FDA WARNING_LETTER - Eidon Incorporated - March 05, 2015

On November 5, 2015, the FDA issued a Warning Letter to Eidon Inc. following an inspection from February 19 to March 5, 2015, at their dietary supplement manufacturing facility in Poway, California. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), rendering products like Eidon® Ionic Minerals Immune Support and Eidon® Ionic Minerals Magnesium adulterated.

Additionally, FDA review of product labeling and the company website (eidon.com) on April 22 and October 7, 2015, found that several Eidon® products, including Eidon® Ionic Minerals Immune Support, Eidon® Ionic Minerals Sulfur, Eidon® Ionic Minerals Silica, and Eidon® Ionic Minerals BSE Brown Seaweed Extract, were promoted with therapeutic claims. These claims, such as treating cold/flu, pain/inflammation, digestive disorders, and detoxifying metals, cause the products to be considered unapproved new drugs under sections 201(g)(1)(B) and 201(p) of the Act, and misbranded under section 502(f)(1) due to inadequate directions for use.

Specific CGMP violations included failure to use scientifically valid methods for component testing (e.g., HPLC for Zinc Sulfate Heptahydrate), failure to establish written procedures for packaging examination and identification (