FDA Clarifies Position on Alcohol Hand Sanitizers : NOT effective

In a recent letter from a District Director of the FDA to the CEO of E.I. Dupont--which instructed the company to curtail making inappropriate claims about their alcohol-based hand sanitizer, we excerpt:

May 7, 2007

Charles O. Holliday, Chairman and CEO
E.I. duPont de Nemours and Company
1700 Market Street
Wilmington, DE 19802-4809

WARNING LETTER
07-PHI-04

Dear Mr. Holliday:

This letter concerns your firm's labeling and marketing of the products "DuPont RelyOn Antiseptic Spray" and "DuPontRelyOn Antiseptic Hand Wipes." As presently labeled and promoted, these products violate the new drug and misbranding provisions of the Federal Food, Drug, and Cosmetic Act (the Act) as described in detail below.

"..we are not aware of sufficient evidence to show that that they are. generally recognized as safe and effective for these labeled uses. In particular, we are not aware of evidence that these products are safe and effective in preventing.individuals from becoming infected with Hepatitis A, B, and C, HIV-1 (AIDS virus), methicillin-resistant Staphylococcus aureus (MRSA), Vancomycin-resistant Enterococcus faecalis (VRE), and the other diseases listed in the product labeling..."

Regarding claims that "DuPont RelyOn Antiseptic Spray" and "DuPont RelyOn Antiseptic Hand Wipes" are acceptable under guidelines issued by the Centers for Disease Control and Prevention (CDC), as reflected by the above statement, we acknowledge the existence of that agency's guideline titled "Guideline for Hand Hygiene in Health-Care Settings." Like many CDC guidelines, this one is intended to assist health-care professionals.

The guideline discusses the possible efficacy of "alcohol hand rubs," but it does not specifically recommend their use in preventing the diseases caused by the specific microorganisms referenced in the labeling and promotion for "DuPont RelyOn Antiseptic Spray" and "DuPont RelyOn Antiseptic Hand Wipes."

Rather, the guideline provides a general recommendation that "alcohol hand rubs" be used, among other things, "to reduce the transmission of pathogenic microorganisms to patients and personnel in health-care settings," and only if hands are not visibly dirty or contaminated with proteinaceous material or soiled with blood or other body fluids.

Further, the guideline acknowledges the need for additional data and study to substantiate specific antimicrobial claims and that differing formulations can affect a product's efficacy. It does not authorize or recommend the inclusion of disease-prevention. claims like the ones described above on product labeling.

Japanese Journal of Infectious Diseases: Benzalkonium Chloride

Effects of several virucidal agents on inactivation of influenza, Newcastle disease, and avian infectious bronchitis viruses in the allantoic fluid of chicken eggs.

Abe M, Kaneko K, Ueda A, Otsuka H, Shiosaki K, Nozaki C, Goto S.

The Chemo-Sero-Therapeutic Research Institute, Kumamoto 860-8568, Japan. abe-mo@kaketsuken.or.jp

General theories on the inactivation of viruses in the presence of a concentrated protein, such as the allantoic fluid of chicken eggs, are not useful. That is, although sodium hypochlorite and sodium hydroxide are generally known as strong virucidal agents, they do not sufficiently inactivate viruses in allantoic fluid. We found that benzalkonium chloride (BC) is an effective virucidal agent against influenza, Newcastle disease, and avian infectious bronchitis viruses even in the presence of a concentrated protein. BC is easily biodegradable by activated sludge and is not very harmful to humans. We strongly recommend BC as a useful virucidal agent, especially in the manufacture of vaccines for these viruses.

Lysol brand adds more fuel to the fire--with alcohol hand sanitizer

One would think that Lysol a respected, leading brand, would 'get it' insofar as introducing a hand sanitizing product that uses the same active ingredient that's being systematically banned across the country by schools, licensed day care facilities and others--all of whom are reaching out for safer and friendlier alcohol-free products that provide equal, if not better germ/virus killing efficacy.

A point that didn't pass over the head of a leading brand expert:
"..Still, it remains to be seen whether it will convert consumers from their existing brands, said Robert Passikoff, president of Brand Keys, New York. "It takes time to migrate brands into other categories," he said, "and not all brands are as flexible as others. Lysol would not be the first company that mistook a marketing opportunity as a brand strategy."

