Colorado Politics

Illegal GLP-1 compounding puts Coloradans at risk | OPINION

By Laura Howard

In 2024, Black or African-American adults were 28% more likely to be obese than adults of the total population. This stark health disparity is one of many concerns the Colorado Council of Black Nurses works tirelessly to address.

Our organization was founded to ensure people of color and all people receive safe, equitable and quality care. We believe empowering Black nurses to not only participate but also actively contribute to the health care system will result in better care for all people. Nurses believe safety is of the utmost importance as we care for our patients, communities and speak out when our communities are suffering.

Obesity is a public health crisis. The medical community is prescribing GLP-1s, as one of many tools that can help  medically manage patients’ weight loss needs. However, the increased demand for GLP-1s stateside has been accompanied by foreign actors exploiting Americans.

The popularity of GLP-1s also came with temporary domestic shortages of the active pharmaceutical ingredients (API): semaglutide and tirzepatide. During that time, the FDA allowed bulk compounding to fill the gap. Shortages have since ended, and theoretically, bulk GLP-1 compounding should have ended with it.

But that’s far from the reality.

Compounding is a “break in case of emergency” process meant to personalize a medication to meet patient need. In the most regulated compounding scenarios, there’s still an inherent risk given compounded medications are not FDA-approved.

The current market doesn’t resemble any regulated scenario.

Hundreds of illegal shipments, most containing enough API for millions of GLP-1 doses, are arriving from abroad. Despite laws to prevent these products from being accepted at ports of entry, a recent study showed four out of five illegal shipments were accepted. In the last couple years, more than 230 arrived in the U.S., and a whopping 82% were accepted.

These illicit ingredients are primarily produced and sold by manufacturers not registered with the FDA. The APIs are labeled as “for research only”, and therefore more likely to contain dangerous additives.

In some cases, the ingredients are marketed directly to consumers, who then reconstitute the raw powders and produce their own GLP-1s at home. As a medical professional, I cannot stress enough how dangerous this can be. Nothing is worth the risk to your life, and patients should talk to their primary care physician to ensure they are using FDA-approved GLP-1s.

This photograph taken in Paris shows the anti-diabetic medication Ozempic (semaglutide) made by Danish pharmaceutical company Novo Nordisk. (Gazette file)

But in most cases, these shipments are marked for compounding and then moved to telehealth companies and unregulated med spas across the country to be marketed and sold to consumers as a cheap alternative to FDA-approved GLP-1s. But despite the misleading marketing, compounded GLP-1s are not simply a generic or white label version.

What the marketing fails to mention are the serious risks that come with using non-FDA-approved GLP-1s, which don’t receive the same approval, oversight, and safety checks, nor are they required to provide the same instructions or labeling. As of July 2025, the FDA received reports of 17 deaths, more than 100 hospitalizations and more than 1,000 adverse events associated with compounded GLP-1s. These events can be caused by incorrect dosing, the addition or replacement of ingredients, or counterfeit components can lead to infection and even sepsis.

Our federal and state governments must work together to address this. Following several calls to action, including from Attorney General Phil Weiser and members of the Colorado congressional delegation, the FDA instituted a “green list” import alert that will go a long way to stopping new shipments of these dangerous ingredients.

But more can be done to address the companies using APIs already in the country and continuing to sell illegally compounded GLP-1s. The FDA recently sent warning letters to several around the country reminding them of the law. But at a state level, there can also be action, including from law enforcement and the State Board of Pharmacy to enforce laws against these companies’ practices and protect consumers from these predatory practices. This is especially important for communities of color and low-income patients targeted on social media by these companies.

As a health care professional, I cannot overstate enough the dangers associated with this unregulated market. For marginalized communities in particular, who already face barriers to safe and effective health care access, these sellers are taking advantage of people’s real medical needs and vulnerabilities. Patients deserve access to safe, effective FDA-regulated medications and must have transparency in the products being marketed to them. Safety being the number one priority will help to ensure health equity and deny predatory sellers in our community.

Laura Howard has worked in a variety of roles in her registered nursing career and is serving currently as president of the Colorado Council of Black Nurses Inc. (CCBN) and as public information officer for social action and legislation for CCBN. Howard is also a member of Chi Eta Phi, Iota Eta Chapter, a Professional Nursing Organization, and the Colorado Nurses Association.

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