FDA WARNING_LETTER - Natural Products Services, Inc. - October 22, 2012

On July 23, 2013, the FDA issued a Warning Letter to Natural Products Services, Inc. following an inspection from October 11-22, 2012. The inspection revealed significant violations of dietary supplement Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), rendering products adulterated.

Additionally, products like CircuForce, HealthForce Liver Rescue 4+, HealthForce Scram, and HealthForce Nopal Blood Sugar were deemed unapproved new drugs due to therapeutic claims on their labels, such as "increasing blood circulation," "Helps protect the skin from ultraviolet radiation," and "Nutritionally Supports Anti-Microbe, Anti-Fungal – Anti-Bacterial Functions." HealthForce Nopal Blood Sugar was also misbranded as it lacked adequate directions for layperson use for conditions not amenable to self-diagnosis.

Key CGMP violations included: 1. Failure to conduct identity testing for dietary ingredients (e.g., Milk Thistle Seed Extract, Dandelion Root Extract). 2. Failure to establish specifications for finished product identity, purity, strength, composition, contamination limits, component purity, strength, composition, and packaging/labeling. 3. Absence of written master manufacturing records for each unique formulation and batch size. 4. Incomplete batch production records, lacking information on equipment identity, cleaning dates, actual yield, test results, and proper