FDA WARNING_LETTER - 5th & Nine Co. d/b/a 5th & Nine Alternatives Co. - April 07, 2022

The FDA issued a Warning Letter to 5th & Nine Co. d/b/a 5th & Nine Alternatives Co. on April 7, 2022, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, which are deemed tobacco products under the FD&C Act and subject to FDA regulation.

The primary violation identified is the marketing of a "new tobacco product," specifically "5th & Nine Vape Co. Ta’ Musu 6mg 100ml e-liquid product," without the required premarket authorization. This product was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no required notice or information was provided under section 905(j).

The FDA cited prohibited acts under sections 301(k) and 301(p) of the FD&C Act for holding for sale an adulterated or misbranded product and failing to provide a required report, respectively. The company, a registered manufacturer with over 30 listed products, is responsible for ensuring all tobacco products comply with the FD&C Act and FDA regulations.

The FDA requires