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SUBJECT 미국 FDA, 항균 비누에 사용하는 항균성분을 금지 시킨이유
WRITER j**** (ip:)
  • DATE 2017-05-22
  • RECOMMMEND 추천하기
  • HIT 1330
POINT 0점

항균비누....

어쩌면 좋은 효과가 있을 것이라고 생각들게 합니다. 좋은 효과가 있어서 피부병으로 어려움을 겪는 사람들에게 도움이 됐으면 좋겠는데,

사실은 그렇지 않은 모양입니다. 미국 FDA에서 항균 비누에 사용하는 항균성분 19가지를 사용 금지 시켰다고 합니다.

이유는?

효과가 있다는 것을 증명하지 못해서 그렇다고 합니다. 더블어 장기간 사용시에 부작용이 우려 된다고 합니다.


그러면서 제안하는 손 씻는 방법은 보통 비누나 흐르는 물에 손을 씻는 것이 좋으며, 이렇게 할 수 없을때 항균제품을 사용하여
손을 씻으라고 합니다. 항균 비누라고 광고 하기전에 효과를 증명하라 했으면 더 좋았을텐데... 그나마 다행인것은 지금이라도 진실이 밝혀 졌다는 것이지요.


원문을 참조 하세요.


The U.S. Food and Drug Administration today issued a final rule establishing that over-the-counter (OTC) consumer antiseptic wash products

containing certain active ingredients can no longer be marketed. Companies will no longer be able to market antibacterial washes with these ingredients because 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 infections. Some manufacturers have already started removing these ingredients from their products.

This final rule applies to consumer antiseptic wash products containing one or more of 19 specific active ingredients, including the most commonly

used ingredients – triclosan and triclocarban. These products are intended for use with water, and are rinsed off after use. 

This rule does not affect consumer hand “sanitizers” or wipes, or antibacterial products used in health care settings.

“Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence

that they are any better than plain soap and water,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and

Research (CDER). “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”

The agency issued a proposed rule in 2013 after some data suggested that long-term exposure to certain active ingredients used in

antibacterial products — for example, triclosan (liquid soaps) and triclocarban (bar soaps) — could pose health risks, such as bacterial

resistance or hormonal effects. Under the proposed rule, manufacturers were required to provide the agency with additional data on the safety and

effectiveness of certain ingredients used in over-the-counter consumer antibacterial washes if they wanted to continue marketing antibacterial

products containing those ingredients. This included data from clinical studies demonstrating that these products were superior to non-antibacterial

washes in preventing human illness or reducing infection.

Antibacterial hand and body wash manufacturers did not provide the necessary data to establish safety and effectiveness for the 19 active ingredients

addressed in this final rulemaking. For these ingredients, either no additional data were submitted or the data and information that were submitted

were not sufficient for the agency to find that these ingredients are Generally Recognized as Safe and Effective (GRAS/GRAE). In response to

comments submitted by industry, the FDA has deferred rulemaking for one year on three additional ingredients used in consumer wash

products – benzalkonium chloride, benzethonium chloride and chloroxylenol (PCMX) – to allow for the development and submission of new safety and effectiveness data for these ingredients. Consumer antibacterial washes containing these specific ingredients may be marketed during this time while data are being collected. Washing with plain soap and running water remains one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others. If soap and water are not available and a consumer uses hand sanitizer instead,

the U.S. Centers for Disease Control and Prevention (CDC) recommends that it be an alcohol-based hand sanitizer that contains at least 60 percent alcohol.Since the FDA’s proposed rulemaking in 2013, manufacturers already started phasing out the use of certain active ingredients in antibacterial washes, including triclosan and triclocarban. Manufacturers will have one year to comply with the rulemaking by removing products from the market orreformulating (removing antibacterial active ingredients) these products.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by helping to ensure the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for helping to ensure the safety and security of our nation’s food supply, cosmetics, dietary supplements, and products that give off electronic radiation, and for regulating tobacco products.

출처: 미국 FDA 홈 페이지, 블러그 science 815


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