FDA WARNING_LETTER - SK Investment Inc d/b/a SK Novelty Wholesale - February 01, 2024

The FDA Center for Tobacco Products issued a Warning Letter to Karim Shermohammed of SK Novelty Wholesale on January 31, 2024, following a review of their website, sknoveltywholesale.com. The review determined that the company offers Electronic Nicotine Delivery System (ENDS) products for sale or distribution in the United States without required premarket authorization.

The identified violations include the marketing of "new tobacco products" that lack a marketing authorization order, rendering them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. Specifically, the products cited are Elf Bar 5000 Puff Disposable BC5000 – Mango Peach; Kangvape Onee Stick 3000 Puffs Disposable Vape Pen – Strawberry Cream; and Lost Mary Rechargeable Disposable – Designed by Elf Bar Space Edition OS5000 – Strawberry Sundae. These products are considered "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and do not have an FDA marketing authorization order or exemption.

The letter requires a written response within 15 working days detailing actions taken to address the violations, including discontinuing sales and a plan for future compliance. Failure to comply may result in regulatory or legal actions such as civil money penalties, seizure, and/or injunction