No Soap: FDA Finally Acts on Antibacterials

Health advocates have been saying for years that consumers shouldn’t use antibacterial soaps. Yet manufacturers have continued to put antibacterial agents into liquid soaps, to the extent that for a while it was hard to find products on store shelves that didn’t contain them. Now the Food & Drug Administration has finally gotten the message. The FDA today issued a final rule prohibiting use of some common antibacterial agents in soaps and body washes, as well as a consumer update entitled, “Antibacterial Soap? You Can Skip It—Use Plain Soap and Water.” It’s good news that the FDA has taken this step. The bad news is that it took the agency almost 40 years to do it, and in the meantime these products became entrenched in the marketplace, and Americans were exposed to them in massive quantities.

So what’s the big deal about antibacterial soaps? First, the antibacterial agents used (often substances called triclosan or triclocarban) may not be safe for long-term use in human beings: The physiological effects of long-term exposure to large amounts of these substances, to which consumers are exposed from a multitude of sources, are unknown. Second, their effectiveness is highly questionable: There’s little reason to think they are any better than regular soap and water at protecting people against infection or disease. Third, and most troubling, there’s a lot of reason to think that the widespread use of these antibacterial agents may contribute to the development of resistant “superbugs.”

Although these products are available on the same shelf in the supermarket as old-fashioned soap, for FDA regulatory purposes they are classified as over-the-counter (OTC) drugs, and they can be marketed only if they are “generally recognized as safe and effective” (GRAS/GRAE). An OTC drug that is not GRAS/GRAE is, in FDA parlance, “misbranded.” The rule issued today finds that antibacterial soaps are not GRAS/GRAE and will effectively halt their sale after a one-year phase-in period. Manufacturers have seen this coming for some time and already begun to phase out use of some antibacterial substances.

Given the questions about the safety and effectiveness of antibacterial soaps, one might wonder how they came to be so ubiquitous in the marketplace in the first place. The answer is that the FDA has a process for determining whether a product meets the GRAS/GRAE standard, and until it finalizes its determinations, OTC drugs can stay on the market unless the FDA finds that they post a health hazard.

That may not be a huge problem when the FDA conducts its OTC review reasonably quickly. But that wasn’t the case with the process for products including antibacterial soaps. The FDA issued a tentative determination in 1978 that antibacterial soaps were not GRAS/GRAE. Instead of finalizing it, the FDA issued another one in 1994 that reached the same conclusion. But it didn’t finalize that determination, either.

In 2010, the Natural Resources Defense Council sued the FDA in a federal district court in New York for unreasonable delay in failing to finalize its determination about antibacterial soaps. The district court threw out the case for lack of standing, but in the spring of 2013, the U.S. Court of Appeals for the Second Circuit reversed and sent the case back to the district court for a ruling on the merits.

That ruling got the FDA off the dime. In fairly short order, the FDA agreed to a consent decree giving it a timetable to complete action on antibacterial soaps, with a September 15, 2016, deadline. With today’s action, the FDA appears to have met that deadline and, what’s more, come out generally the right way. The agency found that the evidence doesn’t establish that antibacterial agents including triclosan and triclocarban are either safe or effective. The FDA estimates that consumers will face a 2.2 million-pound reduction in annual exposures to the 19 chemicals affected by the rule. NRDC’s press release treats the rule as a major victory, albeit one that comes much later than it should have.

It’s possible industry may challenge the action, but many manufacturers have already shifted to promoting the benefits of regular soap. Softsoap, for example, now promotes its liquid soaps that don’t use antibacterials with the slogan “wash away bacteria.”

The FDA’s rule still leaves the status of three antibacterial agents in doubt, subject to further study. And the FDA’s action today doesn’t affect use of antibacterials in health care settings, nor does it regulate “hand sanitizers,” which are typically alcohol-based and present different considerations. But, under the terms of the consent decree, the FDA is actively looking into those subjects as well, and is under deadlines to finalize its action on them in 2018 and 2019, respectively.

It’s hard to know whether to cheer or boo when the agency does something like this so belatedly. The FDA knew it should take the same step in 1978, and its failure to do so allowed companies to market unnecessary and potentially harmful products on a huge scale for many years under the guise of promoting public health.

But, to use a phrase that could be the agency’s unofficial slogan, “Better late than never.”

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