Statement by John Bailey, Chief Scientist, The Personal Care Products Council, in Response to FDA Triclosan Announcement
In response to a letter sent in January by Rep. Edward Markey (D-MA) to the U.S. Food & Drug Administration (FDA) inquiring about the status of the agency’s ongoing review of triclosan in consumer products, FDA announced today that it is continuing its scientific review and will incorporate “the most up-to-date data and information into the regulations that govern consumer products containing triclosan.” FDA also noted that “triclosan is not currently known to be hazardous to humans” and the agency “does not have sufficient safety evidence to recommend changing consumer use of products that contain triclosan at this time.”
Triclosan is an antimicrobial used as an active ingredient in skin and oral care over-the-counter (OTC) drug products and as a preservative in water-based formulations of a range of other skin, bath, and hair care products. The FDA permits the use of triclosan in antibacterial soaps and as an antiseptic drug preparation. Additional approvals permit the use of triclosan in antibacterial surgical sutures and in antibacterial pre-operative mouth cleansers to prepare for dental work.
The European Commission has evaluated the safety of triclosan and permits its use as a preservative in cosmetics and personal care products at a maximum concentration of 0.3%.
“The Personal Care Products Council, as a member of the Topical Antimicrobial Coalition, has worked for many years to provide voluminous scientific research and information to FDA on both the safety and the efficacy of triclosan as an important ingredient in a range of personal care products. We will continue to support the agency’s review of triclosan and have confidence that the final result will be a thorough, science-based evaluation of the ingredient. We are also happy to work with Rep. Markey to address any concerns he may have about the ingredient.
“Triclosan has been safely and effectively used for decades. It has been shown in recent studies submitted to the agency to have a distinct germ-killing benefit as it is used in anti-bacterial soaps. This is an important public health benefit in light of the spread of influenza; the millions of cases of food borne illnesses reported to the U.S. Centers for Disease Control and Prevention (CDC) each year, and the potential for serious infections and gastrointestinal disease due to poor hand washing practices.
“In 2005, an FDA advisory panel examined whether these products are more effective than non-antibacterial hand washes. By 2008, additional data and clinical trials were conducted and a panel of independent experts determined that these products are more effective than non-anti-bacterial hand wash products at reducing the risk of infection.
“It is critical that antibacterial hand wash products continue to be available to consumers in high risk settings that potentially increase the general population’s risk of acquiring disease or illness from the transmission of infection from skin that may occur in everyday life. Some examples of high-risk situations include, changing diapers, preparing family meals, using public restrooms and toilets, shaking hands, and traveling.
“We support FDA’s efforts to fully evaluate all available scientific data on triclosan. As part of our ongoing product stewardship efforts and due diligence, our industry also constantly monitors and assesses any new information. We have confidence that the final result of FDA’s review will be a thorough, science-based evaluation of the ingredient that will confirm its safety and efficacy.”