FDA WARNING_LETTER - MMWTA Mothers Milk WTA - May 24, 2022

The FDA's Center for Tobacco Products reviewed the website https://mothersmilkwta.com and determined that e-liquid products, specifically French Kiss and HoneyDew, are manufactured and offered for sale in the U.S. These products are deemed tobacco products under section 201(rr) of the FD&C Act and are subject to FDA regulation, requiring premarket authorization. The FDA found that these e-liquid products are new tobacco products marketed without the required authorization under section 910(a) of the FD&C Act. Consequently, they are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notice or information under section 905(j). The firm's Premarket Tobacco Product Applications (PMTA) STN PM0001252 and STN PM0001273, covering 1,526 products, received Marketing Denial Orders on September 15, 2021, rendering those products also adulterated and misbranded. The FDA considers products without premarket authorization, especially those with Marketing Denial Orders, as high enforcement priorities. The firm must submit a written response within 15 working days detailing actions to address these violations, including discontinuing violative sales and a plan for future compliance, to avoid potential regulatory actions such as civil money penalties, seizure, or injunction.