any binding regulations. The debate on the issues and options continues.

In 1995, the MCA issued a leaflet entitled "What Is A Medicinal Product?" In determining whether a product should be viewed as a food or a medicine, the MCA explained that although in the past, product claims were a key factor in determining whether a product was a medicine, changing circumstances, ECJ [European Court of Justice] judgements, the evolution of professional opinion and changes in marketing practices have required corresponding changes to the way the Agency assesses products whose status is in doubt. In particular, it takes full account of the EC view that competent authorities of Member states should consider all the characteristics of the individual product and are obliged to consider what impression of the product "an averagely well-informed consumer" would be likely to gain.(129)

The MCA concluded that a product should be regulated as a drug if:

  • it contains any ingredients(s) with a significant pharmacological effect;

contains significant quantities of medicinal herbs such as ephedra, lobelia or valerian;

claims to treat or prevent disease, or to interfere with the normal operation of a physiological function;

  • claims to relieve symptoms or to cure, remedy or heal a specific disease or adverse conditions such as stress, anxiety, and nervous tension;
  • uses the following words: restores, repairs; eliminates, controls; counteracts, combats; alleviates; clears; stops; removes; heals; cures; remedies; treats; avoids; protects; prevents.(130)
  • Uses other words that indicate or imply a medicinal claim when used in the context of a disease, illness or specific adverse condition such as: help with/may help with; traditionally used for; is said to benefit those who suffer from; can lower cholesterol; strengthens or boosts the immune system; fights gum disease; stops craving for, burns fat; increases metabolic rate; helps body adjust after crossing time zones; strips off sun-damaged pre-cancerous cells; detoxifies; helps maintain normal water balance; stimulates the nervous system.

The MCA concluded that the following words do not generally indicate or imply a medicinal claim: "beneficial, revitalizing, relaxing (except for products containing sedative), refreshing, invigorating, uplifting, soothing."(131) Similar words were endorsed by the U.S. FDA in its recent proposal to clarify permissible structure/function claims for dietary supplements.(132)

The MCA statement, produced by its aptly-named Borderline Unit, was attempting to clarify the distinction between drugs and foods. Products making medicinal claims would be treated as medicines and regulated by the MCA under its various prior approval arrangements. But the MCA has no authority to regulate products that fall on the other side of the borderline, namely foods. So long as food products stopped short of claiming to prevent, treat or cure disease, their health claims were largely unregulated. Attempts to fill in this hole have led to several years of regulatory confusion.

B.  Self-Regulation

In 1996, the Food Advisory Committee (FAC) of the Ministry of Agriculture, Food and Fisheries (MAFF) circulated draft guidelines on health claims for foods.(133) The guidelines, however, were put on hold pending the 1997 elections and were never finalized. Local government officials, consumer groups, and the food industry grew impatient with the failure of the MAFF to act. Thus, in 1997, the Food and Drink Federation (representing the food industry), the National Food Alliance (representing consumer and health groups) and Local Authorities Coordinating Body on Food and Trading Standards (LACOTS) (representing local consumer protection authorities) established the Joint Health Claims Initiative (JHCI) and began work on a voluntary code for health claims that could be made within the confines of the law. In August 1998, the JHCI released a draft voluntary Code of Practice on Health Claims on Food with respect to both labeling and advertising. A final draft was released last November and is now being ratified. Final publication is expected soon.

The purpose of the JHCI code is to provide guidance on permissible claims for foods providing health benefits so that the claims do not constitute prohibited medicinal claims. The proposed code also provides guidance on the level of scientific evidence needed to substantiate health claims.

The Initiative follows from increased recognition of the role of diet in maintaining good health and an anticipated growth in the market for so called functional foods. The need to prevent the use of false, exaggerated, misleading and prohibited health claims has therefore become a priority issue for the food industry, law enforcement officers and consumers, not only to protect the consumer but to also promote fair trade.(134)

However, in issuing the proposed code, the drafters also stated that "there was a need for the government to review the existing law on food claims in the light of scientific advances." In particular, the JHCI targeted for review "the prohibition on foods claiming to prevent, treat or cure diseases" because the prohibition "can inhibit communication of the role of a healthy diet in maintaining good health and reducing the risk of disease."(135)

To some observers, the proposed code may appear to combine elements of both the U.S. and Japanese frameworks for regulating health claims. Under the proposed code, there are two categories of permissible claims which require different levels of substantiation: generic claims, which parallel U.S. health claims, and innovative claims, which are modeled on FOSHU claims.

