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FDA Investigating Safety and Effectiveness of Hospital Hand Sanitizers

May 4, 2015

The Food and Drug Administration (FDA) is investigating the safety and effectiveness of the hand sanitizers hospital workers uses dozens of times a day.

The FDA is asking manufacturers to submit data about medical hand washes and sanitizers, including the long-term health effects of their daily use on the skin and how well they actually fight the spread of germs, The Associated Press (AP) reports.

Under a proposed rule published last week, companies must submit new studies of key safety issues, including possible hormonal effects and the sanitizers' contribution to the development of antibiotic-resistant bacteria. Products that are not shown to be safe and effective by 2018 would have to be reformulated or removed from the market, according to the AP.

According to an FDA estimate, it could cost companies between $64 and 90 million to conduct the requested studies. The FDA advises for now that health care workers continue using hand washes, sanitizers and surgical scrubs, which are considered the primary tools for preventing the spread of infection in health care settings. In an interview with the AP, Dr. Theresa Michele, director of the FDA's Center for Drug Evaluation and Research, said, "We're not asking for any of these products to come off the market at this time."

Alcohol and iodine have been used by doctors and nurses for decades, according to the AP. The FDA said routine use of these and other antiseptics has increased over the past 20 years as hospitals step up efforts to fight infections. Under current guidelines, doctors and nurses are directed to sanitize their hands before and after visiting a patient's room, which means that health care personnel may use the products a hundred times a day.

Recent research suggests the antiseptics are absorbed into the body at higher levels than previously thought; they show up in the blood and urine of users, the AP reports. The FDA wants data from both human and animal studies on absorption rates, blood levels, toxicology and possible links to cancer and hormonal problems. The agency will use the information to determine safety thresholds, with particular concern for vulnerable groups like pregnant and breastfeeding health care workers.

The FDA is also gathering information about possible links between the use of hand sanitizers and the growth of “superbugs," bacteria that are resistant to antibiotics. The FDA review of nearly 30 antiseptic ingredients has been a decades-long process fraught with delays. The FDA first began evaluating antiseptic soaps and scrubs in 1972 under a law designed to set guidelines for hundreds of drugs and chemicals that were already on the market but had never been formally reviewed. The FDA last updated its review of health care hand cleaners in 1994, according to the AP. The agency has agreed to complete its review after a three-year legal battle with the Natural Resources Defense Council. The environmental group accused the agency of delaying action on potentially dangerous chemicals. In 2013 the FDA agreed to a legal settlement that included timetables for completing the review of various chemicals, including the hand sanitizers.

A major concern for environmentalists is triclosan, an ingredient in most antibacterial soaps sold to consumers. In late 2013, the agency issued a separate review of consumer products containing triclosan. More data are needed to establish their safety and effectiveness, the AP reports. Triclosan is less common in health care hand washes and cleaners than ingredients like alcohol and chloroxylenol, FDA officials say.

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