New Spirit Naturals Inc. – FDA Warning Letter, May 7, 2020

The FDA issued a Warning Letter to New Spirit, Inc. in May 2020, following an April 2020 review of their website, www.newspirit.com. The agency determined that the firm's products—PolyMeal Body Fuel, Cardioplex, Super Curcumin Complex with Boswellia, CoQ-10 & Cinnamon, and Colloidal Silver—are unapproved new drugs and misbranded. Website claims, such as those for combatting heart disease, reducing inflammation, and acting as disinfectants or antibiotics, establish drug intent under 21 U.S.C. § 321(g)(1)(B). As these products are not generally recognized as safe and effective (GRAS/E) for their intended uses, they are "new drugs" under 21 U.S.C. § 321(p), and their introduction into interstate commerce without FDA approval violates 21 U.S.C. §§ 331(d) and 355(a). Additionally, PolyMeal Body Fuel, Cardioplex, Super Curcumin Complex with Boswellia, and CoQ-10 & Cinnamon are misbranded under 21 U.S.C. § 352(f)(1) due to lacking adequate directions for layperson use, as they target conditions requiring professional supervision. The Colloidal Silver product is also a "new drug" and misbranded per 21 CFR 310.548 and 21 U.S.C. § 352, given its promotion for disease treatment/prevention. The introduction of these misbranded drugs violates 21 U.S.C. § 331(a). New Spirit must take prompt corrective action within fifteen working days, providing a written response detailing steps taken and preventative measures, or face potential legal action including seizure and injunction.