FDA WARNING_LETTER - Disposable Vapes Wholesale - August 23, 2023

On August 23, 2023, the FDA issued a Warning Letter to Steven Chen regarding the website disposablevapeswholesale.com, which offers Electronic Nicotine Delivery System (ENDS) products for sale in the U.S. These products are classified as tobacco products under the FD&C Act, including those containing nicotine from any source, as amended on March 15, 2022.

The FDA identified several ENDS products, specifically Lavie Milk 7000 Puffs Disposable Vape – Peach Juice, Lavie Space Man 7000 Puffs Disposable Vape – Watermelon Ice, R&M Funbox 6600 Puffs Disposable Vape – Grape Ice, and Elf Bar BC5000 Disposable Vape Wholesale – Blue Razz Ice, being sold without the required premarket authorization. These are considered "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack 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.

The FDA expressed particular concern that the labeling and advertising for Lavie and R&M products imitate food items, toys, and portable game devices, potentially promoting youth use and concealing the products' nature as tobacco products.