MistVapor USA – FDA Warning Letter, Sep 8, 2020

The FDA Center for Tobacco Products issued a Warning Letter to Mistvapor.com on August 14, 2020, after reviewing their website and determining that they offer Electronic Nicotine Delivery System (ENDS) products for sale or distribution in the United States. These products are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation identified is the sale of "new tobacco products" without the required premarket authorization. Specifically, products like Remit Orange Cream Pod Packs, Remit Orange Dream Nic Salt Pod Packs, Remit Tropical Blend Pod Packs, and Remit Tropical Oasis Nic Salt Pod Packs were found to be new tobacco products, as they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions.

Consequently, these products are 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 premarket notification or information under section 905(j).

Mistvapor.com is required to promptly correct these violations and ensure all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations. Failure to comply may result in regulatory action, including detention and refusal of admission for imported products. A written response detailing corrective