Sometimes plain soap and water is not good enough. The acquisition and transfer of transient bacteria via the hands is recognized as a major factor in the spread of disease. Antibacterial handwash products are specially formulated to reduce the number of transient bacteria on the hands and thus reduce the potential for transmission or acquisition of disease more effectively than plain soap.
The American Medical Association's (AMA) 2000 opinion (American Medical Association, 2000) was based on an untested scientific theory. According to the federal Centers for Disease Control and Prevention, doctors write 50 million unnecessary prescriptions for antibiotics each year. It is this over-prescription of drugs -- and their misuse by patients -- that are the key reasons for the emergence of antibiotic resistance. A tangible solution to this problem of antibiotic resistance is in doctors' hands. Putting the burden on consumers and other users of antibacterial products - and taking away effective defenses against disease-causing bacteria - is not the answer.
Furthermore, as patients are spending less recovery days in the hospitals and are sent home earlier to recuperate, the use of antibacterial soaps becomes a more important choice for protecting oneself and one’s family from the spread of germs and the risk of infections. Antibacterial soaps deliver an important public health benefit.
FDA’s statement is based on the available data for evidence of clinical benefit of antibacterial washes that was last reviewed by FDA and the Nonprescription Drugs Advisory Committee in October 2005. It does not reflect the more recent antibacterial wash benefits data that was submitted to the agency after its 2005 review, which includes the extraordinary results of a new study published in the prestigious, peer reviewed Journal of Food Protection (Fischler et al., 2007. The effect of hand wash agents on controlling the transmission of pathogenic bacteria from hands to food. J. of Food Protect. 70: (12) 2873-2877). This study demonstrated that not all hand soaps are alike in their performance. In fact, it showed that a leading brand of antibacterial foaming hand soap containing triclosan helps protect people from significantly more food illness-causing germs than ordinary soap.
Alcohol and antibacterial hand soaps are held to the same standard of efficacy by FDA. Antibacterial products for handwashing are specially formulated with different ingredients to reduce the number of transient bacteria on the hands and thus reduce the potential for transmission or acquisition of disease more effectively than plain soap. Alcohol products are convenient to use when soap and water are not available.
Overall, consumers are exposed to a variety of settings and potentially “high risk” situations inside and outside of the home that increase the risk of exposure or transmission of germs that may cause illness and disease. Examples of typical “high risk” situations or settings that potentially increase one’s chance of acquiring disease or illness from the transmission of bacteria on the skin include: changing diapers; caring for sick, elderly or invalid family members; preparing family meals; having contact with pets; handshaking; gardening and performing yard work; attending daycare, school or work; visiting restaurants and public eating establishments; using public restrooms and toilets; visiting offices of physicians, dentists and other health care providers; sharing objects such as telephones, exercise equipment and money; and traveling.
The truth of the matter is that sometimes plain soap and water is not good enough. Having a product available that is specially formulated to reduce the number of potentially harmful bacteria on the hands and thus reduce the potential for transmission or acquisition of disease more effectively than plain soap should be considered as being a right for protecting oneself of illness and disease. Why give up the chance to protect yourself?
The potential for the transmission of opportunistic pathogens to oneself or to others is significant, in the home, in institutional and commercial settings, as well as in healthcare settings. The risk of infection or acquisition of disease from the transmission of microorganisms can be correlated to specific tasks in all of these settings. Everyday consumers are exposed to a variety of bacteria and situations that have the potential to cause infection. The acquisition and transfer of transient bacteria via the hands is recognized as a major factor in the spread of disease. Products for handwashing are formulated to reduce the number of transient bacteria on the hands and thus reduce the potential for transmission or acquisition of disease. As more and more patients spend less recovery days in hospitals and are sent home to recuperate, the use of antibacterial soaps becomes more a important choice for protecting oneself and one’s family from the spread of germs and the risk of infections becomes more important from a public health benefit.
