It’s Time to Put Guardrails on GLP-1 Compounding Leave a comment
If ever there was a time for federal regulators and lawmakers to ensure that all medications are safe, contain high-quality ingredients, and are held to rigorous production standards, it would be now.
The need is especially important due what is described as “America’s second obesity crisis,” a largely unregulated exploitative market where telehealth companies and others take advantage of regulatory gaps to sell untested compounded GLP-1 drugs that have not been reviewed or approved by the Food and Drug Administration and may pose serious risks.
This marketplace is a national threat, and not only due to fraud. Today, consumers are inundated with false information circulating online about GLP-1 medicines, which causes confusion and can lead to potentially serious health problems resulting from dosing errors and adverse reactions to ingredients in compounded GLP-1 products. Documenting the severity of the situation, as of July 31, FDA reported receiving 1,150 reports of adverse events associated with compounded GLP-1 drugs, including hospitalizations and some deaths.
Combating this crisis must start by understanding why we are here. Compounded drugs are made by altering, mixing or combining ingredients in a prescription medicine so a person can take the drug when they need a different dosage or form. Thus, FDA regulates compounded drugs as one drug for one person and exempts licensed compounding pharmacies from clinical testing, providing risk information, and adverse event reporting requirements. However, these exemptions also apply when there is a national shortage of widely prescribed prescription medicines and FDA allows the mass production and sale of compounded versions to fill the supply gap. Consequently, regulators are faced with a situation that was never intended where sellers can exploit regulatory loopholes to make massive profits.
This was the case between 2022 and early 2025 when there was a shortage of the GLP-1 drugs semaglutide and tirzepatide. Because booming consumer demand for GLP-1s was a primary reason for the shortages, it was a gold rush situation for compounders who made full use of regulatory gaps to advertise their GLP-1s without disclosing the risks and by making inferences that compounded drugs are the same as the FDA-approved versions.
Many consumers believed the claims and profits soared. Thus, despite FDA announcing the end of the GLP-1 drug shortage in March 2025 and setting May 22 as the last day when compounded versions could be sold, large-scale production continues. And now, some compounders have pivoted to marketing “personalized” formulations with added vitamins or microdoses of GLP-1s that have never been evaluated.
Today’s exploitative market also includes companies promoting patches and oral supplements and bad actors illegally selling the active pharmaceutical ingredient (API) in GLP-1 drugs directly to consumers both in powder form labeled as “not for human consumption” or as vials labeled as a “research chemical” along with dosing instructions. Also of concern, patient safety experts warn that the source of the API used in compounded GLP-1s is often from China, where quality standards can vary widely and the API may go uninspected.
All these developments are concerning, which is why consumer advocates celebrated when the Trump Administration launched a crackdown on misleading direct-to-consumer advertising of prescription drugs in September 2025. As part of the crackdown, FDA sent warning letters to over 55 online sellers of compounded GLP-1 medications, including the telehealth company Hims & Hers. Yet it seems that Hims was undeterred, because on February 5 the company made the audacious move of starting to sell a compounded copy of the first GLP-1 pill only two months after FDA approval.
This set off alarm bells, FDA took immediate and decisive action, and Hims backed down. But the episode serves as a warning: only a concerted effort by FDA and the Congress will improve the regulation of compounded drugs and restore compounding to its intended purposes.
This is the good news part of the story. Policymakers are paying attention. FDA Commissioner Marty Makary has pledge to restrict the API for use in non-FDA-approved compounded drugs. And now with the introduction of the Safeguarding Americans from Fraudulent and Experimental (SAFE) Drugs Act in both the House and the Senate, Congress has an important opportunity to strengthen FDA oversight, close dangerous regulatory gaps, and help ensure that active pharmaceutical ingredients used in compounded drugs come from registered, inspected facilities that meet safety and quality standards.
Clearly, this is an inflection point and the time for lawmakers to make patient safety a top priority.
Photo: Peter Dazeley, Getty Images
Nancy Glick is Director of Food and Nutrition Policy for the National Consumers League, a position she has held since September 2020. Building on a long career in health and nutrition advocacy, Ms. Glick works to ensure the consumer’s voice is heard in championing policies that will improve food safety and combat diet-related chronic diseases. She also leads NCL’s obesity policy initiatives, including spearheading the development of the first Obesity Bill of Rights for the nation.
Prior to joining NCL, from 2009 through mid-2020, Ms. Glick was Director of Health Affairs and Advocacy at the public relations firm MSL. She also served in executive positions at three other leading public relations agencies – Ruder Finn, Porter/Novelli and Hill and Knowlton, Inc. –and was a press officer at the Food and Drug Administration, where she handled food, cosmetics, drugs and consumer issues and agency announcements about product recalls.
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