Genesis Fajardo – In light of the growing trend of health gurus and supplement enthusiasts, the market’s unprecedented expansion has raised significant concerns about consumer safety and regulatory practices. The passage of the Dietary Supplement and Health Education Act (DSHEA) in 1994 transformed the supplement industry, increasing its market value from $4 billion to over $40 billion; this growth resulted from relaxing regulations and reclassifying supplements as food instead of drugs, a practice not implemented before the enactment of the new legislation. Although the reclassification provides consumers with a sense of assurance and perceived lower risk, these products remain significantly underregulated and require reform.
Both the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) play vital roles in regulating dietary supplements: the FTC oversees the advertisement of dietary supplements, while the FDA focuses on safety, quality, and labeling of supplements. Despite the FDA’s crucial role, its effectiveness in regulating dietary supplements is constrained by insufficient legal authority and resources, putting consumers’ health and safety at increased risk. Manufacturers can sell dietary supplements without proving their efficacy beforehand, leading to widespread unverified health claims. This differs from the rigorous approval process pharmaceutical drugs must undergo to gain FDA approval, which requires demonstrating both safety and effectiveness. Under Title 21 of U.S. Code §342 (f), the government must establish that a dietary supplement is unsafe before it can be removed from the market. In contrast, pharmaceutical medications undergo extensive pre-market evaluations, including clinical trials and comprehensive research. Such a reactive approach for supplements, which addresses safety concerns only after the product is being sold, thus provides a lower level of consumer protection compared to the pharmaceutical industry.
While stricter regulations may limit access to some dietary supplements, it is crucial to acknowledge that access to numerous products is meaningless if the concentrations of essential ingredients are inaccurate. Without accurate labeling, the public gains no benefit and economic waste occurs. The lack of strict oversight allows companies to prioritize profits over consumer protection, a practice implicitly supported by the current law.
Given the rising popularity of fitness supplements and protein powders, consumers are increasingly vulnerable to deception by companies seeking to capitalize on this trend for quick profits. By rushing to place a particular type of product into the market to compete, companies are more likely to skip thorough testing and market products with appealing but inaccurate claims. This competitive environment compromises consumer safety, leaving ordinary people vulnerable to the influence of major players in the vitamin and supplement space.
While the FDA has taken steps to modernize its regulation of dietary supplements, the system remains largely favorable to the industry, closely resembling a self-regulatory model. Emerging trends in social media and the supplement market continue to encourage this independent, minimally regulated behavior.
Celebrity and influencer-endorsed supplements have become increasingly common, raising concerns about misinformation. For example, Kourtney Kardashian, best known from the reality show Keeping Up with the Kardashians, launched her own vitamin brand called “Lemme,” which offers supplements like “Lemme Debloat” and “Lemme Burn,” focusing on enhancing physical appearance. Recently, Kardashian faced controversy over her latest product, “Lemme GLP-1,” which is marketed as an alternative to Ozempic, a prescription medication typically used for diabetes and weight management. Although “Lemme GLP-1” does not contain the GLP-1 ingredient implied by its name, the company has not violated any existing laws despite consumer backlash over the misleading title. Since the FDA primarily focuses its enforcement on manufacturers making illegal claims, particularly those related to disease treatment or prevention, this type of misleading marketing practice goes unaddressed.
While social media influencers have become a key part of vitamin companies’ marketing strategies, the lack of regulatory oversight increases the risk of ingredient misrepresentation and inadequate testing, resulting in the presence of ineffective or unsafe levels of key ingredients. Such misrepresentation poses serious health risks and misleads consumers, ultimately resulting in financial loss. Moreover, uncertainty regarding the efficacy of supplements discourages investors from supporting smaller businesses promoted by influencers, leading them to favor larger companies acquiring these businesses. With greater resources, broader customer bases, and stronger brand recognition, larger companies provide investors with a sense of security, as they are better positioned to manage risks like lawsuits and public backlash. This trend ultimately stifles innovation and growth within the industry, hindering the potential of small supplement businesses.
Moreover, judicial decisions have also favored the low regulatory standard. In Malgeri v. Vitamins Because LLC, a group of consumers who bought dietary supplements marketed by a defendant company filed suit for misrepresentation and violation of several consumer protection acts after claiming the SAM-e supplement contained less of the active ingredient than advertised. Despite expert testimony highlighting the product’s potential defects, the court dismissed the case because the plaintiffs failed to prove that the specific products they purchased were defective. An expert testified that only 10% of the defendant’s similar products met label specifications, which the court found sufficient to avoid imposing consequences on the company. This decision sets a heavy burden for plaintiffs to demonstrate significant economic injury, allowing supplement companies to evade accountability until more severe harm can be proven.
While industry-friendly legislation and lenient judicial rulings may encourage deceptive marketing practices among supplement companies, they also facilitate convenient access to essential vitamins recommended by healthcare professionals. For instance, patients with Vitamin D deficiencies or those requiring Vitamin C for immunity can easily obtain supplements at local supermarkets without the lengthy and costly process of obtaining physician approval. However, if regulations become excessively stringent, this convenience could be significantly reduced, ultimately impacting public health and individual well-being. Balancing regulation is essential to ensure both safety and accessibility. As the American Medical Association, consumers, and various organizations advocate for stricter regulations, legislators must carefully consider the trade-off between maintaining easy access to vitamins and ensuring higher quality supplements in the marketplace before coming to a decision on its regulation. Consumers are not just buyers- they are people, and their well-being must come first.
