In the case of triclosan, Congress passed a law in 1972 requiring that the FDA set guidelines for dozens of common antibacterial chemicals found in over-the-counter soaps and scrubs. The guidelines function like a cookbook for manufacturers, detailing which chemicals can be used in what products, and in what amounts.
In 1978, the FDA published its first tentative guidelines for chemicals used in liquid hand soaps and washes. The draft stated that triclosan was “not generally recognized as safe and effective,” because regulators could not find enough scientific research demonstrating its safety and effectiveness.
The FDA published several drafts of the guidelines over the years, but the agency never finalized the results. So, companies have not had to remove triclosan from their products.
Meanwhile, the agency did approve triclosan for use in Colgate’s Total toothpaste in 1997, after Colgate-Palmolive Co. submitted data showing that the ingredient helped fight gingivitis.
Then, last summer, the FDA said its review of triclosan would be complete by late 2012. That target date then slipped to February, which has also come and gone. But pressure on the agency from outside critics didn’t let up.
In March, a federal appeals court said a lawsuit by the nonprofit Natural Resources Defense Council aimed at forcing the FDA to complete its review could move forward. A three-judge panel reinstated the 2010 lawsuit, which had been tossed out by a lower court, saying the nonprofit group presented evidence that triclosan could potentially be dangerous.
Now, four decades after it was charged with reviewing triclosan, the FDA is planning to complete its review.