FDA WARNING_LETTER - Country Doctor Herbals - December 17, 2014

On December 15-17, 2014, the FDA inspected Country Doctor Herbals' manufacturing facility in Cheyenne, WY. The inspection and review of product labels and websites (countrydoctorherbal.us, countrydoctornutritionalcenter.us) revealed serious violations of the Federal Food, Drug, and Cosmetic Act.

Multiple products, including "Herbal Flu Be-Gone" and "Herbal Multi-Bac," were deemed unapproved new drugs under sections 201(g)(1)(B) and/or (g)(1)(C) of the Act due to therapeutic claims for disease treatment, cure, mitigation, or prevention, and/or affecting body structure/function. These products are also misbranded under section 502(f)(1) for lacking adequate directions for use, as they are intended for conditions not amenable to self-diagnosis/treatment, making them prescription drugs requiring professional supervision. Introducing these unapproved new drugs into interstate commerce violates sections 301(d) and 505(a) of the Act.

Additionally, all dietary supplement products were found to be adulterated under section 402(g)(1) due to significant Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 111). Deficiencies included: 1. Failure to establish and follow written procedures for quality control operations (21 CFR 111.103