FDA Letter API

E-Cig Outlet, LLC

Letter data

Company
E-Cig Outlet, LLC
Recipient
Mark Mills and Tom Wasilewski | E-Cig Outlet, LLC | United States | e-cigoutlet@comcast.net | (b)(6)
Issue date
2022-05-27
Posted date
Not available
FDA office
Center for Tobacco Products
Subject
Not available
Product
Tobacco
CMS ID
613472
Reference number
RW2101508
FEI
Not available
Inspection dates
Not available

Normalized citations

21 CFR: 21-CFR-PART-114021-CFR-PART-1141

21 U.S.C.: 21-USC-301

Related FDA links

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

Full source text

CLOSEOUT LETTER E-Cig Outlet, LLC MARCS-CMS 613472 — May 27, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Reference #: RW2101508 Product: Tobacco Recipient: Recipient Name Mark Mills and Tom Wasilewski E-Cig Outlet, LLC United States e-cigoutlet@comcast.net (b)(6) Issuing Office: Center for Tobacco Products United States Dear Mark Mills and Tom Wasilewski: 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 March 8, 2021, and March 18, 2021 in response to our Warning Letter dated February 26, 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://e-cigoutlet.net. 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 cc: GoDaddy.com, LLC abuse@godaddy.com Google, LLC google-cloud-compliance@google.com Content current as of: 06/10/2022 Regulated Product(s) Tobacco