FDA WARNING_LETTER - The Health Management Group Inc. - January 26, 2018

The FDA conducted an inspection of Health Management Group Inc. from December 28, 2017, to January 26, 2018, identifying significant violations. The "AM/PM FAT BURNING & APPETITE SUPPRESSING WEIGHT CONTROL PATCHES" product was deemed an unapproved new drug under sections 505(a) and 301(d) of the Act [21 U.S.C. §§ 331(d) and 355(a)], due to claims like "Fat Burning & Appetite Suppressing" and "Burn the fat . . . Kill the hunger . . . Lose the weight . . .", making it an unapproved new drug not generally recognized as safe and effective.

Additionally, the company violated Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR 111), specifically failing to establish and follow written procedures for quality control operations, including material review, disposition decisions, and reprocessing approval (21 CFR 111.103). The company's response regarding outsourcing manufacturing was deemed insufficient, as the firm remains responsible for ensuring product quality and compliance.

Several dietary supplement products, including Diet Center Cal-Mag, Vitamin & Mineral, and Anti-Oxidant, were found to be misbranded under section 403 of the Act [21 U.S.C. § 343