Is my soap safe?

Anti-bac­te­rial soaps may not curb bac­te­ria af­ter all.

The Star Malaysia - Star2 - - LIVING - By MATTHEW PER­RONE

AF­TER more than 40 years of study, the US gov­ern­ment said on Mon­day that it has no ev­i­dence that the anti-bac­te­rial chem­i­cals used in count­less com­mon soaps and washes help pre­vent the spread of germs, and it is re­view­ing re­search sug­gest­ing that they may pose health risks.

Reg­u­la­tors at the US Food and Drug Ad­min­is­tra­tion (FDA) said that they are re­vis­it­ing the safety of chem­i­cals such as tri­closan, in light of re­cent stud­ies that sug­gest the sub­stances can in­ter­fere with hor­mone lev­els and spur the growth of drug-re­sis­tant bac­te­ria.

The gov­ern­ment’s pre­lim­i­nary rul­ing lends new sup­port to out­side re­searchers who have long ar­gued that the chem­i­cals are, at best, in­ef­fec­tive, and at worst, a threat to pub­lic health.

“The FDA is fi­nally mak­ing a judg­ment call here and ask­ing in­dus­try to show us that th­ese prod­ucts are bet­ter than soap and wa­ter, and the data doesn’t sub­stan­ti­ate that,” said Stuart Levy of Tufts Univer­sity School of Medicine, Bos­ton.

Un­der a pro­posed rule re­leased on Mon­day, the agency, which mon­i­tors prod­uct safety, will re­quire man­u­fac­tur­ers to prove that anti-bac­te­rial soaps and body washes are safe and more ef­fec­tive than plain soap and wa­ter.

Prod­ucts that are not shown to be safe and ef­fec­tive by late 2016 would have to be re­for­mu­lated, re­la­belled or re­moved from the mar­ket.

“I sus­pect there are a lot of con­sumers who as­sume that by us­ing an anti-bac­te­rial soap prod­uct, they are pro­tect­ing them­selves from ill­ness, pro­tect­ing their fam­i­lies,” said San­dra Kweder, deputy di­rec­tor in the FDA’s drug cen­tre. “But we don’t have any ev­i­dence that that is re­ally the case over sim­ple soap and wa­ter.”

A spokesman for the clean­ing prod­uct in­dus­try said the FDA al­ready has “a wealth of data” show­ing the ben­e­fits of its prod­ucts.

An FDA anal­y­sis es­ti­mates it will cost com­pa­nies US$112.2mil (RM363.7mil) to US$368.8mil (RM1.2bil) to com­ply with the new reg­u­la­tions, in­clud­ing re­for­mu­lat­ing some prod­ucts and re­mov­ing mar­ket­ing claims from oth­ers.

The rule does not ap­ply to hand sani­tis­ers, most of which use al­co­hol rather than anti-bac­te­rial chem­i­cals.

The agency will ac­cept data from com­pa­nies and re­searchers for one year be­fore be­gin­ning to fi­nalise the rule.

Wider im­pli­ca­tions

The pro­posal comes more than 40 years af­ter the FDA be­gan eval­u­at­ing tri­closan, tri­clo­car­ban and sim­i­lar in­gre­di­ents.

Ul­ti­mately, the gov­ern­ment only agreed to pub­lish its find­ings af­ter a three-year le­gal bat­tle with the Nat­u­ral Re­sources De­fense Coun­cil, an en­vi­ron­men­tal group that ac­cused the FDA of de­lay­ing ac­tion on po­ten­tially dan­ger­ous chem­i­cals.

Tri­closan is found in an es­ti­mated 75% of anti-bac­te­rial liq­uid soaps and body washes sold in the US, in­clud­ing some brands of Dial from Henkel AG & Co, one of the na­tion’s largest soap mak­ers.

More than 93% of bar soaps also con­tain tri­clo­car­ban or tri­closan, ac­cord­ing to the FDA.

While the rule only ap­plies to per­sonal hy­giene prod­ucts, it has im­pli­ca­tions for a broader US$1bil (RM3.24bil) in­dus­try that in­cludes thou­sands of anti-bac­te­rial prod­ucts, in­clud­ing kitchen knives, toys, paci­fiers and tooth­paste.

Over the last 20 years, com­pa­nies have added tri­closan and other clean­ers to thou­sands of house­hold prod­ucts, tout­ing their germ-killing ben­e­fits.

The FDA was tasked with con­firm­ing those ben­e­fits in 1972, as part of a law de­signed to set guide­lines for dozens of com­mon anti-bac­te­rial clean­ers. But the guide­lines got bogged down in years of reg­u­la­tory de­lays and missed dead­lines.

The agency pub­lished a pre­lim­i­nary draft of its find­ings in 1978, but never fi­nalised the re­sults un­til Mon­day.

Most of the re­search sur­round­ing tri­closan’s safety in­volves lab­o­ra­tory an­i­mals, in­clud­ing stud­ies in rats that showed changes in testos­terone, oe­stro­gen and thy­roid hor­mones.

Some sci­en­tists worry that such changes in hu­mans could raise the risk of in­fer­til­ity, early pu­berty and even, can­cer.

FDA sci­en­tists stressed on Mon­day that such stud­ies are not nec­es­sar­ily ap­pli­ca­ble to hu­mans, but the agency is re­view­ing their im­pli­ca­tions.

On a con­fer­ence call with jour­nal­ists, Kweder noted that the gov­ern­ment’s Na­tional Tox­i­col­ogy Pro­gram is al­ready study­ing whether daily skin ex­po­sure to hor­mone-al­ter­ing chem­i­cals could lead to can­cer.

Other ex­perts are con­cerned that the rou­tine use of anti-bac­te­rial chem­i­cals such as tri­closan, con­trib­utes to a surge in drug-re­sis­tant germs, or su­per­bugs, that ren­der an­tibi­otics in­ef­fec­tive.

In March 2010, the Euro­pean Union banned the chem­i­cal from all prod­ucts that come into con­tact with food, such as con­tain­ers and sil­ver­ware.

A spokesman for the Amer­i­can Clean­ing In­sti­tute, a soap and clean­ing prod­uct trade or­gan­i­sa­tion, said the group will sub­mit new data to reg­u­la­tors, in­clud­ing stud­ies show­ing that com­pany prod­ucts do not lead to an­tibi­otic re­sis­tance.

“We are per­plexed that the agency would sug­gest there is no ev­i­dence that anti-bac­te­rial soaps are ben­e­fi­cial,” said Brian San­soni. “Our in­dus­try sent the FDA in-depth data in 2008 show­ing that anti-bac­te­rial soaps are more ef­fec­tive in killing germs when com­pared with nonanti-bac­te­rial soaps.”

The group rep­re­sents man­u­fac­tur­ers in­clud­ing Henkel, Unilever, Col­gate-Pal­mo­live Co and Dow Chem­i­cal Co. — AP

Clean enough? Anti-bac­te­rial soap man­u­fac­tur­ers will now have to prove that their prod­ucts (con­tain­ing a germ-killing chem­i­cal called Tri­closan, inset) are bet­ter than plain old soap and wa­ter. — Filepic

Newspapers in English

Newspapers from Malaysia

© PressReader. All rights reserved.