A generic health claim is defined as:

A health claim based on well-established, generally accepted knowledge from evidence in the scientific literature and/or to recommendations from national or international public health bodies such as the Committee on Medical Aspects of Food and Nutrition Policy (’COMA’), the US Food and Drug Administration (’FDA’) or the EU Scientific Committee for Foods (’SCF’).(136)

Any manufacturer whose product claim qualifies as a "generic health claim" may make that claim without specific substantiation. As in the U.S., a list of approved generic claims would be published.

Claims that are not generic are considered innovative.(137) This category was created to cover situations where an international scientific consensus has not emerged about the health effects of a food component. This may be the case with relatively novel food components. It may also arise because few companies have conducted relevant research, as for example with probiotic products based on patented bacteria (e.g., the Yakult range).

If an innovative health claim were made, companies would have to show that the health claim was likely to be true and that the scientific evidence in support of the health claim outweighs opposing evidence or opinion. That standard may be weaker than the "significant scientific agreement" standard used in the U.S. which requires health claims to be supported by more than a preponderance of the scientific evidence. Products such as Benecol margarine would be considered innovative until such time as an international scientific consensus develops about the health effects of phytosterols, enabling a "generic health claim."

The proposed code sets out the substantiation required for innovative products. It would permit claims "based on a systematic review of all the available scientific evidence relating to the validity of the health claim including published scientific literature." It advises that the conclusion of the review should be based on:

the totality of the evidence, not just data which support the health claim;

human studies or evidence, not just biochemical, cellular or animal studies;

studies in humans which are the most methodologically sound available.(138)

The proposed code specifies that "[h]ealth claims which could encourage high levels of consumption must not be made for any substances where there is evidence that high intakes of the food or substance could be harmful or unlikely to contribute to a healthy diet."(139) In addition, the code provides that "A food for which a health claim is made should, apart from the component(s) to which the claim refers, have a nutritional profile comparable to other foods. The making of a health claim should not encourage an unreasonable intake of ingredients or components that are unlikely to make a significant overall contribution to a healthier diet."(140) This provision may have the same effect as the U.S. law which prohibits products from making health claims if they contain high levels of fat, saturated fat, cholesterol and sodium. The proposed code, however, is less specific than related provisions in U.S. law, and it is questionable whether these provisions of the code will have the same effect. The proposed code also would permit reference to the maintenance of good health in general or of a specific part or organ of the body (e.g. "food ‘x’ helps to maintain a healthy heart or ‘food x’ helps to keep your body healthy"). Such claims in the U.S. are referred to as structure/function claims.(141) Examples of other acceptable words and phrases in health claims include:

  • Maintains bowel regularity which can help to ensure a healthy digestion and bowel
  • Is beneficial to the health of the stomach and the digestive system
  • Contributes to healthy metabolism and blood circulation which keeps the heart and blood vessels clear and healthy
  • Helps maintain normal blood flow to the brain which is particularly important in old age.

The proposed code would allow reference to risk factors that may adversely affect good health — e.g., "food x helps to keep your cholesterol levels healthy." But any such reference would have to make it clear that the overall benefit is within the context of a healthy diet and lifestyle with the aim of reducing the risk factors for disease rather than having any preventative effect on the development of a disease.

But, on an issue which has assumed central significance in the evolving British debate, the proposed code cautions against the use of references to a specific disease or disease in general

because that is likely to imply that the food has a medicinal effect in relation to a disease and/or influence consumer’s perception of the medicinal purpose and/or properties of the food.

The proposed code encourages companies to provide nutrition and serving size information on labeling and in advertising when making health claims. In addition, the proposed code recommends that companies disclose the:

  • target population and anyone who should avoid using the food
  • a statement indicating the quantity of the food and the pattern of consumption required to achieve the beneficial effect(142)
  • where there is evidence that high intakes could be harmful, a safe maximum intake
  • wherever a food component provides the basis for a health claim, a declaration of the amount of this functional ingredient in 100g and/or one serving of the food, whichever is more appropriate.(143)

Similar disclosures on the labels of functional foods are required for FOSHU products sold in Japan, but are not required by the FDA on functional foods making health claims in the U.S.

The code provisions are intended to be used as guidance for implementing the Code of Practice of the Independent Television Commission, the Radio Authority, and the Committee of Advertising Practice (for enforcement by the Advertising Standards Authority.)(144) Labeling violations would be subject to enforcement by trading standards officers. Under the proposed code, a Code Administration Body would be established to provide pre-market advice to companies wanting to make health claims, and companies would be strongly advised to seek such advice before making a new health claim.(145) An Expert Authority would also be established to assess the scientific evidence companies submit in support of innovative claims. It would determine, prior to launch, whether a claim was substantiated or not. The problem is that the code is just a "voluntary agreement" so companies are not obliged to use this pre-market approval mechanism.

