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