DC Laboratories Inc., d/b/a Dynamic Creations – FDA Warning Letter, Apr 10, 2019

The FDA issued a Warning Letter to DC Laboratories Inc., d/b/a Dynamic Creations, for violations related to their e-liquid products. The FDA determined that several e-liquid products, including "Salted The Fourth Firecracker Popsicle" and "Chill Salted Cool Lime," are adulterated under section 902(6)(A) of the FD&C Act for lacking required marketing authorization. These products are also misbranded under section 903(a)(6) because required notices or information were not provided, as they were not commercially marketed in the U.S. as of February 15, 2007, or August 8, 2016, and thus required premarket review.

Additionally, "Salted The Fourth Firecracker Popsicle" and "Hit That Cookie Smores" e-liquids are misbranded under section 903(a)(1) due to false or misleading labeling that imitates food products appealing to children, posing a risk of accidental nicotine ingestion. These products also violate section 903(a)(7)(B) and 903(a)(1) because their labeling does not display the required nicotine warning statement ("WARNING: This product contains nicotine. Nicotine is an addictive chemical.") in the manner required by 21 C.F.R. § 1143.3, including incorrect wording and improper placement/size.