FDA WARNING_LETTER - Eidon Incorporated - March 31, 2011

The FDA issued a Warning Letter to Eidon, Inc. on April 8, 2011, following a March 2011 review of their website, http://www.eidon.com. The letter states that Eidon, Inc.'s "Liquid Iodine" product is promoted with therapeutic claims that classify it as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)].

The FDA cited specific claims on the website, including statements under "A Short Note on Iodine Supplementation" and "Iodine Supplementation" on the "Iodine as Thyroid Protection" webpage. These claims suggest the product is intended for the cure, mitigation, treatment, or prevention of disease, specifically for thyroid, breast, and prostate protection from radioactive iodine-131 absorption, especially in the context of the Japan earthquake disaster.

Because the product is not generally recognized as safe and effective for these uses, it is considered a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs cannot be legally marketed in the U.S. without prior FDA approval, as described in section 505(a) of the Act [21 U.S.