FDC Nutrition Inc. – FDA Warning Letter, Feb 19, 2021
The FDA issued a Warning Letter to Quanzheng Sui regarding their Inositol 100% Pure Free Form product, sold via www.fdcnutrition.com. A December 2020 website review found claims establishing the product as an unapproved new drug and a misbranded drug under the Federal Food, Drug, and Cosmetic Act (the Act).
The product is deemed a "drug" under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] due to claims on the website and product label indicating intent for "cure, mitigation, treatment, or prevention of disease." As it is not generally recognized as safe and effective for these uses, it is an "unapproved new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)], violating sections 301(d) and 505(a) [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 lacks adequate directions for use. Since it's intended for diseases not amenable to self
ID · 9625e3ed-c225-4c18-84ed-17f702a710f5
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