FDA WARNING_LETTER - LifeSilver - October 31, 2014

In October 2014, the FDA and FTC reviewed LifeSilver's website (lifesilver.com) and Facebook page, identifying violations related to their products: "ASAP Solution," "Patis 30 Fortified Silver Solution," "ASAP Ultimate Skin & Body Care Gel," "Combo Wellness Pack," and "Combo Gel Pack."

The agencies determined that therapeutic claims on the website and Facebook, such as "EBOLA AND NANO-SILVER VIRAL IMMUNIZATION" and claims about preventing/treating viral infections (including Ebola), cause these products to be unapproved new drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. These products are not generally recognized as safe and effective for their claimed uses, making them "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)], requiring prior FDA approval.

Furthermore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] because they are offered for conditions not amenable to self-diagnosis and treatment, meaning adequate directions for layperson use cannot be provided. The letter also notes that while