The Food and Drug Administration (FDA) has requested evidence proving that hand disinfectant products are safe for consumers to use. Disinfectant product manufacturers have been asked to provide scientific evidence showing the effectiveness of the goods they sell. The agency does not believe that over-the-counter gels are unsafe but wants to analyze more data about certain active ingredients.

Hygiene of the hands is fundamental to prevent infections spreading, said the Centers for Disease Control and Prevention (CDC). Millions of Americans are currently using hand sanitizers as a practical alternative to water and soap.

The federal agency wants to make sure that daily use of these products is safe. Image Credit: Medical Daily
The federal agency wants to make sure that daily use of these products is safe. Image Credit: Medical Daily

The FDA’s proposed rule seeks to collect scientific data about some chemicals used in topical consumer antiseptic rubs. The latter is not usually rinsed off with water.

People often use antiseptic rubs to remove bacteria from their hands, even in places were “risk of infection is relatively low,” said the FDA in a press release issued on Wednesday. The hand disinfectant industry has 180 days to comment on new requests and a year to provide evidence.

Janet Woodcock, director of the agency’s Drug Evaluation and Research, said on Wednesday there are scientific gaps surrounding some active ingredients included in hand sanitizers. The FDA wants to determine the products’ effect when it enters the bloodstream.

“Hand sanitizers are a convenient alternative when hand washing with plain soap and water is unavailable. It’s our responsibility to determine whether they are safe and efficient so that consumers can be confident when using them on themselves multiple times a day,” added Woodcock in a statement.

FDA is primarily concerned about the long-term effect of hand sanitizers in pregnant women and children

The CDC recommends hand disinfectant products containing at least 60 percent alcohol as a great alternative to hand and soap. Manufacturers need to provide data for alcohol, isopropyl alcohol, and benzalkonium said the FDA.

The popularity of these products has been increasing since 2009. 90 percent of manufacturers have been using ethanol as the main active ingredient since that time. The FDA stated that hand sanitizer products would not be removed “at this time.”

Manufacturers who want to sell these products over-the-counter need to evaluate their safety and absorption consequences. The FDA explained that new technology is capable of detecting low levels of antiseptic in the body.

“The FDA is particularly interested in gathering additional data on the long-term safety of daily, repeated exposure to these ingredients by consumers, and on the use of these products by women and children, for which topical absorption of the active ingredients may be necessary,” said the FDA on Wednesday.

‘Emerging science: full body exposure to some pure ingredients is higher than previously thought.’

New findings demonstrate that full body exposure to some purifying ingredients, detected in the blood or urine, may be higher than expected. The FDA is following recommendations by the Natural Resources Defense Council, which filed litigation in 2010 to evaluate the products.

Richard Sedlak, executive vice president for technical and international affairs at the American Cleaning Institute, said hand disinfectant products are “critical” for maintaining health hygiene. He mentioned the CDC, which also recommends the use of these commodities.

Marketers will have to change the chemical composition of hand sanitizers if they are not able to provide evidence of their effectiveness. Image Credit: Deposit Photos
Marketers will have to change the chemical composition of hand sanitizers if they are not able to provide evidence of their effectiveness. Image Credit: Deposit Photos

The American Cleaning Institute and the Personal Care Products Council said they have the requested data, according to The Washington Post.

Both institutions remarked that hand disinfectants are safe. They denied a theory saying that such products are contributing to the development of superbugs. They stated that eliminating antibacterial products from the market could lead to an increase in infection rates.

The FDA is constantly updating regulations regarding antibacterial products. It proposed in 2013 that antibacterial soap may not be different to plain soap. Manufacturers were requested to demonstrate their effectiveness. A final decision will be announced later this year.

Why is proper hand hygiene so important?

The strong effects of washing hands were first discovered by Ignaz P. Semmelweis, a Hungarian obstetrician. He found that newborns were less affected by infections when physicians regularly watched their hands.

An estimated 67 percent of Americans have a proper hand hygiene, according to B4 Brands, a company that makes hand sanitizers. Diseases transferred by touch can be eradicated by washing our hands several times a day.

40 percent of diarrhea cases may be caused by improper hand hygiene. This condition is the second cause of death among children, said B4 Brands. To prevent bacteria spreading, people should wash their hands for at least 15 seconds.

The ideal washing time is 30 seconds, especially after flushing a toilet. Scientists have determined that bacteria such as E. coli “is spread over an area of six square meters,” when doing so. After using the bathroom, the number of bacteria on our fingerprints doubles.

Here is a video featuring Jimmy Kimmel and Dr. Poland of Mayo Clinic in Minnesota, talking about hand hygiene:

Source: Food and Drug Administration