LIV Health LLC dba INFINIWELL and DEAL Media LLC dba HARMONIA

CLOSEOUT LETTER LIV Health LLC dba INFINIWELL and DEAL Media LLC dba HARMONIA MARCS-CMS 613114 — May 25, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Dietary Supplements Food & Beverages Recipient: Recipient Name Roger Frantz and Jeremy S. Delk LIV Health LLC dba INFINIWELL and DEAL Media LLC dba HARMONIA 881 Corporate Drive Lexington , KY 40503 United States Jeremy.Delk@delkinc.com Issuing Office: Office of Human and Animal Foods Operations‐East V United States Dear Messrs. Frantz and Delk: The Food and Drug Administration (FDA) completed an evaluation of your firm’s corrective actions in response to our Warning Letter No. 613114. Based on our evaluation, it appears 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/ Zada L. Giles Compliance Officer, Division V Office of Human and Animal Foods Operations-East Cc: Dustin Cappelletto, CEO via Dustin@livhealth.com Content current as of: 07/05/2022 Regulated Product(s) Dietary Supplements Food & Beverages