Guest Opinion: New Yorkers Need Protection From Illicit GLP-1 Pharmaceuticals

BY MARILYN REYES-SCALES | Communities across New York and the country are facing dual public health crises. On one hand, obesity rates are continuing to climb steadily, fueling the prevalence of chronic conditions like diabetes, joint issues, and heart disease. On the other hand, the popularity of GLP-1 drugs (medications used to treat type 2 diabetes and obesity) and the now-concluded shortages of them created a parallel threat–a flood of dangerous, illicit GLP-1 active pharmaceutical ingredients (API) flowing into the country and endangering lives. 

Photo via Grassroots Strategies.

The sellers of API, who are unregistered in the U.S., operate predominantly in China. These suppliers produce raw ingredients that they sell both directly to U.S. consumers and to compounding pharmacies, which in turn mass-produce compounded GLP-1s for telehealth companies like Willow and Hims & Hers. 

Serving on the board of VOCAL-NY, I understand the cruciality of access to safe, effective care. In the last couple of weeks, we saw counterfeit HIV medication enter the supply chain and subsequent action to shut it down. 

The flow of illicit API into the U.S. and the sale of compounded medications containing these ingredients is equally as concerning and demand a similar response.  

The APIs being shipped from overseas all come with similar labeling, which generally states that the products are for research purposes and not intended for human use. Yet that hasn’t stopped consumers from accessing them. 

The API can often contain high levels of impurities, and recent reports from the FBI have noted that a shipment of semaglutide—the API in Ozempic and Wegovy—from an unregistered seller didn’t contain any of the product. The fact of the matter is that there are no assurances of what’s in these products.

As a result, there’s a heightened risk of severe consequences. Poison control centers have already reported a 1,500 percent increase in calls related to potential overdoses from GLP-1s, and that’s in addition to the 17 reported deaths from unregulated GLP-1s. 

But the danger doesn’t just lie in the product. It also lies in how they’re being marketed to consumers. Sellers advertise across social media platforms and elsewhere that raw API or compounded GLP-1s are a lower-cost solution to access GLP-1s. 

Photo of Marilyn Reyes-Scales courtesy of Reyes-Scales.

The advertising fails to warn of the consequences or dangers associated with their products. Instead, they’re billed as the trendy thing to do, and ads are targeted at vulnerable communities, particularly young women. 

Fortunately, steps have been taken to mitigate this threat. Several members of New York’s congressional delegation signed onto a bipartisan letter urging the FDA to step up its enforcement efforts against the illegal importation of APIs. The letter called for them to work with U.S. Customs and Border Protection to stop the flow of ingredients—an important step, given the significant volume that passes through JFK Airport. But the FDA also needs to shut down the compounders that are using illicit API to continue to skirt the law and mass-produce compounded GLP-1s. 

Beyond that, the FTC and New York Attorney General Tish James must also investigate questionable marketing practices by telehealth companies and sellers of illicit API and hold these retailers accountable. 

Obesity and the flow of illicit API are intertwined public health threats for which New Yorkers are paying the price. Every day that fake weight loss drugs continue to spread in our communities, residents remain at risk. 

GLP-1 medications are an important tool for improving health—but only when they are safe, FDA-approved versions. Federal agencies and New York’s state and federal elected officials must act now to protect public health and prevent these unsafe products from entering our country.

Marilyn Reyes-Scales is a Bronx community leader, activist, and public health advocate.

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NOTE: The views expressed by our Guest Opinion writers are not necessarily those of Chelsea Community News.

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