FDA WARNING_LETTER - Health Cabin - May 19, 2020

On May 11, 2020, the FDA's Center for Tobacco Products issued a Warning Letter to De Zhang regarding the sale and distribution of Electronic Nicotine Delivery System (ENDS) products through the website https://www.healthcabin.net to customers in the United States.

The FDA determined that the products, including VEEX Vitabon Pod Cartridge - Mango Iced, Veebon Pod Cartridge - Iced Cola, and ZXLE Pre-Filled Pods - Tropical Mango, are "new tobacco products" as defined by section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007.

These products are being offered for sale without the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as the necessary notice or information under section 905(j) was not provided.

The letter emphasizes the company's responsibility to ensure compliance with the FD&C Act and FDA regulations for all tobacco products, labeling, and advertising. Failure to correct these violations may lead to FDA actions such as civil money penalties, seizure, and/