FDA examining antibacterial soaps, body washes
updated 4:40 AM EST, Tue December 17, 2013
FDA on antibacterial soap: Prove it
STORY HIGHLIGHTS
- The FDA says there's no evidence antibacterial washes are better than soap and water
- Some data shows there may be long-term health risks from exposure
- Hand sanitizers and wipes are not covered by the proposed rule
Those manufacturers also will be required to prove their products are safe for long-term use, the agency said.
"Millions of Americans
use antibacterial hand soap and body wash products," the agency said in a
statement. "Although consumers generally view these products as
effective tools to help prevent the spread of germs, there is currently
no evidence that they are any more effective at preventing illness than
washing with plain soap and water.
"Further, some data
suggest that long-term exposure to certain active ingredients used in
antibacterial products -- for example, triclosan (liquid soaps) and
triclocarban (bar soaps) -- could pose health risks, such as bacterial
resistance or hormonal effects."
About 2,000 individual products contain these products, health officials said.
"Our goal is, if a
company is making a claim that something is antibacterial and in this
case promoting the concept that consumers who use these products can
prevent the spread of germs, then there ought to be data behind that,"
said Dr. Sandra Kweder, deputy director of the Office of New Drugs in
FDA's Center for Drug Evaluation and Research.
"We think that companies ought to have data before they make these claims."
Studies in rats have
shown a decrease in thyroid hormones with long-term exposure, she said.
Collecting data from humans is "very difficult" because the studies look
at a long time period.
Before the proposed rule
is finalized, companies will need to provide data to support their
claims, or -- if they do not -- the products will need to be
reformulated or relabeled to remain on the market.
"This is a good first
step toward getting unsafe triclosan off the market," said Mae Wu, an
attorney for the Natural Resources Defense Council. "FDA is finally
taking concerns about triclosan seriously. Washing your hands with soap
containing triclosan doesn't make them cleaner than using regular soap
and water and can carry potential health risks.
The FDA first proposed
removing triclosan from certain products in 1978, the council said, "but
because the agency took no final action, triclosan has been found in
more and more soaps."
In 2010, the council
said it sued FDA to force it to issue a final rule. The new proposed
rule stems from a settlement in that suit, according to the NRDC.
The rule is available
for public comment for 180 days, with a concurrent one-year period for
companies to submit new data and information, followed by a 60-day
period for rebuttal comments, according to the FDA.
The target deadline is
June 2014 for the public comment period, then companies will have until
December 2014 to submit data and studies. The FDA wants to finalize the
rule and determine whether these products are "generally recognized as
safe and effective" by September 2016.
"Antibacterial soaps and
body washes are used widely and frequently by consumers in everyday
home, work, school and public settings, where the risk of infection is
relatively low," said Dr. Janet Woodcock, director of the FDA's Center
for Drug Evaluation and Research.
"Due to consumers'
extensive exposure to the ingredients in antibacterial soaps, we believe
there should be a clearly demonstrated benefit from using antibacterial
soap to balance any potential risk."
The action is part of FDA's ongoing review of antibacterial active ingredients, the agency said.
Hand sanitizers, wipes and antibacterial products used in health care settings are not affected.
Most hand sanitizers
have 60% alcohol or ethanol and are generally recognized as safe when
water isn't available, Kweder said. However, health officials still
believe washing hands with soap and water is the best method.
end quote from:
FDA: Beware antibacterial soapsLike a lot of problems these days it is all in the fine print or in this case in strange sounding chemicals
created in laboratories that don't occur in the natural world.
It's a similar problem to Monsanto creating corn, soy, wheat and other "Frankenstein" grains that never existed before. The long term consequences of all these new things might extinct large segments of the human race ongoing on into the future like they are killing them one by one now across North, South and Central America.
No comments:
Post a Comment