FDA WARNING_LETTER - Vapor Lab - May 01, 2025

On May 1, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to Vapor Lab, identifying that the company manufactures, sells, and/or distributes e-liquid products, including "Chevy 57," to customers in the United States. These products are classified as tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, to include nicotine from any source.

The primary violation cited is the marketing of "new tobacco products" without the required premarket authorization order. A "new tobacco product" is defined as any tobacco product not commercially marketed in the U.S. as of February 15, 2007, or any modified product marketed after this date. Vapor Lab's "Chevy 57" e-liquid product is identified as a new tobacco product lacking the necessary FDA marketing authorization under section 910(c)(1)(A)(i) of the FD&C Act, and is not exempt.

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 premarket notification or information under section 905(j).

Vapor Lab is required to submit a written response within 15 working