June 15, 2007
A Food and Drug Administration letter dated May 7 warned DuPont Co. for violating new drug provisions and "misbranding" its RelyOn antiseptic spray and hand wipes. Addressed to Charles O. Holliday, DuPont's chairperson and CEO, the letter said the company has insufficient evidence to support its claims that RelyOn products prevent diseases including hepatitis A, B, and C, and HIV type 1.
"We are not aware of evidence that these products are safe and effective in preventing individuals from becoming infected with hepatitis A, B, and C, and HIV-1," the letter said. FDA ordered DuPont to investigate and determine the cause of the violations and prevent their recurrence, or face legal action.
"FDA has taken the position that viral and fungal claims, however accurate, should not be on the label for over-the-counter antiseptic products," Stephanie Jacobson, spokesperson for DuPont, said in a statement. She added that DuPont was working closely with the agency to "bring the subject labels in line with their expectations."
News Journal (Wilmington, Del.)
06.13.2007; Luladey B. Tadesse