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100 August 2014 | beautystorebusiness.com Beauty & The Law Minnesota has banned triclosan . . . Illinois has banned synthetic plastic microbeads . . . WHAT DO ANTIBACTERIAL SOAPS AND FAKE mustaches have in common? They are cosmetics. They both fit the definition of "cosmetic" under the Federal Food, Drug, and Cosmetic Act (FFDCA), the federal law that governs cosmetics as well as foods and drugs. A cosmetic is defined as an article that is "intended to be rubbed, poured, sprinkled or sprayed on, introduced into, or otherwise applied to the human body ... for cleansing, beautifying, promoting attractiveness or altering the appearance." Fake mustaches may not actually make people more beautiful, but they do alter appearances and so they are regulated as cosmetics. Soaps are a special category under cosmetics law. A traditional soap without any detergents, moisturizers or abrasives usually is not a cosmetic at all, even though it is rubbed onto the body for cleansing. Traditional soap is made by boiling fats or oils with an alkali such as lye. Colonial settlers made it from animal fat and ashes from wood fires. The reaction product of fat or oil and alkali has to be the only cleansing agent in the final product, or it won't be defined as a soap. In addition, the product has to be labeled and advertised as a cleanser only—it can't be marketed as a moisturizer or deodorant. If all of these conditions are met, then these traditional soaps are not regulated as cosmetics at all and so the Federal Drug Administration—which regulates cosmetics under the FFDCA—doesn't have authority over them. To dis- tinguish these products from the wide variety of items we usually think of as soap, these will be referred to as traditional soaps. Any other soaps that are made with detergents, chemicals that are antibacterial, abrasives or moistur- izers are defined as cosmetics; and so are soaps that are advertised as making people smell better. None of these additives need to be approved by the FDA. The only ingredients in soaps that the FDA needs to approve are color additives. Some soaps are drugs, and they can be cosmetics and drugs at the same time. Examples include any soap that's intended to kill bacteria, treat itching, act as a deodorant, relieve psoriasis or prevent acne, each of which is classified as a drug. That's because any article "intended for use in the diagnosis, cure, mitiga- tion, treatment or prevention of disease" is defined as a drug under the FFDCA. Over-the-counter drugs that can be bought without a prescription must have ingredients that are approved by the FDA. Soaps that are cosmet- ics and drugs have to follow the regulations for both categories of products. Antibacterial soaps are prime examples of products that are cosmetics because they are for cleansing and are not traditional soaps, and are also drugs because they make claims to prevent the spread of disease. FDA ACTION ON ANTIBACTERIAL SOAPS Last December the FDA announced an investigation into antibacterial soaps. The FDA said that millions of people use antibacterial soaps and body washes, but there is no evidence that these products are any more effective than regular soap and water. In fact, daily use of antibacterial soaps may be harmful because they may lead to bacteria that resist antibiotics and have adverse hormonal effects, according to the FDA's public announcement. Using its authority to regulate drugs, the FDA proposed a new rule that would require more data on the safety and effectiveness of antibacterial soaps. If they aren't proven to be safe and more effec- tive than regular soap and water, they won't be able to be sold. The proposed rule—or tentative final mono- graph—weighs the benefits of using an antibacterial soap against the risks of using it. The proposed rule says that there are no antibacterial ingredients for soaps and body washes that are generally recognized as safe and effective. Ingredients in drugs that are generally recog- nized as safe and effective can be used without further approval by the FDA so long as they are manufactured, labeled and advertised properly. The rule would become effective one year after it's finalized—if it is finalized in its current form. In the 20 years since the FDA last thoroughly reviewed antibacterial ingredients, it says new information has been developed on their potential risks. Under the pro- posed rule, antibacterial ingredients in soaps and washes must be proven to be safe for long-term daily use. The studies that the FDA proposes include studies on the substances' toxicology, whether they cause cancer, whether they affect hormones, and how they work. Of particular note, the FDA wants studies that will assess safety to pregnant women and children because they are among the groups of people who use antimicrobial soaps. Another potential risk that has to be studied according to the proposed rule is the possibility of breeding antibiotic- resistant bacteria. The FDA says that "bacteria use some of the same resistance mechanisms against both antiseptics and antibiotics" and as a result, the use of antibacterial soaps could conceivably cause bacteria to resist antibiotics. The FDA concluded that antibacterial soaps haven't been proven to be better at reducing infec- tions than plain soap and water. Manufacturers will have to show that their antibacterial soaps reduce infections before the antibacterial ingredients will be classified as generally recognized as effective. MINNESOTA BANNED TRICLOSAN Triclosan and triclocarban are the most frequently used antibacterial additives in soaps and body washes, although there are many chemicals that can kill bacteria or viruses. Triclosan in particular has become a target for state regulation, in part because the FDA first proposed Recent Developments In Regulating Soaps Find out the latest on triclosan and microbeads. by Jean Warshaw Image courtesy of Barry Burns B e a u t y & T h e L a w 8 1 4 . i n d d 1 0 0 6 / 2 6 / 1 4 4 : 5 3 P M 6/26/14 4:53 PM