Regulators failed to halt production and importation of illegal GLP-1 compounds.
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The Center for Medicine in the Public Interest (CMPI) published its newest report, noting regulators, such as FDA, have failed to stop the mass production of illegal compounded GLP-1 drugs.

Despite mounting evidence suggesting these illegal drugs harm its users, CMPI’s report catalogs the importation of dangerous ingredients into mass compounding pharmacies, directly misleading patients of ingredients being used in manufactured medications. The report further documents the dangerous of using the untested and unapproved weight loss and diabetes drugs, which include semaglutide and tirzepatide.

CMPI President and former FDA Associate Commissioner Peter J. Pitts commented on the report’s findings saying, "The FDA is allowing a black market of pharmaceutical-grade knockoffs to thrive right under its nose, this is not just regulatory negligence—it's a public health crisis in the making."¹

Trimming the fat

The report “FDA Regulatory Failures in Enforcing Limits on GLP-1 Compounding” was authored by Pitts, and its finding will be reported at a Congressional briefing hosted by the Obesity Society. The goal of the briefing is to unearth the health threat that mass production of illegally compounded GLP-1’s has on the population. The briefing will focus on the exploitation that mass compounding pharmacies have on the health system, and the deceiving marketing tactics employed.

CMPI’s report highlights the critical discoveries of the illegal manufacturing noting that compounders have discovered workarounds of existing laws, claiming personalization to allow for the addition of unnecessary ingredients, while noting many compounded GLP-1’s rely on the use of unapproved foreign pharmaceutical ingredients from China.

Continued findings unveiled the severity of harm tied to the illegally compounded GLP-1’s noting patients suffered from:

• Overdose
• Hospitalization
• Contamination

Copycats and false advertisements are also to blame for the increased threats. Stemming from social media testimonials all the way to T.V. adverts, which claim the illegally produced compounded GLP-1’s are safe, and FDA approved both of which are false.

Pitts spoke on his reports finding saying, "We've seen this story before—from the deadly New England Compounding Center fungal meningitis outbreak to countless smaller tragedies, this time, the warning signs are flashing, and we have the laws in place to prevent it. What's missing is regulatory enforcement."¹

Changing for the better

CMPI’s report also mentions suggested changes to polices to better defend and prevent mass fraud and malpractice which is currently affecting compounded GLP-1 products. The report suggests the FDA to tighten its law and policy enforcement, blocking importation of illegal ingredients, strict enforcement of the 5% Rule, and properly disbursing resources to the FDA.

The CMPI report was not the first and won’t be the last acknowledgement of the ongoing concern surrounding compounded GLP-1s. Over the last six months, reports of concern has spread like wildfire, ranging from reports form over a dozen government organizations including, US Chamber of Commerce, and the FDA itself.

Reports don’t stop there, non-profit groups including consumer, physician, and patient advocacy groups have also voiced concern over the lack of effort to end the production of these harmful drugs.

Sources

1. New CMPI Report Finds FDA Inaction on Illegal GLP-1 Compounding Threatens U.S. Patients Center for Medicine in the Public Interest July 22, 2025 https://www.prnewswire.com/news-releases/new-cmpi-report-finds-fda-inaction-on-illegal-glp-1-compounding-threatens-us-patients-302510125.html