Fred Jeffery and Daniel Jeffrey
Blue Lab Vapors, LLC
3970 Tampa Road Ste C
Oldsmar , FL 34677
United States
(b)(6)Issued Mar 12, 2021Center for Tobacco Products
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.
Violations1
Issue DateMar 12, 2021
Product TypeTobacco
StatusClosed
Closeout LetterJul 19, 2021
Letter Details
Firm
Blue Lab Vapors, LLC
Location
Fred Jeffery and Daniel Jeffrey
Blue Lab Vapors, LLC
3970 Tampa Road Ste C
Oldsmar , FL 34677
United States
(b)(6)
FEI Number
N/A
Country
United States
Issue Date
March 12, 2021
Issuing Office
Center for Tobacco Products
Product Type
Tobacco
Status
Closed
Closeout Letter
July 19, 2021
Summary
Blue Lab Vapors, LLC was warned that its e-liquid products sold through their website are regulated tobacco products under FDA jurisdiction that require premarket authorization orders before legal marketing in the United States. The company failed to comply with the Federal Food, Drug, and Cosmetic Act requirements applicable to newly deemed tobacco products, specifically the requirement that "new tobacco products" obtain marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act. The FDA determined that the e-liquids, being made or derived from tobacco and intended for human consumption, fell under the deeming rule effective August 8, 2016, which extended FDA regulation to electronic nicotine delivery systems and related products.
Blue Lab Vapors, LLC FDA Warning Letter, March 12, 2021