Hand Santizer and Antiseptics Safety and Effectiveness Data to be Required by FDA

Growing concerns over ingredients used in many common hand sanitizers and antiseptics has prompted the FDA to request additional safety data from manufacturers of antibacterial soap and gel, which is designed to establish that their products are safe and effective.

The FDA proposed a new rule on April 30, which would require additional safety data on hand-sanitizer products. The new rule would require companies producing antiseptic products to thoroughly examine the chemicals and ingredients used in those products, and report proof of the sanitizer’s safety to the agency.

The FDA will allow public comment on the rule for the first 6 months. Companies will have a year to submit safety data to the agency. That data is supposed to include information on absorption, hormonal effects, and development of bacterial resistance.

The FDA’s efforts to examine the safety of antibacterial products on the current market were due to a growing popularity of antiseptic dispensers and products in offices, homes, hospitals, healthcare facilities, and many other business and public areas. Recent data has also suggested that daily, repetitive exposure to some ingredients is higher than previously thought, raising concerns of the long term side effects.

The focus of the proposal is to try and catch any foreseeable hazards that may cause complications for pregnant women, the breastfeeding, and those who are frequently exposed to the sanitizers.

Triclosan is one of the ingredients that has been specifically targeted. Some studies have suggested that triclosan side effects can cause hormonal problems and possibly alter the thyroid and reproductive systems of newborns. However, many manufacturers such as Purell, Gojo and EcoLab have phased out the use of triclosan because the FDA doesn’t allow the ingredient to be used in “leave-on” products.

Typically, the most common ingredients found in consumer antiseptics are alcohol and iodine, which the FDA does not believe carry any longer term effects if used in moderation.

According to the FDA, hand sanitizer products are an important product on today’s market. In fact, the CDC claims that at least 2 million Americans become infected with bacteria that are resistant to antibiotics each year, and 23,000 die as a result of those infections that could have been prevented by use of sanitizers and increased hygiene awareness. However, the FDA has become concerned about the potential long terms effects of exposure to those sanitizers.

Theresa Michele, director of the FDA’s division of nonprescription products, stated that some health care providers have recorded using hand sanitizer’s products up to 100 times a day between seeing patients. FDA officials stated that hand hygiene is an essential part of the healthcare system and is key to helping keep patients safe.

Sales from the U.S. soap and cleaning compound market is estimated to total $55.4 billion, and healthcare providers account for an estimated 14.3 percent of those sales, drawing concerns from federal safety agencies.

The proposed rule by the FDA does not require any sanitizer products to be removed from the market at this time and the agency is still encouraging consumers to practice frequent hand hygiene.