FDA WARNING_LETTER - Dropsmoke, Inc. - January 15, 2021

The FDA issued a Warning Letter to Joe Cweiber and Yitzchak Cweiber of 1550 Coney Island Ave, Brooklyn, NY, on January 15, 2021, following a review of their website, https://dropsmoke.com. The review determined that e-liquid products, specifically "Lemon Fire Menthol" and "Waffle Delight Menthol," were manufactured and offered for sale or distribution in the United States.

These e-liquid products are classified as "tobacco products" under section 201(rr) of the FD&C Act (21 U.S.C. § 321(rr)) and are subject to FDA jurisdiction. The FDA's Final Rule, effective August 8, 2016, deemed ENDS (including e-cigarettes and e-liquids) subject to regulation.

The primary 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 (21 U.S.C. § 387j(a)). Since "Lemon Fire Menthol" and "Waffle Delight Menthol" were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization, they are deemed adulterated under section 902(6)(