FDA WARNING_LETTER - Nutrasilver.com

The FDA issued a Warning Letter to Beneficial Solutions, LLC regarding its product "NutraSilver," marketed on www.nutrasilver.com and other labeling. The FDA determined that NutraSilver is promoted for conditions that cause it to be an unapproved drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act, due to therapeutic claims for cure, mitigation, treatment, or prevention of disease. Examples of claims included killing pathogens like MRSA, eColi, Salmonella, Candida, viruses, and treating/preventing colds, flu, sinus infections, Lyme Disease, and Celiac Disease. Consequently, NutraSilver is considered a "new drug" under section 201(p) because it is not generally recognized as safe and effective for its intended uses, and is being marketed without prior FDA approval, violating section 505(a). Furthermore, the product is misbranded under section 502(f)(1) as its labeling lacks adequate directions for use for conditions not amenable to self-diagnosis and treatment. The introduction of this misbranded drug into interstate commerce violates section 301(a). The firm must take prompt action to correct these violations, review all promotional materials, and notify the FDA within fifteen working days of the specific steps taken, or face potential enforcement actions including product seizure and injunctions.