VCI Enterprise, Inc d/b/a DRIPTECH

Warning LetterOpen

Daniella Maggie Rodriguez VCI Enterprise, Inc d/b/a DRIPTECH 2545 SW 20th St Miami , FL 33145 United States driptechcontact@gmail.comIssued Aug 21, 2023Center for Tobacco Products

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateAug 21, 2023

Product TypeTobacco

StatusOpen

Letter Details

Firm: VCI Enterprise, Inc d/b/a DRIPTECH
Location: Daniella Maggie Rodriguez VCI Enterprise, Inc d/b/a DRIPTECH 2545 SW 20th St Miami , FL 33145 United States driptechcontact@gmail.com
FEI Number: N/A
Country: United States
Issue Date: August 21, 2023
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

VCI Enterprise, Inc d/b/a DRIPTECH was warned on August 21, 2023, for offering electronic nicotine delivery system (ENDS) products for sale through their website without required premarket authorization. The company failed to comply with the Family Smoking Prevention and Tobacco Control Act by marketing tobacco products containing nicotine without obtaining an FDA premarket authorization order, which is required for all new tobacco products. The FDA also noted that the company's products were subject to FDA jurisdiction under the expanded definition of tobacco products, which as of April 14, 2022, includes any product containing nicotine from any source, and must comply with age restriction requirements (minimum age 21 for purchase).

VCI Enterprise, Inc d/b/a DRIPTECH FDA Warning Letter, August 21, 2023