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antibacterial (personal care products)
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| LABEL REPORT CARD |
| How meaningful is the label? |
Is the label verified? |
Is the meaning of the label consistent? |
Are the label standards publicly available? |
Is information about the organization publicly available? |
Is the organization free from conflict of interest? |
Was the label developed with broad public and industry input? |
| Not Meaningful |
No |
No |
Yes1 |
Yes |
Yes |
Yes |
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1. The standards for most personal care products, where they exist, are only proposed; the proposals are publicly available.
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LABEL CATEGORY:
General Claims |
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WHERE YOU'LL FIND THIS GENERAL CLAIM:
 PERSONAL HYGIENE PRODUCTS
ORAL HYGIENE PRODUCTS
SKIN CARE PRODUCTS
SUN PRODUCTS
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WHAT THIS GENERAL CLAIM MEANS:
Generally speaking, "antibacterial" or "antimicrobial" claims describe a substance(s) or product that kills or inhibits the growth of bacteria, generally in/on foods, inanimate surfaces, or hands. FDA regulates the use of this claim on lotions, hand washes, soaps, cosmetics and other personal care products. Antimicrobial/antibacterial claims mean different things on different products (discussion of this term on laundry detergent, household cleaning, recreational and other products).
Technically, antibacterials (similar to antibiotics) are considered by EPA and FDA to be a subset of antimicrobials, although EPA states that in the US consumer marketplace, “antimicrobial” has typically been associated with the protection of articles (e.g., tents) and “antibacterial” has been more frequently associated with products designed to control human disease-causing microorganisms.
PERSONAL CARE PRODUCTS
FDA requires all manufacturers wanting to make antibacterial claims on lotions to submit data demonstrating safety and effectiveness of each product and obtain FDA approval prior to marketing. To date, FDA has not approved an “antibacterial” claim on any lotion, and has questioned the validity of such claims. However, it is not clear how strongly FDA is enforcing its rules. A website sponsored by the industry (www.germsmart.com) lists lotions as one type of antibacterial personal care product “designed to enhance personal hygiene.” If you see any "antibacterial" claim on lotions, contact the FDA.
For other personal care products that make an antibacterial claim, including soaps, manufacturers currently are not required to submit safety and testing data for evaluation by FDA. Therefore, consumers cannot be sure that the antibacterial ingredient is safe or that it actually works. The FDA first published recommendations for antimicrobial drugs sold over-the-counter (OTC) in 1974, and in the 1990s published a proposed rule (monograph) outlining safety and effectiveness testing requirements but to date, these have not been finalized. Until these proposals are finalized, they serve only as voluntary guidance to industry, and industry may thus choose not to use them.
Dishwashing soaps that claim to be "antibacterial" would normally be considered to be household cleaners and therefore be regulated by EPA. However, to date, EPA has not registered nor reviewed any antibacterial dishwashing soaps despite the fact that there are many "antibacterial" dish soaps on the market. Based on our research, it appears that these antibacterial dishwashing soaps are actually classified and labeled by the manufacturer as hand soaps, which means they are personal hygiene products and fall under the authority of the FDA. Since FDA has no current testing requirement in place for antibacterial active ingredients, these "antibacterial" labeled dishwashing products are not tested for safety or effectiveness.
Some critics think that antibacterial / antimicrobial claims even when truthful are playing on consumers' fears. They advise consumers not to buy these products except in unusual circumstances. Stuart Levy, M.D., president of the Alliance for the Prudent Use of Antibiotics and a researcher in the field, believes that antibacterial products should only be used by hospitals, sick people coming home from the hospital, and those with compromised immune systems. “Good soap and water is sufficient in most cases,” Levy says. Overuse of antibacterial substances can lead to bacteria becoming resistant to them, which is a problem for public health.
