There’s a Pill for That: Fixing America’s Supplement Industry

A photo of overflowing and mixed-up pill capsules.

Edited by Ella Farina, Allison Szvetitz, and Owen Andrews

Where Jay Gatsby had his green light , the average American may have a pill. A walk down the supplement aisle has become an almost theological experience as acolytes to the industry place their faith that the right combination of unproven capsules can solve all their ailments. Dietary supplements entice consumers in the spells of pseudoscience, invoking the prestige of medical scrutiny to conjure a sense of legitimacy. These empty, and often dangerous, promises must be checked, and supplement manufacturers must be held accountable through stricter regulation by the Food and Drug Administration (FDA). 

Almost three-quarters of Americans now take at least one dietary supplement regularly, making their ubiquity a salient concern to ensure public safety. However, in a market of over 100,000 products, the vast majority remain unvetted. The FDA is meticulous with oversight of prescription and non-prescription drugs, but supplement manufacturers are subject to shockingly little supervision. Under the 1994 Dietary Supplement Health and Education Act (DSHEA), the FDA regulates dietary supplements as a class of food, rather than medication, allowing more lenient control than over nonprescription or prescription drug classes. 

In theory, the FDA reviews each supplement before it enters the market. However, the 1958 Food Additives Amendment ended this inspection requirement for supplements containing only ingredients that are “Generally Recognized as Safe” (GRAS). While originally conceived with good intentions, the GRAS pathway has opened the window for corporations to exploit the FDA’s leniency and flood the market with unsafe and ineffective supplements. With an average cost of $349,000 as of 2017, the cost of standard clinical review to companies poses a major disincentive to undergo such review. Thus, formulating supplements with only GRAS ingredients has become a tantalizing way for companies to bypass essential regulation. In fact, since 2000, companies have certified nearly 99% of new chemicals introduced to the supplement market through GRAS, without pre-market inspection.

Even worse, GRAS is not determined by the FDA but by individual profit-driven companies, who are incentivized to opt for less stringent standards in the name of cutting costs. Under its jurisdiction, the FDA is not permitted to regulate a product through GRAS until after it has launched into an overcrowded market, meaning that these products do not need to be demonstrated as safe or effective before they can be dangled before eager-eyed consumers looking for a quick fix. The FDA only begins regulation after a supplement is reported to be unsafe, and even then, it must undergo a costly inspection process to prove the product is at fault before it can intervene. These inspections take an average of 45.09 hours and $15,285.51 per inspection. 

This poses two problems. First, the inefficacy of many of these products harms the consumer. A study of 450,000 people showed that despite claims by many manufacturers, common supplements did not provide the benefits they promised, such as reduced risk for chronic disease or increased mental functioning. Second, and more critically, is that adverse effects from dietary supplements send up to 23,000 Americans to the emergency room each year. In fact, many supplements that claim to aid in weight loss, sexual enhancement, muscle growth, or other desired ends may contain. but not list, ingredients not approved for market sale. Because they can declare their products GRAS and avoid further inspection, these products can enter the market without issue, driving profits up and consumer welfare down. 

This issue is especially pressing as the FDA is now overseen by Health and Human Services (HHS) Secretary Robert F. Kennedy, who advocates for even fewer measures of precaution and a decreased budget for the FDA. Recent funding cuts to the FDA exacerbate this threat, as their budget has already been lowered from $7.2 billion in 2025 to $6.8 billion in 2026. Kennedy's public position on supplements has been one of liberation from what he characterizes as bureaucratic overreach. This has significant political appeal in an America where many feel the medical establishment has failed them. Kennedy’s appeals surrounding the FDA’s paternalism are resonant for many buyers, who choose to exert their autonomy by engaging independently with the supplement industry over more formalized healthcare. Rather than going to a professional for advice to manage their weight, consumers may feel more comfortable in this media environment to buy a supplement purporting to fast-track fat loss, opting for the alluring price tag of instant self-improvement.

All this leads to a ludicrous advantage that dietary supplements have over their neighbors on pharmacy shelves. Over-the-counter (OTC) medications such as ibuprofen, antihistamines, or antacids must undergo explicit FDA pre-market approval through a “monograph review” process, which specifies acceptable ingredients and uses before allowing the product’s release. Pharmaceutical companies pay for this review, which on average costs $587,529 for a monograph application, plus $37,556 annually to cover routine inspection costs. This greater scrutiny pays off: the entire OTC drug sector generated only 116 warning letters related to adverse events between 2015 and 2019. While the different metric creates an imperfect comparison, it proves a fundamentally different magnitude of safety than the supplement industry's 23,000 annual emergency room visits.

Therefore, the FDA should reclassify dietary supplements as a type of OTC drug, subject to the same proven regulations as the nonprescription drugs. This solution would shift the burden of proof from a cash-strapped federal agency onto the actual companies who stand both to gain and to lose from their product’s efficacy and success. Unlike an entire upheaval of the FDA’s regulatory process, this solution simply extends an existing framework, closing the GRAS loophole without requiring new statutory authority from Congress. 

The supplement industry, Secretary Kennedy, and many others on the right will see this as an unacceptable imposition on an already broken and increasingly inaccessible healthcare system. However, shelves of unvetted supplements do not serve to exalt individual liberties but rather exploit and market that perceived grievance into a never-ending quest for self-improvement.