However, in an effort to encourage submission to the Expert Authority, the drafters suggest that compliance with the code would provide a "due diligence defense" to manufacturers prosecuted for making a health claim under the Food Safety Act of 1990 and other applicable laws.(146) The code, however, would not set up a complaint procedure and was not designed to replace or compete with existing enforcement systems. Rather, the code would be intended to be a standard of reference for courts and advertising regulators to use when considering the validity of claims.(147)

In determining whether specific claims violate the code, "the overriding principle . . [would be] that the likely consumer perception of the health claim is paramount." If a claim were subject to more than one interpretation, all interpretations would have to comply with the code. Health claims would be evaluated based on how they are perceived at a quick glance, as well as on a more detailed reading.

Consumer groups are split over whether to support the JHCI. Some groups are eager to have a guidance document in place, even if it is a compromise. Other groups would prefer to have statutory controls rather than a voluntary code. Another segment would prohibit all claims unless they are approved by the government’s Chief Medical Officer based on a consensus opinion among public health experts. Approved claims could then be used on all qualifying products, regardless of the manufacturer.

LACOTS expressed concern that the proposed code does not specifically prohibit certain health claims that are "common through custom and practice" even though they "may amount to illegal medicinal claims for foods."(148) Examples, according to LACOTS, are claims that a functional food can lower or reduce serum cholesterol levels. The proposed code merely notes that such claims have not been tested in the courts and that companies should seek advice from LACOTS and the MCA prior to making them and other claims that are linked to the avoidance of a disease.(149) In September 1998, LACOTS published its own guidelines for the enforcement of medicinal claims. Its guidelines are intended to complement both the MCA guidance and the JHCI. The focus of the guidelines is primarily jurisdictional and addresses whether products making prohibited claims or containing pharmacologically active ingredients should be regulated by the MCA as unlicensed medicines or as foods by local trading standards officers. Essentially, the LACOTS guidelines conclude that if a product is presented and labeled as an "everyday" food, regardless of any claims made, enforcement action is the responsibility of the TSO. If, however, the products are unlicensed medicines containing pharmacologically active ingredients, MCA has jurisdiction regardless of whether a claim is made.(150)

LACOTS explained how TSOs will evaluate claims under the foodstuffs law:

Under foodstuffs law, a claim that consumption of a foodstuff will restore or correct physiological function falls within the definition of a medicinal claim and is therefore prohibited in relation to foodstuffs.

However, a claim that a foodstuff is capable of modifying a physiological function does not necessarily constitute a medicinal claim. (151)

No examples were provided of products that can lawfully claim to modify a physiological function. However, the most conspicuous example currently on the UK market is Nestle’s LC1 Yoghurt which claims it "helps boost your body’s immune system." Many have expressed reservations about this claim, but no one has yet challenged it.

The guidelines, however, indicate that products claiming to affect respiration, digestion and circulation will be considered medicinal where they are presented as capable of having a significant effect on a physiological function. These products would fall under MCA’s jurisdiction. Examples include products claiming to "increase the production of urine, alter the rate of metabolism, or lower blood pressure."(152)

In the future, two institutions which have so far been quiet about functional foods and health claims may have major roles to play. Following its landslide victory in the 1997 general elections, the new Labour government promised a major overhaul of how food is controlled and regulated in the UK. Early in 1999, the government committed itself to establishing a new Food Standards Agency (FSA).

The new agency, which already exists in "shadow" form, is expected to become operational by 2001. Formally, the FSA will be independent of government, the food industry or any other producer interest. In addition to providing guidance on a healthful diet, the agency is expected to have authority to propose legislation relating to the nutritional aspects of foods, including labeling and claims. Specifically on functional foods, the shadow agency has been supportive behind the scenes to the JHCI initiative. Many participants in the JHCI hope that the proposed code becomes the starting point for the FSA’s work in this area.(153)

In addition, the European Union and its Commission have formal responsibility for new legislation on food claims. During the 1980s and early 1990s, the Commission tried many times to produce a food claims directive, but could never secure agreement. It gave up trying just as functional foods began arriving in Europe.

The legislative stalemate at the European level provided the stimulus to attempts to produce quasi-legal "guidelines" and "voluntary agreements" in the UK such as the JHCI.(154) Sooner or later, the Commission will have to reengage the issue, but it is not certain when that will occur.

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Copyright 1998 by the Center for Science in the Public Interest. References available by request.