Antibacterial Soap Ingredients Banned by FDA

Just a short time ago the US FDA banned the manufacture of antibacterial hand soaps and body wash containing certain active chemical ingredients. This follows a proposed rule that began in December of 2013 to determine the effectiveness of the chemicals and consumer safety over an extended period of daily use, as concerns began to arise from studies that showed that Triclosan could be a key factor in bacterial resistance to antibiotics and other serious health concerns.

The rule was a part of a settlement of a lawsuit against the FDA by the Natural Resources Defense Council in 2010 after the FDA’s failure to take action on the issue since it was first proposed in 1978. The council claims that the FDA’s lack of action has led to Triclosan, and many similar chemicals, being found in more than 2,000 individual products including body wash, bar soap, hand soap, toothpaste, fabrics, textiles, and plastics.

The rule stated that if the companies that manufactured consumer OTC products containing antibacterial chemicals could not demonstrate that their products were more effective than plain soap and water, and that their products were safe for long term daily use, the products would need to be reformulated and relabeled in order to remain on the market. The deadline for companies to submit all data and studies was December of 2014.

Blackboard with the chemical formula of Triclosan

Since 1978 concern has grown for the use of these chemicals in a daily household setting, after studies found Triclosan in the urine and breast milk of about 75 percent of individuals. More studies have linked Triclosan to bacterial resistance and hormonal changes, and have even showed that the presence of Triclosan can remain in the environment for an excessive amount of time.

As of September of this year, 19 of the chemicals included in the rule have been banned by the FDA, including Triclosan and Triclocarban. There are three chemicals which have been given an extended time for further study and data collection. These chemicals will remain on the market until their deadline is reached. They are Benzalkonium Chloride, Benzethonium Chloride, and Chloroxylenol.

Companies that manufacture products containing these ingredients have complied with the rule quickly and thoroughly. Some companies, such as the Henkel Corporation which manufactures Dial antibacterial products, have already reformulated their products with safer ingredients and still remain on shelves.

At this time, the ruling does not include hand sanitizer or hand wipes, and does not affect the use of these ingredients in healthcare settings such as hospitals and nursing homes. One brand of toothpaste, Colgate Total, was able to support the use of Triclosan in its product as studies and data showed that the benefits of the ingredient, which significantly reduces plaque and tartar, outweigh the risks.

The FDA and other health organizations agree that there is no scientific evidence available to date that shows antibacterial chemicals are more effective at killing germs than plain soap and water. The FDA has recommended that consumers continue to use soap and water to wash their hands several times a day to prevent the spread of germs and keep up good personal hygiene.

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