FDA questions hand sanitizers’ safety and effectivity

The request for more studies on hand sanitisers doesn’t necessarily mean that the FDA believes that these products are ineffective or unsafe.

Having children turns most parents into a germaphobe; afraid of their children getting sick, they start to be more cautious of the things that they get in contact with.

As a result, parents start carrying bottles of hand sanitisers to keep germs and bacteria at bay.

But how effective are hand sanitisers in the first place? Are they really functioning they way they are advertised? Do they have any harmful side-effects?

The answers to these questions are what the FDA seeks to establish.

According to a Yahoo! report: “The Food and Drug Administration is asking for new studies on how the antiseptic gels and rubs fight germs and get absorbed into the body, with a particular focus on children and pregnant women.

“The proposal unveiled Wednesday is part of an ongoing government effort to review decades-old chemicals that have never had a comprehensive federal review.”

Officials say that the request for more studies on hand sanitisers doesn’t necessarily mean that the FDA believes that these products are ineffective or unsafe.

However, manufacturers, under current regulations, make broad claims about their products’ effectiveness.

Bottles of the Purell, say, claim that theirs “Kills 99.99 percent of illness-causing germs.”

Now the FDA considers tightening such claims after the information submitted by the manufacturers are reviewed.

“We’re not trying to alarm people,” said Dr. Janet Woodcock, director of the FDA’s drug center. “Obviously ethanol and humans have co-existed for a long time so there’s a lot that’s known about it.”

But the agency is concerned in particular about its long-term effects to children and pregnant women and breastfeeding mothers.

The Yahoo! report also said that regulators are also concerned about possible links between use of antiseptic chemicals and the emergence of so-called superbug bacteria, which are resistant to antibiotics.

“We need to get this additional information so if there are situations where caution is warranted we can label that or inform the public,” Woodcock said.

Meanwhile, the American Cleaning Institute, a trade organisation of cleaning products, said that already the FDA “has a wealth of data on hand sanitisers in their possession to judge them as generally recognised as safe and effective.”

However, they also said that providing further information on the matter would work.

“FDA scientists were first charged with evaluating antiseptic soaps, scrubs and sprays in 1972 as part of a law designed to set guidelines for hundreds of drugs and chemicals that were already on the market but had never been formally reviewed,” said the same report.

“Environmentalists are mainly concerned about an ingredient called triclosan, which was used in many antibacterial soaps.

“The FDA is collecting safety and effectiveness data on that chemical with the goal of issuing new rules on its use by early 2018.”

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