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  5. Legend Vapor, Inc. d/b/a Legend Vapor - 614222 - 08/12/2022
  1. Warning Letters

CLOSEOUT LETTER

Legend Vapor, Inc. d/b/a Legend Vapor MARCS-CMS 614222 —

Delivery Method:
VIA Electronic Mail
Product:
Tobacco
Recipient:
Recipient Name
Donal Bush, Kelly Bush and Chris Moore
Legend Vapor, Inc. d/b/a Legend Vapor

United States

sales@legendvapor.com
Issuing Office:
Center for Tobacco Products

United States

Dear Donal Bush, Kelly Bush and Chris Moore:

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 April 26, 2021, May 6, 2021, June 23, 2021, November 8, 2021 and July 28, 2022, to our Warning Letter dated April 9, 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.legendvapor.com.

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

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