How FDA Has Made Buying Soap Difficult

Oh no, we're out of soap.

When you run out of hand soap at home and go the store to buy more, my guess is that the most pressing question might be “Lemon verbena, lavender, or sweet tangerine?” (Lavender.) Or maybe it’s “Which color bottle looks better in the bathroom – blue or yellow?” (Blue.) My guess is that you’re not wondering “Is this soap safe?” There’s probably even a passing assumption that anything you pick will be safe since it’s on the shelf and available to be sold.

Unfortunately, in the case of antibacterial soap, that’s not necessarily true. But we’re working to fix that.

Some hand soaps are marketed as “antibacterial.” Because of that label, the Food and Drug Administration treats the chemical added to the soap to make it “antibacterial” as a drug. FDA must determine that a drug is both safe and effective before it can be sold on the market. Unfortunately, the agency has been lagging way behind for over-the-counter drugs, that is, those that can be bought without a doctor’s prescription. And the antibacterial soaps – and the chemicals that are in them – have been proliferating in the American marketplace in response to the delay.

In 1978, the FDA first proposed to regulate antibacterial soaps and only allow those that it determined were safe and effective on the market. However, FDA created a loophole for most of the chemicals where FDA could not call them safe or effective. The agency said that there was not enough data to say those chemicals were safe or effective, but allowed them on the market until FDA finalized its proposal. Then, if companies still couldn’t prove to FDA that the chemicals were safe and effective, then they would be denied approval. Unfortunately, after three decades, FDA still had not acted. It took an NRDC lawsuit to get FDA to promise a final date for this rule.

The first milepost has passed. FDA proposed a revised rule (called Tentative Final Monograph) and allowed the public to submit comments on that proposal. The proposal covers about a dozen chemicals that can be added to “antibacterial” soap, including triclosan, triclocarban, benzalkonium chloride, and benzethonium chloride. In the proposal, FDA said that same thing it has been saying since 1978. There is not enough evidence to show that these chemicals are safe or effective. We support FDA’s proposal, and submitted these comments that show that the most recent science only further supports that these chemicals are not safe. Check out my colleague Kristi Pullen’s blogpost, too.  

At this point, the companies have until the end of the year to submit data to try to show that their products are safe and effective. And there will be two more months for the public to respond to those data. Then FDA goes into its black hole and will emerge with a final decision on antibacterial soaps in September, 2016.

When that day comes, we will hopefully be able to focus just on what our hand soap smells and looks like and to assume rightly that whatever we pick will be safe.