FDA Letter API

E Vapor Hut LLC

Letter data

Company
E Vapor Hut LLC
Recipient
April Hardy | E Vapor Hut LLC | United States | april@evaporhut.com
Issue date
2022-07-01
Posted date
Not available
FDA office
Center for Tobacco Products
Subject
Not available
Product
Tobacco
CMS ID
626435
Reference number
RW2201736
FEI
Not available
Inspection dates
Not available

Normalized citations

21 CFR: None found

21 U.S.C.: None found

Related FDA links

No related FDA letter link is present in the source index.

Full source text

CLOSEOUT LETTER E Vapor Hut LLC MARCS-CMS 626435 — July 01, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Content current as of: 07/14/2022 Regulated Product(s) Tobacco