Most studies that analyze H-RCs and the information about products on the advertising side of food additives cite the Dietary Supplement Health and Education Act, 1994, from the U.S. Food and Drug Administration. In this manner, manufacturers promoted their products using Japanese characteristics of highly contextualized communications with finesse. In Japan, health promotion LAWS on unreasonable premiums and misrepresentations govern dietary supplements advertising. These laws ban misleading and unverified claims that products can prevent or treat diseases. The advertisements were designed to evade these legal restrictions and appeal to consumers regarding preventive effects of COVID-19.
Although some studies have shown that most dietary supplement advertisements fail to provide accurate and comprehensive information (References Kava, Meister, and Whelan, References Shaw, Zhang, and Metallinos-Katsaras and do not identify the primary ingredient (79%) (References Ethan, Basch, and Berdnik others have concluded that this type of advertising includes an identifiable ingredient (91%*1%) of products containing two or more ingredients (References Lee, Vasquez, and Wong. Some companies attempted to evade review or made claims on supplement labels about ingredients not commonly recognized as safe, or were food additives, and perhaps unsafe at levels added.
It is undisputed that manufacturers must shoulder the burden to provide accurate, readily available information on potential limitations and risks associated with food supplements. Advertisements of dietary supplements should not make claims unsupported by scientific evidence, but they should include relevant information on adverse effects; this is true for advertisements for therapeutic medications. Researchers must examine the effects of advertising unfit food additives on consumers perceptions and behaviors. Advertisers of dietary supplements need to recognize that using journal articles, abstracts from scientific studies, or other third-party literature to promote a specific brand or product may influence the way consumers interpret advertising, and which claims advertisers would be liable for supporting. Made can make consumers think the FDA has authorized the stronger advertising for the dietary supplement, or that it has reviewed the supporting evidence for a claim and found that their product is effective.
Analysis of Advertisements on Dietary Supplements
The DSHEA sets out requirements regarding dietary supplement labels, including Manufacturers should have evidence when making the claims, establishing the claims are truthful and non-misleading, and labels should include the statement, This product is not intended to diagnose, treat, cure, or prevent any disease. The DSHEA is intended to achieve a proper balance between providing consumers with access to safe dietary supplements that they can choose to aid in maintaining and improving their health, and giving FDA regulatory power to act on supplements and dietary supplements ingredients causing problems with safety, or that make false or misleading claims, or are otherwise promoted or misbranded. Unlike pharmaceutical products, which must prove they are safe and effective for the intended use before they are sold, the Act does not contain any provisions that would allow the FDA to approve dietary supplements for safety or efficacy before they are available to consumers.
For supplements that do not have new food ingredients, i.e., food ingredients not sold in government prior to Oct. 15, 1994, manufacturers are not required to submit proof of the products safety to FDA, before or after marketing. Except for the case of a new dietary ingredient, in which premarket reviews of safety data and other information are required by law, there is no requirement for a company to submit to the FDA the evidence that it relies upon to support safety or efficacy either before or after marketing of the product. In addition, manufacturers must register themselves under the Bioterrorism Act with the FDA before producing or selling supplements. While the DSHEA does require manufacturers to label their products as supplements and provide a complete list of ingredients, manufacturers are not required to notify the Food and Drug Administration of adverse event reports that they might obtain from consumers.
Under DSHEA, supplement manufacturers are not required to prove safety or effectiveness; Rather, DSHEA intentionally minimizes the supervision by the U.S. Food and Drug Administration and emphasizes the industrys value to the U.S. economy. This new law, which amended the federal Food, Drug, and Cosmetic Act, created a new regulatory framework for dietary supplement safety and labeling. Under DSHEA, it is a companys responsibility to ensure that dietary supplements that they produce or distribute are safe, and that any statements or claims made about them are supported by sufficient evidence showing they are not false or misleading. Because all H-RCs are required to be truthful, and because the European Food Supplement Directive allows for only vitamins and minerals to be substantiated, the primary purpose of this work was to analyze for the existence of misleading and false claims and unapproved ingredients, in order to determine if dietary supplements are in violation of these regulatory principles.
The FTCs approach to supplements advertising is best illustrated by its Statement of Policy for the Administration of Enforcement in Food Advertisements (Food Policy Statement). Although the Food Policy Statement does not refer specifically to supplements, the principles that guide FTCs rulemaking regarding health claims in food advertising are relevant to the agencys approach regarding health claims in supplements. Exacerbating the existing regulatory limitations is the proliferation of influencer marketing (i.e., giving or receiving compensation in exchange for endorsements of products through social media), which has made it easier to use false or misleading claims about supplements to promote the purchase and use of supplements, and to influence consumer trends.
We grouped dietary supplement products by their claimed purposes as health-promoting, disease-specific, sexual-assisted, cosmetic, and weight-loss, according to their advertised purposes. DSHEA goes much further than that, including vitamins; minerals; herbs or other botanicals; amino acids; other food substances for supplementation to diet through increased food intake; and any concentration, metabolite, component, extract, or combination of any of these ingredients.