FDA WARNING_LETTER - Mr Fog Switch - September 13, 2024

The FDA's Center for Tobacco Products issued a Warning Letter on September 12, 2024, to the entity operating mrfogswitch.com, identifying violations related to the sale of electronic nicotine delivery system (ENDS) products. The FDA determined that ENDS products listed on the website are offered for sale or distribution in the U.S. and are considered tobacco products under section 201(rr) of the FD&C Act, subject to FDA jurisdiction.

Specifically, the FDA found that "Mr Fog Max Air Puffs – Apple Blueberry Ice" and "Mr Fog Switch 5500 Puffs – Raspberry Sour Apple" are "new tobacco products" that lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. These products were not commercially marketed in the U.S. as of February 15, 2007, and do not have FDA marketing authorization or exemptions. 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 notice or information under section 905(j).

The letter mandates a written response within 15 working days detailing actions taken to address the violations, including discontinuation of violative sales and a plan for future compliance. Failure to