VallHund Vapes Inc. – FDA Warning Letter

The FDA issued a Warning Letter to Michael Mario De Pinto regarding e-liquid products sold on vallhundvapes.com. The FDA determined the "Chill Purple Grape e-liquid" is a tobacco product under the FD&C Act.

The product is deemed misbranded under sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act because its labeling and advertising are false or misleading. The product's packaging, including its cylindrical shape, foil covering, and color scheme, along with statements like "Purple Grape" and "Refreshing Soda Flavor," and a "Nutrition Facts" style label, imitate grape soda, particularly products appealing to children. The strong grape soda scent further contributes to this imitation. This poses a risk of accidental ingestion by children, given the nicotine content (6mg/mL, 60mL volume), which could lead to acute toxicity, severe harm, or death.

Additionally, the product is misbranded under section 903(a)(7)(B) of the FD&C Act because it was sold to a person younger than 18 years of age, violating 21 C.F.R. § 1140.14(b).

The FDA requires immediate corrective actions, including discontinuing violative labeling, advertising, sales, and distribution, and ensuring compliance with the FD&C Act across all sales platforms. Failure to