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Dr. Stephanie Persondek: Stop the importation and sale of illicit GLP-1 ingredients to protect Washingtonians
There is a litany of information online around obesity. Today, my patients have more information at their fingertips than ever before.
I know how difficult it can be to synthesize this information and turn it into actionable steps. I founded Inclusa Health and Wellness for the purpose of helping to streamline this process through personalized and holistic weight management solutions.
In many of my initial consultations, the one thing that all my patients come ready to discuss is GLP-1 medications for treating obesity. When brought to me, I can ensure they are taking FDA-approved versions, and I can guarantee safe use via correct dosing and monitoring.
But for those consumers that are pursuing their weight loss journey independent of a trusted physician, there is a serious risk of using non-FDA-approved GLP-1s, whether that be from the “gray market” or from telehealth companies selling illegally compounded GLP-1s.
Over the past few years, high demand and domestic shortages of FDA-approved GLP-1s have led to the growth of an unregulated market for semaglutide, the active pharmaceutical ingredient in Ozempic and Wegovy, and tirzepatide, the active ingredient in Mounjaro and Zepbound.
In times of drug shortages, the FDA permits bulk compounding to meet demand. In this case, compounding pharmacies turned to foreign sellers to procure the necessary active ingredient to produce their product.
Since early this year, GLP-1s have no longer been in a shortage, and as a result, compounders have not been permitted to bulk produce GLP-1s. Despite this, the market that shortages created is continuing to thrive. And now dual threats are facing Washingtonians.
Compounding paved the way for the mass importation of API from abroad. Dangerously, much of this has come from unregistered sellers, is produced in facilities without any oversight or safety checks and is liable to contain harmful additives. In some cases, what’s produced in these facilities may not contain any active pharmaceutical ingredient.
While this is not legally supposed to be allowed into the country, enough of it for millions of doses has entered our supply chain. Between September 2023 and January 2025, 239 large shipments of illicit ingredients were sent to the U.S., and 82%t were allowed into our drug supply. Last year alone, Chinese suppliers shipped enough product for almost 80 million doses.
When this active pharmaceutical ingredient arrives in the U.S., it’s either directed to compounding pharmacies that bulk produce GLP-1s and use telehealth companies as intermediaries to get their product into the hands of consumers, or, in some cases, it’s shipped directly to consumers, who then mix their own GLP-1s at home.
The commonality with all illicit ingredients is that it’s generally labeled as a research product, i.e. it’s not safe for human use. Yet that hasn’t stopped suppliers from advertising illicit API to consumers on social media as a low-cost alternative to FDA-approved GLP-1s. Similarly, the use of illicit active pharmaceutical ingredients by compounders hasn’t stopped telehealth companies from marketing the products to consumers across the internet, all without warnings on the dangers of the product.
The fact that illicit ingredients is in our supply chain shows the need for immediate action. The FDA’s “green list” import alert is a start, but it doesn’t prevent the ingredient that’s already in the country from reaching the hands of consumers. To do this requires state and federal cooperation, including from the state Pharmacy Quality Assurance Commission, the attorney general, and the governor, to shut down compounders and confiscate their illicit ingredients. It also demands action, including cease and desist letters, preventing telehealth companies from partaking in deceptive marketing and sales.
The importation of illicit active pharmaceutical ingredients and the sale of illegal GLP-1s takes advantage of consumers looking to treat their disease. Consumers across the U.S. deserve safe and effective treatment through legitimate channels, not targeted ads and dangerous knockoffs that put their lives at risk.
Stephanie Persondek, DO, is the founder and medical director of Inclusa Health & Wellness in Liberty Lake.