Health Claims Regulation Research Articles

Folgerungen der IARC-Neubewertung von alkoholischen Getränken und Ethylcarbamat für die Lebensmittelüberwachung

In February 2007, the International Agency for Research on Cancer (IARC) has reassessed the carcinogenicity of alcoholic beverages within its monographs programme. Ethanol in alcoholic beverages was classified as to humans (Group 1). Many studies have consistently shown that regular alcohol consumption is causally related with an increased risk for cancer of the oral cavity, pharynx, larynx, oesophagus, liver, female breast and colorectum. In contrast to the previous evaluation of alcohol drinking in 1988, the IARC working group found evidence that ethanol and not other constituents or contaminants cause the carcinogenicity. In general, the risk for cancer increases with the amount of alcohol intake, e.g. the daily consumption of around 50 g of alcohol increases the risk of cancer of the oral cavity three-fold, compared to the risk of non-drinkers. An association with different types of alcoholic beverages (beer, wine, or spirits) was not observed. A separate evaluation was made for ethyl carbamate (urethane), a frequent contaminant of fermented foods and beverages. Ethyl carbamate was upgraded into Group 2A (probably carcinogenic to humans). The IARC evaluations emphasize the importance and necessity of avoiding and of controling further carcinogenic contaminants in alcoholic beverages (besides ethyl carbamate, e.g. nitrosamines, mycotoxins, lead, cadmium, arsenic), as there exists the possibility of synergistic effects on carcinogenicity between ethanol and other contaminants. In consideration of the IARC evaluation of alcohol as carcinogenic, the EU Health Claims Regulation is appreciated for its prohibiton of nutrition or health claims in the labelling of alcoholic beverages. Furthermore, the proposals for warning labels on alcoholic beverages similar to those on tobacco products are discussed.

Allégations de santé des aliments : une perspective communautaire

The development of health claims for food is driven by a strong industrial impetus and by consumer demand. From the regulatory point of view, the European legislation is fragmented; food and health legislations are contradictory on some aspects. National authorities carry out the regulation of health claims for food according to their own rules. A more comprehensive and harmonized approach within the European Community will be provided by the European regulation currently under discussion between the European Commission and the Parliament. Nevertheless, its final adoption and its implementation will take time. In addition, it won't solve the difficulties related to the assessment of the scientific substantiation of these claims. The role of health authorities in the implementation of rules regarding the safety of consumers remains unadressed.

Legislation relating to nutraceuticals in the European Union with a particular focus on botanical-sourced products

Nutraceuticals are food or food ingredients that have defined physiological effects. They do not easily fall into the legal categories of food or drug and often inhabit a grey area between the two. These products in general terms cover health promotion, “optimal nutrition” the concept of enhanced performance – both physically and mentally – and reduction of disease risk factors. In this paper the focus is mainly on legislation governing botanical-sourced nutraceuticals in the European Union (EU). Nutraceutical concept in general has been defined. Different pieces of legislation influencing botanical nutraceuticals are described. The issue of the borderline between food and drug is discussed. The regulatory status of botanical nutraceuticals as food supplement, food ingredient, functional and fortified food, novel foods and foods for particular nutritional use in the diversified, complex and ever-changing European regulatory environment is described. Botanical nutraceuticals present additional problems because of their complex nature and composition particularly with respect to the quality aspects, which in turn affect safety parameters and overall efficacy of the products. Quality issues relating to botanical sources, growth conditions, end products, their specifications and other technical criteria are highlighted. Guiding principles to be observed for conducting in vitro, in vivo studies in animals and their impact on clinical safety data are discussed. Finally, health claims, their types and criteria of substantiation in light of ongoing discussions with regard to the EU frame work of regulation on nutrition and health claims and role of process for the assessment of scientific support for claims (PASSCLAIM) initiative is discussed. The concept of grading of evidence to substantiate different claims and to establish standards, which should not be revoked or reversed by emerging science at a later stage has been considered. These issues are crucial and are being discussed at EU Parliament and Commission level during the development of the health claim regulations.

