FDA WARNING_LETTER - Revitalize Energy, Inc. - April 14, 2025

**FDA Warning Letter Summary**

**Company Name:** Revitalize Energy

**Inspection Date:** April 14, 2025

**Main Violations/Issues:** The FDA identified significant regulatory violations concerning the marketing of Revitalize Energizing Eye Drops. The product is classified as an unapproved new drug under sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as it is introduced into interstate commerce without FDA approval. Additionally, the product is misbranded under section 502(ee) of the FD&C Act. The eye drops are marketed with claims that suggest they are intended to diagnose, cure, mitigate, treat, or prevent disease, which necessitates FDA approval. The product"s labeling and promotional materials on the company"s website and social media platforms make claims about relieving eye strain, boosting focus, and refreshing tired eyes, which further support its classification as a drug.

**Regulatory Framework:** The product is subject to the FD&C Act, specifically sections 505(a), 301(d), and 502(ee), which govern the approval and marketing of drug products. The eye drops do not conform to the applicable Over-the-Counter (OTC) monograph M018 for ophthalmic drug products, as they contain active ingredients like menthol, camphor, caffeine, and taurine, which are not permitted under the monograph.

**Required Actions:** Revitalize Energy must cease the introduction of the unapproved and misbranded product into interstate commerce. The company is required to obtain FDA approval for the product or modify its formulation and labeling to comply with applicable OTC monograph standards. Immediate corrective actions are necessary to address these violations, and the company must respond to the FDA with a plan to rectify the issues.