Delivery Method: VIA Electronic Mail Reference #: RW2001279 Product: Tobacco

Issuing Office: Center for Tobacco Products

United States

Dear Joseph Pirrota:

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 1, 2020 and April 23, 2020 in response to our Warning Letter dated March 27, 2020. Based on our evaluation, it appears that you have taken steps to address the violations contained in the Warning Letter regarding your website

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.

David Rice
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products

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