FDA WARNING_LETTER - Dotmod, Inc. - February 28, 2023

The FDA issued a Warning Letter to Ling Wang, Alex Bellman, and Leigh McCarthy of Dotmod, Inc. on February 17, 2023, after reviewing their website, https://dotmod.com. The review determined that the company manufactures and offers for sale Electronic Nicotine Delivery System (ENDS) products, specifically "dotPLUS Guava Monster" and "dotPLUS Peach Mango," to U.S. customers.

These products are classified as tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, because they contain nicotine from any source. The FDA asserts that these ENDS products are "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is that these products are being marketed without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, nor are they exempt from this requirement. Consequently, the products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because the necessary notice or information under section 905(j) was not provided.

The FDA has not received any marketing authorization applications for these products from Dotmod, Inc.