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CLOSEOUT LETTER

Flavor Concepts LLC MARCS-CMS 614179 —

Delivery Method:
VIA Electronic Mail
Reference #:
RW2101565
Product:
Tobacco

Recipient:
Recipient Name
Susannah VanWinkle
Flavor Concepts LLC

United States

flavorconcepts7330@gmail.com
Issuing Office:
Center for Tobacco Products

United States


Dear Susannah VanWinkle,

The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your Warning Letter responses dated April 27, 2021 and May 11, 2021, in response to our Warning Letter dated April 9, 2021. Based on our evaluation, it appears that you have addressed the violations contained in the Warning Letter regarding your website https://conceptsinflavor.com.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained 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 Bowling
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products

VIA Electronic Mail

cc:

Flavor Concepts, LLC
info@karmacloudmaker.com

GoDaddy.com, LLC
abuse@godaddy.com

InMotion Hosting, Inc.
abuse@inmotionhosting.com

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