FDA WARNING_LETTER - Tinted Brew, Inc

The FDA and FTC issued a Warning Letter to Jonathan Nemr regarding V?Nilla Cookies & Milk e-liquid products sold on http://www.tintedbrew.com. The FDA determined these e-liquids are tobacco products under the FD&C Act.

The primary violation is misbranding under sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act. The product's labeling and advertising are deemed false or misleading because they imitate food products, specifically cookies marketed towards children (e.g., Nilla Wafers, Golden Oreos). Examples include "V?Nilla," "Cookies & Milk," an illustration of cookies in milk, and packaging similar to cookie packages. This imitation is particularly concerning due to the severe health risks of accidental nicotine ingestion by children, including potential fatality from cardiac arrest.

The FTC also reviewed the marketing under Section 5 of the FTC Act, prohibiting unfair or deceptive practices that present unwarranted health or safety risks. The FTC noted the product's packaging resembles popular children's cookie brands and has a similar scent, posing an unwarranted risk to children.

The letter requires a written response to the FDA within 15 working days detailing corrective actions, including discontinuing violative labeling, advertising, sale, and distribution, and a plan for compliance. A separate notification to the FTC within 15 days regarding actions taken to address their concerns is also