Hand Sanitizers - Part 1 - Effectiveness
10/13/2009 9:03:11 AM
The Internet is a wonderful tool for consumers and holds the promise for providing them with more information to balance product effectiveness, product safety and price when making purchase decisions. In the case of a Hand Sanitizer this would include the effectiveness of the active ingredient, the safety and side effects of active ingredient and the cost per application.
Unfortunately, the Internet is also used by many companies both directly and indirectly to spread misinformation and mislead consumers, making it difficult to compare hand sanitizers. Such deceptive marketing ranges from false claims that their product is Natural, Eco-friendly or “Green”, to Exaggerations of Safety or Side Effects of competitive products by paid “Experts”. Some companies even fake consumer support thru company written customer testimonials, biased one sided blogs, paid bloggers and even operate consumer blogs under the guise of providing advice on how to live and clean well.
Effectiveness Of Active Ingredient – Hand and Skin sanitizers are regulated by the FDA under its’ Final Tentative Monograph for Over the Counter Sanitizers (leave-on sanitizers not requiring a rinse). The active ingredients recognized or grandfathered under this monograph include Isopropyl Alcohol, combination's of Isopropyl Alcohol and Ethanol and Benzalkonium Chloride. Products with active ingredients which are not on this Monograph by virtue of a New Drug Application or are grandfathered face enforcement action by the FDA. The active ingredients listed above have shown to be effective as “leave on no rinse” sanitizers and are thus meet the FDA TFM requirements.
It is important to note that the statement “Kills 99.99% of Germs” that appears on virtually all hand sanitizers refers to a 99.99% rate of kill for a specific germs being tested, not the percent of germs it can kill. With the number of unnamed bacteria and viruses estimated 10 million or more and companies testing their sanitizer on no more than 50 of the most common, the inference that their product is effective against 99.99% of germs is misleading at best. Hand Sanitizers with published or readily available ATCC rate of kill results of between 99.9 to 99.9999% for at least 25 common germs represent the most effective product offerings. However, despite what some companies assert, simply testing a product on more bacteria and viruses does not mean it is a superior product to others with the same active ingredient. The quality of the active ingredients being utilized is a key factor in determining product effectiveness, safety and side effects.
Finally, a word about toxicity and the balance between effectiveness and product safety. Hand sanitizers are effective because their active ingredient is Toxic to the living bacteria and fungi that it has been tested on. In the case of viruses which are not a living organism, “toxic” would refer to an active ingredients ability to inactivate the virus. This is true whether the active ingredient is a synthetic or naturally derived compound, organic or an essential oil like Thyme. Because of this capability, ALL active ingredients used in ALL hand sanitizers on the market are considered Pesticides by the EPA. What consumers need to be concerned about is whether the amount of active ingredient needed to kill/inactivate 99.99 % or more of the common germs is safe for adults and children and does not have any significant side effects. The products that use the active ingredients Alcohol & Benzalkonium Chloride, recognized or grandfathered under the FDA monograph are considered safe for adults and children if they comply with the monograph and are used as directed within the Drug Facts section of their label. Safety and Side Effects of the active ingredients will be the focus of Part 2 of this three Part Series.
Alcohol - Alcohol is used widely in health care as an antiseptic and is found in many popular hand sanitizers. Ethyl alcohol, also know as ethanol is the active ingredient in the most popular alcohol hand sanitizers. It is a volatile, flammable colorless liquid that is also used as a solvent, as an additive in gasoline (gasohol) and is the intoxicating ingredient in beer, wine and distilled spirits. At the amount present in most hand sanitizers (62% or more) alcohol kills bacteria by disrupting the cell wall and denaturing proteins (i.e. loss or disruption of their structure). While effectiveness of alcohol improves by increasing the percentage used to as high as 75%, there are efforts to improve effectiveness, particularly with respect to the norovirus by combining alcohol with quaternary compounds and organic acid. - Products that list alcohol as their active ingredient include Germ-X®, Purell®, Lysol®, most store brand and off brand hand sanitizers.
Triclosan – Is an anti-bacterial and anti-fungal agent found in many deodorants, toothpastes, shaving cream, mouthwashes and a few hand sanitizers. Triclosan kills bacteria by impeding fatty acid synthesis which weakens the cell membrane and effectively stops bacteria from functioning properly.
Triclosan has been shown to be effective in reducing and controlling bacterial contamination on the hands and on treated products. Triclosan has been combined into numerous consumer product such as clothing, toys, trash bags and kitchen utensils although some claims regarding the benefit to consumers had to be withdrawn. Triclosan is used widely despite some evidence and concerns regarding antibacterial resistance and development of “superbugs”, limitations on its use as an agricultural pesticide and mounting environmental concerns. - Products that list Triclosan as their active ingredient include SkinWear® and Vicks Early Defense®.
Benzalkonium Chloride – Is a broad spectrum antimicrobial compound that is the most common active ingredient found in water based hand sanitizers. It is an organic compound that is used widely in eyewashes, hand and face washes, mouthwashes, spermicidal creams, and in various other cleaners, sanitizers, and Disinfectants Registered by the EPA as effective against Influenza A. Benzalkonium Chloride’s exceptional anti-bacterial and anti-microbial capability is driven by its ability to disrupt the cell walls and cause leakage of cell contents. The US EPA has stated that, based on available science, they believe that products registered for use against Influenza A will be effective against the 2009 H1N1 flu strain. However, the FDA does not permit any hand sanitizer from making claims related to the H1N1 virus and will take enforcement action against offending companies and place them on the FDA Fraudulent H1N1 Product List. Products that list Benzalkonium Cloride as there active ingredient include; MicroArmor™, GentleCare™ and SoaPopular®.
Thyme – Thyme is an essential oil that is distilled from the fresh or dried flowers of the thyme plant and has varying chemical compositions depending upon where the source plant is from. Essential refers to the essence of the plant from which they are derived, not that they are essential compounds like vitamins or minerals. Thymol, a crystalline phenol and terpene alcohols are the active ingredients which are responsible for its antiseptic and antibacterial properties. Thymol was registered as a Pesticide with the EPA in 1964 and kills bacteria in a similar manner to alcohol. Studies seem to indicate that blends of Red and White Thyme along with other anti-bacterials is necessary to achieve high effectiveness against bacteria and viruses that are of most concern. As of this writing no natural ingredients such as Thyme are listed in the FDA TFM for hand sanitizers. Thus natural antimicrobials such as Thyme are precluded from legal use in the US unless an approved new drug application (NDA) is obtained and, as of September 2009, none had been granted. www.cosmeticsandtoiletries.com/regulatory/region/northamerica/60657047.html Products that list Thyme (Thymol) include CleanWellTM.and EO Products.
Benzethonium Chloride - Is synthetic quaternary ammonium compound that is an odorless white solid that is soluble in water. It is used as a surfactanat, antiseptic, disinfectant and is also found in cosmetics and toiletries such mouthwash, occasionally disguised as grapefruit seed extract. Benzethonium chloride kills bacteria in a similar manner to Benzalkonium Chloride, although up to twice the percentage of active ingredient is utilized to obtain equivalent effectiveness. Benzethonium chloride is not grandfathered under the FDA monograph for leave on hand sanitizers and thus products without an approved NDA do not meet FDA’s TFM requirements. Products that list Benzethonium Chloride as their active ingredient include Pureworks® and Safespace®.