Chris Lee Miller
Owner
HotHead Vapor
333 Heritage Drive, Suite 1
Spearfish , SD 57783
United States
poetofisis@yahoo.comFEI 3014027908Issued Oct 19, 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 3014027908.
Violations1
Issue DateOct 19, 2021
Product TypeTobacco
StatusOpen
Letter Details
Firm
HotHead Vapor
Location
Chris Lee Miller
Owner
HotHead Vapor
333 Heritage Drive, Suite 1
Spearfish , SD 57783
United States
poetofisis@yahoo.com
FEI Number
3014027908
Country
United States
Issue Date
October 19, 2021
Issuing Office
Center for Tobacco Products
Product Type
Tobacco
Status
Open
Summary
HotHead Vapor manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA, violating the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products, classified as newly deemed tobacco products under FDA jurisdiction as of August 8, 2016, were not in compliance with Federal Food, Drug, and Cosmetic Act requirements, specifically lacking the marketing authorization order required for new tobacco products under section 910 of the act.
HotHead Vapor FDA Warning Letter, October 19, 2021