Yuni Wholesale, Inc. d/b/a Blow Disposables

Warning LetterOpen

Mohammad Awad Yuni Wholesale, Inc. d/b/a Blow Disposables 6430 Green Bay Rd., Ste 102 Kenosha , WI 53142 United States info@blowdisposable.com support@blowdisposable.com blowdisposables@gmail.comFEI 3015321027Issued Jan 21, 2022Center for Tobacco Products

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3015321027.

Violations1

Issue DateJan 21, 2022

Product TypeTobacco

StatusOpen

Letter Details

Firm: Yuni Wholesale, Inc. d/b/a Blow Disposables
Location: Mohammad Awad Yuni Wholesale, Inc. d/b/a Blow Disposables 6430 Green Bay Rd., Ste 102 Kenosha , WI 53142 United States info@blowdisposable.com support@blowdisposable.com blowdisposables@gmail.com
FEI Number: 3015321027
Country: United States
Issue Date: January 21, 2022
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Yuni Wholesale, Inc. d/b/a Blow Disposables was warned for manufacturing and selling electronic nicotine delivery system (ENDS) products through its website without required premarket authorization. The company failed to comply with FDA regulations requiring "new tobacco products" to obtain premarket approval orders before being legally marketed in the United States, as mandated by the Family Smoking Prevention and Tobacco Control Act and the FD&C Act. The FDA determined that the ENDS products offered on blowdisposable.com were subject to FDA jurisdiction and tobacco product regulations but lacked the necessary compliance documentation for lawful distribution.

Yuni Wholesale, Inc. d/b/a Blow Disposables FDA Warning Letter, January 21, 2022