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CLOSEOUT LETTER

E Vapor Hut LLC MARCS-CMS 626435 —

Delivery Method:
VIA Electronic Mail
Reference #:
RW2201736
Product:
Tobacco

Recipient:
Recipient Name
April Hardy
E Vapor Hut LLC

United States

april@evaporhut.com
Issuing Office:
Center for Tobacco Products

United States


Dear April Hardy:

The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your letters dated February 7, 2022, in response to our Warning Letter dated February 4, 2022. Based on our evaluation, it appears that you have addressed the violation contained in the Warning Letter by no longer offering for sale e-liquids manufactured by you that were cited as not having market authorization on https://evaporhut.com to customers in the United States.

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/
Mallory Johnson
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products

 
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