FDA WARNING_LETTER - theecig.com - April 01, 2025

On March 28, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to "To Whom It May Concern" regarding the website https://www.theecig.com. The FDA determined that the website offers for sale or distribution in the U.S. electronic nicotine delivery system (ENDS) products that are considered "tobacco products" under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, to include nicotine from any source.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. Specifically, the products "Funky Republic Fi3000 Disposable – Malaysian Mango" and "Funky Republic Fi3000 Disposable – Strawberry Peach Sakura" were cited. These products are deemed "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization or exemption. Consequently, these products are considered adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter requires a written response within 15 working days detailing actions taken to address the violations, including dates of discontinued sales