FDA WARNING_LETTER - Vaporize & Accessorize, LLC, d/b/a Cloud Factory Vapes - June 07, 2022

On June 7, 2022, the FDA issued a Warning Letter to Vaporize & Accessorize, LLC, d/b/a Cloud Factory Vapes, for manufacturing and distributing unapproved new tobacco products. The FDA determined that e-liquid products, including "Cloud Factory Vapes Vanilla Clouds 3mg 30ml," "Cloud Factory Vapes Blue Dream 12mg 30ml," and "Cloud Factory Vapes Extreme Ice 18mg 30ml," are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007.

These products lack the required FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, rendering them adulterated under section 902(6)(A) and misbranded under section 903(a)(6). The failure to provide a required report under section 905(j) is also a prohibited act.

While the firm submitted a Premarket Tobacco Product Application (PMTA) (STN PM0002582) on September 10, 2020, covering 72 products, it received a Refuse To Accept determination on September 30, 2021. The FDA emphasizes that all new tobacco products on the market without premarket authorization are