FDA WARNING_LETTER - Silver Soft for Skin - November 24, 2009

The FDA issued a Warning Letter to Silver Soft For Skin after reviewing their website (silversoftforskin.com) on October 13, 2009. The agency determined that the firm was marketing products, including Silver Soft for Skin Care, First Aid, and Hand Sanitizer, with claims to diagnose, mitigate, prevent, treat, or cure the H1N1 Flu Virus. These products are unapproved, uncleared, or unauthorized by the FDA for such uses, violating the Federal Food, Drug, and Cosmetic Act (FFDC Act), specifically 21 U.S.C. §§ 331, 351, and 352. The letter highlighted specific claims like "Fighting the Swine Flu Virus" and "Swine flu problem solved. Silver soft kills 99.9994% of germs and viruses," along with relevant metatags, as evidence of the violative marketing. Given the nationwide public health emergency declared for the H1N1 Flu Virus, the marketing of unapproved products poses a significant threat to public health. Silver Soft For Skin was instructed to immediately cease marketing these unapproved products and to send an email to FDAFLUTASKFORCE-CDER@fda.hhs.gov within 48 hours detailing corrective actions. The firm must also review all labeling and promotional materials for compliance. Failure to comply could lead to enforcement actions such as seizure, injunction, criminal prosecution, and inclusion on FDA's public list of non-compliant firms. Unapproved products from non-U.S. firms are subject to detention upon importation.