FDA WARNING_LETTER - Omnia E-Liquid

The FDA and FTC issued a Warning Letter to Michael Eshragh concerning Twirly Pop e-liquid products sold via omniaeliquid.com, which are classified as tobacco products under the FD&C Act. The FDA identified three violations: First, the e-liquid is misbranded under sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act because its labeling and advertising are false or misleading, imitating child-appealing lollipops and posing a severe nicotine poisoning risk. Second, it is misbranded under section 903(a)(7)(B) of the FD&C Act and 21 C.F.R. § 1140.14(b) for selling the product to a person younger than 18. Third, the product violates section 201(rr)(4) of the FD&C Act by being marketed and co-packaged with a food product, specifically a Unicorn Pop lollipop. The FTC also noted that the product's candy-like marketing presents an unwarranted health and safety risk under Section 5 of the FTC Act. The firm must submit a written response to the FDA within 15 working days detailing corrective actions and a compliance plan, and notify the FTC within 15 days of actions taken. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and injunction.