FDA Hits P&G About Hand Sanitizer

he Food and Drug Administration has taken Procter and Gamble to task for what it calls unlawful claims about the packaged goods giant’s Vicks Early Defense brand hand sanitizer, especially its use as a purported colds preventer.

According to today’s Wall Street Journal, the company was also cited because the FDA says the product needs to be rinsed off after use, not left on the hands to dry naturally, as PandG states in the sanitizer’s instructions.

“Although FDA is not aware of significant health risks associated with Early Defense, the agency is concerned because this product has not been proven safe and effective for these claims,” the agency said in a statement.

P and G said it would work with the FDA to clear up any problems.
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The Dirt on Hand Sanitizers

It's nearly lunchtime for second-graders at David Wolfle Elementary School, and Ms. Syverson's students demonstrate their favorite way of washing up.

Karleigh Gomez reaches into her desk and pulls out a small bottle of Germ-X. "Hand sanitizer!" the 7-year-old announces with a grin, squeezing a glob of clear goo into her palm and rubbing it over her hands.

"It's really fun to use," she says. "It feels, like, really squishy and really tingly. It's really cool."

A lot of people apparently agree. In the 10 years since the first waterless hand cleanser, Purell, appeared on the consumer market, hand sanitizer sales have gone crazy. So far this year, Americans have spent more than $85 million on alcohol-based sanitizer, and that's not counting what Wal-Mart sells, according to market research company Information Resources, Inc.

The germ-killing gel is becoming ubiquitous. You find it not only for sale in stores, but for free at the entrances to hospitals and nursing homes, on ferry boats and in classrooms.

A number of teachers in the North Kitsap School District, for example, put hand sanitizer on their class supply lists for the first time this year, alongside pencils, erasers, crayons and folders.

In a variation on the theme, Town & Country Markets provides free wipes to customers for swabbing the handles of shopping carts, which have the reputation of harboring more germs than public toilets. The wipes seem popular. Tom Hall, director of Central Market in Poulsbo, estimates his store goes through nearly 2,000 sheets a week.

Waterless sanitizer users love the convenience. "It's easier," Cheyanne Beninger, a second-grader at Wolfle Elementary School in Kingston, said, pointing out that using sanitizer is faster than taking a trip to the sink. "You get to do it without going in a line and waiting."

Her teacher, Cara Syverson, said Wolfle second-grade teachers decided this year to add sanitizer to their supply lists so students could have more options for getting clean. Often, students visit the restroom not long before it's time to get ready for lunch. In such cases, they may wash up with sanitizer rather than soap again, Syverson said: "It's just offering a choice."

Public health authorities cheer the attention to what they call "hand hygiene," and they applaud the proliferation of products that promote it — but not without caveats.

"One concern I have with alcohol-based sanitizers is that their availability makes it easy to use when it's not appropriate," said Marcia Goldoft, Washington's acting state epidemiologist. "Soap and water is recommended for all situations, but sanitizer is appropriate for only certain situations."

Which situations? For the general public, that would be when soap and water are not available, and hands are not visibly soiled. "When I've maybe touched some surfaces, doorknobs, shaken hands with people, before lunch, I'll use sanitizer," Goldoft said.

Unlike soap and water, which slide grime and germs down the drain, sanitizer doesn't cleanse hands that are just plain dirty. "A little bit of dirt is a mountain from the bacterial point of view," Goldoft said. "If you're inside that foothill of dirt, the sanitizer goes over the surface."

Another detail to note is the alcohol concentration. To be effective, waterless sanitizer needs 60 percent to 95 percent alcohol, research shows.

Even the most effective sanitizer doesn't kill all pathogens. For example, sanitizer doesn't work against Cryptosporidium, a parasite that causes diarrhea; or bacterial spores such as those that cause anthrax.

And what about recent news that children got sick licking the gel off their hands?

Vonnie Saucerman, district nurse supervisor for North Kitsap and Central Kitsap schools, said the reports, involving children ages 2 and 4, were credible, and that the risk is real. "Sixty percent alcohol, that's enough to get a buzz on a little person. But," she added, "you're not seeing an epidemic of kids" getting sick.

For most users, the more relevant issue is using the gel correctly. "A lot of people ... you see them wiping their hands off the side of their jeans. That kind of negates it," Saucerman said. "You need to rub until it's all gone."

Another thing to be mindful of: No one knows whether there is harm in children using alcohol on their hands long-term. "It's something that hasn't been done in the past," said Dr. Estella Whimbey, medical director for health care epidemiology and employee health at University of Washington Medical Center. "It's something the scientific community as well as the general public should pay attention to."

The nation's obsession with clean hands can be traced to SARS, or Severe Acute Respiratory Syndrome, which appeared in late 2002, followed by an avian flu scare that flared in 2003 and continues to percolate. Add to that our off-and-on worries about the possibility of bioterror attacks, and you've got a populace ready to do battle on bugs.

Numerous studies show that clean hands help stem the spread of disease, but it's an open question whether the popularity of sanitizers and wipes is making a difference.

