A nonprofit environmental group has sued the U.S. Food
and Drug Administration, claiming the agency failed to regulate toxic
chemicals found in "antimicrobial" soap and other personal care
products.
The National Resources Defense Council
alleges that two common ingredients, triclosan and triclocarban, can
damage reproductive organs, sperm quality and the production of thyroid
and sex hormones.
According to the suit, which also names U.S. Department of
Health and Human Services Secretary Kathleen Sebelius as a defendant,
recent bio-monitoring results found "residues of triclosan in 75 percent of Americans over the age of 6."
The lawsuit was filed in U.S. District Court in Manhattan on
Tuesday. Representatives of the FDA and the Department of Health and
Human Services declined to comment, saying it was a matter of policy not
to comment on lawsuits.
Plaintiffs contend that the FDA violated federal law in its
delay over establishing safe conditions of use. More than 30 years ago,
the agency first proposed to regulate such products for over-the-counter
use, but they remain on the market and are unregulated, the group said."As a result of the FDA's lengthy delay, consumers remain
exposed to triclosan and triclocarban through a variety of
over-the-counter drug products, such as antimicrobial hand soaps, that
proliferate on the market," the lawsuit stated.
The suit seeks an order requiring the FDA to finish its study on the conditions of use by a specific deadline.No manufacturers or retailers were named as defendants or were cited in the lawsuit.
The FDA said in April it was reviewing the safety of
triclosan. It noted there was no evidence it could be harmful to people
and did not recommend changing consumer use of products that contain the
agent.
POPULAR PRODUCTS
The popularity of antimicrobial products has grown in recent
years and the products are increasingly found in homes and offices,
where germs can easily be passed from person to person.
The lawsuit cites various recent studies that associate the
chemicals with a host of health risks, from lower thyroid hormone levels
to the disruption of testosterone production.
In 1978, according to the lawsuit, the FDA proposed to ban
from interstate commerce both triclosan and triclocarban either six
months or two years after publication of its final study, but no action
was taken until 1994, when some ingredients were reclassified.
"Healthcare antiseptics containing these chemicals remained on
the market and increased in prevalence" since 1994, the lawsuit said.
The National Resources Defense Council said it had met with the FDA to try to hasten the study, to no avail.
Responding to a letter from U.S. Rep. Edward Markey of
Massachusetts in February, the FDA said it could not give a specific
timeline, but said it was "working diligently" to publish the proposed
rule. It also cited a lack of long-term data regarding potential health
effects from exposure to the toxins.
The case is National Resources Defense Council v. USDA et al, 10 CIV 5690.
