FDA WARNING_LETTER - Chill6 - August 10, 2021

The FDA issued a Warning Letter to Chill6 after reviewing their website, www.chill6.com, in July 2021, identifying that their Chill6 products (Margarita Lime, Watermelon Jolly, Orange Mango, Pink Lemonade) are marketed as unapproved new drugs and misbranded drugs. Website claims, including testimonials, establish the products' intent for disease treatment or prevention, making them drugs under 21 U.S.C. 321(g)(1)(B). As they are not generally recognized as safe and effective, they are unapproved new drugs under 21 U.S.C. 321(p), violating 21 U.S.C. 331(d) and 355(a). Furthermore, the products are misbranded drugs under 21 U.S.C. 352(f)(1) because they lack adequate directions for use, as their intended purposes require supervision by a licensed practitioner (21 CFR 201.5). The letter also states that Chill6 products are adulterated food under 21 U.S.C. § 342(a)(2)(C)(i) because they contain phenibut HCl, an unsafe food additive under 21 U.S.C. § 348(a), which is neither GRAS nor a dietary ingredient. Finally, the products are misbranded food under 21 U.S.C. 343(a)(1) because they are labeled as "dietary supplements" but represented as conventional foods on the website, making the label false or misleading. The company must respond within 15 working days with corrective actions and supporting documentation to prevent legal action, including seizure and injunction.