FDA WARNING_LETTER - Vape Hut Inc - November 16, 2021
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On November 10, 2021, the FDA issued a Warning Letter to Bridgette Norris of Vape Hut, following a review of their website, http://www.vapehut.com. The FDA determined that e-liquid products, specifically Forest Berry by Subzohm, Sparkling Orchard by Subzohm, and Booblegum by Subzohm, were being manufactured and offered for sale or distribution in the United States.
These e-liquid products are classified as "new tobacco products" under section 201(rr) of the FD&C Act because they are derived from tobacco, intended for human consumption, and were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that these products lacked 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.
Although a Premarket Tobacco Product Application (PMTA) (STN PM0003808) was submitted on September 8, 2020, it received a Marketing Denial Order on September 13, 2021, covering 84 products. The FDA emphasized that all new tobacco products marketed without statutory pre
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