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FDA often receives questions from soap makers about how their products are regulated. Here is information to help small-scale soap producers understand the laws and regulations they need to know about.
Ordinary soap is made by combining fats or oils and an alkali, such as lye. The fats and oils, which may be from animal, vegetable, or mineral sources are degraded into free fatty acids, which then combine with the alkali to form crude soap. The lye reacts with the oils, turning what starts out as liquid into blocks of soap. When made properly, no lye remains in the finished product. In the past, people commonly made their own soap using animal fats and lye that had been extracted from wood ashes.
Today there are very few true soaps on the market. Most body cleansers, both liquid and solid, are actually synthetic detergent products. Detergent cleansers are popular because they make suds easily in water and don't form gummy deposits. Some of these detergent products are actually marketed as "soap" but are not true soap according to the regulatory definition of the word. FDA Taking Closer Look at 'Antibacterial' Soap
When you're buying soaps and body washes, do you reach for the bar or bottle labeled "antibacterial"? Are you thinking that these products, in addition to keeping you clean, will reduce your risk of getting sick or passing on germs to others?
Not necessarily, according to experts at the Food and Drug Administration (FDA).
Every day, consumers use antibacterial soaps and body washes at home, work, school and in other public settings. Especially because so many consumers use them, FDA believes that there should be clearly demonstrated benefits to balance any potential risks.
In fact, there currently is no evidence that over-the-counter (OTC) antibacterial soap products are any more effective at preventing illness than washing with plain soap and water, says Colleen Rogers, Ph.D., a lead microbiologist at FDA.
Moreover, antibacterial soap products contain chemical ingredients, such as triclosan and triclocarban, which may carry unnecessary risks given that their benefits are unproven.
"New data suggest that the risks associated with long-term, daily use of antibacterial soaps may outweigh the benefits," Rogers says. There are indications that certain ingredients in these soaps may contribute to bacterial resistance to antibiotics, and may have unanticipated hormonal effects that are of concern to FDA.
In light of these data, the agency issued a proposed rule on Dec. 16, 2013 that would require manufacturers to provide more substantial data to demonstrate the safety and effectiveness of antibacterial soaps. The proposed rule covers only those consumer antibacterial soaps and body washes that are used with water. It does not apply to hand sanitizers, hand wipes or antibacterial soaps that are used in health care settings such as hospitals.
According to Rogers, the laboratory tests that have historically been used to evaluate the effectiveness of antibacterial soaps do not directly test the effect of a product on infection rates. That would change with FDA's current proposal, which would require studies that directly test the ability of an antibacterial soap to provide a clinical benefit over washing with non-antibacterial soap, Rogers says.
What Makes a Soap "Antibacterial?"
Antibacterial soaps (sometimes called antimicrobial or antiseptic soaps) contain certain chemical ingredients that plain soaps do not. These ingredients are added to many consumer products in an effort to reduce or prevent bacterial contamination.
A large number of liquid soaps labeled "antibacterial" contain triclosan, an ingredient of concern to many environmental and industry groups. Animal studies have shown that triclosan may alter the way hormones work in the body. While data showing effects in animals don't always predict effects in humans, these studies are of concern to FDA as well, and warrant further investigation to better understand how they might affect humans.
In addition, laboratory studies have raised the possibility that triclosan contributes to making bacteria resistant to antibiotics. Such resistance can have a significant impact on the effectiveness of medical treatments.
Moreover, recent data suggest that exposure to these active ingredients is higher than previously thought, raising concerns about the potential risks associated with their use regularly and over time.
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
1-888-INFO-FDA (1-888-463-6332)
10903 New Hampshire Avenue
Silver Spring, MD 20993
1-888-INFO-FDA (1-888-463-6332)
