FDA WARNING_LETTER - JDL Engineering Associates Incorporated

The FDA Center for Tobacco Products issued a Warning Letter to Mr. Livingston regarding the website http://www.originalobie.com, which sells e-liquid products. The FDA determined that BatCig.com Bubble Gum e-liquid, offered on the website, is a tobacco product under section 201(rr) of the FD&C Act and is subject to FDA jurisdiction.

The primary violation identified is that BatCig.com Bubble Gum e-liquid was sold 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 the sale of covered tobacco products, including e-liquids, to minors. The FDA's investigation confirmed a minor purchased the product from http://www.originalobie.com.

The letter requires immediate correction of this violation and similar issues, ensuring all tobacco products and related advertising comply with the FD&C Act and FDA regulations. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions, including discontinuation dates and a compliance plan, is required within 15 working days.