FDA WARNING_LETTER - Blue Ridge Silver - February 11, 2019

The FDA issued a Warning Letter to Blue Ridge Silver, Steven Griffin, CEO, on February 5, 2019, following a review of their website, www.blueridgesilver.com, in October 2018. The FDA determined that the company's BLUE RIDGE SILVERTM Colloidal Silver products are marketed with claims that establish them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) because they are intended for the cure, mitigation, treatment, or prevention of disease.

The letter cites numerous examples of drug claims from the company's website, including claims related to preventing dementia, treating mycoplasma infections, killing cancer cells (breast, liver, cervical), aiding vital functions, and treating kidney infections. The website also features personal testimonials supporting these intended uses.

The FDA states that these products are "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their intended uses. Introducing or delivering new drugs into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act.

Furthermore, the products are deemed misbranded under section 502(f)(1) of the Act because they lack adequate directions for use by a layperson, as their intended uses are for conditions not amenable to self-diagnosis or