FDA questions consumer use of antimicrobial soap
■ The move comes in the wake of increasing concerns that bacteria are becoming resistant to a growing number of antibiotics.
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Soaps and lotions that include antibacterial agents have no benefit over ordinary soap and water, but more research is needed to allay or substantiate concern that these substances may be leading to increased rates of antibiotic resistance. This is the conclusion of the Food and Drug Administration's Nonprescription Drugs Advisory Committee, which met last month to consider the use of these products outside of the health care setting.
"In the absence of proven benefit, there's no real reason to encourage the use of these products," said Alastair J.J. Wood, MD, committee chair and associate dean at Tennessee's Vanderbilt Medical School.
The agency is not bound by its committee's recommendations but usually follows them.
The finding was praised by physicians who have long expressed concerns that the use of antibacterial soaps and lotions by consumers may be doing more harm than good. For example, the American Medical Association's Council on Scientific Affairs published a report in the August 2002 Archives of Dermatology that it was prudent to avoid these products since evidence on their efficacy was lacking and the issue of antibiotic resistance is so critical.
"We urge the FDA to evaluate the safety and effectiveness of antimicrobials in consumer products and strongly urge FDA regulation of them where resistance against antimicrobials has been demonstrated," said AMA Trustee Ronald M. Davis, MD.
Manufacturers countered that these products were a valuable option for consumers.
"Antibacterial products are proven to control the risks associated with exposure to potentially pathogenic organisms, providing consumers with a valuable extra measure of protection," read a joint statement issued after the meeting by the Soap and Detergent Assn. and the Cosmetic, Toiletry and Fragrance Assn.
Committee members argued, however, that evidence that these products kill various infectious agents was not sufficient to conclude that they also reduce illness. The question of the contribution these products may make to resistance also needs to be answered.
"What matters is whether they reduce the incidence of infection," said Dr. Wood.