FDA WARNING_LETTER - Kure Corporation-Outlet - May 19, 2020

On April 22, 2020, the FDA issued a Warning Letter to Kure Corp. following a review of their website, kurevapes.com, which offers Electronic Nicotine Delivery System (ENDS) products for sale in the U.S. The FDA determined that ENDS are tobacco products subject to regulation under the FD&C Act and 21 CFR § 1100.1, effective August 8, 2016.

The primary violation identified was the sale of "MyBluPods 2PK - Citra Zing," which is considered a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007. This product lacks the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act and is not exempt. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required information under section 905(j).

Kure Corp. is responsible for ensuring all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations. Failure to correct these violations may lead to civil money penalties, seizure, and/or injunction. The company must submit a written response within