Report’s cancer scare in popular toothpaste

As thousands of Tanzanians put Colgate Total in their mouths every day to brush their teeth, could they also be putting themselves at the risk of acquiring cancer? That could be the case, going by a new report published by the news agency, Bloomberg.

Colgate Total is made from a chemical known as triclosan which, reports Bloomberg, has been linked to cancer-cell growth and disrupted development in animals.

Yesterday, the local regulator—Tanzania Foods and Drugs Authority (TFDA) confirmed it had been made aware of the report. The agency’s spokesperson, Ms Gaudensia Simwanza, said TFDA has instructed its experts to work on the Bloomberg report before determining the fate of the product.

Ms Simwanza, however, further told The Citizen that Colgate Total was approved for us in the country, after the agency conducted a test and established that the amount of triclosan available in the product (0.3 per cent) doesn’t have any health hazards to human beings.

She noted that the 0.3 amount contained in Colgate Total is fit for human consumption from the age of 12 and above.

For their part, US regulators are currently reviewing whether it is safe to put the chemical in soap, and toys and consumer firms are phasing it out.

The Citizen yesterday, established that Colgate Total was available in various supermarkets and shops in the city—and a brand of choice for high-end users.

The manufacturer, Colgate Palmolive insists that Total is safe, citing the rigorous US Food and Drug Administration process that led to the toothpaste’s 1997 approval as an over-the-counter drug, according to a report published yesterday by Bloomberg News.

But, according to Bloomberg report, a closer look at that application process, however, reveals that some of the scientific findings Colgate put forward to establish triclosan’s safety in toothpaste weren’t black and white—and weren’t, until this year, available to the public.

The pages show how even with one of the US’s most stringent regulatory processes— FDA approval of a new drug—America’s government relies on company-backed science to show products are safe and effective, says a report by Bloomberg.

The recently released pages,. Colgate’s Total application included 35 pages summarising toxicology studies on triclosan, which the FDA withheld from view.

The agency released the pages earlier this year in response to a lawsuit over a Freedom of Information Act request. Later, following inquiries from Bloomberg News, the FDA put the pages on its website.

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.

The recently released pages, taken alongside new research on triclosan, raise 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, said three scientists who reviewed the pages at Bloomberg News’s request. Colgate’s application materials also show that the FDA asked questions about the thoroughness of cancer studies, which are partly addressed in recently released documents.

Mr Thomas Zoeller, a biology professor at the University of Massachusetts Amherst, who specialises in how chemicals affect the endocrine system was quoted by Bloomberg as saying:

“We have created a system where we are testing these chemicals out on the human population. I love the idea they are all safe.” He added:

“But when we have studies on animals that suggest otherwise, I think we’re taking a huge risk.”

New York-based Colgate isn’t accused of wrongdoing, and the 35 pages don’t prove triclosan is harmful. It was the America’s FDA’s decision to keep the documents off of its website, Colgate Palmolive told Bloomberg.

The America’s FDA, according to Bloomberg, followed standard procedure by redacting information that had come from a third party, said spokeswoman Andrea Fischer.

Some studies were done in the labs of Ciba-Geigy, the first triclosan maker and a predecessor to its current primary maker, BASF SE, according to the documents.

The pages didn’t denote which studies were done by an outside party, or who the party was. Fischer declined to identify them.

Colgate said Total’s effectiveness and safety are supported by more than 80 clinical studies involving 19,000 people, and that it gave the FDA 98 volumes, numbering hundreds of pages each, in support of Total. Colgate spokesman Thomas DiPiazza says:

“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,” DiPiazza said.

Mr Zoeller, the endocrine specialist, said that while an estimated 800 to 1,000 chemicals are believed to disrupt the endocrine system, triclosan is one of about 10 to which people are regularly exposed. “We may not have to change very much to have a big impact,” he said.