FDA Scrutinizes Safety of Hand Sanitizers

The Food and Drug Administration has asked manufacturers of hand sanitizers to provide additional proof that their germ cleansers are safe and effective. Despite the review, industry suppliers of antibacterial products stand by their hand sanitizers and feel the review will have little effect on the sale of this increasingly popular item.

The review is the latest in a series of similar moves by the FDA, which previously initiated a deeper evaluation of consumer soaps with hand-sanitizing properties (of which a final determination is expected to be released soon) and health-care antiseptics. The FDA says it does not believe these products are ineffective or unsafe, but wants to ensure that “unknown safety and efficacy concerns” aren’t present due to the heightened use of these products multiple times a day in environments that present a low threat of infection.

“These products provide a convenient alternative when hand washing with plain soap and water is unavailable,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, “but it’s our responsibility to determine whether these products are safe and effective so that consumers can be confident when using them on themselves and their families multiple times a day. To do that, we must fill the gaps in scientific data on certain active ingredients.”

The FDA is requesting additional data on three active ingredients: alcohol (ethanol or ethyl alcohol), isopropyl alcohol and benzalkonium chloride. Over 90% of hand sanitizers since 2000 use ethanol or ethyl alcohol as their active ingredient. The FDA recommends that alcohol-based hand sanitizers contain at least 60% alcohol.

SnugZ/USA Inc. (asi/88060) offers hand sanitizer products that are made up of 62%-63% food grade ethyl alcohol. Richard Massey, regulatory affairs director for SnugZ, said the company conducts both in-house and independent testing by an FDA-certified facility to ensure its hand sanitizers are effective and safe.

“We are happy to share our information with everyone to show that our products are safe to use as defined by the FDA,” said Massey. “But there are companies out there who are not. There is comfort for distributors that SnugZ and other companies like us have testing to support the claims. So we say ask for the testing. If there is a product that makes a claim, ask for the testing. If they don’t have it, or give you the runaround, run away.”

Massey adds that SnugZ makes all of its hand sanitizer products in its West Jordan, UT-based facility, and if there is ever a complaint about the product, SnugZ keeps retention samples of each batch and will send them for further testing.

Ariel Premium Supply Inc. (asi/36730) also offers several hand sanitizer products, which are also made of 62% ethyl alcohol. The Overland, MO-based supplier said its products are tested at the factory that creates and supplies the hand sanitizers to Ariel. The supplier adds that interest in hand sanitizers has remained steady, and that it feels additional proof is not needed to demonstrate its products are safe. “As long as our factory has FDA registration, and proper certification for each formula, we believe that is sufficient,” said Product Associate Alicia Robinson, who helps with the supplier’s compliance and product safety efforts.

Massey said that SnugZ has seen an uptick every year in hand-sanitizer orders, with the portable 1.9 ounce bottle remaining the most popular. He anticipates that the actions of the FDA and increased public awareness won’t dampen sales. “We do see people asking more questions, and that is not a bad thing,” said Massey. “We want people to ask questions, because that shows they are getting a good product.”