Sprout Health Partners LLC dba Sprout Health Warning Letter Details

Summary

Sprout Health Partners LLC sold unapproved and misbranded compounded drug products, specifically semaglutide and tirzepatide, directly to U.S. consumers via their website in violation of the Federal Food, Drug, and Cosmetic Act. The company's website contained false or misleading claims stating that "GLP-1 medications are FDA-approved," which falsely implied that their compounded products were equivalent to FDA-approved drugs when compounded products are not FDA-approved. This marketing claim violated sections 502(a) and 502(bb) of the FDCA, which prohibit misbranded drug advertising and labeling, and constituted unlawful introduction of misbranded drugs into interstate commerce under section 301(a) of the FDCA.