FDA WARNING_LETTER - Pink Spot Vapors, Inc - October 07, 2021

The FDA issued a Warning Letter to Sandra Elletson of Pink Spot Vapors, Inc. following a review of their website, https://pinkspotvapors.com. The FDA determined that e-liquid products, specifically Fresh Strawberry 30mL and Blueberry Cobbler 30mL, are manufactured and offered for sale or distribution in the U.S. These products are deemed "tobacco products" under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The key violation identified is the marketing of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. These e-liquid products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization. Consequently, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Pink Spot Vapors is a registered manufacturer with over 3,900 products listed with FDA. Their Premarket Tobacco Product Application (PMTA) STN PM0001220, submitted on September 7, 2020, received a Marketing Denial Order on September 1, 2021, covering 1,300 products.