FDA WARNING_LETTER - HS Wholesale Limited - October 01, 2025

On October 16, 2025, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to HS Wholesale Limited of Addison, IL, based on a review of its inspection records. The letter identified violations concerning the company"s sale and distribution of specific e-liquid products, notably "BAD DRIP SALT GOD NECTAR 25mg 30ml," to customers in the United States.

The primary violation stems from the classification of these e-liquid products as "new tobacco products" under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This designation applies because the products were not commercially marketed in the U.S. before February 15, 2007. HS Wholesale Limited failed to obtain the mandatory premarket authorization order from the FDA, rendering these products unlawfully marketed. As a result, they 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. The regulatory framework, which includes the expanded definition of "tobacco product" to cover nicotine from any source, mandates such authorizations.

HS Wholesale Limited is required to submit a written response within 15 working days, detailing the actions taken to discontinue the violative sale and distribution of these products and outlining a plan for maintaining future compliance. Failure to comply may lead to significant enforcement actions, including civil money penalties, product seizure, or injunctions.