Herbal Vitality, Inc.

CLOSEOUT LETTER Herbal Vitality, Inc. MARCS-CMS 640206 — March 19, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Yvan P. Rochon, PhD Recipient Title President Herbal Vitality, Inc. 2810 Hopi Drive Sedona , AZ 86336 United States herbalvitality@sedona.net Issuing Office: Division of Human and Animal Food Operations West IV United States Secondary Issuing Offices United States Dear Dr. Rochon: The Food and Drug Administration has completed the evaluation of your firm’s corrective actions in response to our Warning Letter #640206, issued on March 7, 2023. Based on our evaluation, it appears the you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ Carrie Lawlor, Branch Chief Dietary Supplements Enforcement Branch Office of Compliance and Enforcement Human Foods Program U.S. Food and Drug Administration Content current as of: 04/07/2026 Regulated Product(s) Medical Devices