In 2011, Colgate-Palmolive removed a chemical called triclosan from its soap products, citing “changing consumer preferences.” But according to a New York Times article, the change was more likely motivated by concerns raised by consumer groups and Congressional leaders over the potentially harmful effects of the chemical.
However, triclosan still remains an active ingredient in Colgate Total, the company’s number one selling toothpaste. Why is a product that may not be safe for our hands still in a product that goes into our mouths?
The Role of the FDA
A Bloomberg News investigation places some of the blame on the U.S. Food and Drug Administration approval process, highlighting 35 pages of recently released toxicology data from the approval application for Colgate Total. Those pages show that there may have been some red flags about triclosan’s safety that the FDA should have examined further.
For instance, the application included a study that found “fetal bone malformations in mice and rats.” It is important to recognise that chemicals can affect animals differently than humans, especially because animal testing can involve sky-high doses of the chemical in question. However, often these kinds of findings in animals mean further testing is warranted before the product is approved for humans.
Another issue is that the FDA “relies on company-backed science to show products are safe and effective,” according to the Bloomberg story. This means that instead of having independent, third-party researchers determine the effectiveness and safety of a given product, the FDA often accepts research studies funded by the company that is trying to seek approval.
Triclosan is an antimicrobial agent, meaning that it helps to “slow or stop the growth of bacteria, fungi, and mildew,” according to the Environmental Protection Agency. It first started to appear in antibacterial hand soap products in the 1970s.
The FDA has never issued a comprehensive ruling on triclosan’s effectiveness and safety — even though it originally said it would look into triclosan in 1974. That was two years before “the U.S. Toxic Substances Control Act of 1976, which aimed to comprehensively regulate chemicals, grandfathered in existing substances with no safety testing,” Bloomberg notes. Now the FDA says it will issue a ruling on triclosan in 2016.
While companies have an obligation to the safety and health of their customers, they can also have a lot of money riding on the approval of a new product.
The Risks and Benefits of Triclosan
When it comes to consumer safety, the FDA needs to determine whether the benefits of a product outweigh the risks. In the case of toothpaste, clinical trials showed that triclosan helped fight plaque germs found in the mouth, reducing the individual’s risk of gingivitis, a common gum disease.
According to the company website, “Colgate Total is clinically proven to work better than other toothpastes to reduce these germs that can cause the gum disease gingivitis.” Colgate’s website also states that the “safety and effectiveness” of the product is supported by more than 80 scientific studies, involving 19,000 people.
Last year, an independent review of the existing research on triclosan in toothpaste concluded that the chemical “reduced plaque, gingival inflammation and gingival bleeding” but that those reductions “may or may not be clinically important.” Triclosan was also associated with a “small reduction” in cavities.
“There do not appear to be any serious safety concerns regarding the use of triclosan… toothpastes in studies up to three years in duration,” the reviewers concluded.
Colgate is quick to point out that real-world evidence seems to echo these results.
“In the nearly 18 years that Colgate Total has been on the market in the U.S., there has been no signal of a safety issue from adverse-event reports,” Thomas DiPiazza, a Colgate spokesperson told Bloomberg. (We have reached out to Colgate for further comment and will update this post if we hear back.)
Still, given the questions raised by animals studies, this kind of logic — that triclosan isn’t harmful because ill effects haven’t been reported in humans yet — doesn’t cut it for the Natural Resources Defence Council, or NRDC. The nonprofit environmental organisation has actively been involved in educating consumers about triclosan’s potential risks and also pressuring the government to take action.
It was a Freedom of Information Act request from the NRDC that led to the release of the FDA approval documents for Colgate Total.
The NRDC’s position: Is even a small potential risk worth it, when the benefits seem to be small-to-none?
The organisation has focused on hand soap and toothpaste because those products are required to list triclosan in the ingredient lists. In many other products, it may simply fall under the label “preservative.”
“It’s also used in other products that you wouldn’t normally think of — cutting boards and shoes and shopping carts and bath tubs,” Mae Wu, an attorney for the NRDC Health Program told Business Insider. “It’s hard to avoid it.”
On its website, the NRDC tells consumers to “urge the FDA to pull products containing triclosan…from store shelves in order to protect public health.”
Ultimately, the FDA ruling in 2016 will determine whether increased regulation is on the way.