Dietary Supplement Advertising: Policies Based on Politics, Not Science

Regulation of health claims made for dietary supplements is shared by two federal agencies, the Federal Trade Commission (FTC) for advertising and the Food and Drug Administration (FDA) for labels. The agencies define their regulatory roles differently. Whereas the FTC has one policy for all types of claims for all products, the FDA distinguishes—and requires much higher levels of scientific support for—health claims as opposed to “statements of nutritional support.” In recent years, the supplement industry has been increasingly successful in convincing the public, Congress, and the courts to weaken FDA restrictions on such claims and to make its policies consistent with the weaker FTC approaches. These actions have produced new sales opportunities for dietary supplements and conventional foods, but whether they also will benefit the public remains to be determined.

The Impact of Health Claims on Consumer Search and Product Evaluation Outcomes: Results from FDA Experimental Data

The authors report results of a mall-intercept study regarding the effects of health claims on consumer information search and processing behavior. Results suggest that the presence of health and nutrient-content claims on food packages induces respondents to truncate information search to the front panel of packages. Respondents who either truncate information search or view claims provide more positive summary judgments of products and give greater weight to the information mentioned in claims than to the information available in the Nutrition Facts panel. The presence of a claim also is associated with a halo effect (rating the product higher on other health attributes not mentioned in the claim) and, for one of the three products tested, a magic-bullet effect (attributing inappropriate health benefits to the product). The authors discuss the policy implications of these results for Food and Drug Administration health claim regulations.

The Importance of Nutrition Labeling and Health Claim Regulation on Product Choice: An Analysis of the Cooking Oils Market

The Nutrition Labeling and Education Act (NLEA) prohibits health claims for foods containing more than a certain amount of fat per serving. This disqualifier level eliminates health claims for cooking oils since these products have approximately 14 grams of fat per serving, above the acceptable threshold. However, a number of scientific studies indicate that, from a heart-health perspective, cooking oils lower in saturated fat and higher in monounsaturated fats are superior to other oils. Prior to the NLEA, firms actively competed on this basis, with manufacturers of cooking oils making explicit heart-health claims in print advertising and labeling. This study utilizes supermarket scanner data from twenty stores to examine the type of cooking oil chosen by consumers. The results indicate that after implementation of the NLEA, consumers shifted purchases toward cooking oils higher in saturated fat and lower in monounsaturated fat. This study does not address whether consumers changed their total consumption of cooking oil after implementation of the NLEA.

Functional foods and health claims: a public health policy perspective.

To propose a policy framework for the regulation of functional foods and health claims within a public health context. This article reviews the empirical evidence and public health principles associated with functional foods and health claims to analyse the issues, challenge the assumptions that have emerged and explore options for moving forward. Functional foods and health claims are among the more controversial and complex issues being debated by food regulators internationally. Proponents of functional foods and health claims state that functional foods may reduce health care expenditure and health claims are a legitimate nutrition education tool that will help them inform consumers of the health benefits of certain food products. Conversely, opponents of these developments respond that it is the total diet that is important for health, not so-called 'magic bullets'. Moreover, they argue that health claims will enable manufacturers to indulge in marketing hyperbole and essentially blur the distinction between food and drugs. This topic provides a valuable case study of public policy in relation to food and health. The need to maintain a general prohibition on health claims while accommodating specific exemptions supported by scientific substantiation is recommended. Nutrition education and monitoring and evaluation are integral to the proposed regulatory framework. The intention of this policy position is to encourage research and development of innovative food products while avoiding an inappropriate medicalization of the general food supply.

Research and Policy Issues in Ringold and Calfee's Treatment of Cigarette Health Claims

Volume 8 of the Journal of Public Policy & Marketing contained a content analysis of cigarette advertising from 1926–1986 [Ringold and Calfee 1989], together with critiques of both the analysis and its implications [Cohen 1989; Pollay 1989]. In a subsequent paper, Ringold and Calfee [1990] (1) argued that “the evidence supports our exclusion of mildness and most filter claims from the health claims category,” (2) defended their exclusive focus on coding of explicit advertising content (i.e., rather than the likely meaning/interpretation of such claims), and (3) presented a lengthy and speculative analysis to the effect that regulation of tar, nicotine, and related health claims (particularly by the Federal Trade Commission) was ill-advised. This paper responds to each of these issues.

Legislation and Regulation: Bill Limits FDA Regulation Of Health Claims for Foods

Legislation and Regulation: Bill Limits FDA Regulation Of Health Claims for Foods