FDA WARNING_LETTER - www.kiwicigs.com - November 17, 2022

The FDA reviewed iwiLife's website (iwilife.com), social media (facebook.com/MyiwiLife/), Amazon, and Walmart product pages in October 2022, determining that the "iwi Cholesterol" product is marketed with claims that establish it as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)]. The claims indicate the product is intended for the cure, mitigation, treatment, or prevention of disease.

The iwi Cholesterol product is deemed a "new drug" under section 201(p) of the Act [21 U.S.C. 321(p)] because it is not generally recognized as safe and effective for its intended uses. Introducing or delivering this product into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)].

Furthermore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] because it fails to bear adequate directions for its intended use. As it is intended for diseases not amenable to