FDA WARNING_LETTER - Evolution Vaping Limited - February 11, 2020

On January 14, 2020, the FDA issued a Warning Letter to James and Sharon Burr of Evolution Vaping (evolutionvaping.co.uk) for violations related to the sale and advertising of e-liquid products in the United States. The FDA determined these e-liquids are tobacco products under the FD&C Act.

The first violation cited was the sale of IVG Apple Berry Crumble e-liquid to a person under 18 years of age, which misbrands the product under section 903(a)(7)(B) of the FD&C Act and violates 21 C.F.R. § 1140.14(b).

The second violation involved the misbranding of several e-liquid products, including Ohm Baked Apple and Rhubarb Crumble, Dinner Lady Apple Sours Nic Salt, and Ohm Baked Apricot Roulade. Their website advertising failed to include the required nicotine warning statement ("WARNING: This product contains nicotine. Nicotine is an addictive chemical.") as mandated by 21 C.F.R. § 1143.3(b), thus violating section 903(a)(7)(B) of the FD&C Act.

Evolution Vaping must immediately correct these violations and ensure all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations. Failure to comply may result in civil money penalties,