“When Diet and Exercise Are Not Enough”: An Examination of Lifestyle Change Inefficacy Claims in Direct-to-Consumer Advertising

Previous research suggests that direct-to-consumer (DTC) advertisements for pharmaceutical drugs have the potential to influence consumers’ perceptions of whether symptoms should be treated medically and/or through behavior change. However, the relative frequency of messages emphasizing these approaches in pharmaceutical advertising remains largely unknown. A content analysis of print and television advertisements for cholesterol management medication between 1994 and 2005 (for print) and between 1999 and 2007 (for television) was conducted. First, the extent to which established theoretical constructs drawn from health communication scholarship are depicted in the content of DTC cholesterol advertisements is quantified. Second, specific claims about behavior change inefficacy when a pharmaceutical alternative is available are identified. Findings indicate that DTC ads offer many mixed messages about the efficacy of diet and exercise in reducing cholesterol and risk of heart disease. Theoretical and practical implications of this work are discussed.     

Health claims for food made in Australian magazine advertisements

Aim: The aim was to describe the level of health claims being used in magazine advertisements, the categories of foods carrying health claims, and the types of benefits being claimed for particular foods or food ingredients. Data were compared with similar studies of food labels and Internet sites to reflect the impact of rule governance of the different media and highlight implications for the current proposed changes in food standards legislation. Methods: From January to June 2005, a survey of all print advertisements for food in Australia's 30 top‐selling magazines was undertaken. The results were compared with those from a 1996 survey of health claims in Australian magazines and more recent surveys of claims for food on product labels and on Internet sites. Results: The survey found that 29.5% of 390 advertisements for food carried a health claim. Many of the claims were high‐level claims (29%) or therapeutic claims (8%), which are not permitted by current food standards. The most common benefits being promoted related to cardiovascular disease, energy, cancer and weight control, and most claims referred to the effect of the whole food, rather than specific ingredients. Results were similar to previous studies of food labels and Internet sites. Conclusion: Health claims are being used widely in the print advertising of food products in Australia. Moreover, the presence of high‐level and therapeutic claims in this media bears significant implications for the implementation of rules governing health claims on foods across the different media.     

Communicating about race and health: a content analysis of print advertisements in African American and general readership magazines

A content analysis was conducted to investigate advertisements for consumption products (food, beverages, vitamins, and supplements) in a major magazine aimed at an African American female population as compared to one with a more general female readership. All advertisements for consumption products from Essence and Cosmopolitan magazines from January 2004 to December 2004 were included in the study. The data revealed that the 3 most advertised products in Essence were individual food items, nonalcoholic beverages, and fast food. In Cosmopolitan individual food items, alcoholic beverages, and weight loss products were most advertised. Both magazines included a number of ads making health claims regarding the products. Cosmopolitan had more weight loss claims in the magazine's advertisements than did Essence. The results indicated that marketing of consumption products differs based on the magazine's target population in regard to race.     

Evaluating Direct-to-Consumer Marketing of Race-Based Pharmacogenomics: A Focus Group Study of Public Understandings of Applied Genomic Medication

Some medical providers have advocated applied genomics, including the use of genetically linked racial phenotypes in medical practice, raising fear that race-based medication will become justified. As with other emerging medical genetic technologies, pharmaceutical companies may advertise these treatments. Researchers fear that consumers will uncritically accept pharmaceutical messages and demand the product. In this exploratory study, we examined public reactions to advertisements for applied genomic medications. A focus group methodology was employed. Participants tended to resist the message and generated warrants for doing so, indicating critical reception of the messages. Message accepters also provided warrants. Warrants for resistance and acceptance differ between self-identified racial groups. Consumers, health care providers, and pharmaceutical corporations will benefit from a better understanding of direct-to-consumer advertisements as medical communication. Our study concludes that both advocates and opponents of direct-to-consumer advertisements should recognize that potential consumers of pharmacogenomics act as critical consumers of health advertising discourse.     