FDA’s statement is based on the available data for evidence of clinical benefit of antibacterial washes that was last reviewed by FDA and the Nonprescription Drugs Advisory Committee in October 2005. It does not reflect the more recent antibacterial wash benefits data that was submitted to the agency after its 2005 review, which includes the extraordinary results of a new study published in the prestigious, peer reviewed Journal of Food Protection (Fischler et al., 2007. The effect of hand wash agents on controlling the transmission of pathogenic bacteria from hands to food. J. of Food Protect. 70: (12) 2873-2877). This study demonstrated that not all hand soaps are alike in their performance. In fact, it showed that a leading brand of antibacterial foaming hand soap containing triclosan helps protect people from significantly more food illness-causing germs than ordinary soap.
Triclosan is safe and effective for its intended use as a nonprescription antibacterial ingredient in consumer products. The extensive database, collected over more than 40 years of study and real-world application, confirms that Triclosan is effective and safe for humans and the environment. An extensive database also exists for Triclocarban and it shows that is unlikely for Triclocarban to cause harm to human or environmental health.
Triclosan is not bioaccumulative and its presence in the body does not indicate that it is causing harm. Triclosan does not accumulate in food-chains because it is excreted by animals and man by their metabolism. It is important to note that the mere presence of a chemical in the body is not mean that it is dangerous to people. Sufficient toxicology testing has been conducted on triclosan which shows that it is safe levels at current of exposure to both the general population and subgroups that may be more sensitive.
The results of these studies have been evaluated by federal agencies, such as the U.S. Environmental Protection Agency and it has been determined that the use of triclosan in antibacterial products, or the consumption from environmental sources (such as drinking water and crop plants), does not present a risk to human health. Similarly, Triclocarban is also metabolized and excreted in urine and feces within hours indicating low potential for bioaccumulation. Furthermore, triclocarban has not been detected in drinking water or edible crop plants, therefore the risk for consumer exposure is unlikely or non-existent.
Triclosan and Triclocarban do not accumulate in food-chains because they are metabolized and excreted by animals and humans. Triclosan and Triclocarban in the environment are mainly bound to sediment or soil particles which limits its uptake by plants or terrestrial organisms. The uptake by plants will be significantly low, if any, therefore representing no safety risks if ingested.
There has been a significant amount of speculation associated with the potential impact from the presence of triclosan and triclocarban in the environment, however these levels are extremely low and do not pose harm to humans or the environment.
The use of antibacterial soaps does not lead to antibiotic cross-resistance in bacteria. For example, in over 40 years of real world use, there are no known cases or any evidence that triclosan causes resistance in bacteria. Triclosan is an antimicrobial agent that slows or stops the growth of bacteria on surfaces. Triclosan is NOT an antibiotic. It does not treat systemic (inside the body) bacterial infections, which is what antibiotics do. It has been widely recognized throughout the medical community that bacterial resistance is the result of misuse and over-prescription of antibiotic drugs, not the use of antibacterial soaps.
Credible scientific data indicates that triclosan does not disrupt hormonal activity or function and there is extensive data that demonstrates that triclosan is neither genotoxic nor mutagenic. The predominant route of excretion for triclosan is the urine. Therefore it would not be surprising to be able to measure triclosan in random samples from the population.
Claims that antibacterial products triclosan may be harmful to human health and the environment are fundamentally wrong and seriously misguide consumers, serving to deny them the choice of protecting themselves and their families from the spread of germs, the risk of infections, and dental diseases. Companies have spent nearly 40 years and billions of dollars demonstrating the safety and efficacy of the ingredients used in antibacterial products and these products have been used safely and effectively for more than 40 years. The use of this beneficial product should not be discouraged based on allegations that stir up disproved fears rather than address real-life, present day health concerns.
Antibacterial products have been used safely and effectively for more than 40 years. FDA and other federal agencies agree that insufficient evidence exists to demonstrate that the use of antiseptic drug products harms human health. These products provide a public health benefit by reducing or eliminating pathogenic bacteria on the skin to a significantly greater degree than plain soap and water. The use of antibacterial hand wash products for infection control in both clinical and non-clinical settings has been documented in the published literature.
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