Mohammed Wazwaz
Maduro Distributors d/b/a The Loon
255 Roselawn Ave E, Suite 41
Maplewood , MN 55117
United States
theloonmn@gmail.comFEI 3019635324Issued Aug 20, 2021Center for Tobacco Products
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 3019635324.
Violations1
Issue DateAug 20, 2021
Product TypeTobacco
StatusOpen
Letter Details
Firm
Maduro Distributors d/b/a The Loon
Location
Mohammed Wazwaz
Maduro Distributors d/b/a The Loon
255 Roselawn Ave E, Suite 41
Maplewood , MN 55117
United States
theloonmn@gmail.com
FEI Number
3019635324
Country
United States
Issue Date
August 20, 2021
Issuing Office
Center for Tobacco Products
Product Type
Tobacco
Status
Open
Summary
Maduro Distributors d/b/a The Loon was cited for manufacturing and distributing electronic nicotine delivery system (ENDS) products through their website without required FDA premarket authorization. The company failed to comply with the Federal Food, Drug, and Cosmetic Act by offering "new tobacco products" for sale without obtaining the legally required marketing authorization orders under section 910 of the FD&C Act. As deemed tobacco products subject to FDA jurisdiction since August 8, 2016, the ENDS products were in violation of applicable tobacco product regulations and restrictions on sale and distribution.
Maduro Distributors d/b/a The Loon FDA Warning Letter, August 20, 2021
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