Soaptronic’s Germstar Antiseptic Rubs Clean On Ingredients, Not On Claims
Claims that Germstar antiseptic cleanser line treat swine flu, E-coli, salmonella and norovirus are not part of an OTC final monograph or TFM, FDA says in warning letter. The products contain active ingredients FDA deferred from OTC monographs for consumer and health care rubs to await additional data.
You may also be interested in...
The majority of over-the-counter hand sanitizers and wipes on the US market rely on ethyl alcohol, one of three active ingredients for which final rulemaking has been deferred to allow industry to generate additional safety and effectiveness data. FDA's final rule, released April 11, completes a series of related actions pertaining to OTC antiseptic drug products.
A complaint filed in federal court in California seeks an order to block Innovative BioDefense from distributing Zylast antiseptic hand sanitizer products that, due to its claims, are unapproved new drugs under FDA regulations. A warning letter to Silver Armor states that drug claims render its Silver Ramon and Natural Health brand products, which contain colloidal silver, unapproved new drugs and that the is noncompliant with supplement GMP regulations.
An FDA final rule rejects generally regarded as safe and effective status for 24 OTC monograph antiseptic ingredients regarding products intended for use by health care professionals in hospitals or similar venues. However, six ingredients on which FDA deferred its decision also are used in consumer antiseptic washes, which GRASE decisions pending in separate rulemakings.