Tracey Breuer and Daniel J. Breuer
Visible Vapors, LLC
2007 Ryans Run
Lansdale , PA 19446
United States
visiblevapors@gmail.comIssued Jul 28, 2021Center for Tobacco Products
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.
Violations1
Issue DateJul 28, 2021
Product TypeTobacco
StatusClosed
Closeout LetterJun 7, 2022
Letter Details
Firm
Visible Vapors, LLC
Location
Tracey Breuer and Daniel J. Breuer
Visible Vapors, LLC
2007 Ryans Run
Lansdale , PA 19446
United States
visiblevapors@gmail.com
FEI Number
N/A
Country
United States
Issue Date
July 28, 2021
Issuing Office
Center for Tobacco Products
Product Type
Tobacco
Status
Closed
Closeout Letter
June 07, 2022
Summary
Visible Vapors, LLC was cited for manufacturing and selling e-liquid tobacco products without required premarket authorization from the FDA. The company's e-liquids, offered through their website, were deemed tobacco products subject to FDA jurisdiction under the Family Smoking Prevention and Tobacco Control Act, but lacked the legally mandated marketing authorization orders necessary for new tobacco products. The warning specifically noted that as e-liquids fall under the FDA's deeming rule effective August 8, 2016, they cannot be legally marketed in the United States without proper premarket review and approval.
Visible Vapors, LLC FDA Warning Letter, July 28, 2021