Lysol's new product "Healthy Touch" is pictured on the right. A 5 oz. serving (dispensed in foam) can be had for $4.77 at select Wal-Mart stores. Mix it up with club soda, and you'll be the life of the party.

Alternatively, you can purchase an 8.4 oz bottle (60%+ more formula) of Soapopular's Alcohol-Free/Fragrance Free product (pictured on left side) at Target for $4.79.

Its safer, equally if not more effective i.e. germ/virus killing (same active ingredient as Bacteine), providers greater persistency, and it will leave hands feeling soft--whereas alcohol-based products necessarily cause hands to become dry and irritated. According to the manufacturer, Soapopular will also be available at Wal-Mart starting in May--so it'll be interesting to see whether Bob Passikoff's observation about Lysol's marketing strategy works--or goes up in flames.

1.2 Million U.S. Patients Get Resistant Staph Each Year

As many as 1.2 million U.S. hospital patients may be infected each year with a virulent staph infection that's resistant to antibiotics -- a rate almost 10 times greater than previous estimates, a new study finds.

The research, conducted by the Association for Professionals in Infection Control and Epidemiology, also found that as many as 119,000 hospital patients each year may die from the tough-to-treat strain of bacterium, called methicillin-resistant Staphylococcus aureus (MRSA). The germ is spread by touch and can lead to dangerous skin infections, blood infections and pneumonia.

"This is a wakeup call that hospital administrators should understand the importance of this problem," said report author Dr. William Jarvis, an epidemiologist and president of the consulting firm, Jason and Jarvis Associates.

And a wakeup call to those that are implementing hand sanitizer programs...

Parents Magazine : Soapopular is the Popular Choice

From the latest issue of Parent Magazine:

De-germ your kids with this alcohol-free hand sanitizer.

As a parent, especially during flu season, you probably wish it were possible to carry a sink and soap with you everywhere, because there's never a washroom around when you need it. And when you're not there to nag your kids -- who knows how long they go between soap sessions?

But here's something that might get them washing up: Soapopular, a new FDA-approved, no-water-needed foaming hand sanitizer that's alcohol-free so it's safe for schools (some classrooms have banned hand sanitizers because they contain alcohol). Soapopular's main ingredient, benzalkonium chloride, has been proven to kill 99.9 percent of commonly transmitted germs, bacteria, and viruses -- many related to colds and the flu. And this stuff is scent-free, rubs on easily, and doesn't leave hands all sticky. Good old soap and water is still the best way to keep your kids from getting sick, but for those times when it's not available, this may be the next best thing -- and the novelty foam factor might make them actually want to lather up.

It comes in several sizes, so keep one in the car, one in your purse, and give the kids travel-sized bottles to stash in their backpacks.

Soapopular retails at $32.94 for six 8.45-ounce bottles; $20.94 for six 3.4-ounce bottles, and $21.48 for 12 1-uunce bottles. To order online go to:

soapyusa.com

Purell Claims It Kills Norovirus: University of Minnesota Raises Their Hand and Says "Not Quite.."

Every hand sanitizer manufacturer is obliged to elbow under the back board and come up with new claims that purportedly make their product sound more effective

In December, Johnson & Johnson's Purell introduced a special Purell for cruise lines, and claims that their enhanced formula (which has 70% alcohol vs. their consumer and bar tender friendly 62% alcohol) kills norovirus. For those hand hygiene and product experts that responsibly say ...really??? we thought the only thing that kills norovirus on the hands is bleach..or iodine.."

here's a study from University of Minnesota--hot off the press..click on the link or read the excerpt...what do we think?...we're sticking with alcohol-free.


Department of Veterinary Population Medicine, University of Minnesota, St Paul, MN 55108, USA.

Hand disinfection is considered important in preventing the transmission of viruses, including norovirus. We investigated the virucidal efficacy of nine hand sanitisers (four alcohol-based sanitisers, three non-alcoholic sanitisers and two triclosan-containing antimicrobial liquid soaps) against feline calicivirus, a surrogate for norovirus, on artificially contaminated fingertips for 30s and 2min contact periods. Among alcohol-based sanitisers, a product containing 99.5% ethanol was more effective than those containing 62% ethanol, 70% isopropanol or 91% isopropanol. A log(10) virus reduction factor of 1.00-1.30 was achieved with 99.5% ethanol but those containing a lower alcohol concentration only achieved a log(10) reduction factor of
PMID: 18207605 [PubMed - in process]

