Comment from Health Equity Coalition for Chronic Disease

June 26, 2026 The Honorable Kyle Diamantas Acting Commissioner of Food and Drug Administration Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 2099 Attention: FDA-2018-N-3240 Re: List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Dear Acting Administrator Diamantas: We are writing today on behalf of the Health Equity Coalition for Chronic Disease (HECCD), a coalition established to eliminate barriers to quality healthcare by lifting the voices of those in marginalized communities, with a particular focus on chronic disease. 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. 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. More than two in five American adults live with obesity - these rates are higher for Black and Latino adults (50%), and adults living in rural communities (40%). Despite these high rights of obesity, coverage for obesity care remains inconsistent, with many patients struggling to either gain or maintain access to obesity treatments, including GLP-1s. This, combined with the boom in companies selling non-FDA approved compounded GLP-1s, has pushed many consumers to access obesity treatment from these unofficial channels. As the FDA noted in their own report, FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss, unapproved versions of GLP-1s are not subject to FDA’s review for safety, efficacy, or quality before being marketed, sold, and utilized by consumers. In the same report, FDA noted that as of May 31, 2026, they had received more than 1,700 reports of adverse events associated with both compounded semaglutide and tirzepatide. This is of particular concern for HECCD as the communities we represent are often disproportionately harmed by the prevalence of these compounded GLP-1s. Oftentimes, the very same communities with the highest rates of obesity have the most tenuous access to the healthcare system or even insurance itself, making them all the more susceptible to misleading campaigns by telehealth companies, medspas, and others who may be selling compounded GLP-1s. In a poll conducted by the National Consumers League, 71% of US women polled incorrectly believed that compounded GLP-1s must be tested and proven safe to be on the market. Additionally, Spanish language ads often omit critical safety information altogether. For many Spanish speakers these ads may be their only source of information, making them particularly vulnerable to misleading claims. Lack of consistent access to healthcare may leave many of these patients without the guidance of a healthcare provider, which studies have shown is critical for patient success on GLP-1s and may prevent them from using an unapproved GLP-1 in the first place. HECCD is pleased by the recent actions taken by FDA to conduct oversight on telehealth providers making misleading claims regarding compounded GLP-1s and to educate consumers about the potential dangers associated with these products. We share FDA’s goal in protecting consumers and patients, and agree that compounded products should be used in limited circumstances under the direction of a medical provider that prioritizes the health and safety of their patient. HECCD encourages FDA to finalize the decision to remove semaglutide, trizepatide, and liraglutide from the bulk substances list and thanks the FDA for their efforts. We also encourage FDA to continue to take decisive action in order to further limit the dangers of these products to consumers. Sincerely, Health Equity Coalition for Chronic Disease