Northwest Vapors LLC – FDA Warning Letter, Apr 13, 2021

The FDA Center for Tobacco Products issued a Warning Letter to William Krause Jr. on April 9, 2021, after reviewing the website https://www.nwvapors.com. The review determined that e-liquid products, specifically "Taste e-Liquid Toasted Almond" and "Summit Cloud Peak," are manufactured and offered for sale or distribution in the United States.

These e-liquid products are classified as "new tobacco products" under section 201(rr) of the FD&C Act because they are derived from tobacco, intended for human consumption, and were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that these products lack the required premarket marketing authorization order 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) of the FD&C Act and misbranded under section 903(a)(6) of the FD&C Act, as the required notice or information under section 905(j) was not provided. The letter emphasizes the firm's responsibility, as a registered manufacturer with over 4,400 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