FDA WARNING_LETTER - EzyPayway.com Limited

The FDA's Center for Tobacco Products issued a Warning Letter to Nicotine2U after reviewing their website, nicotine2u.com, and determining that their e-liquid products are offered for sale in the U.S. The FDA classified these e-liquids as tobacco products under section 201(rr) of the FD&C Act, subject to FDA jurisdiction per section 901(b).

The primary violation identified was the sale of Nicotine2U Nicotine Mix e-liquid to a person younger than 18 years of age, which constitutes misbranding under section 903(a)(7)(B) of the FD&C Act. This violates 21 C.F.R. § 1140.14(b), which prohibits retailers from selling covered tobacco products, including e-liquids, to minors.

Nicotine2U is required to immediately correct this violation and any similar issues to ensure full compliance with the FD&C Act and FDA regulations. Failure to comply may result in further FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. The company must submit a written response within 15 working days detailing their corrective actions, including dates of discontinued violative sales and their plan for maintaining compliance.