FDA WARNING_LETTER - Musclepower Enterprise Ltd. dba MONSTER KING and GE LABS - November 30, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Musclepower Enterprise Ltd. dba MONSTER KING and GE LABS on December 12, 2025. Between March and November 2025, the FDA reviewed the company"s websites and obtained product samples, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The primary issues involve the marketing of products, including “GE Labs Ykarine” and “GE Labs MK 677,” as selective androgen receptor modulators (SARMs). The FDA determined these products are unapproved new drugs because they are not generally recognized as safe and effective for their intended uses. Labeling claims, such as "MYOSTATIN INHIBITOR" and "INCREASE MUSCLE MASS," demonstrate their intended use as drugs. Furthermore, "GE Labs Ykarine" was found to be a misbranded drug, as laboratory analysis confirmed it contains undeclared trendione, an anabolic steroid and controlled substance. Both "GE Labs Ykarine" (containing NAC) and "GE Labs MK 677" (containing ibutamoren) were unlawfully marketed as dietary supplements, as their ingredients are excluded from the dietary supplement definition due to prior drug approvals or investigations. The FDA expressed serious safety concerns regarding SARMs and anabolic steroids, citing risks such as liver toxicity, heart attack, and stroke. Musclepower Enterprise Ltd. is required to address these violations promptly and provide a written response detailing corrective actions.