FDA Ponders – Is Tricolsan Safe?

FDA Ponders – Is Tricolsan Safe?

May 6th, 2013 // 2:13 pm @

Updated Daily – Read our latest FDA, cGMP Compliance News

Tricolsan has been in US products of many kinds for over 40 years, including the body wash in your shower, the knives in your kitchen, and the bedding in your children’s bed. But now, FDA officials are wondering if tricolsan – the germ killing chemical that is in most anti-bacterial soaps and body washes marketed in the US -  is truly effective, and possibly even harmful.

FDA is going to do a review this year on whether tricolsan is safe. The ruling is going to decide if tricolsan can be used in the future for household cleaners and soaps. This could have huge effects on a huge industry of $1 billion per year. Some of the products include many types of anti-bacterial products, such as, toothpastes, soaps and toys.

The FDA review is coming as pressure is growing from legislators, advocates for consumers and many other organizations that are worried about the safety of the chemical. Some clinical studies for triclosan in laboratory animals indicate that there could be a higher risk of sterility, early puberty and several problems related to hormones in humans.

Some clinical trial experts think that the risks outweigh the benefits that are associated with many anti-bacterial products. The concerns over the chemical show that many of the chemicals in every day products were never actually approved by FDA. This is because many of the chemicals that kill germs were invented decades in the past when there were few laws in place for the approval of such chemicals.

This blow up over tricolsan also shows that it can take many years for the US government to review the safety of these types of chemicals. To date, FDA has not generally recognized the chemical as safe and effective because there was not enough evidence.FDA has come out with several drafts of guidance on this chemical over the years, but they never came up with anything final. So no companies had to take tricolsan out of their products.

A new review of tricolsan was supposed to be finished in 2012, but now FDA plants to complete the review this year.

Right now, FDA’s website states that FDA does not have evidence that tricolsan as it occurs in antibacterial soaps has any benefit over regular soap and water.

The American Cleaning Institute says that it has much data to show that the chemical is safe and effective. But The Endocrine Society has identified tricolsan as a chemical that changes thyroid hormone levels and reproductive hormones.

Some think that the use of anti-bacterial chemicals is causing a big surge in germs that are resistant to drugs and immunity to antibiotics. Lab studies have shown that some strains of e coli can grow in a culture with high amounts of triclosan.

Some top pharmaceutical companies and health organizations have stopped using triclosan. Kaiser Permanante stopped using triclosan in 40 hospitals. It now uses regular soaps and hand sanitizers based on alcohol.

Johnson & Johnson is going to take triclosan out of all baby products in the near future. And it will take the chemical out of all toiletry products by the end of 2106.

 

 


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