Flavor Concepts LLC

CLOSEOUT LETTER Flavor Concepts LLC MARCS-CMS 614179 — July 16, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Reference #: RW2101565 Product: Tobacco Recipient: Recipient Name Susannah VanWinkle Flavor Concepts LLC United States flavorconcepts7330@gmail.com Issuing Office: Center for Tobacco Products United States Dear Susannah VanWinkle, The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your Warning Letter responses dated April 27, 2021 and May 11, 2021, in response to our Warning Letter dated April 9, 2021. Based on our evaluation, it appears that you have addressed the violations contained in the Warning Letter regarding your website https://conceptsinflavor.com. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. This letter also will not preclude any regulatory action should violations be observed in the future. Sincerely, /S/ Mallory Bowling Branch Chief Division of Promotion, Advertising, and Labeling Office of Compliance and Enforcement Center for Tobacco Products VIA Electronic Mail cc: Flavor Concepts, LLC info@karmacloudmaker.com GoDaddy.com, LLC abuse@godaddy.com InMotion Hosting, Inc. abuse@inmotionhosting.com Content current as of: 07/21/2021 Regulated Product(s) Tobacco