The long-term safety of triclosan, a widely used antibacterial in personal care prodcuts, and its effectiveness in products other than toothpaste is particularly controversial. EPA has registered triclosan as a pesticide, but Lester Crawford, Deputy Commissioner of the FDA, stated in October 2002, “In 1974, our agency published the recommendations of its advisory panel on over-the-counter antimicrobial drug products. Among other findings the panel … identified triclosan as one of the ingredients of antimicrobial products that lacked sufficient evidence of safety and effectiveness. … The FDA still is looking for data on the long-term health effects of triclosan, and at present there is no joint effort to trace the effect, if any, of antiseptic products on antimicrobial resistance. … consumers and health care professionals are not as fully protected as they deserve, expect, and have the right to be.”
In the meantime, FDA has taken no action against the use of Triclosan. Triclosan may also impact the environment. Triclosan has been found in the majority of surface waters tested for pollutants from common household chemical products. There is some evidence that triclosan adversely affects freshwater algae. Other studies indicate that it can be converted by sunlight into a member of the dioxin family.
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WHO VERIFIES THIS GENERAL CLAIM?
With the exception of antibacterial claims on lotions, there is no verification for this type of claim on personal care products. FDA requires antibacterial / antimicrobial claims on lotions to obtain FDA approval, based on data showing safety and efficacy, prior to marketing (FDA has not approved any antibacterial claims for lotions to date).
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CONSUMERS UNION EVALUATION:
How meaningful is the label?
An antibacterial claim is not meaningful on Personal Care Products, including Soaps, Lotions, Hand Washes and Dishwashing Detergent. The FDA has not approved any use of this claim on lotions. Contact the FDA if you encounter an “antibacterial” claim on lotions.
For other personal care products, including soaps, FDA has not yet finalized its rules, so no safety and effectiveness testing is required and there is no approval required before putting the claims on a product.
Foods, drugs, and cosmetics are required to list their ingredients (with a few exceptions, such as fragrances in cosmetics), but household cleaning products are not required to disclose their ingredients (except for disinfectants or other ingredients considered to be antimicrobial pesticides).
Does an organization verify that the label standards are met?
With the exception of antibacterial claims on lotions, there is no verification for this type of claim on personal care products. FDA requires antibacterial / antimicrobial claims on lotions to obtain FDA approval, based on data showing safety and efficacy, prior to marketing(FDA has not approved any antibacterial claims for lotions to date).
Is the meaning of the label consistent?
No, the antibacterial label can have different meanings on different Personal Care Products, including Soaps, Lotions, Hand Washes and Dishwashing Detergent. FDA has determined that lotions making antibacterial claims are new drugs requiring the submission of data to demonstrate their safety and effectiveness and agency approval prior to marketing. FDA does not have final standards in place for soaps or body washes. Therefore, some companies making antibacterial soaps or body washes may follow FDA proposed standards, but some may not. Different antibacterial agents could be used that have varying levels of safety and effectiveness against variable numbers or types of microbes.
In addition, FDA's proposed effectiveness testing is specific for the type of product (e.g., a handwash product must meet a different standard than an oral antiseptic). Finally, for some types of products, no standards have been proposed (e.g., antibacterial bodywashes or for handwashes for use in the food industry).
Are the label standards publicly available?
Yes, all laws and government standards and policies are publicly available.
Is information about the standard organization publicly available?
Yes, information about government agencies is available (by phone, through publications, and through their websites).
Is the organization behind the label free from conflict of public interest?
Yes, in that it is a government agency.
Was the label developed with broad public and industry input?
Yes.
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LINKS FOR MORE INFO:
Food Safety A to Z Reference Guide,” FDA Center for Food Safety and Applied Nutrition
“Antibacterials and Disinfectants: Are They Necessary” by S. Hartman, at the Children’s Health Environmental Coalition Health-e-House website
“Antibacterials and Disenfectants: Safer Ways to Keep Germs at Bay,” by S. Hartman, at the Children’s Health Environmental Coalition Health-e-House website
“Antimicrobial Pesticide Products,” EPA, updated 11/17/99
“Consumer Products Treated With Pesticides,” EPA, 4/28/98
“Questions and Answers: Applicability of the “Treated Articles Exemption” to Antimicrobial Pesticides.” EPA, February 2000
"Coming Clean on Bath Soap"
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