The regulatory aspects of the food additives industry offer a backdrop to several areas of public health concern, including consumer behaviors regarding usage, safety, and effectiveness, as well as studies that address health effects from regular use of supplements. This paper reviews federal regulatory mechanisms that have been established to regulate dietary supplements and suggests strategies on how U.S. laws–both administrative regulations and the common law–can enhance the regulation of dietary supplements in a new age of influencers. The FDA regulates dietary supplement quality, safety, and labeling, while the Federal Trade Commission oversees advertising and marketing; however, there are vast challenges in enforcing regulations, and optimum state supervision has yet to be achieved.
The Federal Trade Commission is charged with regulating advertisements–a wide range of media, which can include print, broadcast, infomercial, catalog, direct-marketing, and Internet promotions2–of dietary supplements. Herbal supplements are regulated by the FDA, but they are regulated less rigorously than prescription or over-the-counter (OTC) drugs. Herbal supplements typically do not get as much scientific review, nor are they as rigorously regulated as medications.
Herbal products may present unanticipated risks, because many supplements contain active ingredients with powerful effects on the body. Herbal supplement manufacturers are responsible for making sure the claims they make about their products are not false or misleading, and are supported by sufficient evidence. The FDA may take action against companies who make false or unsupported claims in order to market their supplements.
Natural Supplements law in Virginia
Have studies supporting claims the product addresses a nutritional deficiencies or supports health, and include a disclaimer saying that FDA has not evaluated this claim. The DSHEA outlines requirements for labeling of food additives, including Manufacturers should have evidence when making the claims, establishing the claims are truthful and non-misleading, and labels should include a phrase, This product is not intended to diagnose, treat, cure, or prevent any disease. A critical weakness of the regulatory framework created by DSHEA is that manufacturers are not required to submit safety information prior to marketing of dietary supplements.
To further support public health goals of the Dietary Supplement Health and Education Act (DSHEA), FDA has also issued guidance documents, which provide nonbinding recommendations, to assist industry with understanding and implementing all regulations and laws. As the standards-setting body committed to public health, USP supports manufacturers of dietary supplements in continuing to produce quality products that address the needs of consumers. USPs DSC also includes General Chapters related to Good Manufacturing Practices that manufacturers can use to help ensure their supplements are made using safe, sanitary, and well-controlled production practices.
Instead of solely relying on the active regulation by regulatory agencies, we need direct-to-consumer healthcare product regulation that recognizes their place in the healthcare landscape, stresses the need for both accurate acquisition and dissemination of information, and uses digital tools to effectively communicate. Fifth, health professionals should be better educated on direct-to-consumer health products within their own fields. Fourth, in order to conduct a meaningful public education campaign, we need to conduct more studies about the effectiveness, safety, and efficacy of direct-to-consumer health products, about how consumers choose to access them, and about the ways they use those products. Second, DTC health products need to be reconceptualized as mostly presenting informational, not regulatory, problems.
In this reframe, DTC health products are a challenge that could be addressed much like public health messaging campaigns, aimed at increasing consumers knowledge about the evidence, risks, and benefits. First, it is necessary to develop alternative regulatory solutions better aligned to the current landscape for DTC health products.
Perhaps more health-related information monitoring in content rating systems is warranted, especially for pages that we know are likely to thrive with health disinformation. Given the fact that the quality of overall health information on the internet cannot be guaranteed, at this point, it is incumbent upon individuals to be discerning and to evaluate the information that they are reading with critical care.
Individuals have always obtained information outside of the formal health system, and health disinformation are not new. More troubling, sites generally considered reliable sources of health information are susceptible to disinformation. It appears the vast majority of people, not just people with a basic level of health literacy, are using poor-quality websites when looking for health information. Although many studies have noted improvements in quality over time, 55% of articles reviewed concluded that quality of health information on the internet is poor.
Although certain individuals are unlikely to obtain health information online, such as older adults and individuals with lower levels of education and income, there is little question that the Internet has democratized health care. No longer is a patient the passive recipient of health care recommendations, but he or she may play an active role in the consumption and evaluation of health care information. Find easily understood information that you can trust on diseases and health conditions, medications and supplements, and medical studies and clinical trials. Even if they are unaware of a particular supplement, they can probably direct you to the latest medical guidelines on its use and risks.
An easy way to compare ingredients in products is by using the Database of Dietary Supplement Labels, available through the website for the US National Institutes of Health. Dietary supplements may include generic health claims, nutrient-content claims, or structural-function claims. Certain scientific verifications are required to be submitted only to the Food and Drug Administration for health claims that demonstrate a direct relationship between use of the supplement and reduced risk for disease.
Exacerbating the present regulatory constraints is the spread of influencer marketing (i.e., giving or receiving compensation in exchange for endorsements of products through social media), which has made it easier to make false or misleading claims about dietary supplements in order to promote their purchase and use, and to influence consumer trends. USDAs mission is to improve food security and reduce hunger by providing children and people with low incomes access to food, healthy eating, and nutrition education in ways that support American agriculture and build public trust.