This document examines the FDA warning letter issued to Revibe, Inc. on May 18, 2018, highlighting the regulatory concerns raised regarding the company’s marketing and manufacturing practices of kratom products. The letter outlines significant issues, including the promotion of unapproved medical claims, misleading claims about product efficacy, and deficiencies in adherence to Good Manufacturing Practices (GMP). The FDA’s concerns underscore the necessity for compliance with federal regulations to ensure patient safety and product effectiveness. The letter also delineates the required corrective actions Revibe must undertake to address these issues, while warning of potential consequences for continued non-compliance. This analysis emphasizes the importance of regulatory oversight in maintaining industry standards and protecting public health.

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