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CLOSEOUT LETTER

Nicotine Nirvana MARCS-CMS 614671 —

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:

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nicotinenirvana.com@contactprivacy.com

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