FDA WARNING_LETTER - Top Class Ejuice, Inc. d/b/a The Dollar E-Juice Club - August 23, 2022

On August 11, 2022, the FDA issued a Warning Letter to James Kim and Jonathan Lee of The Dollar E-Juice Club, following a review of their website, https://thedollarejuiceclub.com. The FDA determined that e-liquid products, specifically "Apple Sourbelt by The Dollar E-Juice Club" and "Pineapple Candy by The Dollar E-Juice Club," were manufactured and offered for sale or distribution in the United States.

These products are classified as "tobacco products" under section 201(rr) of the FD&C Act, as they contain nicotine from any source and are intended for human consumption. A recent amendment to the FD&C Act, effective March 15, 2022, expanded this definition to include products with nicotine from any source, not just tobacco-derived nicotine.

The primary violation identified is that these e-liquid products are "new tobacco products" that were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notice