FDA WARNING_LETTER - Vaproma Inc. - December 20, 2023

The FDA issued a Warning Letter to Ming Wai Ng regarding the sale and distribution of unauthorized electronic nicotine delivery system (ENDS) products on the website https://vaproma.com. The Center for Tobacco Products determined that products like "LUCKEE Vape Daniel’s 8000 Disposable Vape – Coke Ice," "Cool Mojitos," and "Lush Mule" are tobacco products under section 201(rr) of the FD&C Act, as amended to include nicotine from any source.

These ENDS products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, they 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 product labeling and advertising for the Luckee Vape Daniel's ENDS products imitate alcoholic beverages, potentially appealing to youth. The letter emphasizes that sales of such unauthorized products are prohibited and contribute to public health concerns.

The firm must submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing sales and a plan for future compliance. Failure to comply may result in regulatory actions such