FDA WARNING_LETTER - Lost Coast Liquid, LLC - May 22, 2020

On May 22, 2020, the FDA issued a Warning Letter to Eric Cooke regarding e-liquid tobacco products sold on lostcoastliquid.com. The FDA determined these products are "tobacco products" under the FD&C Act.

The primary violation is that several e-liquid products, including "Lemon Berry A Sweet Tart Strawberry Lemonade Candy" and "Lost Coast MFG Cold Snap Pure Menthol Spearmint," are misbranded under sections 903(a)(7)(B) and 903(a)(7)(A) of the FD&C Act. This is because their website advertising fails 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). The absence of this material fact also renders the advertising misleading.

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