In its report published at the end of October, the FDA said that a panel of experts from its Center for Drug Evaluation and Research Advisory Committee, had shown particular concern for anti-bacterial washes containing triclosan, stating that it was uncertain whether the chemical met with both anti-bacterial and environmental requirements.
During the FDA assessment, the committee recognized that the active ingredient ethyl alcohol at a 62 percent level provides for safe and effective antibacterial protection in hand sanitizer gel products.
Vi-Jon Laboratories, based in St. Louis, Missouri, claims that its Germ-X hand sanitizer, contains the ethyl alcohol ingredient, which makes it an effective anti-bacterial soap. The company stresses that because this formulation is triclosan-free it is still seen as an effective product by the FDA.
During its session on October 20, the FDA Advisory Committee concluded that in lieu of readily available soap and water, alcohol-based hand sanitizers are a sensible and recommended alternative.
Vi-Jon says that multiple presenters to the committee cited the benefits of alcohol-based hand sanitizers, seeking that these products be removed from the antibacterial hand soap review.
Dr. Sally Bloomfield, PhD., International Scientific Forum of Home Hygiene, concluded in her speech to the committee, "Alcohol-based hand sanitizer provides an effective alternative in situations where soap and water are not available. Based on their safety and lack of antimicrobial resistance, alcohol-based hand sanitizers are appropriate for use in consumer settings."
Vi-Jon's claims were also backed up by both the Cosmetic, Toiletry and Fragrance Association and the Soap and Detergent Association, which, in a joint-statement, defended the use of such products.
i>"More than thirty years of research has proven that antibacterial products reduce or eliminate bacterial that can lead to commonly transmitted disease. As our presentation to the FDA demonstrated, these products play an invaluable role in the everyday lives of consumers," the two industry associations said in a joint statement.
The industry associations went on to say that, although the laboratory studies had speculated over a link between antimicrobial products and bacterial resistance, there was no categorical evidence to prove this.
"We are confident that alcohol-based products, such as Germ-X hand sanitizer are effective, safe and environmentally friendly," said Tom Marren, vice president of Technical Services at Vi-Jon Laboratories.
"Consumers should feel completely confident that using Germ-X is safe and beneficial in helping to prevent the spread of germs and other bacteria that can lead to illness. We are proud of our products and continually adhere to the highest level of health standards."