FDA WARNING_LETTER - Agebox Inc. - September 30, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Agebox Inc. on December 19, 2025, following a review of their website and social media in September 2025. The letter addresses the unlawful marketing and sale of "iKids-Growth IGF-1 Support Day Formula" and "iKids-Growth IGF-1 Support Night Formula." FDA laboratory analysis confirmed that these products contain undeclared ibutamoren mesylate, an active ingredient not approved by the FDA, with unknown long-term effects and potential serious side effects like increased appetite, water retention, and heart failure risk. The FDA determined that ibutamoren is excluded from the definition of a dietary supplement. Despite being marketed as dietary supplements, the products are considered unapproved new drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act) due to drug claims implying they affect the body"s structure and function by promoting growth and increasing IGF-1 levels. Furthermore, the products are misbranded because their labeling falsely identifies them as dietary supplements and makes misleading claims. Agebox Inc. is in violation of sections 301(d), 505(a), and 301(a) of the FD&C Act for introducing unapproved and misbranded drugs into interstate commerce.