Health-related claims in food supplements endorsements: a content analysis from the perspective of EU regulation.

OBJECTIVES: Based on the legal framework regulating the advertisement of food supplements in the EU, the aim of this article is to analyse the relationship between the presence of endorsers, the different types of health-related claims (H-RCs) and product content information. STUDY DESIGN: We applied a quantitative approach based on the content analysis of all radio spots broadcast throughout 2017 on full-service radio stations in Spain. METHODS: A corpus of 10,556 radio spots was obtained of the three radio stations with the highest audience levels (165 without repetitions). We incorporated data on the accumulated broadcast frequencies to supplement the content analysis specific to each radio spot with its weight in relation to the overall advertising discourse. We developed a coding scheme to assess the type of endorser, the types of H-RCs, and the product content information. RESULTS: Results show that European directives are breached in different ways. Healthcare experts prevail in disease claims, although they are prohibited. Celebrities are the most widely used endorsers (25%) in the function and reduction of disease risk claims. In addition, although these types of claims require substantiation by authorised ingredient, 73% of H-RCs lack this information. CONCLUSIONS: The high presence of illicit H-RCs and endorsers, such as physicians, and the omission of compulsory product information suggest that public administrations must apply stricter monitoring and sanctioning mechanisms to dissuade advertisers from further breaches of the law and to protect consumers. Implications for public health policy are made.

Digital Manipulation of Images of Models' Appearance in Advertising: Strategies for Action Through Law and Corporate Social Responsibility Incentives to Protect Public Health.

CONTEXT: Widespread digital retouching of advertising imagery in the fashion, beauty, and other consumer industries promotes unrealistic beauty standards that have harmful effects on public health. In particular, exposure to misleading beauty imagery is linked with greater body dissatisfaction, worse mood, poorer self-esteem, and increased risk for disordered eating behaviors. Moreover, given the social, psychological, medical, and economic burden of eating disorders, there is an urgent need to address environmental risk factors and to scale up prevention efforts by increasing the regulation of digitally altered advertising imagery. METHODS: This manuscript summarizes the health research literature linking digital retouching of advertising to increased risk of eating disorders, disordered weight and appearance control behaviors, and body dissatisfaction in consumers, followed by a review of global policy initiatives designed to regulate digital retouching to reduce health harms to consumers. Next, we turn to the US legal context, reporting on findings generated through legal research via Westlaw and LexisNexis, congressional records, federal agency websites, law review articles, and Supreme Court opinions, in addition to consulting legal experts on both tax law and the First Amendment, to evaluate the viability of various policy initiatives proposed to strengthen regulation on digital retouching in the United States. FINDINGS: Influencing advertising practices via tax incentives combined with corporate social responsibility initiatives may be the most constitutionally feasible options for the US legal context to reduce the use of digitally alternated images of models' bodies in advertising. CONCLUSIONS: Policy and corporate initiatives to curtail use of digitally altered images found to be harmful to mental and behavioral health of consumers could reduce the burden of eating disorders, disordered weight and appearance control behaviors, and body dissatisfaction and thereby improve population health in the United States.

Promotions of breastmilk substitutes, commercial complementary foods and commercial snack products commonly fed to young children are frequently found in points-of-sale in Bandung City, Indonesia.

Few studies have documented the marketing of commercial foods and beverages for infants and young children in West Java, Indonesia. To assess the prevalence of promotions at points-of-sale for commercially produced products commonly fed to young children in Bandung City, 43 small and large stores were visited in 2017. Promotions for breastmilk substitutes (BMS), commercially produced complementary foods (CPCF), and select types of commercial snack products were photographed and information recorded on promotion characteristics. There were 402 and 206 promotions observed with BMS and CPCF products, respectively. Sixteen promotions with BMS products for infants under 12 months were found in 42.9% of stores selling BMS, violating national regulations. Almost all BMS promotions (98.3%) included BMS products for ages 1 year and above ("growing-up milks"). Of all BMS products available for sale, half of all infant/follow-up formula and 77.2% of growing-up milks were promoted. CPCF were found in 97.7% of stores, and 81.0% of these stores had promotions; 70.5% of all available CPCF products were promoted. Of the 2,451 promotions observed for commercial snack products, 17.3% used promotional techniques targeting young children or caregivers. Joint-promotions were common, with BMS and CPCF marketed in combination with commercial snack products; 49.0% of BMS promotions were joint BMS-snack promotions, and 80.0% or more of infant/follow-up formula promotions included a commercial snack. Revising and enforcing infant food and beverage marketing regulations to ensure consistency with global standards are necessary to protect and promote optimal infant and young child feeding in Indonesia.

