Over the past few years there has been an increase in the availability of non-FDA approved compounded GLP-1 drugs. The proliferation and marketing of these drugs is especially dangerous to the vulnerable populations HECCD has continuously fought for, including communities of color, rural Americans, and older adults. These groups are especially vulnerable due to gaps in both private and public insurance coverage through programs like Medicaid. When evidence-based treatments are financially out of reach, alternative markets often fill the void.
Patients facing unfair and discriminatory coverage barriers should not be pushed towards the gray market where they might be exposed to potentially dangerous and ineffective treatment options. Patients with obesity deserve access to the best standard of care. HECCD urges lawmakers to strengthen oversight of compounded medications and curb misleading marketing to protect patients’ health and uphold the integrity of the FDA approval process. Lasting solutions must expand access to safe, evidence-based obesity care recommended by medical providers.
What Leaders Are Saying
“Our communities should never have to guess whether an advertisement tells the whole story. As compounded weight-management medications become more widely marketed, families deserve transparency about what a product is and what it is not.”
— Dr. Ray Serrano | League of United Latin American Citizens (LULAC)
“Greater transparency strengthens patient confidence and supports safer healthcare choices.”
— Dr. Yanira Cruz | National Hispanic Council on Aging (NHCOA)
“Latinas are often the healthcare decision-makers in their households, not only for themselves but also for their children, parents, and loved ones. That responsibility depends on having information they can trust.”
— Amy Hinojosa | MANA, A National Latina Organization
“Obesity remains one of the most significant chronic diseases affecting Hispanic communities, and patients deserve clear, accurate information about the treatments available to them.”
— Dr. Elena Rios | National Hispanic Health Foundation (NHHF)
“CHL stands with the National Consumer League and other consumer and public health advocates in calling for greater accountability, transparency, and oversight of these compounded products. Our communities deserve accurate information, safe treatment options, and protection from misleading or dangerous practices.”
— Organization | ChooseHealthyLife
What You Need to Know
Compounded GLP-1 Drugs Are Dangerous for Populations Disproportionately Impacted by Obesity.
- Compounded GLP-1 drugs are not FDA-approved and have not been reviewed for safety, effectiveness, or quality. Compounded GLP-1s are not subject to the same rigorous evaluation process as FDA-approved GLP-1s — meaning patients have no guarantee that what they’re taking is safe, effective, or accurately dosed.
- Many of the active pharmaceutical ingredients used in compounded GLP-1s have come from unregistered foreign manufacturers, which means they can contain unsafe levels of these ingredients and bring about significant health risks.
- Compounded versions of semaglutide, the active ingredient in FDA-approved diabetes and obesity drugs Ozempic and Wegovy, have been associated with hundreds of adverse events and dozens deaths. As of January 21, 2026, compounded semaglutide has been associated with 961 adverse events, including 21 deaths.
- Compounded GLP-1s may not even work at all. Effectiveness is not guaranteed since there is less oversight. The FDA does not review compounded drugs for safety, effectiveness or quality before they are marketed. Patients can take on real risk for a product that doesn’t even deliver the treatment they believe they’re getting.
Compounded Drugs Are Too Easily Accessible and Can Hurt Already-Vulnerable Populations.
- Compounded GLP-1 products are misleadingly marketed to vulnerable populations — including low-income patients, seniors, communities of color, and rural Americans — who lack adequate insurance coverage of FDA-approved GLP-1 treatments.
- The lack of FDA oversight has allowed a largely unregulated market to flourish online. The FDA has sent nearly 100 warning letters to dozens of telehealth firms selling compounded GLP-1 drugs since September 2025 for making claims implying sameness with FDA-approved products and obscuring product sourcing of these compounded products.
- Compounded GLP-1 products can contain uneven levels of doses and concentrations and can be improperly stored and preserved. Unlike FDA-approved medications, which come in standardized prefilled pens, compounded versions often arrive in multi-dose vials with varying concentrations and not at recommended storage temperatures — creating additional risk of dosing error for patients managing their own injections at home.
- The true toll is likely undercounted. Traditional compounding pharmacies — the source of most telehealth-marketed copycat GLP-1s — face no explicit FDA requirement to report adverse events, unlike FDA-approved drugmakers, meaning the hospitalizations and deaths reported so far may be just the tip of the iceberg.
The Proliferation of Compounded Drugs Can Be Stopped, Protecting the Health of Millions of Americans.
- The real solution is expanding access to FDA-approved treatments — not tolerating dangerous substitutes. State legislatures should expand Medicaid coverage for FDA-approved obesity medications, ensuring access to comprehensive, evidence-based obesity treatments that would improve health outcomes, strengthen health equity, and help reduce long-term healthcare costs by preventing avoidable chronic disease progression.
- Lawmakers must empower the FDA to protect public health. Congress should strengthen the FDA’s enforcement authority over compounded products, ensuring that the lowest-income Americans — who face the highest barriers to care and the greatest risk of turning to unregulated alternatives — can access safe, evidence-based care through their doctors and trusted providers.