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Regulatory Issues in the Nutritional Supplement Industry

This is an excerpt from Governance in Sport-2nd Edition by Bonnie Tiell.

By Bonnie Tiell

Nutritional Supplements

As indicated in the chapter lead-off, the manufacturing, sale, and use of nutritional supplements are widespread and lightly regulated. According to the U.S. Food and Drug Administration (2024), dietary supplements are products taken or ingested by mouth that contain a dietary ingredient. The term was initially defined by Congress in the 1994 Dietary Supplement Health and Education Act. Examples of dietary ingredients include vitamins, minerals, amino acids, and herbs or botanicals (FDA, 2024). Supplements are used for a variety of reasons, from enhancing athletic performance to improving general health. Given the prevalence of nutritional supplements in the daily lives of Americans, it is important to understand the governance structures and processes that shape the supplement industry in the United States.

Production

Currently, manufacturers do not need to obtain FDA approval before producing a nutritional supplement. Neither do they need to prove that the supplement is safe or effective, or that it is produced in a clean, uncontaminated facility. The lax stipulations for dietary supplements are described in Rules and Regulations Corner 11.3.

The lack of direct regulation in the supplement industry is often defended from a free market perspective. If supplement manufacturers do not produce a safe and effective product, so the reasoning goes, they will soon be out of business. Consumers will not want to buy a product that does not work or has negative side effects, and perhaps more importantly, a company that produces a low-quality product will harm its brand, potentially affecting sales of its other products.

Are market forces an effective regulation mechanism? An example testing the theory is in an (in)famous scene from the 2008 documentary Bigger, Stronger, Faster. Director Chris Bell hires a few day laborers to help him produce a legal nutritional supplement designed to promote muscle growth. The catch? The “supplement” is actually gel capsules filled with little more than rice flour. Bell claimed that a bottle of this product, which costs approximately $1.40 to produce, can be sold for $60, equating to a markup of almost 4,200 percent. While reputable manufacturers may be able to resist the “get rich quick” temptation, as this example demonstrates, the profit motive might not always lead to good product quality when it comes to nutritional supplements.

Marketing

Similar to the stipulations regarding production, the marketing and advertising of nutritional supplements are also loosely regulated. The FDA is responsible for monitoring product labeling, while the Federal Trade Commission (FTC) regulates marketing communication, including print, broadcast, and online advertising (see Rules and Regulations Corner 11.4).

The FTC requires supplement advertisements to comply with basic truth-in-advertising standards. This means that advertisements cannot overstate (or outright fabricate) the effects of a supplement, and they must disclose information about the known risks and potential side effects of taking the supplement. Further, manufacturers must be able to substantiate all claims made in any marketing materials, though the standards for adequate substantiation are somewhat flexible (FTC, 2022). Once a dietary supplement hits the market, while working in cooperation with the FTC, the FDA (2024) maintains the authority to investigate and penalize organizations or individuals that produce adulterated or misbranded products.

Usage

While there are guidelines in place governing how nutritional supplements are produced and marketed, consumers are also expected to play a role in regulation. As the FDA (2024) itself notes, its role with investigation or enforcement begins after a product enters the marketplace. Especially given their limited resources, regulatory agencies only learn of deceptive or unsafe practices after a problem has occurred. Consumers thus bear most of the burden for (1) ensuring that a supplement is safe and (2) triggering the enforcement systems that are in place by making a complaint, either to the product manufacturer or to the FDA.

Athletes who are subject to anti-doping protocols have an additional incentive to pay close attention to the supplements they put into their bodies. The rules enforced by anti-doping organizations—most notably the World Anti-Doping Code—do not provide exceptions to athletes who mistakenly take supplements tainted with banned performance-enhancing substances.

Due to the lax regulation of the supplement industry, it is often difficult to know whether a product’s label is accurate or if the product was produced in a clean facility. These questions are a clear example of inconsistent governance in sport. Relatively limited regulation in the supplement industry, combined with very rigid regulation of performance-enhancing substance use in sport, leaves athletes (some of whom might rely on nutritional supplements to support their training and general health) in a precarious situation.

More Excerpts From Governance in Sport-2nd Edition

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