Moti Global – FDA Warning Letter, Nov 16, 2022

The FDA Center for Tobacco Products issued a Warning Letter to China United States on November 16, 2022, after reviewing the website https://motiplanet.com. The review determined that the company manufactures and offers for sale or distribution in the U.S. electronic nicotine delivery system (ENDS) products, which are deemed tobacco products under the FD&C Act.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order. Specific examples cited include MOTI POPI Disposable 1500 Puffs in Lush Ice, Juicy Grape, and Strawberry flavors. These products are considered new tobacco products because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the necessary 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 information under section 905(j).

The FDA also expressed concern that the product labeling and/or advertising for MOTI POPI products imitate children's popsicle treats, which is likely to promote youth use, contributing to public health and safety concerns.

The company is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the violative labeling, advertising