Okami Brand LLC – FDA Warning Letter, Mar 15, 2022

The FDA issued a Warning Letter to Andrew Pham and John Nguyen of Okami Brand on March 9, 2022, following a review of their website, https://okamibrand.com. The FDA determined that e-liquid products, including Berry Goyard, Melon Milk, and Lychee Wintour, were manufactured and offered for sale in the U.S. These products are classified as "new tobacco products" under section 201(rr) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is the sale of these new tobacco products without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. Although the firm submitted a Premarket Tobacco Product Application (PMTA) (STN PM0004006) on October 8, 2020, covering 26 products, it received a "Refuse to Accept" determination on January 13, 2022.

The FDA requires a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution