FDA WARNING_LETTER - Steep Slope Vape Supply - February 18, 2025

The FDA issued a Warning Letter to Steep Slope Vape Supply after reviewing inspection records, determining the company manufactures, sells, and/or distributes e-liquid products, specifically "Apex Apple," 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.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order. "Apex Apple" is considered a new tobacco product because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks FDA marketing authorization or exemption. 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 or information under section 905(j).

The FDA requires Steep Slope Vape Supply to submit a written response within 15 working days detailing actions taken to address the violations, including dates of discontinued sales/distribution and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.