FDA Letter API

Mac Vapes LLC d/b/a Oishi Jusu

Letter data

Company
Mac Vapes LLC d/b/a Oishi Jusu
Recipient
Frederick McCullough | Mac Vapes LLC d/b/a Oishi Jusu | 361 Cleveland Place | Suite 105 | Virginia Beach | , | VA | 23462 | United States | oishijusu@gmail.com
Issue date
2019-11-13
Posted date
Not available
FDA office
Center for Tobacco Products
Subject
Not available
Product
Tobacco
CMS ID
585031
Reference number
RW1901116
FEI
Not available
Inspection dates
Not available

Normalized citations

21 CFR: 21-CFR-1143.3

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 Mac Vapes LLC d/b/a Oishi Jusu MARCS-CMS 585031 — November 13, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UPS and Electronic Mail Reference #: RW1901116 Product: Tobacco Recipient: Recipient Name Frederick McCullough Mac Vapes LLC d/b/a Oishi Jusu 361 Cleveland Place Suite 105 Virginia Beach , VA 23462 United States oishijusu@gmail.com Issuing Office: Center for Tobacco Products 10903 New Hampshire Avenue Silver Spring , MD 20993 United States Dear Frederick McCullough: On August 8, 2019, the United States Food and Drug Administration's (FDA) Center for Tobacco Products (CTP) issued a Warning Letter to you informing you that your The Ronins e-liquid tobacco product is misbranded because its labeling does not display the required nicotine warning statement in the manner required by 21 C.F.R. § 1143.3. We acknowledge receipt of your e-mail correspondences dated August 8, 2019 and September 12, 2019, regarding the Warning Letter and corrective actions taken. In addition, FDA held a teleconference with you on September 11, 2019 to provide clarification regarding the Warning Letter. Based on our evaluation, it appears that you have taken steps to address the violations identified in the Warning Letter. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the FD&C 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/ Ele Ibarra-Pratt Director 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: 11/19/2019 Regulated Product(s) Tobacco