Flair Products LLC/Flair Vapor LLC – FDA Warning Letter, Oct 26, 2021

The FDA issued a Warning Letter to Hiren Patel and Mitul Patel on October 15, 2021, after reviewing their website, flairvapor.com. The FDA determined that the company was manufacturing and selling ENDS (electronic nicotine delivery system) products, including Flair Plus 5% Nicotine (Blue Razz), Flair Plus 5% Nicotine (Cool Mint), and Flair Plus 5% Nicotine (Pink Lemonade), without the required premarket authorization.

Under sections 201(rr) and 901(b) of the FD&C Act, ENDS products are considered tobacco products subject to FDA jurisdiction. The FDA stated that these products are "new tobacco products" as they were not commercially marketed in the U.S. before February 15, 2007, and lacked the necessary marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA noted that a Premarket Tobacco Product Application (PMTA) assigned STN PM0002067, submitted by the company on September 9, 2020, received a Marketing Denial Order on September 10, 2021