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FDA Issues Final Rule To Ensure Safety Of Hand Sanitizers

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The FDA has ruled out 28 active ingredients found in hand sanitizers for evaluation under its OTC Drug Review. However, the agency is still reserving judgment on three other ingredients, including ethyl alcohol, until it completes its analysis.   ( Pixabay )

The Food and Drug Administration has declared that certain active ingredients should not be used in the production of over-the-counter hand sanitizers.

The agency announced on Thursday that 28 active ingredients featured in most antiseptic rub products failed to qualify for its OTC Drug Review. These include benzethonium chloride and triclosan, both of which are used to prevent bacterial infection.

The FDA also raised the need for more information on other ingredients, such as ethyl alcohol, to make sure that consumers can use hand sanitizers on a regular basis.

"Our action today aims to help provide consumers with confidence that the over-the-counter hand sanitizers they're using are safe and effective when they don't have access to water to wash with soap," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

Using Hand Sanitizers

To help prevent the spread of infectious diseases, the Centers for Disease Control and Prevention recommends regularly washing hands with soap and running water. Even this simple act can reduce the chances of diarrheal and respiratory illnesses from transmitting from person to person.

In case there is no access to soap and water, the CDC said people can use hand sanitizers as an alternative to clean their hands. Products with at least 60 percent alcohol can kill most known microbes in certain situations.

The recent popularity of hand sanitizers among consumers led the FDA to evaluate the safety and effectiveness of such products. In 2016, the agency requested additional scientific data to support the claim that antiseptic rubs can reduce bacteria on human skin.

The FDA has already ruled out 28 of the active ingredients included in most hand sanitizers. However, it is still reserving judgment on three additional ingredients while it continues to review studies and additional data on their use. These are ethyl alcohol, isopropyl alcohol, and benzalkonium chloride.

Active Ingredients In Antiseptic Rubs

Ethyl alcohol (ethanol) is a common ingredient used in beauty and cosmetic products. The substance is often used to serve as an astringent to help clean the skin, as well as a preservative in lotions to prevent their ingredients from separating. Its antimicrobial properties also make it an ideal choice for killing viruses, bacteria, and fungi.

Isopropyl alcohol is also an antiseptic ingredient in hand sanitizers. It is used as an astringent in most skin toners and tightening formulas.

Benzalkonium chloride is added to antiseptic rubs not only to kill germs upon application but to inhibit their future growth as well. It can also be found in antibacterial hand wipes and anti-itch ointments.

The FDA said it will release its ruling on ethyl alcohol, isopropyl alcohol, and benzalkonium chloride once it completes its analysis of the three active ingredients. It does not have any plans to have hand sanitizers with these ingredients pulled from markets as of the moment.

The agency's final ruling is expected to affect less than 3 percent of the marketplace since most OTC hand sanitizers contain ethyl alcohol as one of its active ingredients.

Products that include ineligible active ingredients will be required to get approval from the FDA under a new drug application before they could be made available again.

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