FDA WARNING_LETTER - Natural Path / Silver Wings, LLC - August 05, 2010

This FDA Warning Letter to Natural Path/Silver Wings, LLC, addresses serious violations regarding the marketing and distribution of HMD? Heavy Metal Detox and Natural Path Silver Wings Colloidal Silver products. An FDA review of labeling and websites in January 2011, coupled with an August 2010 inspection, determined these products are unapproved new drugs and misbranded drugs. HMD? Heavy Metal Detox is promoted with disease treatment claims, classifying it as an unapproved new drug (Sections 505(a), 301(d) of the Act) and a misbranded prescription drug lacking adequate directions for use (Section 502(f)(1)). Colloidal silver products are similarly marketed with bactericidal claims, making them unapproved new drugs and misbranded under 21 CFR 310.548(b) and Section 502(f)(1). The inspection also revealed significant Current Good Manufacturing Practice (CGMP) violations for dietary supplements, which would render the products adulterated (Section 402(g)(1)). Deficiencies included failure to prepare and follow written Master Manufacturing Records (21 CFR 111.205(a)), failure to collect representative samples of components (21 CFR 111.80(a)), and failure to collect and hold reserve samples of finished products (21 CFR 111.83(a)). The firm's previous response was inadequate. The FDA mandates prompt corrective action within fifteen working days, requiring a written explanation and documentation. Non-compliance may lead to legal action, including seizure and injunction, and could affect federal contracts or FDA approvals.