On September 2, 2016, FDA issued a final rule prohibiting the sale of antiseptic
wash products (including liquid, foam, gel hand soap, bar soaps,
and body washes) that contain one or more of 19 specific active
ingredients, including two of the most common used
ingredients—triclosan and triclocarban. When issuing the proposed rule in 2013, FDA requested safety
and efficacy data regarding use of certain active ingredients in
antibacterial products. Those ingredients are added to consumer
products with the intent of reducing or preventing bacterial
infection. FDA concluded that "antibacterial hand and body
wash manufacturers did not demonstrate that the ingredients are
both safe for long-term daily use and more effective than plain
soap and water in preventing illness and the spread of certain
infection." In fact, Janet Woodcock, M.D., director of
FDA's Center for Drug Evaluation and Research, said that
"... some data suggests that antibacterial ingredients may do
more harm than good over the long-term." Some of the potential
health risks that are under study include bacterial resistance or
hormonal effects. FDA issued a proposed rule in June 29, 2016,
requesting information to address data gaps on safety and efficacy
of consumer hand "sanitizers"or wipes
(used when no water is available as opposed to antiseptic wash
products that are intended for use with water and are rinsed off
after use). For now, these products are not affected by the final
rule. Likewise, antibacterial products used in health care settings, such as hospitals and
nursing homes, have not been prohibited. In addition, FDA will
allow the use of three active ingredients—benzalkonium chloride, benzethonium chloride, and chloroxylenol (PCMX)—in antibacterial
products for one more year, pending the collection by the agency of
new safety and effectiveness data regarding the use of such
ingredients. Industry has one year to comply with the rule, which
will become effective on September 6, 2017.
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