FDA WARNING_LETTER - Twisted Tongue Inc. - April 05, 2022

The FDA issued a Warning Letter to William and Kimberly Hollman of Twisted Tongue Vapor on November 24, 2021, following a review of their website, https://www.twistedtonguevapor.com. The FDA determined that their e-liquid products, including "Twisted Tongue Fruit Cereal Milk" and "Twisted Tongue Something Fruity," are "new tobacco products" under the FD&C Act (21 U.S.C. § 321(rr)) because they were not commercially marketed in the U.S. as of February 15, 2007.

These products are being marketed without the required premarket authorization order (21 U.S.C. § 387j(c)(1)(A)(i)), rendering them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The FDA noted that while the firm is a registered manufacturer with over 90 products listed, their multiple Premarket Tobacco Product Applications (PMTAs) submitted on September 8 and 9, 2020, covering 99 products, received Marketing Denial Order determinations on September 13 and October 5, 2021.

The FDA requires a written response within 15 working days detailing actions taken to address violations, including discontinuing the sale