FDA WARNING_LETTER - C P Health Products Inc. - October 10, 2013

On October 1-10, 2013, the FDA inspected C P Health Products, Inc. (doing business as Green Pharm) in Hauppauge, NY, a manufacturer and re-packer of dietary supplements. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), rendering their dietary supplement products adulterated under 21 U.S.C. § 342(g)(1).

Additionally, a May 2014 review of product labels and the website www.greenpharmaus.com showed that products like BellyKetone, LifeBoost, Diabetes Control, BreastCare, Blood Sugar Control, and NeuroCare are promoted with therapeutic claims, classifying them as unapproved new drugs under 21 U.S.C. § 321(g)(1)(B) and 21 U.S.C. § 321(p). These products are not generally recognized as safe and effective for their claimed uses and lack FDA approval, violating 21 U.S.C. § 355(a) and 21 U.S.C. § 331(d). LifeBoost, Diabetes Control, BreastCare, Blood Sugar Control, and NeuroCare are also misbranded under 21 U.S.C. § 352(f)(1) due to inadequate