FDA WARNING_LETTER - GreenSmartLiving, Inc. - February 15, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Adrian Chiaramonte of GreenSmartLiving on February 3, 2022, following a review of their website, greensmartliving.com. The review determined that the company manufactures and sells electronic nicotine delivery system (ENDS) products, specifically GreenSmartLiving Menthol Refill, GreenSmartLiving Virginia Tobacco Refill, and GreenSmartLiving Tobacco Gold Refill, in the U.S. without the required premarket authorization.

These ENDS products are classified as "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that these products lack the necessary marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Although GreenSmartLiving is a registered manufacturer with over 100 products listed with the FDA and submitted a Premarket Tobacco Product Application (PMTA) (STN PM0000898) on August 24, 2020, this application, covering 15 products, received a