Matthew Berger
Seditious Vapours, LLC d/b/a Butt Out Labs
3201 N 16th St Ste 14
Phoenix , AZ 85016
United States
buttoutphoenix@gmail.com
(b)(6)FEI 3013053071Issued Aug 27, 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 3013053071.
Violations1
Issue DateAug 27, 2021
Product TypeTobacco
StatusOpen
Letter Details
Firm
Seditious Vapours, LLC d/b/a Butt Out Labs
Location
Matthew Berger
Seditious Vapours, LLC d/b/a Butt Out Labs
3201 N 16th St Ste 14
Phoenix , AZ 85016
United States
buttoutphoenix@gmail.com
(b)(6)
FEI Number
3013053071
Country
United States
Issue Date
August 27, 2021
Issuing Office
Center for Tobacco Products
Product Type
Tobacco
Status
Open
Summary
Seditious Vapours, LLC d/b/a Butt Out Labs was warned that its e-liquid tobacco products sold through buttoutecigs.com were not in compliance with the Family Smoking Prevention and Tobacco Control Act and applicable FDA regulations. The company failed to obtain required premarket authorization orders for its "new tobacco products" before marketing them in the United States, as mandated under section 910 of the FD&C Act for any tobacco products not commercially marketed as of February 15, 2007. The FDA's Center for Tobacco Products determined that the e-liquids met the definition of tobacco products subject to FDA jurisdiction and were being manufactured and offered for sale without the legally required premarket approval.
Seditious Vapours, LLC d/b/a Butt Out Labs FDA Warning Letter, August 27, 2021