Nicotine Nirvana

CLOSEOUT LETTER Nicotine Nirvana MARCS-CMS 614671 — June 02, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UPS and Electronic Mail Reference #: RW2101591 Product: Tobacco Recipient: Recipient Name Cliff Loeb Nicotine Nirvana United States Issuing Office: Center for Tobacco Products United States Dear Cliff Loeb: The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your responses, dated May 10, 2021, May 21, 2021, May 23, 2021, and May 24, 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://www.nicotinenirvana.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 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/ David Rice Branch Chief Division of Promotion, Advertising, and Labeling Office of Compliance and Enforcement Center for Tobacco Products VIA Electronic Mail cc: Contact Privacy Inc. Customer 0144274739 nicotinenirvana.com@contactprivacy.com Tucows, Inc. domainabuse@tucows.com Google LLC google-cloud-compliance@google.com Content current as of: 06/07/2021 Regulated Product(s) Tobacco