Follow us twitter facebook
Edition: Global
Click here to subscribe toour free weekly newsletter click here
Industry buzz

FDA bans triclosan and triclocarban from over-the-counter antibacterial washes

The U.S. Food and Drug Administration has prohibited certain active substances from over-the-counter (OTC) consumer antiseptic wash products. This 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.

Manufacturers will have one year to comply with the new rule. Photo: © Chakrapong Zyn / shutterstock.com

Manufacturers will have one year to comply with the new rule. Photo: © Chakrapong Zyn / shutterstock.com

According to the FDA, these ingredients were not demonstrated safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Actually some data suggested that long-term exposure to certain active ingredients used in antibacterial products could pose health risks, such as bacterial resistance or hormonal effects.

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).

As a consequence, companies will no longer be able to market antibacterial washes with these substances.

The rule only addresses products that are intended for use with water, and are rinsed off after use. It 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.

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.

Final Rule 2016-21337

Final Rule 2016-21337

Manufacturers will have one year to comply with the rulemaking by removing products from the market or reformulating (removing antibacterial active ingredients) these products.

© 2016 - Premium Beauty News - www.premiumbeautynews.com
latest news
Focus
MakeUp in newYork hosted more than 3800 visitors, with a growth of 12% of international guests.

MakeUp in New York moves to Javits Center to continue growing

The latest edition of MakeUp in NewYork was a huge success, announced the organisers. Held at the Center415 on 5th Avenue, in Manhattan, on September 11&12, 2019, the two-day B2B event dedicated to the makeup and skincare supply chain welcomed more than 3800 visitors, with a growth of 12% of international guests. Brazil, Canada, (...)

read more
job opportunities
Experts’ views
Victoria's Secret or the failure of a conservative positioning?

Laurence Bacilieri
Victoria’s Secret or the failure of a conservative positioning?

When the Victoria’s Secret show was cancelled it didn’t come as a surprise. In May, it was reported by The New York Times that the show would no longer be broadcast on network television. “We must evolve and change to grow. With that in mind, we have decided to re-think the traditional Victoria’s Secret Fashion Show". From 2001 to 2018, (...)

read more
Webinars
E-shop - latest publications
Safety of perfumes and cosmetics. Belarus, Kazakhstan and Russia
200.00 € excl. tax
Regulations on the registration of cosmetic products in China (part1)
135.00 € excl. tax
LuxePack Monaco 2017 - Show Report
30.00 € excl. tax
Go to top ↑

Features

We use cookies to give you a better browsing experience. By continuing your visit to this site, you accept the use of cookies. Read more and set cookies
close