FDA WARNING_LETTER - Peaks Curative, LLC dba Peaks - December 31, 2025

The FDA issued a Warning Letter to Peaks Curative, LLC dba Peaks on February 20, 2026, following a December 2025 review of its website, peakscurative.com. The letter addresses significant violations concerning the company's promotion and sale of compounded semaglutide drug products.

The primary issues involve misbranding under the Federal Food, Drug, and Cosmetic Act (FDCA), specifically sections 502(a) and 502(bb). Peaks Curative's website falsely implies that "Peak Now" is the compounder of these drugs. Additionally, the company makes misleading claims that its compounded semaglutide products are "FDA-approved treatment," "clinically proven," and "safe, affordable, and effective." The FDA clarifies that compounded drugs are not FDA-approved and that these claims are false or misleading, rendering the products misbranded. Introducing these misbranded products into interstate commerce also constitutes a prohibited act under FDCA section 301(a).

Peaks Curative is required to respond within fifteen working days, detailing corrective actions taken to resolve these violations and prevent their recurrence. This includes identifying actual product compounders, providing sample product labeling, and justifying or revising all potentially false or misleading website claims. Failure to comply may lead to legal action, including product seizure or injunction.