Michael Cotellese
MJM Distribution Inc dba Asheville Vapor
2144 Hendersonville Rd., Ste. B
Arden , NC 28704
United States
sales@mjmdistro.comIssued May 28, 2021Center for Tobacco Products
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.
Violations1
Issue DateMay 28, 2021
Product TypeTobacco
StatusClosed
Closeout LetterJul 30, 2021
Letter Details
Firm
MJM Distribution Inc dba Asheville Vapor
Location
Michael Cotellese
MJM Distribution Inc dba Asheville Vapor
2144 Hendersonville Rd., Ste. B
Arden , NC 28704
United States
sales@mjmdistro.com
FEI Number
N/A
Country
United States
Issue Date
May 28, 2021
Issuing Office
Center for Tobacco Products
Product Type
Tobacco
Status
Closed
Closeout Letter
July 30, 2021
Summary
MJM Distribution Inc dba Asheville Vapor was cited for manufacturing and distributing e-liquid tobacco products without required premarket authorization from the FDA. The company's website listed e-liquids for sale in the United States, but these products had not obtained marketing authorization orders as required under section 910 of the Federal Food, Drug, and Cosmetic Act for new tobacco products deemed subject to FDA regulation as of August 8, 2016. The violation involved failure to comply with the Family Smoking Prevention and Tobacco Control Act requirements applicable to electronic nicotine delivery systems (ENDS).
MJM Distribution Inc dba Asheville Vapor FDA Warning Letter, May 28, 2021