Evaluating direct-to-consumer marketing of race-based pharmacogenomics: a focus group study of public understandings of applied genomic medication

Some medical providers have advocated applied genomics, including the use of genetically linked racial phenotypes in medical practice, raising fear that race-based medication will become justified. As with other emerging medical genetic technologies, pharmaceutical companies may advertise these treatments. Researchers fear that consumers will uncritically accept pharmaceutical messages and demand the product. In this exploratory study, we examined public reactions to advertisements for applied genomic medications. A focus group methodology was employed. Participants tended to resist the message and generated warrants for doing so, indicating critical reception of the messages. Message accepters also provided warrants. Warrants for resistance and acceptance differ between self-identified racial groups. Consumers, health care providers, and pharmaceutical corporations will benefit from a better understanding of direct-to-consumer advertisements as medical communication. Our study concludes that both advocates and opponents of direct-to-consumer advertisements should recognize that potential consumers of pharmacogenomics act as critical consumers of health advertising discourse.     

Communicating About Race and Health: A Content Analysis of Print Advertisements in African American and General Readership Magazines

A content analysis was conducted to investigate advertisements for consumption products (food, beverages, vitamins, and supplements) in a major magazine aimed at an African American female population as compared to one with a more general female readership. All advertisements for consumption products from Essence and Cosmopolitan magazines from January 2004 to December 2004 were included in the study. The data revealed that the 3 most advertised products in Essence were individual food items, nonalcoholic beverages, and fast food. In Cosmopolitan individual food items, alcoholic beverages, and weight loss products were most advertised. Both magazines included a number of ads making health claims regarding the products. Cosmopolitan had more weight loss claims in the magazine's advertisements than did Essence. The results indicated that marketing of consumption products differs based on the magazine's target population in regard to race.     

The EFSA health claims 'learning experience'

The European Food Safety Authority (EFSA) has recently highlighted the need to provide scientific requirements for health claims and to find new regulatory issues for healthy food products. For this reason, EFSA asked its Dietetic Products, Nutrition and Allergies (NDA) panel to draft additional guidelines on scientific assessment of these claims. A new approach for a strict substantiation of health issues in selected fields: the Regulation (EC) No. 1924/2006 established in fact that health claims applications should only be authorized after a high level of scientific validation conducted by EFSA using appropriate measures in this evaluation. The legislation should not only protect consumers but also define specific research areas with appropriate outcome measures to assess the quality, relevance and adequacy of studies conducted for scientific validation of health claims. The new system was not only a necessary support for consumers to make the correct choice of products, but rather a way for EFSA to demonstrate transparency of this new approach. This was the field of the pharmaceutical industry, this new regulation is, therefore, also for EFSA, an expensive learning process.     

Governance of nutrivigilance in the Netherlands: Reporting adverse events of non-registered products

The Dutch Pharmacovigilance Centre Lareb receives an increasing number of reports on products that fall within the grey area of non-registered health-enhancing products, including supplements. Currently, there is no structural vigilance approach to handling these spontaneous reports of suspected adverse events. This explorative study identified whether and how a vigilance framework in the Netherlands can be organised to contribute to consumer protection from adverse reactions to health-enhancing food products. Conducted interviews showed that involved organisations form a complex network, without official governance structures. Organisations lack a legal basis to handling reports, whilst representatives do feel the need to take reports seriously. Interviewees identified various opportunities to improve vigilance, including raising consumer awareness. Following our study, first steps were taken towards improving safety by officially designating Lareb to study adverse events. Further advances to food supplement safety were announced by the Dutch Ministry but have not yet been implemented. With highly differing approaches to governing vigilance in- and outside the EU, it remains necessary to further analyse how nutrivigilance can be organised best to stimulate consumer protection from unsafe substances.     

Medicalisation of food advertising. Nutrition and health claims in magazine food advertisements 1990–2008

Food advertising increasingly portrays food as a type of medicine. A content analysis of magazine food advertisements in 1990 through 2008 shows that this was manifested with time more in the (a) nutrition claims and (b) health claims made in food advertisements, as well as the (c) food groups and (d) media genres to which nutrition and health claims in food advertising pertained. This so-called “medicalisation” of food advertising may promote images of the body and mind as malfunctioning unless remedied by the use of – advertised – products.     

