RYOSupply.com – FDA Warning Letter, Mar 4, 2019

The FDA Center for Tobacco Products issued a Warning Letter to RYOSupply.com after reviewing their website, http://www.ryosupply.com, which advertised and sold various tobacco products. The FDA identified two significant violations. Firstly, RYOSupply.com sold an Oliver Twist Original Chewing Tobacco Bits smokeless tobacco product to a minor, a person younger than 18 years of age. This action misbrands the product under section 903(a)(7)(B) of the FD&C Act, violating 21 C.F.R. § 1140.14(a). Secondly, the labeling and/or advertising for several waterpipe tobacco, ENDS, and e-liquid products offered for sale on their website failed to include the mandatory nicotine warning statement: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This omission misbrands these products under section 903(a)(7)(B) of the FD&C Act (violating 21 C.F.R. § 1143.3(a) and/or (b)) and also under sections 903(a)(1) and/or 903(a)(7)(A) for false or misleading advertising/labeling. RYOSupply.com is required to immediately correct these and similar violations, ensuring all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations. A written response detailing corrective actions, dates of discontinued violative practices, and a compliance plan must be submitted within 15 working days. Failure to comply could lead to severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, and product seizure.