Antibacterial Hygiene Facts: Products, Ingredients Are Reviewed, Regulated, Researched, Used Safely and Effectively

- SDA Responds to Challenges on Effectiveness, Safety of Antibacterial Ingredient

- Consumers Can Continue to Use Antibacterial Hygiene Products with Confidence

WASHINGTON, April 8 /PRNewswire-USNewswire/ -- The Soap and Detergent Association today expressed concern over statements made by the Food and Drug Administration (FDA) on the effectiveness of a key ingredient used in beneficial antibacterial soaps and body washes.

SDA said it will continue providing an informed perspective to the FDA on the ingredient triclosan.

"The Food and Drug Administration has in its hands a wealth of scientific data showing a distinct germ killing benefit of antibacterial soaps containing triclosan."

Benefits Demonstrated

Two recent scientific papers have been published demonstrating the effectiveness of antibacterial soaps in comparison to non-antibacterial soaps.(I) A substantial body of data demonstrates that over-the-counter (OTC) antibacterial hand wash products are more effective at reducing the risk of bacterial infection compared to washing with non-antibacterial soap.(II)

Additionally, the U.S. Centers for Disease Control and Prevention (CDC) estimates that 76 million cases of foodborne illnesses occur each year in the U.S.  The acquisition and transmission of bacteria during food preparation play a significant role in causing these infections, and published studies have linked outbreaks of gastrointestinal disease to poor hand washing practices.(III)(IV)

Most importantly, these ingredients are used in products that play a beneficial role in the daily hygiene routines of millions of people.  Antibacterial hygiene and cleaning products continue to be used safely and effectively in homes, hospitals, and workplaces every single day. Science-based risk analysis backs this up, thanks to the industry's long-standing research and product stewardship efforts.

Antibacterial ingredients like triclosan are regulated by governmental bodies around the world and have a long track record of human and environmental safety, many of whom have specifically found these ingredients to be safe for use in hygiene and cleaning products.  In the U.S., these ingredients are regulated by the Food and Drug Administration or the Environmental Protection Agency, depending upon the type of product that contains them.

Addressing Rep. Markey's Concerns

SDA said it would look forward to providing information to Rep. Edward Markey (D-Massachusetts), who has challenged FDA and EPA's regulation of antibacterial ingredients and overall product safety.

"We want Congressman Markey to be aware of the wealth of high quality scientific data that has been provided to both EPA and FDA on the safety and efficacy of antimicrobial products."

Consumers Can Use Products With Confidence

"Consumers can continue using antibacterial hygiene products with confidence. We strongly believe consumers should continue to have access to these beneficial products.

"These ingredients are known quantities.  They have been safely and effectively used for decades.  Extensive research shared with authorities in the U.S. and abroad shows wide margins of safety when it comes to human, aquatic or animal exposure."(V)

"We should be wary of over-interpreting FDA's announcement and unrealistically linking the detection of minute traces of ingredients with concerns for ingredient and product safety.  

"Additionally, it's worth repeating that numerous scientific reviews have shown there is no real world evidence linking the use of antibacterial products to antibiotic resistance."(VI)

Examples of research showcasing antibacterial hygiene and cleaning product safety can be found online at www.cleaning101.com/antibacterial.

The Soap and Detergent Association (SDA – www.cleaning101.com), the Home of the U.S. Cleaning Products Industry®, represents the $30 billion U.S. cleaning products market.  SDA members include the formulators of soaps, detergents, and general cleaning products used in household, commercial, industrial and institutional settings; companies that supply ingredients and finished packaging for these products; and oleochemical producers.  SDA and its members are dedicated to improving health and the quality of life through sustainable cleaning products and practices.

Follow SDA on Twitter at www.twitter.com/Cleaning101

NOTES:

(I)  Fischler GE, Fuls JL, Dail EW, Duran M, Rodgers ND, and Waggoner AL. (2007), Effect of hand wash agents on controlling the transmission of pathogenic bacteria from hands to food, J. Food Protection 70(12): 2873-2877; Fuls JL, Rodgers ND, Fischler GE, Howard JM, Patel M, Weidner PL, and Duran MH. (2008), Alternative hand contamination technique to compare the activities of antimicrobial and nonantimicrobial soaps under different test conditions, Appi. Environ. Microbiol. 74(12): 3739-3744.

(II) The Antimicrobial Coalition presented new data and information demonstrating the efficacy of OTC antibacterial hand wash products at the Public Feedback Meeting: Discussion of OTC Consumer Antimicrobial Products with the Office of Nonprescription Drugs, Division of Regulations Development (November 14, 2008). See Docket No. FDA-1980-N-0006 (formerly l980N-02950).

(III) According to the CDC, "[k]eeping hands clean is one of the most important ways to prevent the spread of infection and illness." Wash Your Hands, available at http://www.cdc.gov/Features/HandWashing/.

(IV) Hedberg CW, Levine WC, White KE, Carison RH, Winsor DK. Cameron DN, MacDonald KL, and Osterhoim MT. 1992. An international foodborne outbreak of shigellosis associated with a commercial airline. J. Amer. Med. Assoc. 268: 3208-3212; Lee LA, Ostroff SA, McGee HB, Johnson DR, Downes FP, Cameron DN, Bean NH, and Griffin PM. 1991. An outbreak of shigellosis at an outdoor music festival. Am. J. Epidemiol. 133: 608-615; Naimi TS, WicklundJH, Olsen SJ, Krause G, Wells JG, Bartkus TM, Boxrud DJ, Sullivan M, Kassenborg H, Besser JM, Mintz Ed, Osterhoim MT, and Hedberg CW. 2003. Concurrent outbreaks of Shigella sonnei and enterotoxigenic Escherichia coli infections associated with parsley: implications for surveillance and control of foodborne illness. J. Food Protect. 66:535-541.

(V) A comprehensive review of these studies is available in a paper by Rodricks, J.V., Swenberg, J.A., Borselleca, J.F., Maronpot, R.R., Shipp, A.M. (2010). Safety assessment for triclosan: development of margins of safety for consumer products. In preparation.

(VI)  Examples of these studies are presented below:

Aiello AE, Marshall B, Levy SB, Della-Latta P, Lin SX, Larson E. (2005)

Antibacterial Cleaning Products and Drug Resistance. Emerging Infectious

Diseases. 11(10): 1565 – 1570.

Cole EC, Addison RM, Rubino JR, Leese KE, Dulaney PD, Newell MS, Wilkins J,

Gaber DJ, Wineinger T, Criger DA. (2003) Investigation of antibiotic and

antibacterial agent cross-resistance in target bacteria from homes of antibacterial

product users and nonusers. J Appl Microbiol. 95(4): 664 – 676.

"Goodfellow G, Lee-Brotherton V, Daniels J, Roberts A, Nestmann E. (2003)

Antibacterial resistance and triclosan. Society of Toxicology Annual Meeting, Salt

Lake City, UT.

McBain AJ, Bartolo RG, Catrenich CE, Charbonneau D, Ledder RG, Price BB,

Gilbert P. (2003) Exposure of sink drain microcosms to triclosan: Population

dymamics and antimicrobial susceptibility. Appl Environ Micro. 69(9):5433 –

5442.

Russell AD. (2003) Biocide use and antibiotic resistance: the relevance of

laboratory findings to clinical and environmental situations. Lancet Infect Dis. 3:

794 – 803.

SOURCE The Soap and Detergent Association