At-risk advertising by Australian chiropractors and physiotherapists.

Background: Society expects professionals to promote their businesses in an ethical manner, refraining from misleading or deceptive marketing due to the potential to harm members of the community. In Australia this expectation resides in the Australian registration board advertising guidelines or the Health Practitioner Regulation National Law. Registration board data indicate there are many health care professionals failing to meet these expectations. The aims of this research were to determine the frequency, type and nature of at-risk advertising by Australian chiropractors and physiotherapists and whether there is a correlation between professional association membership and advertising guideline compliance. Method: A cross sectional audit examining practitioner advertising was performed on representative samples of Australian chiropractors and physiotherapists. Two auditors examined advertising by 380 physiotherapists and 359 chiropractors for material potentially in breach of the regulatory authorities' advertising guidelines. The advertising appeared on practitioner websites and linked Facebook pages. Results: Two-hundred and fifty-eight (72%) audited chiropractors and 231 (61%) audited physiotherapists had breaches of the Advertising Guidelines on their websites and linked Facebook pages. The frequency of breaches by chiropractors was higher. The type and nature of the breaches by chiropractors was potentially more harmful. Membership in a professional association influenced neither the frequency nor the severity of breaches with chiropractors. Discussion: Advertising breaches were common in both samples even though regulators and professional associations provide practitioners with explicit information on how to comply with advertising guidelines. Breaches by chiropractors were more numerous and more serious due to their greater potential to lead consumers to make inappropriate and potentially harmful healthcare decisions.Stronger enforcement strategies may have a positive effect on compliance.

A discussion of the unresolved 2016/17 plans for regulating the Polish dietary supplements market.

The Polish dietary supplement market is growing steadily. However, even though these products may have an impact on health they are not as strongly regulated as pharmaceuticals. In 2016/17 the introduction of new regulations covering the marketing of dietary supplements in Poland was proposed. This article briefly describes the Polish market for dietary supplements and assesses the benefits and risks associated with its development. A range of potential legislative changes, such as a total ban on dietary supplements, a ban on using the images and recommendations of authoritative entities, increased fines for breaking the law, and other measures are under consideration. We describe the advantages (e.g., better customer protection, and the limitation of inappropriate, misleading advertising) and disadvantages (e.g., a decrease in product innovation, deterioration in product offerings, and rises in product prices) of the proposed changes. As a European Union member, Poland adopts EU law, but EU directives have only harmonized some issues relating to dietary supplement marketing, other key aspects remaining within the competence of member states, but it is noted that some proposed changes in Polish law (e.g., an advertising ban) are so strict that they are unlikely to be acceptable to the EU.

[Problems with Advertisements for Health Foods].

We have been studying the way advertisements for medicines have been monitored by the Health, Labour and Welfare Sciences Research Grants. In the last fiscal year, we identified products that were being advertised to general consumers, such as OTC drugs and designated quasi-drugs, and made recommendations to the Ministry of Health, Labour and Welfare on the methods of advertisement. Members of our research group, including physicians, pharmacists, and consumers, pointed out that advertisements for so-called health foods and foods with functional claims were much more unregulated than those for drugs, including OTC drugs. Thus, this fiscal year, we decided to focus on health foods. Advertisements for health foods are regulated by the Health Promotion Act and the Act against Unjustifiable Premiums and Misleading Representations; moreover, in many cases, cautions are issued by the Consumer Affairs Agency or prefectures. Several studies also reported health damage in patients who, because of their belief in advertisements, intentionally discontinued treatment or missed the opportunity to receive appropriate medical treatment. Here, we report inappropriate advertisements for health foods that may cause health hazards.

Does Disciplinary Law Protect Us from False and Misleading Health Advertising?

Health-related advertisements should not mislead prospective patients. To do so may deprive patients of their ability to give or withhold consent to treatment and in the case of terminally ill patients, of the opportunity to accept and come to terms with the dying process. Patients should be able to expect that claims in health-related advertising are based on the most recent scientific evidence and are not predatory or exploitative. However, internet advertising and social media continue to provide opportunities for unscrupulous health practitioners to peddle their wares. This article considers whether disciplinary law effectively deals with false, misleading or deceptive health-related advertising in the context of regulated and unregulated practitioners as well as complementary and alternative medicine. It argues that consideration should be given to amending disciplinary law to specify what evidence is required to substantiate claims made in advertising.

