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. 2024 Dec 24;18(1):2441220.
doi: 10.1080/20523211.2024.2441220. eCollection 2025.

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

Michael J DiStefano  1 , Mouna Dardouri  1 , Gina D Moore  1 , Joseph J Saseen  1 , Kavita V Nair  1   2
Affiliations

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

Michael J DiStefano et al. J Pharm Policy Pract. .

Abstract

Background: High 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.

Methods: We 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'.

Results: We 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'.

Conclusion: This 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.

Keywords: Advertising; GLP-1; compounded; direct-to-consumer; obesity; semaglutide; tirzepatide; weight loss.

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Conflict of interest statement

The authors report no funding in support of this manuscript. Dr. Saseen reports serving as a member of the monitoring board for two large cardiovascular outcome trials (VESALIUS, OCEAN(a)) sponsored by Amgen. Dr. Nair reports serving as a consultant for Bristol Myers Squibb, Novartis, Biogen, TG Therapeutics, Genentech, EMD Serono, and PhRMA. Dr. Nair has received speaking fees from Sanofi, Genzyme, Amgen, AJMC, and the American Academy of Neurology.

Figures

Figure 1.
Figure 1.
Physical locations of direct-to-consumer businesses that advertise compounded GLP-1 products for weight loss in Colorado. Note: Physical addresses are mapped according to the metropolitan or micropolitan area in which they are located (one location in Cheyenne County is not located in any metropolitan or micropolitan statistical area). Denver-Aurora-Lakewood: 97; Colorado Springs: 26; Fort Collins: 22; Boulder: 14; Greeley: 7; Glenwood Springs: 5; Pueblo: 4; Edwards: 3; Grand Junction: 3; Durango: 2; Breckenridge: 2; Canon City: 1; Steamboat Springs: 1; Cheyenne County: 1. Source of original map: https://www2.census.gov/programs-surveys/metro-micro/reference-maps/2020/state-maps/08_Colorado_2020.pdf
See this image and copyright information in PMC

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