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FDA Issues Hand Sanitizer Warnings

Mon, 04/25/2011 - 6:41am

(AP) — Federal health regulators have issued warnings to four manufacturers of hand sanitizing products for making unsupported claims about the bacteria-fighting benefits of their products. The Food and Drug Administration has questioned the company's claims about their lotions and gels preventing a variety of infections, including staphylococcus aureas, E. coli and bird flu. Companies that claim their products can prevent a disease must submit scientific studies to the FDA before launching them.

The FDA warning letters cite the following products:

  • Tec Laboratories' Staphaseptic First Aid Gel
  • JD Nelson and Associates' Safe4Hours Hand Sanitizing Lotion and First Aid Antiseptic Skin Protectant
  • Dr. G.H. Tichener Antiseptic Co.'s Antiseptic Gel
  • Oh So Clean Inc.'s CleanWell All-Natural Foaming Hand Sanitizer, CleanWell All-Natural Hand Sanitizer, CleanWell All-Natural Hand Sanitizing Wipes and CleanWell All-Natural Antibacterial Foaming Handsoap

The warning letters order each company to correct the unsupported claims within 15 days. "The FDA cannot allow companies to mislead consumers by making unproven prevention claims," said FDA compliance director Deborah Autor. The FDA regularly issues warning letters to companies that don't follow regulations for manufacturing and marketing drugs, food and other products. The letters are not legally binding, but the FDA can take companies to court if they are ignored, resulting in seizure of products and shutdown of facilities.

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