Bootstrap Runners LLC d/b/a Sinister Liquids

Warning LetterOpen

Donald Angelini Co-Owner Bootstrap Runners LLC d/b/a Sinister Liquids 6104 Westgate Road, Suite 104 Raleigh , NC 27617 United States dsangelini@gmail.comFEI 3013540774Issued Oct 12, 2021Center for Tobacco Products

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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 3013540774.

Violations1

Issue DateOct 12, 2021

Product TypeTobacco

StatusOpen

Letter Details

Firm: Bootstrap Runners LLC d/b/a Sinister Liquids
Location: Donald Angelini Co-Owner Bootstrap Runners LLC d/b/a Sinister Liquids 6104 Westgate Road, Suite 104 Raleigh , NC 27617 United States dsangelini@gmail.com
FEI Number: 3013540774
Country: United States
Issue Date: October 12, 2021
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Bootstrap Runners LLC d/b/a Sinister Liquids manufactured and distributed e-liquid tobacco products without the required premarket authorization mandated by the Family Smoking Prevention and Tobacco Control Act. The FDA determined that the company's e-liquid products, which contain nicotine derived from tobacco and are intended for human consumption, fall under FDA jurisdiction as deemed tobacco products but were being sold in violation of premarket approval requirements that took effect August 8, 2016. The warning was issued after FDA review of the company's submissions and inspection records confirmed the unauthorized commercial distribution of these tobacco products in the United States.

Bootstrap Runners LLC d/b/a Sinister Liquids FDA Warning Letter, October 12, 2021