Social Media Posts by Recreational Marijuana Companies and Administrative Code Regulations in Washington State.

Importance: Recreational marijuana use was legalized in the state of Washington in 2012, and the Washington Administrative Code (WAC) 314-55-155 was implemented to limit the exposure of youths to marijuana advertisements. Objectives: To evaluate the content of social media posts by marijuana companies and to assess the compliance of these posts with WAC regulations. Design, Setting, and Participants: In a cross-sectional study, a content analysis of 1027 social media posts was conducted to identify and assess compliance of WAC regulations with the business pages of recreational marijuana companies located on Facebook and Twitter platforms in the state of Washington from December 1, 2015, through November 30, 2016. Main Outcomes and Measures: Application of coding based on WAC regulations to focus on the prohibition of language that promoted the overconsumption of marijuana, that described its curative or therapeutic benefits, or that was designed to appeal to youths; and the requirements for warnings about intoxication, driving, health risks, and age restrictions for marijuana. Results: Of the 1027 posts on Facebook and Twitter from business pages of 6 marijuana companies, Facebook followers ranged from 342 to 1592 persons and Twitter followers ranged from 374 to 2915 persons per company. Findings for WAC regulations included 17 posts (1.7%) that encouraged overconsumption; 137 posts (13.3%) that promoted therapeutic benefits; and 9 posts (0.01%) that appealed to youths. Requirements for warnings addressing intoxication, driving, health risks, and age restrictions were present on 110 posts (10.7%). Some businesses repeatedly violated particular regulations; 7 of 17 (41.2%) posts encouraging overconsumption derived from 1 marijuana company. Conclusions and Relevance: Most social media posts by marijuana companies were consistent with WAC regulations that prohibit particular messages, but few companies provided required warning messages. Findings can be used toward implementation strategies for marijuana prevention to address these influential media messages.

[Marketability of food supplements - criteria for the legal assessment]. / Kriterien zur Beurteilung von Nahrungsergänzungsmitteln.

To be placed on the market legally, food supplements have to meet national and European food law regulations. This is true for all substances used as well as for the labeling on the packaging of and the advertising for food supplements. The food business operator is responsible for its compliance with all regulations. Therefore, in this article, a concise step-by-step assessment is presented, covering all necessary legal requirements to market food supplements. Additionally, all steps are visualized in a flow chart. All vitamins, minerals and other substances used have to meet the legal conditions. Food business operators have to make sure that their products do not contain medicinal ingredients based on their pharmacologic effect. It is prohibited to place medicinal products as food supplements on the market. Furthermore, food business operators have to make sure that their products are not non-authorized novel foods according to the novel food regulation (EC) no. 258/97. Also, food supplements have to meet the requirements of article 14 of Regulation (EC) No. 178/2002 concerning the safety of foodstuff. Food shall not be placed on the market if it is unsafe. For food supplements that fail the German food-related legal standards but are legally manufactured in another EU member state or are legally put into circulation, the importer requires the so-called general disposition, which must be applied for at the BVL according to § 54 of the German Food and Feed Act. Another possibility for food which fails to meet German food law is to apply for a certificate of exemption according to § 68 of the Food and Feed Act. The food business operator has to meet the harmonized regulations concerning maximum and minimum levels of additives, flavors and enzymes. The packaging has to meet the compulsory labeling as well the voluntary labeling, like health claims. The BVL is also the relevant authority for other tasks concerning food supplements. A figure shows all notifications since 2005 of food supplements in Germany at the BVL. Additionally, an overview for notifications in the rapid alert system for food and feed concerning food supplements is given as well as a brief introduction into the survey of food supplements marketed on the internet.

STOPPING DECEPTIVE HEALTH CLAIMS: THE NEED FOR A PRIVATE RIGHT OF ACTION UNDER FEDERAL LAW.

This Article offers a thorough analysis of an important public health issue, namely how to confront the growing problem of deceptive claims regarding foods and dietary supplements, including increasingly prevalent but unverifiable claims. The authors call for the creation of a limited private right of action under the Federal Trade Commission (FTC) Act for deceptive health-related claims for these products. The proposal responds to the growing market for these products and the inadequacy of current laws and enforcement actions to prevent such claims. In crafting the limited private right of action, the authors attempt to enhance consumer protection without undermining federal agency primacy in enforcement. The Article ends with an appendix setting forth proposed language for a statutory amendment to the FTC Act incorporating the authors' proposal.

THE MEDICO-SCIENTIFIC MARGINALISATION OF HOMEOPATHY: INTERNATIONAL LEGAL AND REGULATORY DEVELOPMENTS.

