FDA Guidelines & Restrictions
Is Fresh Protect in compliance with the FDA TFM or OTC Products?
YES. It is in compliance with the FDA Tentative Final Monograph for OTC Hand Sanitizer preparations (leave-on sanitizers not requiring a rinse). Why can't 'Fresh Protect Hand Sanitizer' disclose to the public it's full potential? Current FDA regulations in the USA do not allow claims about any type of anti-viral or anti-fungal activity for hand sanitizers. In other words, if a hand sanitizer was proven by independent lab testing to effectively kill (in-vitro) molds, fungus or viruses, H1N1, Swine Flu, Norovirus, common flu, Herpes Simplex, MRSA, VRE, C.diff. and many others, in one minute or less, it could not be sold in the USA with those claims. It could only claim to kill bacteria / germs. It cannot claim any persistence. In other words, if a hand sanitizer was proven by independent lab testing to persistently kill germs (staph) (in-vivo) with 100% effectiveness for over 4 hours, it could not be sold in the USA with those claims. It could only claim to kill 99.99% of bacteria / germs. Therefore, we emphatically state that Fresh Protect Hand Sanitizer, sold for use in the USA, do NOT exhibit any of these stated activities. No one should assume or state that Fresh Protect Hand Sanitizers have any biocidal activity other than the antibacterial claims allowed by law. FDA / CDC Now Recommends
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WIKIPEDIA QUOTES
"In a 1998 study utilizing the FDA protocol, a non-alcohol sanitizer utilizing the active ingredient benzalkonium chloride met the FDA performance standards, while Purell, a popular alcohol based sanitizer, did not. The study found that a benzalkonium chloride based sanitizer was the most favorable non-alcohol based hand sanitizer. New generation, plant derived versions are used in hand sanitizers that are more effective and safer than alcohol gels. As an antiseptic, it has the advantage of not burning when put on a wound, which is not the case with ethanol-based antiseptics or hydrogen peroxide. As the antiseptic in Bactine, benzalkonium chloride has been used safely for decades on childhood scrapes and cuts."
"Newer formulations using benzalkonium blended with various quaternary ammonium derivatives can be used to extend the biocidal spectrum and enhance the efficacy of benzalkonium based disinfection products. This technique has been used to improve virucidal activity of quaternary ammonium-based formulations to healthcare infection hazards such as hepatitis, HIV, etc. Quaternary ammonium formulations are now the disinfectants of choice for hospitals. This is on account of user and patient safety even on contact with treated surfaces and the absence of harmful fumes. Benzalkonium solutions for hospital use tend to be neutral to alkaline, non-corrosive on metal surfaces, non-staining and safe to use on all washable surfaces."
"Newer formulations using benzalkonium blended with various quaternary ammonium derivatives can be used to extend the biocidal spectrum and enhance the efficacy of benzalkonium based disinfection products. This technique has been used to improve virucidal activity of quaternary ammonium-based formulations to healthcare infection hazards such as hepatitis, HIV, etc. Quaternary ammonium formulations are now the disinfectants of choice for hospitals. This is on account of user and patient safety even on contact with treated surfaces and the absence of harmful fumes. Benzalkonium solutions for hospital use tend to be neutral to alkaline, non-corrosive on metal surfaces, non-staining and safe to use on all washable surfaces."
