Antibacterial Soaps Containing Certain Ingredients No Longer Allowed on the Market

Manufacturers did not demonstrate safety and effectiveness of ingredients

Hands Washing Using Soap and Water / Antibacterial Soaps Containing Certain Ingredients No Longer Allowed on the Market
Image: Pixabay
September 02, 2016

The Food and Drug Administration (FDA) has issued a rule stating that over-the-counter antibacterial soaps containing certain ingredients are no longer allowed on the market.

Companies can no longer market the products because their manufacturers did not show that these ingredients are safe for daily use over a long-term period or more effective than simple soap and water. Some manufacturers have already begun to take these ingredients out.

The rule applies to soaps that contain one or more of 19 particular active ingredients, such as triclosan and triclocarban. The soaps are intended to be used with water and are rinsed off after being used. The rule does not apply to hand "sanitizers" or wipes, nor to antibacterial products that are used in healthcare.

"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. "In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term."

The FDA first proposed such a rule in 2013 after reviewing data suggesting that health risks—such as bacterial resistance and effects on hormones—may result from long-term exposure to certain ingredients present in antibacterial products. Under this rule, product manufacturers had to give the agency more data about the safety and efficacy of those ingredients if they wished to market products containing them. This data was to include information gleaned from clinical studies showing that the products worked better to either prevent illness or lessen infection than non-antibacterial soaps.

However, the manufacturers did not provide the data needed to establish the efficacy and safety of the ingredients in question. As a response to industry comments, the FDA has postponed issuing a rule on three additional ingredients—benzalkonium chloride, benzethonium chloride, and cholroxylenol—for one year in order for the manufacturers to develop and submit new data regarding their safety and effectiveness. Companies are allowed to market products containing these ingredients during this time.

Washing using regular soap and running water is still one of the most important practices that consumers can do to avoid illness and the spreading of germs. If soap and water are unavailable and hand sanitizer is used instead, it is recommended that the sanitizer be alcohol based and contain at least 60 percent alcohol.

Manufacturers began phasing out the affected ingredients in 2013 after the FDA issued its proposed rule. They now have one year to comply with the final rule by finishing the removal of the ingredients.

Get Connected with Consumer Connections

Stay up-to-date about issues that really matter! Get the Consumer Connections newsletter!

We're committed to providing you with information you need to make you a better, more informed consumer. Whether it's a vehicle recall, a product recall, or a new scam, we feature it in Consumer Connections.

So why not give it a try? Go on. All of your friends are doing it. It's completely free and comes just once a week.

Have you ever noticed that your bank account somehow had 'extra' money in it even though you knew for a fact it wasn't yours? If so, you are not alone. It happens more often than you would think. All it takes is for a bank teller to type in one wrong number at the time a deposit is being made.

Advances in airbag technology have made 10 and two quite dangerous, according to the American Driver and Traffic Safety Association. The old position puts the driver's fingers, hands and arms in the way of the airbag, which deploys at speeds of nearly 250 mph.

Have you ever considered using toothpaste on your car to take out a few of those minor scratches? If the scratch hasn't yet penetrated the clearcoat, there is a good chance that you can fix the problem with a little bit of elbow grease and whitening toothpaste.

Tell all of your friends and family that you have some type of consumer complaint. We bet that at least half of them will tell you to contact the Better Business Bureau (BBB) for some kind of resolution. But can the BBB really help consumers? It really isn't what you think it is.