Sema International Inc.

CLOSEOUT LETTER Sema International Inc. MARCS-CMS 614691 — May 27, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Reference #: RW2101594 Product: Tobacco Recipient: Recipient Name Anan Barbarawi Sema International Inc. United States sema.international@gmail.com Issuing Office: Center for Tobacco Products United States Dear Anan Barbarawi: The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your response dated May 17, 2021 in response to our Warning Letter dated May 7, 2021. Based on our evaluation, it appears that you have taken steps to address the violations contained in the Warning Letter regarding your website https://semavape.com. However, our surveillance shows you continue to offer for sale to customers in the United States other tobacco products that may be subject to market authorization requirements. FDA encourages you to discuss with your suppliers the current status of any particular tobacco product’s marketing application or any product’s marketing authorization. For additional information regarding currently marketed tobacco products that a company generally might manufacture, distribute, or sell without risking FDA enforcement, please visit our website https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/deemed-new-tobacco-product-applications-lists?utm_medium=email&utm_source=govdelivery#list%20of%20deemed. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with each applicable provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA’s implementing regulations or with other relevant legal authority. Please note that if your firm is found to be in violation 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 in the future, this may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction. Sincerely, /S/ David Rice Branch Chief Division of Promotion, Advertising, and Labeling Office of Compliance and Enforcement Center for Tobacco Products VIA Electronic Mail cc: 1&1 IONOS SE abuse@ionos.com 1&1 IONOS Inc. abuse@1and1.com Content current as of: 06/07/2022 Regulated Product(s) Tobacco