Publication

Compounded glucagon-like peptide-1 receptor agonists for weight loss: the direct-to-consumer market in Colorado

Michael J. DiStefano, Mouna Dardouri, Gina D. Moore, Joseph J. Saseen, Kavita V. Nair

Journal of Pharmaceutical Policy and PracticeDec 24, 2024
Abstract

BackgroundHigh prices and other access barriers have contributed to the rise of a market for compounded glucagon-like peptide-1 receptor agonists for weight loss in the United States. This market has not been systematically studied. We conducted a pilot study to assess the prevalence, characteristics, and advertising content of direct-to-consumer providers of compounded glucagon-like peptide-1 products for weight loss in Colorado.

MethodsWe conducted a cross-sectional study of websites advertising compounded glucagon-like peptide-1 products for weight loss in Colorado. Websites were identified using Google searches focused on census-defined statistical areas. Searches were conducted between March 21 and April 12, 2024. Data collected from websites included physical addresses, business type, highest reported staff credential, advertised glucagon-like peptide-1 products, whether businesses referred to Food and Drug Administration approval when describing products, and whether businesses referred to products as 'generic'.

ResultsWe identified 93 business websites advertising compounded glucagon-like peptide-1 products for weight loss corresponding to 188 physical locations throughout Colorado. Most businesses were self-categorized as medical/health spas (33/93) or weight loss services (26/93). Advertised products included semaglutide (92/93), tirzepatide (40/93), liraglutide (2/93), and retatrutide (1/93). Advertised combination products included B vitamins (8/93), levocarnitine (1/93), mannitol (1/93), BPC-157 (1/93), and glycine (1/93). Seven websites advertised oral formulations. Additionally, 41/93 websites referred to Food and Drug Administration approval in their descriptions of compounded products and 5/93 referred to products as 'generic'.

ConclusionThis study identified several instances of unapproved glucagon-like peptide-1 products being compounded and advertised in Colorado. Additionally, 1 product was advertised as compounded with BPC-157, a substance determined by the Food and Drug Administration to be unsafe for compounding. This study also identified numerous examples of misleading claims regarding the regulatory status of compounded glucagon-like peptide-1 products. Regulatory action is needed to ensure the benefits of compounded GLP-1 products outweigh the risks.

1Authors

AuthorAffiliationh-indexCitations
Michael J. DiStefanoUniversity of Colorado Anschutz161,347
Mouna DardouriUniversity of Colorado Anschutz
Gina D. MooreUniversity of Colorado Anschutz7228
Joseph J. SaseenUniversity of Colorado Anschutz3416,345
Kavita V. NairUniversity of Colorado Anschutz201,338

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