Colgate's top-selling toothpaste, Total, is using a chemical ingredient
that has been linked to cancer-cell growth and disrupted development in
animals.
The antibacterial chemical, triclosan, is used in the toothpaste to fight plaque and gingivitis, according to the company.
Total received the US Food and Drug Administration (FDA) approval in
1997 following the agency's rigorous process, and the toothpaste is
safe, according to Colgate.
However, an investigation by Bloomberg into the product found that "some
of the scientific findings Colgate put forward to establish triclosan's
safety in toothpaste weren't black and white".
Colgate's toxicology studies on triclosan submitted to the FDA in
connection with Total application had been withheld from view. The FDA
released the study earlier in 2014 in response to a lawsuit over a
Freedom of Information Act request. Later, the agency put the 35-page study on its website, following inquiries from Bloomberg.
Three scientists who reviewed the pages at Bloomberg's request, taking
into account new research on triclosan, said the FDA's approval of Total
17 years ago raises questions about whether the agency did appropriate
due diligence before giving nod. They added that the approval may not
validly stand in light of new research.
"The pages show how even with one of the US's most stringent regulatory
processes -- FDA approval of a new drug -- the government relies on
company-backed science to show products are safe and effective,"
Bloomberg writes.
The news agency noted that Colgate's studies on triclosan showed foetal
bone malformations in mice and rats, but the company ignored the
findings saying they were not relevant.
"Viewed through the prism of today's science, such malformations look
more like a signal that triclosan is disrupting the endocrine system and
throwing off hormonal functioning," Bloomberg said citing the three
scientists.
Also, the FDA questions about the thoroughness of cancer studies are
found to have partly addressed in recently released documents.
Following new research on triclosan, regulators are reviewing whether
it's safe to put in soap, cutting boards and toys, and consumer
companies are phasing it out. US state of Minnesota voted in May to ban
it in many products.
Meanwhile, Colgate defended Total's effectiveness and safety, saying the
product's approval was supported by more than 80 clinical studies
involving 19,000 people.
"In the nearly 18 years that Colgate Total has been on the market in the
US, there has been no signal of a safety issue from adverse-event
reports," Colgate spokesman Thomas DiPiazza told Bloomberg.
The company added that an independent 2013 review by the Cochrane Oral
Health Group, a network of doctors, researchers and health advocates,
found no evidence of harmful effects associated with using Colgate
Total.
Source: ibtimes.co.uk
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