FDA WARNING_LETTER - breathe easy vapes, lp - May 02, 2022

The FDA issued a Warning Letter to Breathe Easy Vapes on May 2, 2022, following a review of submissions and inspection records. The FDA determined that Breathe Easy Vapes manufactures and distributes e-liquid products, which are classified as tobacco products under the FD&C Act and are subject to FDA jurisdiction.

The primary violation identified is the manufacturing, sale, and/or distribution of Breathe Easy Vapes MELON BERRY 6 mg e-liquid product without the required premarket marketing authorization. This product is considered a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. Prohibited acts include the sale of adulterated or misbranded products and the failure to provide required reports under section 905(j).

Breathe Easy Vapes is a registered manufacturer with over 5,100 listed products. The FDA emphasizes that all new tobacco products marketed without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. The company must submit a written response within 15 working days detailing actions taken to address violations, including discontinuation of violative sales and