To be clear, the FDA is not saying that the claims on the targeted hand sanitizers are false; the issue is they haven't gone through the necessary process to be regulated as a drug, which is what is required when specific over-the-counter products make drug- and disease-prevention claims.
THE DETAILS: The FDA says the following over-the-counter products violate the law because they have not been cleared to make some of the germ-killing claims on their packaging. To be able to do that, the products need to be assessed for effectiveness and cleared by the FDA, an agency spokeswoman said:
• 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
Some of the labeling faux pas pointed out by the FDA include unproven claims like "kills over 99.9% of MRSA," "helps prevent skin infections caused by MRSA and other germs," and "is effective against a broad spectrum of pathogens, including MRSA." The agency also took aim at CleanWell's patented essential oil formulation said to knock out salmonella. (Cleanwell says it uses essential oils instead of alcohol and harsh chemicals to sanitize.)
The company released the following statement:
"CleanWell shares FDA’s concern that the public not be misled regarding self treatment for serious infections. CleanWell is confident that its extensive scientific research, information, data, and other evidence supporting CleanWell products provide ample justification for the claims made in connection with its products, and welcomes the opportunity to share this information with FDA and to address FDA’s questions, some of which appear to be based on a fundamental misunderstanding of CleanWell’s products."
WHAT IT MEANS: In particular, the FDA is voicing its gripe over some hand sanitizers' claims of MRSA-, E. coli-, H1N1-, and/or salmonella-killing power. Of particular concern is drug-resistant MRSA (methicillin-resistant Staphylococcus aureus), a bacterium that can cause severe—even life-threatening—infections that do not respond to standard antibiotic treatment. "Staphylococcus aureus itself is a very aggressive organism," says Edward Cox, MD, MPH, director of FDA’s Office of Antimicrobial Products. "It’s often associated with patients in hospitals who have weakened immune systems, but the bacterium can also cause significant skin infections and abscesses in a normal, healthy person. And it can get into the bloodstream and, less frequently, may involve the heart valve, which is very difficult to treat."
MRSA isn't just in hospitals anymore, but is also turning up in communities, and even in supermarket meat and beach sand! Studies have found—and the FDA recommends—regular hand washing as the best means to prevent a MRSA infection.
Here are tips to help keep MRSA and foodborne illnesses in check without turning to toxic products:
• School yourself on proper hand washing. The FDA, following the lead of several study recommendations, says proper hand-washing techniques are your best bet at combating MRSA, E. coli, and other germs. The trick is to wash your hands often, especially before and after handling food, and to wash with soap and water for 20 seconds. You don't need to rely on hot water to do the germ killing—it's actually the friction and soap that annihilate the germs and cause them to slide off of your hands. Read more on Proper Hand-Washing Techniques.
• Avoid the thyroid-wrecking ingredient. While it may be tempting to turn to antibacterial soaps to protect your family from MRSA and other infections, it's best to use just regular plant-based soaps and water. Triclosan, the main ingredient in most antibacterial soaps, is linked to thyroid problems and even the rise in the drug-resistant superbugs you're trying to rinse off.
• Sanitize safely. Although hand washing is most effective, if you opt for an alcohol-based hand sanitizer, make sure the alcohol content is at least 62 percent. And be sure to read the ingredients label. Avoid products with artificial dyes and fragrances—these man-made ingredients have been linked to health problems, too. Of course, you can always be adventurous try to make your own vodka-based hand sanitzer. Just make sure no one's abusing it. (Currently, the FDA is not going after alcohol-based hand sanitizers that make similar germ-killing claims. Maybe that's because even the U.S. Centers for Disease Control and Prevention recommend using alcohol-based hand sanitizers when hand washing is not possible.)
• Be beach smart. MRSA's turning up on beaches, according to research presented at the American Society for Microbiology's annual meeting in 2009. To prevent MRSA from mangling your vacation, stay out of the water if you have cuts on your body, cover them before lying in the sand, and try to get a shower as soon as you leave the beach.
• Find safer meat. Think MRSA on beaches is surprising? It's in your supermarket, too. A recent analysis found that about half of supermarket meat and poultry harbored staph bacteria, some of it MRSA. That's because most supermarket meat comes from concentrated animal-feeding operations, also known as CAFOs or factory farms, where antibiotic use is high and the animals are exposed to germs in close quarters. A solution is to buy less meat so you can afford the more expensive organic, grass-fed meat and poultry products.
The FDA warning may not warrant abandoning your favorite hand cleaner. But be sure to also utilize the above practices to properly protect yourself from flu, MRSA, and other germs.