Comasphere LLC

CLOSEOUT LETTER Comasphere LLC MARCS-CMS 581207 — December 01, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Reference #: ER2000037 Product: Tobacco Recipient: Recipient Name Justin M. Roseman Comasphere LLC United States admin@comasphere.com Issuing Office: Center for Tobacco Products United States Secondary Issuing Offices United States Dear Justin Roseman: The United States Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) has completed evaluation of your corrective actions in response to FDA’s March 19, 2020 Warning Letter. Based on our evaluation, it appears that you have taken steps to address the violations contained in the 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 ensure sustained compliance with the Federal Food, Drug, and Cosmetic Act (FD&C 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. It is your responsibility to ensure that all of your tobacco products and all related labeling and/or advertising on any websites (including e-commerce, social networking, or search engine websites), in any other media in which you advertise, and in any retail establishments comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to address any violations of the FD&C Act, 21 U.S.C. § 301 et seq., Chapter IX, relating to tobacco products including the tobacco regulations in 21 C.F.R. Parts 1140, 1141, and 1143, may lead to regulatory action, including, but not limited to, civil money penalties, no-tobacco-sale order, seizure, and/or injunction. If you have any questions, please contact CTPCompliance@fda.hhs.gov. Sincerely, /S/ Chad Burger Director Division of Product Compliance Office of Compliance and Enforcement Center for Tobacco Products Content current as of: 09/09/2024 Regulated Product(s) Tobacco