FDA warning letter · #721448
Strut: What the FDA Letter Means for What You Pay
Legal name: Strut Health, LLC
Primary source
Read the original letter on fda.gov →
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/strut-health-llc-dba-strut-721448-02202026
What FDA cited
Read the full letter →Quoted verbatim from the FDA letter dated
“This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://www.struthealth.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products.”
“The compounded semaglutide and tirzepatide products displayed on your website identify "Strut" on the pictured label, suggesting Strut is the compounder of those drugs when in fact it is not.”
“Additionally, the following claims concerning compounded semaglutide and tirzepatide products appear on your website: "Generic Zepbound, Mounjaro" "Semaglutide is the active ingredient in the brand medications." "Tirzepatide is the active ingredient in the brand medications Zepbound® and Mounjaro®."”
“Compounded drug products are not FDA-approved. Your claims imply that your products have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.”
Is Strut still operating?
struthealth.com returned a live storefront when we checked in August 2026, still operating under the Strut name.
What this means for what you pay
Calling a compounded product "Generic Zepbound, Mounjaro" is the most direct brand-substitution language in this dataset — "generic" is a specific FDA-regulated term for an approved, interchangeable copy of a brand drug, which a compounded product is not. That word choice, not the medication itself, is what FDA objected to; it doesn't tell you whether Strut's price or care model is good, only that this specific comparison overstated what FDA has approved.
Has Strut responded?
As of , FDA’s public tracking for this letter does not show a logged company response. Companies are not required to make a response public, and FDA does not always update this field promptly — this is not evidence Strut failed to respond.
Sources
Other letters in this index
View the full index →Editorial disclaimer: An FDA warning letter is a public regulatory communication stating the agency's view. It is not a recall, a fine, a criminal charge, an injunction, or a finding that a company has broken the law.