Pacific Center of Health/Pacific Center of Health & Acupuncture Warning Letter Details

Summary

Pacific Center of Health sold multiple unapproved drug products including Immune Builder, Anti-Viral Herbal Formulas, Colloidal Silver, and Post COVID-19 Recovery products that claimed to mitigate, prevent, treat, diagnose, or cure COVID-19, violating section 505(a) of the Federal Food, Drug, and Cosmetic Act. The products were also misbranded under section 502 of the FD&C Act and were introduced into interstate commerce without FDA approval or authorization. The FDA took this enforcement action during the COVID-19 public health emergency to protect consumers from unproven products making disease claims without regulatory clearance.