Household Hazards

How everyday products make us sick.

False Identity: Generally Recognized As Safe

“GRAS” Gives a Free Pass to Potential Hazards

In an important step, the U.S. Food and Drug Administration (FDA) has decided to take a second look as a “laundry list” of chemical additives the up until now have gotten a free pass. The FDA is revisiting the status of a large group of chemicals that are added to everyday consumer products as “anti-microbial agents” (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm378542.htm).     

The new FDA proposed rule, for now, only applies to antibacterial hand soaps and body washes and takes a small but nonetheless important step. It requires that manufacturers show that their products are safe for regular use every day potential over years. The FDA also wants the makers to prove that adding an anti-bacterial is actually more effective than plain soap and water. The club the FDA can wield is forcing product reformulation or relabeling in order to remain on the market.

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A big part the process concerns figuring out what is “generally recognized as safe" - known in regulatory speak as GRAS (generally recognized as effective or GRAE also comes into play). GRAS may not mean never having to say you’re  sorry, but it does save a manufacturer a lot of  potential expenses related to proving safety, for example with various types of testing. For the antimicrobial additives, which is a big market, GRAS status has meant a lot of green on the manufacturers’ side of the fence.   

The full list of what the FDA is concerned about, and why, was put out in Federal Register on December 17  (https://www.federalregister.gov/articles/2013/12/17/2013-29814/safety-and-effectiveness-of-consumer-antiseptics-topical-antimicrobial-drug-products-for). The technical umbrella term is “Topical Antimicrobial Drug Products for Over-the-Counter Human Use” and, more specifically, various handwashes or “consumer antiseptic products intended for use with water.” Translated into regular language: soap with one of these substances added in.

One of the FDA’s particular concerns, and for good reason, is a substance that most people come in contact with every day but almost no one has ever hear of. It is called triclocarban. Back in 1994, the FDA proposed classifying triclocarban as “GRAS” for over-the-counter consumer antiseptic handwashes. Now the FDA has to admit that, “The existing data, however, are no longer sufficient to fully evaluate the safety of triclocarban. New information regarding potential risks from systemic absorption and long-term exposure to antiseptic active ingredients is leading us to propose additional safety testing.”

One aspect of triclocarban that is particularly concerning to scientists who have started to study this chemical in depth is its potential to interfere with hormonal function. This can adversely affect humans and also can be a problem for the environment if a chemical has the capacity not to break down or even to accumulate in the food chain – like triclocarban.  For example, in a reverse variation on a blame-Canada theme, recent study showed the chemical in earthworms four years after an Ontario field had been treated with triclocarban-containing biowaste (http://www.ncbi.nlm.nih.gov/pubmed/24291564)

The Natural Resources Defense Council is one of multiple environmental groups that have been raising concerns about triclocarban (http://www.nrdc.org/living/chemicalindex/triclosan.asp). They and others have also been worried about other consumer product antimicrobials not likely to change status under the new FDA rules as well as uses of triclocarban that go beyond are not “consumer antiseptic products intended for use with water.” Like toothpaste, for instance.

Paul D. Blanc, M.D., M.S.P.H., is Professor of Medicine and Endowed Chair in Occupational and Environmental Medicine at the University of California San Francisco.

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