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FDA Cracks Down on Hand Sanitizer Claims

The U.S. Food and Drug Administration reported Thursday that some hand sanitizers and antiseptic products come with claims that they can prevent infection from E. coli, Salmonella, the H1N1 flu virus and methicillin-resistant Staphylococcus aureus (MRSA).

Don’t believe them. The statements are unproven and illegal, the FDA said in a news release.

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FDA said it is cracking down on companies that, without agency review or approval, promote their products as preventing these diseases.

“Consumers are being misled if they think these products you can buy in a drug store or from other places will protect them from a potentially deadly infection,” said Deborah Autor, compliance director at FDA’s Center for Drug Evaluation and Research.

“FDA has not approved any products claiming to prevent infection from MRSA, E. coli, Salmonella, or H1N1 flu,” Autor added. “These products give consumers a false sense of protection.”

FDA said it issued warning letters on Wednesday to four companies that make or distribute the following over-the-counter products:

    

Staphaseptic First Aid Antiseptic/Pain Relieving Gel, by Tec Laboratories

Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant, by JD Nelson and Associates

Dr. Tichenor’s Antiseptic Gel, by Dr. G.H. Tichenor Antiseptic Co.

Clean Well All-Natural Hand Sanitizer, Clean Well All-Natural Hand Sanitizing Wipes, and Clean Well All-Natural Antibacterial Foaming Hand Soap, by Oh So Clean Inc., also known as CleanWell Company

If the companies do not correct the violations explained in the warning letters within 15 days, FDA said it may seize their products or take other legal action.

FDA advises that, in general, one should wash hands often, especially before handling food, to help avoid getting sick. Wash hands with warm water and soap for 20 seconds — about the time it takes to sing the “Happy Birthday” song twice.

If you find products on the Internet that you believe make false or unproven claims, the FDA recommends that you report the claims by following instructions at Reporting Unlawful Sales on Internet.

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© Food Safety News
  • Doc Mudd

    Bravo for FDA!
    About time they got started challenging some of the silly quack nostrums that have crept back onto the market in the last few decades.
    The label; “Dr. Tichenor’s Antiseptic Gel, by Dr. G.H. Tichenor Antiseptic Co.” reads precisely like nostrums of a century ago…and it seems we have a large population of gullible ‘believers’ keeping quackery alive and well in the 21st century.
    These days it’s organic food and antiseptic hand lotion, but still the same wishful delusions of a century ago, same charlatans fleecing the ignorant rubes;
    http://thequackdoctor.com/index.php/tag/1900s-advertising/

  • Hand sanitizers are a significant help in reducing outbreaks in hospitals, nursing homes, schools and in restaurants.
    Stick with the major brands. Alcohol may be the only active material but there are significant differences in their overall delivery systems. The majors do their homework, invest in R&D, conduct science-based research and publish in technical journals.
    Here is such an example, where a 51% reduction in school absenteeism was achieved with a blend of hand washing and hand sanitizing:http://www.handwashingforlife.com/posters/school_hand_washing_poster

  • Hand sanitizers are a significant help in reducing outbreaks in hospitals, nursing homes, schools and in restaurants.
    Stick with the major brands. Alcohol may be the only active material but there are significant differences in their overall delivery systems. The majors do their homework, invest in R&D, conduct science-based research and publish in technical journals.
    Here is such an example, where a 51% reduction in school absenteeism was achieved with a blend of hand washing and hand sanitizing:http://www.handwashingforlife.com/posters/school_hand_washing_poster

    • ThinkAboutIt

       Although, there is not emperical data to prove, Hand sanitizers are a significant help in reducing outbreaks in hospitals, nursing homes, schools and in restaurants. Sanitizers don’t kill viruses. The “99% of the microbes” supposedly killed by sanitizers, in a given environment, are the same one airborn, can and will get around a basic mask, and are going to be destroyed by a most people’s immune system. Those persons taking antibiotics because they have a weakened immune system need to encounter the bacteria to allow the antibiotics to work.

  • Donna Ivy

    I use hand sanitizers all the time at the salon where I work. How can I not use hand sanitizers because in school, the instructors taught each and every student to use hand santizers every time the student used the hospital grade disinfectant,(EPA), or had a client before and after each service. I would have to wash my hands with soap and water each and every time I had a client. It’s ok. I agree with the information found about the handsanitizers because the diseases are found to be a little bit much.
    Sincerly,
    Taking one step at a time.