Zainy Electronic Cigarette – FDA Warning Letter, Sep 30, 2020
On September 30, 2020, the FDA issued a Warning Letter to Ainy Zeng regarding e-liquid products advertised and sold on http://zainy.net 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 identified is that several e-liquid products are misbranded under sections 903(a)(7)(B) and 903(a)(7)(A) of the FD&C Act. The website advertising for products like "5pcs x 50ml Dekang PG & VG MIX E-Juice – Chocolate" and "10pcs x 50ml 100% PG Hangsen Liquid Propylene Glycol E-Juice – Watermelon" fails to include the required nicotine warning statement: "WARNING: This product contains nicotine. Nicotine is an addictive chemical," as mandated by 21 CFR 1143.3(b). This omission also renders the advertising misleading, contributing to misbranding under section 903(a)(7)(A).
The letter requires immediate corrective actions, including discontinuing violative advertising, labeling, sale, and distribution. A written response detailing these actions and a plan for future compliance must be submitted within 15 working days. Failure to comply may result in regulatory action, including detention and refusal
ID · e7d2cdae-0e6b-4a7e-b8d8-0505bc294ebf
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