FDA WARNING_LETTER - Pamirs Group Limited d/b/a VapeCig Wholesale - November 16, 2023

The FDA Center for Tobacco Products issued a Warning Letter to vapecigwholesale.com on November 16, 2023, after reviewing their website and determining they offer Electronic Nicotine Delivery System (ENDS) products for sale in the United States. These products are considered tobacco products under the FD&C Act, including those containing nicotine from any source, and are subject to FDA jurisdiction.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the products "Lavie Space Man 7000 Puffs Disposable Vape Wholesale, Cola Ice," "Lavie Max Cup 8000 Puffs Disposable Vape Wholesale, Banana Milk," and "Lavie Milk 7000 Puffs Disposable Vape Wholesale, Strawberry Donut" were found to be new tobacco products not commercially marketed in the U.S. as of February 15, 2007, and lacking FDA marketing authorization. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA expressed particular concern that the labeling and advertising of these Lavie products imitate children's toys, food, and beverage containers, potentially promoting youth use and aiding in concealing the product's nature as a tobacco product.

The company is required to submit a written response within 15 working days detailing actions