FDA WARNING_LETTER - Medline Industries Inc. - March 12, 2010

The FDA issued a Warning Letter to Medline Industries Inc. on March 12, 2010, regarding their SILVERtouch healthcare textiles with SilverClear technology. The FDA determined that Medline was marketing this product in the U.S. without required marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act.

The product is classified as a device under Section 201(h) of the Act. It is considered adulterated under Section 501(f)(1)(B) because Medline lacks an approved premarket approval (PMA) application or an investigational device exemption (IDE). Furthermore, the device is misbranded under Section 502(o) as Medline failed to notify the FDA of their intent to introduce the device into commercial distribution, as required by Section 510(k).

The FDA cited promotional claims on Medline's website, such as "utilizes a unique, highly effective solution called SilverClear? which combines the power of silver ions with surface-active antimicrobial chemistry, delivering a fast kill rate across a broad spectrum of microbes."

The Office of Compliance requested that Medline immediately cease disseminating promotional materials for SILVERtouch textiles. Medline must submit a written response within 15 working days, detailing their compliance plan, listing all similar promotional materials, and explaining their discontinuation plan. Failure to comply may result in regulatory actions including seizure, injunction, or civil money penalties.