FDA WARNING_LETTER - Organic Vapor Labs

The FDA issued a Warning Letter to Tommy Lin of Organic Vapor Labs, citing violations related to the sale of e-liquid products. The FDA reviewed the website http://www.organicvaporlabs.com and determined that e-liquid products, specifically Appletini e-liquid, were offered for sale or distribution in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified was the sale of Appletini 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 (21 U.S.C. § 387c(a)(7)(B)). This violates 21 C.F.R. § 1140.14(b), which prohibits retailers from selling covered tobacco products to individuals under 18.

The letter requires immediate corrective actions, including discontinuing the violative sales and ensuring all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations. Failure to comply may result in further FDA actions, such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions and a compliance plan must be submitted within 15 working days.