Compounding the Crisis: The GLP-1 Gold Rush

How That Hims & Hers' Super Bowl Ad Exposed the Dangerous World of Unregulated Weight Loss Drugs

We gratefully acknowledge the contributions of Dr. Karl Nadolsky (endocrinologist and obesity specialist), Dr. Spencer Nadolsky (family practice physician and obesity/lipid sub-specialist), Jo Arbus, B.Pharm, PGCert (hospital-based clinical pharmacist and Unbiased Science team member), and Dr. Christina Madison, PharmD ("The Public Health Pharmacist"). All have provided invaluable expertise to this work.

Key Points:

• Hims & Hers' Super Bowl ad promotes compounded weight loss drugs that are not required to have FDA approval, which is needed to confirm safety and efficacy

• Injectable agents being used without counseling or education on proper technique increases the risk for infection and injection site reactions

• FDA documented over 392 adverse events with compounded semaglutide as of November 2024

• Using these products without medical guidance increases the likelihood of rebound weight gain after discontinuation of the compounded drug

• Compounded drug advertising faces fewer requirements than FDA-approved drug marketing

• Senators and medical experts condemn ad for downplaying safety risks

• No professional medical organizations endorse compounded GLP-1 products

Super Bowl Ad Sparks National Debate Over Compounded Weight Loss Drugs

In what promises to be one of the most controversial advertisements of Super Bowl LVIII, telehealth company Hims & Hers has crafted a minute-long critique of America's weight loss industry that has ignited fierce condemnation from healthcare professionals and debate among regulators and lawmakers. Set to Childish Gambino's politically charged anthem "This Is America," the advertisement opens with a stark symbol familiar to millions: a scale, silently representing decades of American struggle with weight loss.

Over the haunting soundtrack, a narrator decries the nation's obesity crisis and "the system" that is "built to keep us sick and stuck." The camera pans across images of junk food – cereal boxes, pies, and cheeseburgers – as the voice takes direct aim at the "$160 billion weight-loss industry that feeds on our failure." The message builds to a crescendo with a bold declaration: "Something's broken, and it's not our bodies." “Falsely claiming the system keeps us sick, is a classic marketing strategy straight from the playbook of quacks, grifters, and snake oil salesmen,” suggests Dr. Karl Nadolsky, an endocrinologist and obesity specialist in Holland, MI.

But what has drawn the ire of health experts and lawmakers isn't just the ad's provocative tone – it's what many see as a dangerous oversimplification of the risks associated with compounded weight loss medications. While pharmaceutical compounding serves a legitimate purpose when FDA-approved medications need to be modified for specific patient needs (such as creating liquid forms of pills for patients who can't swallow), companies have exploited a regulatory gap that allows pharmacies to compound versions of FDA-approved drugs without going through the same rigorous safety and efficacy testing required for the original medications. This practice, while technically legal under section 503A of the Federal Food, Drug, and Cosmetic Act, was never intended to enable mass marketing of compounded alternatives to available FDA-approved drugs.

The ad, which cost millions to air during America's most-watched sporting event, promotes what Hims & Hers calls "life-changing" weight-loss medications while offering notably little information about their safety profiles or potential risks. As the ad wasn’t for an FDA-approved medication, it didn’t have to follow the stringent guidelines set out for medication advertising - including risks of using the drug, in a language the general population can understand.

On Friday, February 7, 2025, Senators Richard Durbin (D-Ill.) and Roger Marshall (R-Kan.) escalated the situation by sending a letter to the FDA's acting commissioner. Their concern centers on a critical detail that the advertisement mentions only briefly in small print: the drugs being sold are compounded formulations that haven't undergone rigorous clinical research or the FDA approval process designed to protect consumers.

The Partnership for Safe Medicines, a coalition of nonprofit organizations with ties to the pharmaceutical industry, has gone even further, labeling the ad as "dangerous." The organization's executive director, Shabbir Imber Safdar, points to a fundamental issue: "Americans don't understand the safety profile of compounded medications. So when you make a drug ad and don't disclose it, there's a safety problem."

