June 26, 2026

WASHINGTON, D.C. — Today, the Health Equity Coalition for Chronic Disease (HECCD) called on the Food and Drug Administration (FDA) to finalize its proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulk Drug Substances List. If enacted, the policy would protect our nation’s most vulnerable populations dealing with chronic disease —  including communities of color, rural populations, older adults, and other underserved communities disproportionately impacted by obesity — from unregulated, potentially dangerous copycat GLP-1 drugs flooding the gray market that often make unverified safety and efficacy claims, and are increasingly reaching vulnerable consumers. 

The FDA announced the proposal on April 30, 2026, finding no clinical need for outsourcing facilities to compound these drugs from bulk substances now that FDA-approved treatments are commercially available. The public comment period closes June 30, 2026. As of May 31, 2026, the FDA had received more than 1,700 adverse event reports associated with compounded semaglutide and tirzepatide — a figure that is deeply alarming.

“For the past several years, our coalition has been focused on expanding access to obesity care due to both the high number of chronic diseases associated with obesity and the disparate impacts of the disease on vulnerable communities such as low-income, rural, and communities of color. Many of these communities are also particularly vulnerable to misleading advertisements for compounded GLP-1s due to a lack of consistent access and advice from a trusted healthcare provider,” HECCD said in its written comment to the FDA. “For that reason, we are writing today to express strong support for the Food and Drug Administration’s decision to remove semaglutide, tirzepatide, and liraglutide.” 

The communities that HECCD represents — communities of color, rural communities, low-income families, older adults and underserved communities overlooked by the healthcare system — face the highest rates of obesity and often the least reliable access to trusted medical care. Despite this disproportionate burden, coverage for evidence-based obesity care remains inconsistent, leaving many patients to seek treatment outside traditional healthcare channels. That combination makes them prime targets for misleading marketing around unregulated compounded GLP-1s. These vulnerable populations would benefit most from the FDA finalizing this decision and shutting the door on the grey market of compounded anti-obesity medications.

HECCD submitted formal comments to the FDA docket in support of the proposal, underscoring the patient safety rationale for removing these substances from the 503B Bulks List and urging the agency to move swiftly toward finalization. HECCD also urges the FDA to continue aggressive enforcement against telehealth companies and other entities that continue marketing non-FDA-approved compounded GLP-1 products in violation of federal law.

Advocacy to Combat Compounded Medications 

HECCD has long advocated for stronger patient protections. Earlier this year, HECCD applauded the U.S. Food and Drug Administration for announcing a series of new actions and steps to combat the proliferation and marketing of non–FDA-approved compounded, or “copycat,” GLP-1 obesity drugs, arguing that “Strengthening oversight and curbing misleading marketing are important steps in protecting patients’ health and upholding the integrity of the FDA approval process.” 

Last fall, HECCD joined with the National Consumers League (NCL) and a dozen other prominent national advocacy leaders (including LULAC, MANA, and NHCOA) to petition the Federal Trade Commission (FTC) — asking them “to undertake a thorough investigation of the pervasive, deceptive and misleading marketing practices of telehealth platforms.” The petition argued, “these practices expose consumers to unsubstantiated claims and misleading inferences regarding safety, efficacy and the comparability of the ingredients used in compounded GLP1 products as compared to FDA approved products.” 

More information about the dangers of GLP-1 copycat medications for patients and consumers can be found at the NCL’s website here or in their policy report here. 

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The Health Equity Coalition for Chronic Disease (HECCD) believes that all people deserve the best possible health care. Continuing to allow outdated coverage policies to restrict access for communities dependent on public programs is counter to the principles of health equity. The Health Equity Coalition for Chronic Disease’s mission is to ensure that community experts, policy makers, providers, and other stakeholders work together to eliminate barriers to healthcare for rural communities, seniors, and communities of color, especially as related to access to care and treatment for obesity.