FDA WARNING_LETTER - Pacific Center of Health/Pacific Center of Health & Acupuncture - June 22, 2021

The FDA issued a Warning Letter to Pacific Center of Health on June 22, 2021, following a review of their website, www.pacificcenterofhealth.com, on June 2, 2021. The agency found that the company was offering several products, including Immune Builder, High Risk Environment Pack- NO SYMPTOMS, Anti-Viral Herbal Formula, and Colloidal Silver, with claims to mitigate, prevent, treat, diagnose, or cure COVID-19. The FDA determined that these products are unapproved new drugs, violating section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Furthermore, they are considered misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. § 352. The introduction or delivery of these unapproved and misbranded products into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d). Given the ongoing COVID-19 public health emergency, the FDA is taking urgent measures to protect consumers from fraudulent products. Pacific Center of Health was instructed to immediately cease the sale of all unapproved and unauthorized COVID-19 related products. The firm must respond within 48 hours via email to [email protected], detailing corrective actions taken, steps to prevent recurrence, and supporting documentation. Failure to comply could lead to legal action, including seizure and injunction, and the firm's inclusion on FDA's public list of companies selling fraudulent COVID-19 products.