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What is a Compounding Pharmacy?
Compounding pharmacies specialize in creating custom medications tailored to meet the unique needs of individual patients. Compounding is typically done when a patient requires a medication that is not commercially available, in short supply, or needs a specific formulation that commercial products cannot provide; An example is a medication that is only commercially available as a tablet/capsule, however, a young child who can only swallow liquid medicine needs it. Compounding pharmacies can make this into a liquid medication.

The practice of compounding is subject to regulation by state boards of pharmacy. Pharmacists involved in compounding must comply with relevant standards and regulations for the types of preparations they compound.

The Hidden Dangers: A History of Compounding Concerns

The controversy touches on a deeper issue in American healthcare: the complex and sometimes perilous world of compounded medications. Recent data from the FDA paints a concerning picture of the current surge in compounded weight loss drugs. No professional medical organizations endorse the use of these compounded molecules, and the American Diabetes Association specifically recommends against using non-Food & Drug Administration (FDA)-approved compounded GLP-1 and dual GIP/GLP-1 RA products “due to uncertainty about their content, safety, quality, and effectiveness.”

As of November 30, 2024, the FDA has documented more than 392 reports of adverse events with compounded semaglutide and over 215 reports of adverse events with compounded tirzepatide. These numbers become even more alarming when considering that federal law doesn't require state-licensed pharmacies to submit adverse events to the FDA, suggesting the actual number of incidents could be significantly higher.

A comprehensive study by Pew's drug safety project reveals an even more troubling pattern: researchers identified 71 reported compounding errors associated with 1,416 adverse events, including 115 deaths, from 2001 to 2017. The shadow of the 2012 tragedy, where contaminated compounds led to more than 750 infections and over 60 deaths across 20 states, still looms large over the industry.

"I'm pretty shocked by this advertisement," says Dr. Reshma Ramachandran, a physician and health services researcher at the Yale School of Medicine, "but also am impressed by how cleverly they framed this both in terms of playing to systemic concerns around weight loss and the high prices of novel weight loss medications." The ad's imagery hints at the influence of ultra-processed food on obesity while positioning Hims & Hers as a champion of accessibility and affordability.

The Regulatory Landscape: A Complex Web of Oversight

The controversy highlights critical gaps in the regulatory framework governing compounded medications. The United States Pharmacopeia (USP) provides comprehensive standards for compounding that are recognized in law and play a prominent role in federal and state compliance. USP Chapter 797 is a set of standards for preparing sterile medications in pharmacies.

However, oversight remains fragmented and inconsistent. A 2015 survey revealed that only 30% of states (13 of the 43 that responded) require sterile compounding pharmacies to report serious adverse events. Even in states with strong reporting requirements, illnesses and deaths caused by compounded drugs are not always linked to the compounding error, creating significant blind spots in safety monitoring.

The current situation with compounded semaglutide presents particular concerns. The FDA has identified that some compounders are using salt forms of the drug – semaglutide sodium and semaglutide acetate – that are different from FDA-approved ingredients and have no established safety profile. Multiple reports document adverse events requiring hospitalization, stemming from both patient self-administration errors and healthcare provider miscalculations.

The FDA also issued an alert in 2024, related to overdoses due to dosing errors associated with compounded semaglutide injectable products.

A Tale of Two Standards: Marketing and Safety

The marketing of compounded drugs exists in a regulatory gray zone that the Hims & Hers advertisement appears to exploit. Direct-to-consumer advertising of FDA-approved medications has only been allowed in the US since 1997. Prior to this policy change, it was illegal to market prescription medications to consumers. When direct-to-consumer advertising was legalized, it came with very specific rules around disclosure of side effects associated with the medications. While FDA-approved drugs like Wegovy must meet detailed guidelines for direct-to-consumer marketing – including disclosure of significant risks and side effects – compounded drug advertising faces no such requirements. These requirements exist for good reason, since these important healthcare decisions should be left to a patient and their doctor, not influenced by television ads

Yale researchers examining 79 sites marketing compounded GLP-1s found that nearly half didn't include information about adverse effects, warnings, or contraindications. While Hims & Hers does acknowledge that their drugs are compounded and not FDA-approved, this disclosure appears in fine print for just three seconds of the minute-long advertisement.

