FDA WARNING_LETTER - Smokalo, Inc. - June 15, 2022

The FDA issued a Warning Letter to Smokalo, Inc. on June 15, 2022, for manufacturing and distributing e-liquid products without required marketing authorization. The FDA determined that e-liquid products are tobacco products subject to FDA regulation under the FD&C Act.

Specifically, the products "Bae Dragon Pom 6mg 100ml" and "Nubilus Alto Apple 3mg 60ml" are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. These products lack the necessary FDA marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt.

Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide required reports under section 905(j) is also a prohibited act under section 301(p).

Smokalo, Inc. had a Premarket Tobacco Product Application (PMTA), STN PM0001240, which was refused to file on August 6, 2021, covering 143 products. The FDA emphasizes that all new tobacco products on the market without premarket authorization are unlawful and