FDA WARNING_LETTER - Curtis Jacquot dba Pacific BioLogic Co. - June 29, 2023

The FDA inspected Pacific Biologic's facility from June 1-29, 2023, revealing significant violations of CGMP for dietary supplements (21 CFR Part 111). Additionally, a review of product labels and websites (www.pacificbiologic.com, www.balanceandharmony.com) in July 2023 found that several products (ArteClear Circulation 2, Headache Release, Natura-Mune – 2, Pain Release, Attack 2) are unapproved new drugs due to disease treatment claims, and misbranded drugs lacking adequate directions for use.

Key violations include: - **Unapproved New Drugs**: Products marketed with claims for disease cure, mitigation, treatment, or prevention (e.g., "natural relief for headaches and migraines," "inhibit bacterial, viral, and tumor growth") are considered new drugs requiring FDA approval, which they lack. This is a repeat observation from a 2014 Warning Letter and 2015 Regulatory Meeting. - **Misbranded Drugs**: Products like ArteClear Circulation 2, Natura-Mune – 2, and Attack 2 are misbranded because they are intended for conditions not amenable to self-diagnosis or treatment, thus lacking adequate directions for layperson use. - **Adulterated Dietary Supplements (CGMP Violations)**: - Failure to establish required specifications for components, labels, packaging, and finished products (e