The company's positioning has drawn particular criticism from medical experts. "They try to present themselves as anti-establishment," notes Dr. Scott Hagan, an assistant professor of medicine at the University of Washington who studies obesity, "but the company represents the cutting edge of, basically, capitalism in this space."

“Ironically, they use the shortcomings of our healthcare system to profit off a very transactional relationship with customers rather than promoting appropriate comprehensive medical evaluation and therapy required for people with obesity and obesity-related disease,” stated Dr. Nadolsky

Kate Manne, author of "Unshrinking: How to Face Fatphobia," puts it more bluntly: "The idea that this for-profit company is not exploiting you financially because it's making it a little bit cheaper to get knockoff Ozempic — that is a wild claim."

The Path Forward: Balancing Access and Safety

The controversy surrounding the Hims & Hers Super Bowl advertisement raises crucial questions about the future of weight loss treatment in America. This is clearly a "buyer beware" situation, as not all compounded products are created equal. Consumers should consult with their healthcare professionals before seeking access to compounded weight loss products. While compounding pharmacies can play a valuable role in healthcare, providing needed medications during shortages or for patients with specific requirements, the current surge in compounded weight loss drugs highlights two critical needs: stronger oversight with clearer guidelines, and incentives for pharmaceutical manufacturers to produce sufficient products to meet demand.

The USP has established specific requirements for compounded medication labeling, including:

• Name and strength of each active ingredient

• Instructions for storage and handling

• Beyond-use date for the drug preparation

• Lot number or pharmacy reference number

• The date compounded

Yet without standardized regulatory oversight, these requirements may not be consistently followed or verified across all facilities. The Alliance for Pharmacy Compounding, a trade group that includes Hims as a member, has advised against promoting compounded drugs based on price comparisons to commercially available alternatives. However, this guidance appears at odds with the company's Super Bowl message.

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For the millions of Americans who will watch the Super Bowl this Sunday, the advertisement represents more than just another commercial break. It's a window into one of healthcare's most pressing debates: how to balance increased access to potentially life-changing medications with essential safety protocols and consumer protections. As lawmakers consider new legislation to address these issues, the controversy serves as a reminder that in the complex world of pharmaceutical compounding, the stakes couldn't be higher.

The numbers tell a stark story: with over 392 documented adverse events from compounded semaglutide alone, and experts warning that many more likely go unreported, the true scale of this public health challenge remains unknown. As the American Diabetes Association and other medical organizations stand united in their opposition to these compounded products, their message is clear: when it comes to weight loss medications, FDA oversight isn't optional—it's essential for patient safety.

Stay Curious,

Unbiased Science

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References

1. Blum, Dani. "Millions Will See This Super Bowl Ad. Health Experts (and Two Senators) Aren't Pleased." The New York Times, Feb. 7, 2025.

2. Palmer, Katie. "'Incredibly irresponsible': Hims Super Bowl ad downplays risks of compounded drugs." STAT News, Jan. 28, 2025.

3. Aguilar, Mario. "Lawmakers ask FDA to review Hims' Super Bowl ad for 'misleading' patients." STAT News, Feb. 7, 2025.

4. FDA. "FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss." U.S. Food and Drug Administration, Dec. 18, 2024.

5. "USP Quality Standards for Compounding." United States Pharmacopeia, 2024.

6. "U.S. Illnesses and Deaths Associated With Compounded Medications or Repackaged Medications, 2001-17." The Pew Charitable Trusts, June 23, 2017.

7. "Navigating Compounding Pharmacy Regulations with Labeling." United Ad Label, Aug. 29, 2024.

8. Joshua J. Neumiller, Mandeep Bajaj, Raveendhara R. Bannuru, Rozalina G. McCoy, Elizabeth J. Pekas, Alissa R. Segal, Nuha A. ElSayed; Compounded GLP-1 and Dual GIP/GLP-1 Receptor Agonists: A Statement from the American Diabetes Association. Diabetes Care 22 January 2025; 48 (2): 177–181.

9. https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-patients-dosing-errors-associated-compounded