Hand Sanitizer Manufacturer Claims: Norovirus

Fascinating that Johnson & Johnson's Purell put out a press release in December announcing their "special formula norovirus killing hand sanitizer " targeting cruise ship lines. This version is 70% alcohol (vs. their standard 62%)...makes for a great mix during cocktail hour no doubt..but as far as this new concoction of alcohol protecting passengers against norovirus...the jury is out

Here's the academic study:

Hand disinfection is considered important in preventing the transmission of viruses, including norovirus. We investigated the virucidal efficacy of nine hand sanitisers (four alcohol-based sanitisers, three non-alcoholic sanitisers and two triclosan-containing antimicrobial liquid soaps) against feline calicivirus, a surrogate for norovirus, on artificially contaminated fingertips for 30s and 2min contact periods. Among alcohol-based sanitisers, a product containing 99.5% ethanol was more effective than those containing 62% ethanol, 70% isopropanol or 91% isopropanol. A log(10) virus reduction factor of 1.00-1.30 was achieved with 99.5% ethanol but those containing a lower alcohol concentration only achieved a log(10) reduction factor of hese results indicate that triclosan-containing antimicrobial soaps or alcohol-based hand rubs may be inadequate for preventing norovirus transmission. Further research on alternative hand sanitisers should continue for effective control of norovirus infections.


Authored by SL, Ramakrishnan MA, Goyal SM. Department of Veterinary Population Medicine, University of Minnesota, St Paul, MN 55108, USA.

Published in J Hosp Infect. 2008 Jan 17

New England Journal of Medicine-Alcohol Hand Sanitizer Abuse

a bit dated...but worth clicking on for those that don't believe there are studies that point to the dangers of alcohol hand sanitizers

(Alcohol) Hand Sanitizer Stinks

Courtesy of Feb 18 editorial by Rochester NY's Channel 13 WHAM TV news reporter Jen Markham :


"..Am I the only one out there that hates hand sanitizer? ... Oh,really? Just me? … Well, … erm… never mind …

This comes to mind because today I was in the microbiology lab at Rochester General Hospital. They’re a jovial and very clean bunch but: they do work with and around some pretty skeevy microbes. So on my way out, even though I absolutely loathe the stuff and fastidiously avoid it in favor of soap, I helped myself of a squirt of hand sanitizer on my way out.

It was a choice I instantly regretted. Although I kept amiably chatting with my favorite RGH staffer about the seriousness of deadly infectious diseases, all I could think was, A.) “Bleeeggghhh! This slime on my hands is revolting!” and B.) “How far to the nearest sink?”

"...So taking advantage of germ emergence and American paranoia towards said germs, our nation’s pharmaceutical companies (always on the side of the American consumer) came up with the truly horrifying idea to gelatinize pure alcohol. As if that weren’t bad enough, they made sure the glop left a sticky residue (awesome), added the refreshing scent of Freshly Mopped Hospital Floor, and poured it into tiny adorable bottles emblazoned with fear-inducing claims.."


"...up. But it didn’t escape my notice a few years that whatever genius brainwas- … er, marketing tactics these companies came up with, they were startlingly successful. Suddenly, everyone I knew was toting around a bottle of the gelatinous hooch. It was in people’s cars, purses; people left hand-pumps in communal work areas, and they even conned hospitals into putting the dispensers in every dang room of the place. As if hospitals didn’t smell bad enough before, suddenly the overpowering stench of antiseptic drain cleaner was wafting from the frickin’ walls.

This is my problem with hand sanitizer. It smells absolutely wretched. Am I the only one that doesn’t find the smell of Disinfecting Flammable Chemicals neither comforting, nor appealing? The sales numbers suggest I might be. Apparently, people all across this great nation are enthusiastically rubbing pure alcohol on their hands, a satisfying smile spreading across their faces as the toxic fumes sting their nose and water their eyes. “Whoo!” they think, as the tears stream down their face and their parched hands crackle audibly, “the overpowering aroma of pure isopropanol is way better than that silly old soap and water!”

Jen--if you're going to use a hand sanitizer, here's a news updated: there actually ARE alcohol free, fragrance free foaming hand sanitizers that are as, if not more effective than legacy products, and many retailers, including Target, are now offering them. Target is promoting a brand called Soapopular (CVS is purportedly migrating completely to alcohol free hand sanitizers and rumour is that they won't be carrying Purell after the end of the year...rumour only!)