It’s not exactly new news that Colgate Total toothpaste includes a compound linked in some studies to cancer growth and other possible health issues, but how much information the Food and Drug Administration disclosed to the public and vetted the product before approving it is now being called into question.
Bloomberg News reported that the FDA only recently made public Colgate-Palmolive’s 35-page application, which includes some studies about triclosan, after an earlier lawsuit that involved a Freedom of Information Act request. It wasn’t until Bloomberg pressed the issue further that the FDA put the information on its website, the news site stated.
Bloomberg had three scientists review the application and FDA’s approval, which it said has lead to “questions about whether the agency did appropriate due diligence in approving Total 17 years ago, and whether its approval should stand in light of new research.”
According to a statement from the FDA to TheBlaze, the FOIA request filed in 2012 sought confidential information in the FDA’s approval package for Total, which was initially redacted. This request made by the National Resources Defense Council was initially denied, but the FDA presented the documents after a subsequent lawsuit.
The FDA’s Center for Drug and Evaluation Research released these records in response to the request “because the information that was initially withheld had subsequently become public since the Approval Package was first reviewed and posted.”
Some of the potentially off-putting information included studies that showed issues in bone formation of fetal rats and mice. While Colgate apparently dismissed these findings, according to Bloomberg, the scientists that it had review the package see it as a sign that the antibacterial compound, which helps prevent gingivitis, is causing issues with hormone function.
“We have created a system where we are testing these chemicals out on the human population. I love the idea they are all safe,” Thomas Zoeller with the University of Massachusetts Amherst told Bloomberg. “But when we have studies on animals that suggest otherwise, I think we’re taking a huge risk.”
Later in Bloomberg’s report, Zoeller and the other scientists said that from what they reviewed they don’t think the FDA should have dismissed some of the safety evidence presented in the toxocology studies of triclosan.
Zoeller expressed surprise that this information was only recently made public.
“Wow. They kept that private?” Zoeller told Bloomberg. “The distinction between maternal and fetal toxicity is an excuse to do nothing. And it’s not scientifically justifiable.”
A more recent human study revealed the amount of triclosan in the systems of pregnant women. Triclosan was present in 85 percent of urine samples and more than half of umbilical cord blood samples, CBS News reported.
In a consumer update posted last year, the FDA said that triclosan was “not currently known to be hazardous to humans.” While some studies show concerning effects of the chemical on hormone regulation in animals, this does not necessarily mean it would affect humans in the same way, the FDA wrote. But, in light of more recent information, the FDA is conducting a regulatory review of the compound as it applies to antibacterial soaps while allowing it to remain on the market in the mean time. The FDA is expected to issue a final rule by 2016.
The agency is not reviewing the presence of triclosan in toothpaste and its possible affect on humans at this time, an FDA spokesman told TheBlaze, adding that he could not comment on the opinions the scientists had given to Bloomberg.
“Colgate Total was approved in 1997 under the New Drug Application process for the specific indication and use for which it was approved. As such, the safety and efficacy of Colgate Total was evaluated to determine a benefit/risk profile,” the FDA said in a statement. “The triclosan in Colgate Total is proven effective in reducing plaque and gingivitis. Based on the scientific evidence, in this case, the balance of benefit and risk has been shown to be favorable for this product.
“The FDA reviews all new safety information that is identified for an ingredient and decides whether a reassessment is needed for drugs that that contain that ingredient. In the case of triclosan, its uses in hand soap and toothpaste have different benefit/risk profiles,” the statement continued.
As for its relationship to cancer, Bloomberg reported that the FDA previously expressed concern about the carginogenic effects of triclosan, but this was relieved by a 1997 study. Colgate spokesman Thomas DiPiazza told Bloomberg that the study “supports the FDA’s conclusion that triclosan does not pose a cancer risk for humans.”
While triclosan is still present in Colgate Total toothpaste — something which Bloomberg reported the company does not intend to change — it has already been removed from some antibacterial soaps and other toothpastes. Bloomberg also noted that Colgate Total is the only brand on the market that has triclosan and cited other brands, such as Crest, advertising themselves as triclosan free.
Watch Bloomberg’s video about the compound:
Read Bloomberg’s full report on the compound and the thoughts of the scientists it brought on to review the application and the FDA’s approval.
Front page image via LunaseeStudios/Shutterstock.