Shut down the shadow market for GLP-1s

Over the past several weeks, the U.S. Food and Drug Administration has taken steps aimed at protecting consumers using GLP-1 medications, also commonly known as weight-loss drugs.

First, it announced the creation of a “green list” import alert to prevent the flow of illicit GLP-1 ingredients into the country. That was followed by warning letters to several telehealth companies that continue to illegally sell compounded GLP-1s, urging them to stop their deceptive marketing.

While these actions are a start — and will have some impact on the flow of illicit ingredients and on protecting consumers — eliminating this unregulated market will require much more than lists and warnings.

As the founder of Urban Evaluation Solution, I work daily with families in the Bronx navigating the complex challenges of health, economic hardship and social stress. One common factor we see across households is the impact of obesity, not just on health, but also on financial stability, emotional well-being and more.

Over the past several years, many in our community have turned to FDA-approved GLP-1 medications, which, when properly prescribed and administered, can dramatically improve health outcomes and quality of life. Unfortunately, FDA-approved GLP-1s are not the only versions of these medications on the market.

Despite bans on bulk compounding and the use of illicit ingredients from unregistered foreign sellers, there remains a large market for unregulated GLP-1s. This includes both the bulk shipment of ingredients to U.S.-based compounding pharmacies, which then mass-produce medications for telehealth companies to sell illegally, and the shipment of raw ingredients directly to consumers, who mix their own GLP-1s at home.

In either case, the dangers are severe. With unapproved versions and illicit ingredients, it’s impossible to know whether the product was produced safely or even contains the active ingredient. Warnings from members of Congress and the FBI have highlighted shipments that fail to contain any GLP-1 active ingredients at all.

The FDA’s current actions can only do so much to stop this. While the “green list” and stronger enforcement of import bans, particularly at JFK airport, can help keep new ingredients from entering the country, a major problem remains — the ingredients that are already here.

Last year alone, enough of these dangerous and illegal ingredients entered the supply chain to make nearly 80 million doses. In the first eight months of this year, prior to the import alert, tens of millions more doses likely made it through to compounding pharmacies or individuals.

To truly protect consumers, the FDA, Attorney General Letitia James, Gov. Kathy Hochul and local law enforcement must act together to shut down illegal compounders. They must track where these ingredients came from and confiscate the compounded medications before they reach consumers.

FDA-approved GLP-1s are a valuable tool for improving public health. But illicit ingredients used by illegal compounders — or raw materials reconstituted at home — present the opposite: a real and growing danger.

It’s time for decisive action. The lives of New Yorkers depend on it.

Ethel Moran

President & CEO of Urban Evaluation Solution