Research sponsored by GOJO Industries, inventor of Purell, found that the use of sanitizer in elementary school classrooms and college dormitories did reduce absenteeism due to illness.

Other scientists say the subject is tricky to study. "It's such a complicated situation," Goldoft said. "If people are doing nothing with their hands but are being careful not to sneeze or cough in public — you cough in your sleeve, you cover your cough — disease would go down."

Syverson said she began bringing hand sanitizer into the classroom a year or two ago at her own expense. She hasn't seen any decrease in the frequency or spread of sickness — nor does she expect to.

"They're little kids! They're picking their noses, all of that stuff," she said, laughing. "Germs are germs, they're going to find their way into kids."

Then there is the school of thought that learning to live with germs — at least, some germs — is healthy. "I'm a fan of germs, actually," Syverson said. "I think that there are germs that we need to be exposed to in order to gain an immunity."

As with most things, the key is balance, said Whimbey of UW Medical Center. "It is good that we're promoting basic personal hygiene in the community," she said. "I don't think anyone's promoting taking this to a phobia."

Keep Germs in Check

Public health specialists hail convenience products that promote clean hands, but hope people aren't skipping soap and water. Here's a guide to proper hygiene:

Washing with soap and warm — but not hot — water is always best, especially to remove dirt. Rub hands thoroughly for 15 seconds. Use hand sanitizer after blowing nose, shaking hands, touching doorknobs or other public objects, and whenever soap and running water aren't available.

Rub sanitizer over hands until the product evaporates. Oversee sanitizer use in small children, making sure they don't eat it. Look for sanitizer with 60 percent to 95 percent alcohol content. At best, sanitizer kills many germs, but not all.

Germs typically spread via hands, sneezes and coughs. Cough or sneeze into elbow or tissue, not hands. Avoid touching eyes, nose or mouth with unwashed hands.

src: http://www.kitsapsun.com/news/2007/sep/21/the-dirt-on-hand-sanitizers-augments-doesnt-soap/

Hand Sanitizer Frequently Asked Questions

Antibacterial hand sanitizers are marketed to the public as an effective way to "wash one's hands" when traditional soap and water are not available. These "waterless" products are particularly popular with parents of small children. Manufacturers of hand sanitizers claim that the sanitizers kill 99.9 percent of germs. Since you naturally use hand sanitizers to cleanse your hands, the assumption is that 99.9 percent of harmful germs are killed by the sanitizers. Recent research suggests that this is not the case.

How do hand sanitizers work?
Hand sanitizers work by stripping away the outer layer of oil on the skin. This usually prevents bacteria present in the body from coming to the surface of the hand. However, these bacteria that are normally present in the body are generally not the kinds of bacteria that will make us sick. In a review of the research, Barbara Almanza, an associate professor at Purdue University who teaches safe sanitation practices to workers, came to an interesting conclusion. She notes that the research shows that hand sanitizers do not significantly reduce the number of bacteria on the hand and in some cases may potentially increase the amount of bacteria on the hand. So the question arises, how can the manufacturers make the 99.9 percent claim?

How can the manufacturers make the 99.9 percent claim?
The manufacturers of the products test the products on inanimate surfaces hence they are able to derive the claims of 99.9 percent of bacteria killed. If the products were fully tested on hands, there would no doubt be different results. Since there is inherent complexity in the human hand, testing hands would definitely be more difficult. Using surfaces with controlled variables is an easier way to obtain some type of consistency in the results. But as we are all aware, everyday life is not as consistent.

Current recommendations for hand sanitation
Interestingly enough, the Food and Drug Administration, in regards to regulations concerning proper procedures for food services, recommends that hand sanitizers not be used in place of soap and water but only as an adjunct.

Likewise, Almanza recommends that to properly sanitize the hands, soap and water should be used. A hand sanitizer can not and should not take the place of proper cleansing procedures with soap and water.

Alcohol in hand sanitizer poses threat to children

Hand sanitizer is a common product, but studies show young kids are getting buzzed and sometimes drunk from licking too much sanitizer off their hands.

While beer is 5 proof alcohol and vodka 80 proof, ingested hand sanitizer is 120 proof.

Simply using the sanitizer on a child's hand can place a risk that the child will ingest 62 percent ethyl alcohol. Studies show an average 2-year-old can get buzzed off one teaspoon of sanitizer and legally drunk off of two teaspoons.

Smaller children can ingest smaller amounts and have side affects.

Theresa Lobmeyer said her children have been loopy and even clumsy at times, but was unaware of the dangers of hand sanitizers.

"When I do sanitize them, it's right before we eat," she said. "So, they may not be ingesting it by licking it, but they're handling the food their eating, so they're getting a little of it."

Children's Medical Center of Dallas officials said 12,000 kids under six got sick from sanitizer nationwide last year.

"What you do worry about are the more severe symptoms, excessive lethargy, unable to be aroused, stumbling [and] slurred speech," said Dr. Ben Lee, Children's Medical Center of Dallas.

