FDA WARNING_LETTER - ACH Group, LLC d/b/a Candy Co E-Liquids

The FDA Center for Tobacco Products and the U.S. Federal Trade Commission (FTC) issued a Warning Letter to Allen Park regarding Patches by Candy Co. e-liquid, sold on candycoeliquids.com. The product is classified as a tobacco product under the FD&C Act. FDA determined the e-liquid is misbranded under sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act because its labeling and/or advertising is false or misleading. The product's marketing imitates candy, particularly those appealing to children, using terms like "Candy" and "Patches," images of sugar-coated bottles, and a label similar to a food Nutrition Facts label. This misleading presentation poses a significant health risk to children due to potential accidental ingestion of nicotine, which can cause severe toxicity, including death. Concurrently, the FTC found the marketing to be an unfair or deceptive act under Section 5 of the FTC Act, as it presents unwarranted health or safety risks. The packaging closely resembles popular children's candies like Sour Patch Kids and has a similar scent, making it particularly appealing to young children. The company is required to submit a written response to FDA within 15 working days, detailing corrective actions, discontinuation of violative labeling/advertising/sale, and a plan for future compliance. Additionally, the company must notify the FTC within 15 days of specific actions taken to address their concerns. Failure to comply may result in further enforcement actions, including civil money penalties, criminal prosecution, seizure, and injunction.