FDA WARNING_LETTER - Silver Armor, Inc. - November 11, 2017

The FDA inspected Silver Armor's facility from October 31 to November 11, 2017, identifying serious violations of the Federal Food, Drug, and Cosmetic Act. The company's products, including various "Silver Ramon" and "Silver Armor" brands, are marketed with claims (e.g., "anti-bacterial," "anti-microbial," "anti-cavity," "reduces inflammation," "stimulate stem cells," "effective against causes of disease," "broad-spectrum antibiotic alternative") that classify them as unapproved new drugs for both human and animal use. These products lack FDA approval for safety and effectiveness, violating sections 301(d) and 505(a) of the Act.

Furthermore, several products are misbranded under section 502(f)(1) because they lack adequate directions for use by a layperson, particularly those intended for conditions requiring professional supervision. Products containing colloidal silver promoted for disease treatment are also considered new drugs requiring approval and are misbranded under 21 CFR 310.548.

Even if not classified as unapproved drugs, the "Silver Armor brand Natural Health Immune Support & Protection" products are adulterated dietary supplements due to significant Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 111). Deficiencies include: 1. Failure to establish and follow written procedures for quality control operations (2