ST. GEORGE — The U.S. Food and Drug Administration issued a final rule Thursday designed to help ensure that hand sanitizers available over the counter are safe and effective for those who rely on them.
A press statement from the FDA said the rule establishes that certain active ingredients are not allowed to be used in OTC hand sanitizers – formally known as topical consumer antiseptic rub products which are intended for use without water – that are marketed under the FDA’s OTC Drug Review.
“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,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in the press statement.
Woodcock said the rule would apply to 28 active ingredients, including triclosan and benzethonium chloride, but that they need “more data” on three other active ingredients, including ethyl alcohol – the most commonly used ingredient in hand sanitizers – in order to help the agency ensure that these products are safe and effective for regular use by consumers.
Consumer antiseptic hand sanitizers provide a convenient alternative when hand washing with plain soap and water is unavailable. Millions of Americans use antiseptic rubs daily, sometimes multiple times a day, to help reduce bacteria on their hands.
The Centers for Disease Control and Prevention advises that washing hands with plain soap and water is one of the most important steps consumers can take to avoid getting sick and to prevent spreading infections to others.
If soap and water are not available, the CDC recommends using an alcohol-based hand sanitizer that contains at least 60 percent alcohol.
Besides ethyl alcohol, the other active ingredients being deferred from further rulemaking to allow for the ongoing study and submission of additional safety and effectiveness data are benzalkonium chloride and isopropyl alcohol. At this time, the FDA does not intend to take action to remove hand sanitizers containing these three active ingredients from the market.
According to an article published by the National Center for Biotechnology Information, while there is clear evidence of the carcinogenic properties of ethyl alcohol when ingested in the form of alcoholic beverages, so far there is a lack of evidence to associate topical ethanol use with an increased risk of skin cancer.
However, the author went on to say that there may be industry bias in many of the studies of topical applications and that further independent studies should be carried out.
The press statement from the FDA said that less than 3 percent of the marketplace will be affected by the issuance of this final rule, as most OTC consumer antiseptic rubs use ethyl alcohol as the active ingredient.
The full list of active ingredients banned by the new rule include the following:
- Benzethonium chloride
- Chlorhexidine gluconate2
- Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
- Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
- Methylbenzethonium chloride
- Nonylphenoxypoly (ethyleneoxy) ethanoliodine
- Phenol (equal to or less than 1.5 percent or greater than 1.5 percent)
- Poloxamer iodine complex
- Povidone-iodine 5 to 10 percent
- Secondary amyltricresols
- Sodium oxychlorosene
- Triple dye
- Undecoylium chloride iodine complex
In addition, as previously described in the 2016 Consumer Antiseptic Rub proposed rule, FDA received several submissions in response to the 1994 TFM requesting that the compounds identified below be included in the monograph:
- Polyhexamethylene biguanide
- Benzalkonium cetyl phosphate
- Cetylpyridinium chloride
- Salicylic acid
- Sodium hypochlorite
- Tea tree oil
- Combination of potassium vegetable oil solution, phosphate sequestering agent and triethanolamine
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