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
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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