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Wednesday, May 5, 2010

Hand Sanitizer War Heats Up: WHO, CDC and Competitive Agendas

With the focus on hand hygiene continuing to remain a forefront issue, and competition between hand sanitizer makers remaining fierce, interesting to make note of a comment made yesterday in a CDC teleconference call in advance of WHO Summit by Katherine Ellingson, a CDC epidemiologist.

In acknowledging professional HCW's rapidly-growing acceptance of non-alcohol hand sanitizer products, Dr. Ellingson, whose research has been supported courtesy of financial grants provided (ironically?) by GOJO Industries, the largest maker of alcohol hand sanitizer products), Ellingson commented that "alcohol remains the preferred product by staff at CDC" [with a twist of lemon??), and that "some makers of non-alcohol-based products were aggressive in marketing their products as effective against the pandemic flu virus (HIN1).." Ellingson referenced warning letters issued against them by the FDA.

We've seen a variety of independent laboratory tests from a variety of manufacturers that use quaternary ammonium elements as the active ingredient in their products. The majority of those test results are consistent, and otherwise indicate that benzalkonium chloride, and/or related compounds, which are used by the majority of non-alcohol hand sanitizer makers, provide similar, and most often better results when compared to legacy alcohol-based products.

As posted here in the past, and despite the fact that most manufacturers have successfully performed lab tests against individual pathogens, the FDA prohibits makers of hand sanitizer products from making pathogen kill claims within their advertising, a policy confirmed by FDA enforcement staff members. According to the FDA, this policy is not limited to advertising efficacy claims re: HINI, but extends to any particular pathogen.

That said, we certainly appreciate and respect the FDA policies re: advertising. We're also familiar with select manufacturers that had inadvertently over-looked FDA advertising guidelines, were since advised by FDA of those errors, and those manufacturers subsequently made immediate corrections to their advertising.

We only wonder why FDA has proven highly-selective in enforcing those rules (only a handful of makers have been cited in the past year), and why FDA continues to allow many other companies to continue to advertise pathogen-specific efficacy claims and flaunt FDA enforcement staff.

If a company is making unsolicited claims, whether it be in connection with H1N1, Clostridium Difficile (c.diff), MRSA, Hepatitis, or other pathogens, they are in clear violation of FDA enforcement rules; FDA does provide for manufacturers to offer these efficacy studies /claims upon request.

This isn't to suggest the products in question are not effective. In fact, most experts that have researched the topic would argue that BZK-based products are actually the smartest choice, if the only other choice were alcohol. It is to suggest however, that if a particular company is irresponsible in its regulatory compliance, it begets the question as to what other compliance issues they are overlooking.

Regrettably, some companies are being so bold as to not only challenge direct competitors by presenting misleading and wholly-inaccurate product comparison "efficacy data", but at the same time, they're distributing material that is clearly in violation of FDA rules.

A perfect example of a company that we cannot endorse is "SafeHands Inc." which is blatantly violating FDA guidelines, and by doing so, they risk besmirching the integrity of responsible manufacturers within the industry.

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