FDA WARNING_LETTER - VaporIce Inc. - February 26, 2021

The FDA's Center for Tobacco Products issued a Warning Letter to Murad Jreissat, operating VaporIce, following a review of their website, vaporice.com. The FDA determined that e-liquid products, specifically "VaporIce Monster" and "VaporIce Gummy Rings," are manufactured and offered for sale or distribution 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 jurisdiction.

The primary violation is the marketing of "new tobacco products" without required premarket authorization. The e-liquid products were not commercially marketed in the U.S. as of February 15, 2007, and lack an FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, nor are they exempt. 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 emphasizes the firm's responsibility as a registered manufacturer with over 20,000 listed products to ensure compliance with the FD&C Act and FDA regulations. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction