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CLOSEOUT LETTER

reBreathe Vapor Products MARCS-CMS 617043 —

Delivery Method:
VIA Electronic Mail
Reference #:
RW2101626
Product:
Tobacco

Recipient:
Recipient Name
Debbra Warren
reBreathe Vapor Products

United States

(b)(6)
Issuing Office:
Center for Tobacco Products

United States


Dear Debbra Warren:

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 August 29, 2021 in response to our Warning Letter dated August 20, 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://rebreathevapor.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:

Plush n’ Rich, LLC
Attn: Aaron Jasper
aaronjasper20@gmail.com

GoDaddy.com, LLC
abuse@godaddy.com

 
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