FDA WARNING_LETTER - Mochivap - August 23, 2023

The FDA Center for Tobacco Products issued a Warning Letter on August 23, 2023, after reviewing websites mochivap.com and dahuoo.com, which offer 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, and require premarket authorization.

The identified violations include offering "new tobacco products" without the required marketing authorization order. Specifically, "Mochivap Mini Cup 6000Puffs Disposable Vape Pen 5% Original Vapes Rechargeable - Grape Ice," "Mochivap Banana 2500Puffs Disposable Vape Pen 8ml Original Vapes 1000mAh Mesh Coil Deluxe - Mango Ice," and "Whimsical Banana Model Toy: Perfect for Play and Stylish Home Decoration - Pineapple Ice" were cited. These products are considered "new" as they were not commercially marketed in the U.S. before February 15, 2007, and lack FDA marketing authorization, rendering 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 product labeling and advertising for Mochivap Mini Cup and Whimsical Banana Model Toy Vape products imitate children’s toys and water bottles,