FDA WARNING_LETTER - freedom smoke usa international - February 22, 2022

The FDA issued a Warning Letter to Freedom Smoke USA, specifically David Dettloff and Pamela Workman-Parker, on February 11, 2022, following a review of their website, https://freedomsmokeusa.com. The FDA determined that e-liquid products, including 'Cumbermelon Pre-Mixed Specialty' and 'Cheese Mozzarella Pre-Mixed,' are manufactured and offered for sale in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA regulation.

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. A "new tobacco product" is defined as any tobacco product not commercially marketed in the U.S. as of February 15, 2007, or any modified product marketed after this date. Since the listed e-liquid products were not commercially marketed by the specified date and lack FDA marketing authorization, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Freedom Smoke USA is a registered manufacturer with over 620 products listed with the FDA. The letter emphasizes that all new tobacco products marketed without statutory premarket authorization are unlawful and subject to