VaporBreak – FDA Warning Letter, Feb 11, 2020

On February 6, 2020, the FDA issued a Warning Letter to Liumin Zhang regarding e-liquid products advertised and sold on vaporbreak.com to U.S. customers. The FDA determined these e-liquids are tobacco products under section 201(rr) of the FD&C Act.

The primary violation is that the website's advertising for several e-liquid products, such as Hangsen Exclusive - HS Menthol Sensation and Hangsen Mint and Menthol - Deluxe Menthol, fails to include the required nicotine warning statement: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This violates 21 C.F.R § 1143.3(b) and renders the products misbranded under sections 903(a)(7)(B) and 903(a)(7)(A) of the FD&C Act. The latter citation also notes that failure to reveal material facts (like nicotine warnings) makes advertising misleading.

The letter requires immediate corrective actions, including discontinuing violative advertising, sales, and distribution, and ensuring all tobacco products and related advertising comply with the FD&C Act and FDA regulations across all platforms. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Misbranded products imported into the U.S. are subject to detention. A written