FDA issues proposed rule to determine safety and effectiveness of antibacterial soaps
The U.S. Food and Drug Administration today issued a proposed rule to require manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Under the proposal, if companies do not demonstrate such safety and effectiveness, these products would need to be reformulated or relabeled to remain on the market.
Today’s action is part of a larger, ongoing review of antibacterial active ingredients by the FDA to ensure these ingredients are proven to be safe and effective. This proposed rule does not affect hand sanitizers, wipes, or antibacterial products used in health care settings.
Millions of Americans use antibacterial hand soap and body wash products. Although consumers generally view these products as effective tools to help prevent the spread of germs, there is currently no evidence that they are any more effective at preventing illness than washing with plain soap and water. Further, some data suggest that long-term exposure to certain active ingredients used in antibacterial products—for example, triclosan (liquid soaps) and triclocarban (bar soaps)—could pose health risks, such as bacterial resistance or hormonal effects.
“Antibacterial soaps and body washes are used widely and frequently by consumers in everyday home, work, school, and public settings, where the risk of infection is relatively low,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “Due to consumers’ extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk.”
The widespread consumer use of antibacterial products, the accumulated scientific information and concerns raised by health care and consumer groups have prompted the FDA to reevaluate what data are needed to classify the active ingredients in consumer antibacterial products as “generally recognized as safe and effective” or GRASE. Under the proposed rule, manufacturers who want to continue marketing antibacterial products will be required to provide the agency with additional data on the products’ safety and effectiveness, including data from clinical studies to demonstrate that these products are superior to non-antibacterial soaps in preventing human illness or reducing infection.
“While the FDA continues to collect additional information on antibacterial hand soaps and body washes, we encourage consumers to make an educated choice about what products they choose to use,” said Sandra Kweder, M.D., deputy director, Office of New Drugs at CDER. “Washing with plain soap and running water is one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others.”
Consumers should continue to be diligent about washing their hands. If soap and water are not available, an alcohol-based hand sanitizer that contains at least 60 percent alcohol should be used. More information on appropriate hand washing from the CDC may be found here.
Almost all soaps labeled “antibacterial” or “antimicrobial” contain at least one of the antibacterial ingredients addressed in the proposed rule. The most common active ingredients in antibacterial soaps are triclosan and triclocarban. Some soaps labeled “deodorant” may also contain these ingredients.
The proposed rule does not require the antibacterial soap products to be removed from the market at this time. When the proposed rule is finalized, as previously stated, either companies will have provided data to support an antibacterial claim, or if not, they will have to reformulate (remove antibacterial active ingredients) or relabel (remove the antibacterial claim from the product's labeling) these products in order to continue marketing. The proposed rule is available for public comment for 180 days, with a concurrent one year period for companies to submit new data and information, followed by a 60-day rebuttal comment period.
For more information:
Proposed Rule Safety and Effectiveness of Consumer Antiseptics
Over-the-Counter Topical Antimicrobial Drug Products – Antibacterial Hand Soaps and Body Washes
Consumer Update: FDA Taking Closer Look at ‘Antibacterial’ Soap
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by helping to ensure the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for helping to ensure the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Microwave guru chef Matt Abdoo has his three tips for making the best, fluffiest and perfectly cooked popcorn.
Microwave popcorn is one of the best snacks! But sometimes it's difficult to get that perfect bowl. So microwave guru chef Matt Abdoo has his three tips for making the best, fluffiest and perfectly cooked popcorn.
DON'T USE THE POPCORN BUTTON
As tempting and easy as it may be, don't fall for the "Popcorn" button on your microwave. Not all microwaves are made the same, so they won't cook your bag the same way either. And there's no sensor to determine when the bag is ready, so it'll just keep cooking your popcorn until the set amount of time finishes.
Instead, manually set the microwave and don't remove the bag until you hear the kernels popping 2 seconds apart. That's when it's just right.
NEVER LEAVE UNPOPPED KERNELS
Don't you hate when there's a bunch of unpopped kernels in the bottom of your bag? The problem could be the kernels themselves.
Each grain or kernel has three parts: the hull, the germ, and the endosperm. Popcorn differs from other corn in that it has a thicker hull. And that hull allows pressure from the heated moisture inside to build, until the starchy endosperm bursts open through the hull. So the thicker the hull, the longer the kernel takes to pop. But the problem is that a microwave is constantly cooking what's inside, so the kernels with thinner hulls that have already popped will continue to — and burn — while you wait for the other kernels to pop.
So refer back to the first tip, and listen for kernels to pop 2 seconds apart. Don't wait for those stubborn kernels, or risk a whole bowl of burned popcorn.
TRY A MICROWAVE POPCORN POPPER
To really take the stress out of microwaving popcorn, try a fun gadget that can give you the chewiest and fluffiest popcorn every time.
A microwave-safe popcorn popper doesn't absorb and trap heat from the microwave. That means there's more heat for those other kernels at the bottom to pop! There's more flavor and fluffiness and even less mess! Just toss it in the dishwasher after you're done with it.