Thursday, May 17, 2012

Several antibacterial hand sanitizer and over the counter drugs had violate marketing for unproven claim

Thursday, April 28, 2011 7:09

Some companies producing hand sanitizer and over the counter drug that claim their products can fight bacteria such as staphylococcus aureus, streptococcus, escherichia coli, salmonelia, and H1N1 influenza viruses, received a warning letter from the U.S. Food and Drug Administration (FDA).

According to the agency, their marketing for antibacterial claims has violate the federal’s law, because the efficacy has not proven yet.

These products and companies that received warning letter from FDA included:
- Staphaseptic First Aid Antiseptic/Pain Relieving Gel from Tec Laboratories,
- Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant from JD Nelson and Associates,
- Dr. Tichenor’s Antiseptic Gel from Dr. G. H. Tichenor Antiseptic Co, and
- Clean Well All-Natural Hand Sanitizer and Clean Well All-Natural Antibacterial Foaming Hand Soap from Oh So Clean Inc (known as Clean-Well Company).

The agency stated, “The FDA cannot allow companies to mislead consumers by making unproven prevention claims.”

These companies are give 15 days to run and fix what was warned by the FDA.
Neglect in this warning resulted in legal action by the FDA on all of these products.

For consumers, the agency stated to be more proactive to report the products that have made false claims.
If they believe their products have side effects and make a violation of their claim, the consumers can reports it through:
- MedWatch’s phone line at 1-800-332-1088,
- MedWatch’s fax line at 1-800-322-1078,
- MedWatch’s mail to 5600 Fisher Lane, Rockville, Maryland 20857, or
- MedWatch’s website

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