FDA WARNING_LETTER - Perfect Choice Trading, Inc. and Nutricos Ceuticals, Inc. - October 24, 2018

The FDA issued a Warning Letter to Perfect Choice Trading, Inc. & Nutricos Ceuticals, Inc. following an inspection on October 11 and 24, 2018, identifying serious violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111). These violations render their dietary supplements, including TR Zell P-Centa soft gels, adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).

Additionally, the FDA determined that TR Zell P-Centa soft gels are an unapproved new drug and a misbranded drug. Website claims for TR Zell P-Centa soft gels, including testimonials, establish its intended use for disease cure, mitigation, treatment, or prevention, making it a drug under section 201(g)(1)(B) of the Act. As it is not generally recognized as safe and effective for these uses, it is an unapproved "new drug" (section 201(p)) and cannot be legally introduced into interstate commerce without FDA approval. Furthermore, it is misbranded under section 502(f)(1) because it lacks adequate directions for use, as its intended uses are not amenable to self-diagnosis or treatment.

Even if not classified as an unapproved new drug, TR Zell P-Centa soft gels would be an adulterated dietary supplement due to