Survey of health claims for Australian foods made on Internet sites

Objective: Australia and New Zealand are currently preparing a new food standard code, which will allow the use of health claims on food products and in associated advertising. The aim of the present study was to obtain preliminary information about the current use of health claims on the Internet and the level of compliance of these claims with existing regulations. Methods: From August to October 2005 a survey was conducted of 1068 websites associated with the top 20 food‐processing companies in Australia, and an additional 683 websites for food products found to carry health claims in previous studies of product labels and magazine advertisements. The results were compared with those from a 2003 survey of health claims on the labels of 7850 products. Results: The survey found that 14.5% of food product websites carried a health claim, and 40.7% and 37.0% of products previously identified as carrying claims on product labels or in magazines, respectively, had Internet claims. Of claims 21.4% were located directly on the food product webpage, but the majority (78.6%) were on associated links within the manufacturer’s website. Many of the claims (19.7%) were high‐level or therapeutic claims not permitted by current food standards. Conclusions: Health claims are not being made more frequently on websites compared with product labels, but there is a greater prevalence of high‐level and therapeutic claims made on the Internet. In future, food standards enforcement will need to give greater priority to monitoring the use of health claims on the Internet.     

Food advertising in the age of obesity: content analysis of food advertising on general market and african american television

OBJECTIVE: To document the types of foods advertised and weight-related nutritional claims made during advertisements appearing on general market and African American television programming. DESIGN: Content analysis of 553 food advertisements appearing during 101.5 prime-time television hours. OUTCOME MEASURES: Advertisements were classified according to general category (fast-food restaurant, sit-down restaurant, packaged food), specific food type, and the presence of a weight-related nutritional claim. ANALYSIS: The type of foods advertised and nutritional claims made on general market and African American programs were compared using t and chi-squared tests. RESULTS: More food advertisements appeared during African American programs than general market programs. These advertisements were more likely to be for fast food, candy, soda, or meat and less likely to be for cereals, grains and pasta, fruits and vegetables, dessert, or alcohol. Of all of the food advertisements, 14.9% made a weight-related nutritional claim. More claims related to fat content appeared during African American programming, whereas more light and lean claims appeared in general market advertisements. CONCLUSIONS AND IMPLICATIONS: Practitioners and policy makers should be aware of the prevalence of food advertisements and their potential impact on knowledge and behavior and should consider working more closely with food manufacturers to encourage the creation and promotion of weight-friendly foods. Meanwhile, nutrition educators can help by teaching consumers critical thinking skills as may relate to food advertisements.     

Nutrition and health--sense and nonsense regarding food supplements and functional foods

A functional food is a proprietary food or beverage with a health-related claim. Such functional foods could make it easier to maintain a healthy diet. Unfortunately, in many countries regulations allow manufacturers to imply that a food promotes health without providing proper scientific evidence. At the same time, regulations may forbid claims that a food product prevents disease, even when it does (e.g. folic acid, which reduces the risk of neural tube defects). Functional foods may have beneficial health effects compared with traditional foods in some cases, but current legislation in the Netherlands cannot protect consumers from misleading claims.     

Persuasive food marketing to children: use of cartoons and competitions in Australian commercial television advertisements

While there is a recognized link between high levels of exposure to advertising of unhealthy foods and overweight and obesity among children, there is little research on the extent to which these exposures include persuasive marketing techniques. This study aimed to measure children's exposure to the use of persuasive marketing within television food advertisements. Advertisements broadcast on all three commercial Australian television channels were recorded for an equivalent 1 week period in May 2006 and 2007 (714 h). Food advertisements were analysed for their use of persuasive marketing, including premium offers, such as competitions, and the use of promotional characters, including celebrities and cartoon characters. Advertised foods were categorized as core, non-core or miscellaneous foods. Commercial data were purchased to determine children's peak viewing times and popular programs. A total of 20 201 advertisements were recorded, 25.5% of which were for food. Significantly more food advertisements broadcast during children's peak viewing times, compared to non-peak times, contained promotional characters (P < 0.05) and premium offers (P < 0.001). During programs most popular with children, there were 3.3 non-core food advertisements per hour containing premium offers, compared to 0.2 per hour during programs most popular with adults. The majority of advertisements containing persuasive marketing during all viewing periods were for non-core foods. Persuasive marketing techniques are frequently used to advertise non-core foods to children, to promote children's brand recognition and preference for advertised products. Future debate relating to television advertising regulations must consider the need to restrict the use of persuasive marketing techniques to children.     

