An antimicrobial chemical called triclosan is found in Colgate Total toothpaste. The chemical has been linked to cancer-cell growth and fetal abnormalities in animal studies, Bloomberg News reported (8.11.14).
Triclosan is also one of about 10 chemicals believed to disrupt the endocrine system to which people are regularly exposed. Concern about triclosan has grown as researchers continue to examine possible causes for a global rise in endocrine-related diseases. These diseases include breast, ovarian, prostate and testicular cancers, as well as a growing number of preterm and low birth-weight babies. Endocrine-disrupting chemicals may also be linked to early breast development in girls and undescended testicles in boys, reported Bloomberg News.
Total is the only triclosan toothpaste approved for U.S. sale.
Colgate claimed that the rigorous Food and Drug Administration process that led to the toothpaste’s approval showed that Total was safe. However, Bloomberg News reported that a closer inspection of the application process revealed that some of the scientific findings Colgate submitted to establish triclosan’s safety in toothpaste were not exactly clear.
In 1997, Colgate Total was approved by the Food and Drug Administration as an over-the-counter drug with a 35-page summary of toxicology studies on triclosan. According to Bloomberg News, the 35 pages raised questions about whether the FDA “did appropriate due diligence in approving Total…and whether its approval should stand in light of new research.”
Notably, triclosan’s manufacturer conducted some of the studies.
The U.S. Toxic Substances Control Act of 1976 had grandfathered in triclosan and other existing substances with no safety testing, reported Bloomberg News. Now, in 2014, long-term safety research of triclosan in people is still missing. Studies in rats and mice had found adverse effects at high doses, including reduced fertility, impaired muscle function and the possibility of increased cancer risk. However, it was unclear whether these same risks applied to people.
Manufacturers have the responsibility to ensure that the products they make or sell are safe and that relevant information is made public. If a manufacturer fails to adequately test its product before offering it to consumers and this negligence leads to the injury or death of a user, the manufacturer may be held liable.
Colgate is not accused of wrongdoing, and the 35 pages do not prove triclosan is harmful.
The Bloomberg News article cited was said to be based on interviews with Colgate, former and current FDA staff and oral biology experts, scientists, transcripts of FDA meetings, as well as on the 35 pages.
The Bloomberg News story is “Colgate Total Ingredient Linked to Hormones, Cancer Spotlights FDA Process.”