The 2010 report of the United Kingdom Science and Technology Committee of the House of Commons and the 2015 report of the Australian National Health and Medical Research Council have overtaken in significance the uncritical Swiss report of 2012 and have gone a long way to changing the environment of tolerance toward proselytising claims of efficacy in respect of homeopathy. The inquiry being undertaken in the United States by the Food and Drug Administration during 2015 may accelerate this trend. An outcome of the reports and inquiries has been a series of decisions from advertising regulators and by courts rejecting medically unjustifiable claims in respect of the efficacy of homeopathy. Class actions have also been initiated in North America against manufacturers of homeopathic products. The changing legal and regulatory environment is generating an increasingly scientifically marginalised existence for homeopathy. That new environment is starting to provide effective inhibition of assertions on behalf of homeopathy and other health modalities whose claims to therapeutic efficacy cannot be justified by reference to the principles of evidence-based health care. This has the potential to reduce the financial support that is provided by insurers and governments toward homeopathy and to result in serious liability exposure for practitioners, manufacturers and those who purvey homeopathic products, potentially including pharmacists. In addition, it may give a fillip to a form of regulation of homeopaths if law reform to regulate unregistered health practitioners gathers momentum, as is taking place in Australia.

Too little, too late: ineffective regulation of dietary supplements in the United States.

Millions of people in the United States consume dietary supplements hoping to maintain or improve their health; however, extensive research has failed to demonstrate the efficacy of numerous supplements in disease prevention. In addition, concerns about the safety of routine and high-dose supplementation have been raised. The Food and Drug Administration regulates dietary supplement quality, safety, and labeling, and the Federal Trade Commission monitors advertisements and marketing; still, vast enforcement challenges remain, and optimal governmental oversight has not been achieved. If the composition and quality of ingredients cannot be reliably ensured, the validity of research on dietary supplements is questionable. Moreover, the health of the US public is put at risk.

Origins of the prohibition against off-label promotion.

The statute and regulations administered by the Food and Drug Administration ("FDA") do not explicitly prohibit the promotion of drugs and medical devices for unapproved uses, yet the government has collected billions of dollars in penalties for such "off-label" promotion. The statutory interpretations and regulatory provisions relied on by the government to take enforcement action against off-label promotion are the incidental by-products of initiatives undertaken by FDA through administrative action and litigation early in its implementation of the Federal Food, Drug, and Cosmetic Act. The actions were designed to obtain FDA authority over therapeutic claims made in advertising, even though Congress had assigned authority over advertising to the Federal Trade Commission, and to establish a prescription-only drug system, even though FDA lacked statutory authority for such a system. The principal purpose of both efforts was to prevent inappropriate self-medication. This article describes the history of those strategies, including expansion of the definition of the term "labeling" to encompass matter that was initially regarded as advertising; creation of the rule that the labeling of drugs must have adequate directions for all "intended" uses; and construction of the prescription-only drug system in a manner that allowed FDA to use the statutory requirement for labeling to have "adequate directions for use" to prohibit the off-label promotion of prescription drugs.

Probiotics: achieving a better regulatory fit.

The development and marketing of new probiotic products, substances containing live microorganisms that have a beneficial effect on the human body, have dramatically increased over the last few years. This article examines how the Food and Drug Administration and Federal Trade Commission currently regulate probiotics and makes recommendations as to changes that might be made to ensure that probiotic products are made available to the general public in a way that is both safe and effective.

Regulation of natural health products in Canada.

ETHNOPHARMACOLOGICAL RELEVANCE/INTRODUCTION: In Canada, all natural health products (NHPs) are regulated by Health Canada (HC) under the Food and Drugs Act and the Natural Health Product Regulations. All authorized products undergo pre-market assessment for safety, efficacy and quality and the degree of pre-market oversight varies depending on the risk of the product. OVERVIEW: In Canada, over 70,000 products have been authorized for sale and over 2000 sites have been licensed to produce NHPs. In the management of NHPs on the Canadian market, HC employs a number of active and collaborative methods to address the most common issues such as contamination, adulteration and deceptive or misleading advertising practices. HC is currently evolving its approaches to NHPs to recognize them as part of the larger group of health products available without a prescription. As such, the regulatory responsibility for all over-the-counter (OTC) drugs, including non-prescription drugs and NHPs, has been transferred to a single federal division. CONCLUSION: As a result of this transition a number of benefits are being realized with respect to government efficiency, clarity for industry, support for new innovations and consolidated government interactions with the Canadian market.