Regulatory issues for orphan medicines: A review

Orphan medicines are medicinal products intended for diagnosis, prevention or treatment of life-threatening or debilitating rare diseases. They are ‘orphans’ because the pharmaceutical industry has little interest under normal market conditions in developing and marketing drugs intended for only a small number of patients suffering from very rare conditions. Successful development of new treatments for rare diseases and their sustainable patient access require overcoming a series of challenges related to research and health technology assessment.The orphan drugs legislation provides a set of incentives and conditions to the pharmaceutical industry to develop medicines for the treatment of rare diseases. In fact, the number of orphan products approved (centralized level) is far exceeding anything seen before the orphan drug legislation. However, the final stage relates to whether a patient is able to receive treatment in a timely and reimbursed manner occurs at the payers’ level (decentralized process), which, leads to inconsistency in patient access between European countries. The challenge of regulatory authorities, patient groups, pharmaceutical companies, legislators and payers is to provide access to new therapies, without geographic or economic discrimination. Despite the progress in the field of rare diseases there is still a need of investment.So, the main objective of this paper is to describe the regulatory framework of orphan medicines in the USA and the EU, including specific legislation and guidelines, orphan medicine designation process, economic encouragements and impact of these in market approval, to improve the consistency, effectiveness and sustainability of orphan medicines value assessment.     

Nutrition and Health Claims Spectra of Pre-Packaged Foods on Serbian Supermarket Shelves: A Repeated Cross-Sectional Study

Nutrition and health claims (NHCs) are a powerful tool that influence consumers’ final decision on the choice of food products. The purposes of this repeated cross-sectional study were to (i) assess the prevalence of pre-packaged food products containing nutrition and health claims among different food categories, (ii) to determine the type of NHCs labelled on the examined food products, and (iii) to evaluate the trend in the use of NHCs in comparison to the 2012 survey. The survey was conducted immediately before the full enforcement of the new national legislation on NHCs in 2020. It comprised 3141 pre-packaged food products from 10 product categories. In total, 21.2% of food products contained any claim (19.4% contained any nutrition claim; 8.2% contained any health claim). In comparison to the 2012 survey, we observed a rising trend in the presence of NHCs; the use of nutrition claims on food products increased three times and the use of health claims increased 1.3 times in the 2020 survey. Bearing in mind that NHCs are a powerful tool guiding consumers’ food purchase decisions, NHCs should be supported by precise legislation and strict surveillance by the public health authorities.     

Medicare Drug Price Negotiation in the United States: Implications and Unanswered Questions

The United States is a relatively free-pricing market for pharmaceutical manufacturers to set list prices at the product launch. Few drug price controls exist, and federal price negotiation as a policy has historically been politically untenable. After decades of debate on whether the federal government, specifically the Medicare program, should more actively manage drug prices, the US Congress passed legislation authorizing Medicare to directly negotiate prices with manufacturers. The purpose of this article is to describe elements and implementation of the price negotiation provisions and then comment on the potential impacts on payers, innovations, and the pharmaceutical industry. While impacting only a few drugs each year in the beginning, price negotiation in the Medicare program will have secondary and long-term effects in the US market and beyond. It is clear that in the United States, the Medicare market for drugs will no longer be a free-pricing environment in the industry.     

Consumer understanding of nutrition and health claims: sources of evidence

Provided that they are scientifically substantiated, nutrition and health (NH) claims linked to food products can help consumers make well-informed food choices. The new European legislation on NH claims made on foods entered into force on 19 January 2007. The law sets out conditions for their use, establishes a system for their scientific evaluation, and will create European lists of authorised claims. An important aspect of this proposed legislation is that it states, in article 5.2, 'the use of nutrition and health claims shall only be permitted if the average consumer can be expected to understand the beneficial effects expressed in the claim'. The present review examines consumer understanding of NH claims from a consumer science perspective. It focuses on the type of data and information that could be needed to provide evidence that the average consumer adequately understands a particular NH claim. After exploring several different methodologies, it proposes a case-specific approach using a stepwise procedure for assessing consumer understanding of a NH claim.