While Lobmeyer said she hasn't seen any signs of that with her children, she said she will be more cautious when it comes to hand sanitizers and her children.

Src: http://www.kvue.com/news/top/stories/082107kvuesanitizer-bkm.596ef02c.html

Texas Mom Develops New Kid-Safe, Alcohol-Free Hand Sanitizer

The Invisible Armor launches its new kid-safe alcohol-free antibacterial skin sanitizer and protector. Non-toxic, hypoallergenic hand sanitizer provides (4) hours of protection against dangerous germs and bacteria.

There were 11,914 reported cases of children under the age of six who ingested alcohol-based hand sanitizers last year (source: American Association of Poison Control Centers). When Tammy Powell, mother of two and founder/CEO of The Invisible Armor read that, she could hardly believe her eyes. She says, "First, I thanked God that none of those cases resulted in lasting damage or death and second, I gave my team a new project."

This is a cutting edge product, far superior to regular hand sanitizers. One application in the morning and another after lunch is all that's needed to protect children from even the nastiest germs for the whole day, no matter how many times they wash their hands.
After several months of testing and fine-tuning, The Invisible Armor -- maker of a full line of alcohol-free antibacterial products -- is ready to roll out its kid-safe skin sanitizer. The company says that The Invisible Armor for Kids is effective against most germs and bacteria (including Staph, MRSA and more) but unlike other sanitizers, it protects the skin against recontamination for up to 4 hours, even with repeated hand washings.

Ms. Powell, herself a mother of two says, "This is a cutting edge product, far superior to regular hand sanitizers. One application in the morning and another after lunch is all that's needed to protect children from even the nastiest germs for the whole day, no matter how many times they wash their hands." Several local schools have been using The Invisible Armor with terrific results she adds.

"The teachers love it because its moisture-rich formula doesn't dry out the skin. They also like the idea that they only have to apply The Invisible Armor twice a day, unlike alcohol-based products, which only protect for about 30-40 seconds. Parents love it because it provides the protection the kids need but it's also non-toxic and hypoallergenic so there's no need to worry about them should they ingest it."

Right now Tammy says that she is anxiously awaiting the arrival of Left and Right, the company's two new larger-than-life mascots. "We're busy developing a health and wellness educational campaign that will feature Left and Right, our new seven-foot-tall spokespersons for The Invisible Armor for Kids."

The company's products are sold in Kroger stores, HEB, Brookshire Brothers, Meijer Stores, Walgreens and more. Visit the company's website at www.theinvisiblearmor.net.

Cheaper sanitiser more effective: AUA study

The higher price of hand sanitisers does not necessarily mean a higher efficiency level.

This is according to a study conducted by a group of students from the American University of Antigua (AUA), College of Medicine. It is entitled, “Comparison of the Anti-Microbial Effects of Various Hand Sanitizers”.

Group members were Neeja Dave, Amish Doshi, Brittany Davis, Christian Estrada, Vinod Chadalavada, Staphanie Mazloom, Jonathan Bowers, Thinthiri Chit, Jacqueline Choi, and Ravinder Dhiman.

The research was done as a part of the university’s quarterly microbiology class and was presented at the second Student’s Research Day held in July. The group achieved third place in the class competition.

The objective of the research was to find out which sanitiser, generic or branded, was most effective. Three were chosen from a local supermarket: the $3.39 Lucky Super Soft Instant Hand Sanitizer with Aloe Vera, $4.99 President’s Choice Hand Sanitizer with Aloe Vera and $13.95 Purell Instant Hand Sanitizer with Moisture Therapy. The active ingredient in all three products was 62 per cent ethyl alcohol with slight variations in the inactive ingredients.

It was shown that the Food and Drug Administration (FDA) recommends that a concentration of 60 to 95 per cent ethanol or isopropanol be used in sanitising products, the higher the concentration, the better the germ-killing effects.

The results showed that the brand with the most anti-microbial effects is the Lucky brand of hand sanitiser, the least expensive.

Lucky was able to kill most of the micro-organisms with 83 per cent effectiveness, while Purell, the most expensive, was only able to kill about 20 per cent. President’s fell into the middle efficiency level.

The group hypothesised that the extra moisture therapy may have dampened the germ killing effects in Purell. They concluded that the sanitisers with the simplest ingredients, that is without fragrance or lotions would be the most effective. The study also showed that while sanitisers kill some micro-organisms they were not able to kill the most prevalent ones that are always living on the surface of the skin such as staphylococcus aureus.

The report said, “Although many hand sanitisers claim that their brand kills 99.9 per cent of germs, studies have proven that none of the hand sanitisers showed such a effect.”

In fact, they said that many of them showed an increase in the number of micro organisms after the application of hand sanitisers.

The data was collected on two consecutive Friday afternoons on the campus. Thirty students were selected at random to participate for which before and after swabs were collected.

(The public is asked to remember that these were the conclusions of student research and would need more extensive study to use the results conclusively as fact.)
src: http://www.antiguasun.com