E Vapor Hut LLC – FDA Warning Letter, Apr 5, 2022
The FDA issued a Warning Letter to April Hardy of Evaporhut.com on February 4, 2022, following a review of their website. The FDA determined that Evaporhut.com manufactures and sells e-liquid products, including Cotton Candy, Blue Raspberry, and Epic Menthol, which are considered tobacco products under the FD&C Act.
These e-liquid products are deemed "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that these products lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, making them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.
Evaporhut.com is a registered manufacturer with over 11,600 products listed. Their Premarket Tobacco Product Application (PMTA) (STN PM0001267), submitted on September 8, 2020, received a Marketing Denial Order for 5,439 products on September 9, 2021, and a Refuse to File determination for 189 products on December 7, 2021.
The FDA requires Evaporhut.com to submit a written
ID · 894e2da6-11f5-495a-abd1-49cee8955d26
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