FDA WARNING_LETTER - Ozark Country Herbs - November 13, 2017

On March 30, 2018, the FDA issued a Warning Letter to Ozark Country Herbs following a November 9-13, 2017 inspection. The letter identifies serious violations of the Federal Food, Drug, and Cosmetic Act.

The primary violation is that numerous products, including "Complete Tissue Syrup," "Allergy/Energy Combo," and "Natural Antibiotic (LDM)," are marketed with claims in product labels and a mail order catalog that establish them as unapproved new drugs. These claims suggest the products are intended for the cure, mitigation, treatment, or prevention of disease, making them new drugs under Section 201(p) of the Act, requiring prior FDA approval. Additionally, many of these products are deemed misbranded drugs under Section 502(f)(1) because they lack adequate directions for layperson use, or are intended for conditions not amenable to self-diagnosis/treatment, thus requiring professional supervision.

Furthermore, if these products were considered dietary supplements, they would be adulterated under Section 402(g)(1) due to significant Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 111). Deficiencies include failure to establish specifications for manufacturing processes (21 CFR 111.70(a)), lack of written procedures for quality control operations (21 CFR 111.103), absence of master manufacturing records (