Regulating Weight-Loss Drugs and Supplements

A breakthrough in long-term weight management has sparked demand for a new generation of weight loss drugs. In 2017, the U.S. Food and Drug Administration (FDA) approved Ozempic to treat type-two diabetes. Four years later, the agency approved Wegovy—a higher-dose version containing the same active ingredients—for chronic weight management in overweight adults.

Ozempic and other weight-loss drugs work by mimicking the GLP-1 hormone, which the body naturally produces after eating. The drugs stimulate the body to release more insulin after meals, helping to reduce post-meal blood sugar spikes. These medications also regulate appetite by sending signals to the brain that create a feeling of fullness, which helps to prevent overeating.

The commercial success of prescription weight loss medications is hard to ignore. On TikTok, the hashtag #Ozempic has amassed over 273 million views. Since 2023, the market value of Novo Nordisk—the Danish company that produces Ozempic and Wegovy—has surpassed the entire economy of Denmark.

The popularity of these drugs has created supply shortages. In 2022, FDA added Ozempic and Wegovy to its Drug Shortages Database, allowing pharmacies to produce compound versions to fill supply gaps. Licensed pharmacists custom-make compound medications by mixing or adjusting ingredients to meet specific patient needs, often at a lower cost. In 2024, however, FDA declared that Ozempic and Wegovy were no longer in short supply, which ended access to these more affordable compound options.

Although many employers cover diabetes medications, fewer extend coverage to weight-loss drugs, partly due to their high cost. A four-week supply of Wegovy, for example, costs around $1,350. Even employers that do cover anti-obesity drugs often set strict requirements, such as prior authorization or the use of other weight-loss methods first. Some employers also set higher body mass index (BMI) thresholds than FDA to qualify for obesity medications.

Skeptics of prescription weight-loss medications say that these drugs may not be the quick fix that many people hope for. Ozempic and Wegovy are “forever drugs”—once a person stops taking the medications, they typically regain the weight unless they make changes to their diet or physical activity levels.

Doctors also worry about over-prescription. FDA has approved Ozempic only for diabetes. The agency has authorized the use of Wegovy for adults with a BMI of 30 or more, or those with a BMI of 27 plus at least one weight-related condition, such as high blood pressure, high cholesterol, or type-two diabetes. But many doctors are prescribing these medications off-label for patients who do not qualify under FDA standards. Dr. A. Enrique Caballero, an endocrinologist at Brigham and Women’s Hospital, expressed his concerns: “There isn’t enough evidence to know whether these drugs might be beneficial or dangerous for people who fall outside of the FDA criteria.”

In this week’s Saturday Seminar, scholars discuss the regulatory landscape surrounding weight-loss drugs and supplements.

• In a recent article in the Journal of Food Law & Policy, practitioner Jessie L. Bekker and Alex Flores and Michael Sinha of Saint Louis University School of Law argue that the U.S. Congress should grant broader authority to FDA to regulate dietary supplements. Bekker and coauthors point out that under the Dietary Supplement Health and Education Act (DSHEA), FDA only has authority to conduct post-market safety review of supplements. Without the authority to conduct pre-market review, the Bekker team notes, FDA relies on voluntary consumer reports to learn about harmful ingredients in dietary supplements. To solve this problem, the Bekker team recommends amending DSHEA to allow FDA to regulate dietary supplements before they enter the market.
• In an article in the Indiana Health Law Review, Steven R. Salbu of Georgia Institute of Technology explores a more expansive notion of public health that aims to protect people from their own dietary choices. Salbu notes that traditional public health initiatives only regulate external hazards like public sewage, communicable diseases, and other conditions over which people have no control. Salbu argues that, in recent years, increasing rates of child obesity and other related health conditions have necessitated more aggressive regulations that protect minors from their own food consumption choices. Salbu recommends adopting practices that nudge consumers toward healthier dietary options while maintaining consumers’ ultimate freedom of choice.
• In an article in the Administrative Law Review, Marie Boyd, a professor at the University of South Carolina Joseph F. Rice School of Law, argues that FDA’s fragmented and reactive regulatory approach fails to adequately protect children’s health. Boyd applies the feminist legal framework known as “asking the child question” to highlight how FDA policies consistently overlook the unique vulnerabilities of children. To solve this problem, Boyd proposes establishing an Office of Children’s Health within FDA to fulfill the agency’s public health responsibilities toward children, ensuring child-centered regulation across all product categories, including dietary supplements, for greater safety and oversight.
• In a note in the Arizona State Law Journal, recent Sandra Day O’Connor College of Law graduate Nicholas A. Traver argues that regulation under DSHEA fails to protect consumers from contaminated and mislabeled dietary supplements. Traver explains that DSHEA does not require disclosure of supplements’ ingredients, sometimes with grave consequences, as when the Olympic Committee banned the athlete Jessica Hardy from the games after she unwittingly took supplements containing banned substances. Traver proposes a federally backed, voluntary certification program to distinguish reputable and disreputable products. Modeled after the USDA Organic seal, Traver suggests that such a program would provide consumers with a recognizable quality mark and bolster the supplement market against low-quality “lemons” that undermine industry credibility.
• In an article in the Maryland Law Review, Michael Mattioli of Indiana University discusses supplement manufacturers’ misleading uses of regulatory approvals, such as “FDA-approved,” in advertising. The author notes that such advertisements could be regulated as deceptive speech by the Federal Trade Commission (FTC) and through enforcement of the Lanham Act, which “forbids the registration of trademarks” that could cause viewers to falsely associate products with the government. Mattioli also advocates funding public awareness campaigns against such advertising practices and placing the burden of proof in regulatory enforcement proceedings on accused advertisers to prove that their product claims are not misleading.
• In an article in the Hastings Journal on Gender and the Law, authors Nicholas Cardaci, Marilyn Bromberg, and Kathy Luong analyze the regulation of miracle weight-loss products (MWLPs)—products that promise unrealistic weight-loss effects—and the impact of celebrity advocacy on adolescents’ mental health. The authors note that when celebrities promote MWLPs, they disproportionately harm young and economically disadvantaged audiences. The authors highlight the lack of statutory guidance in the United States to regulate celebrity endorsements and propose legislative reforms that would prohibit false and misleading representations in advertising. Moreover, the authors urge celebrities to put pressure on social media companies to stop advertising MWLPs to young people. Together, the authors conclude, legal reform and celebrity advocacy would help protect young people from miracle weight-loss drugs.