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FDA’s New Triclosan Factsheet Questions Need But Plays Down Hazards

(Beyond Pesticides, April 22, 2010) In a new consumer factsheet posted April 8, 2010, the U.S. Food and Drug Administration (FDA) attempts to moderate the position it took in a February 23, 2010 letter to Congress in which it said, “[E]xisting data raise valid concerns about the effects of repetitive daily human exposure to these antiseptic ingredients” and “FDA shares your concerns over the potential effects of triclosan and triclocarban as endocrine disruptors that has emerged since we issued the TFM [Tentative Final Monograph] in 1994.” Instead, in bureaucractic-speak FDA is now saying, “[T]riclosan is not currently known to be hazardous to humans.” Safety advocates say that the FDA’s latest statement creates public confusion as the triclosan market continues to grow and manufacturers in the soap and cosmetics industry daily push misleading advertising claims about the protection from bacteria attributed to the toxic ingredient triclosan.

While equivocating on the science on triclosan’s adverse effects, FDA does question the efficacy of the widely marketed triclosan products with the statement, “At this time the agency does not have evidence that triclosan in antibacterial soaps and body washes provides any benefit over washing with regular soap and water.” Image Courtesy FDA

The new FDA factsheet, featured on FDA’s Consumer Update webpage, “Triclosan: What Consumers Should Know,” responds to the petition submitted to the agency by Beyond Pesticides and Food and Water Watch outlining the dangers associated with triclosan, which were subsequently echoed by congressional letters submitted by Rep. Markey (D-MA) and recent media attention. However, the agency does not disclose the mounting scientific evidence that suggests triclosan is dangerous to human and environmental health.

Several laboratory studies have shown that triclosan acts as an endocrine disruptor by interfering with the thyroid hormone, as well as estrogen and androgen receptors, which could increase the risk of breast cancer. Triclosan can also transform into dioxin and interact with other chemicals to form chloroform, thereby exposing consumers to even more dangerous chemicals. In light of these data, triclosan is considered hazardous to human health, i.e. posing a threat, risk or danger to human health. For more information of the human health implications surrounding triclosan use, read the factsheet, “Triclsoan: What the Research Shows.”

To add to the confusion, FDA equivocates on its own science, which relies on laboratory animal testing to extrapolate to the human population, a practice that has substituted for direct laboratory testing on humans. FDA states, “[Existing] data showing effects in animals don’t always predict effects in humans,” and then says, “ [I]n light of questions raised by recent animal studies of triclosan, FDA is reviewing all of the available evidence on this ingredient’s safety..” First, FDA is well aware that in the United States, scientists and federal risk assessments (including those carried out by the U.S. Environmental Protection Agency (EPA)) assume that the toxic response observed in laboratory animals are indicative of toxic responses that are likely to occur in people. To predict responses in people, various animals (mammals) species that are biologically similar to humans are often used (e.g. mice) as models for responses in humans. Therefore, data showing effects of triclosan in laboratory animals, such as mice, are used to predict effects in humans. FDA also admits that “several scientific studies have come out since the last time FDA reviewed this ingredient.” The agency has not been able to finalize its regulation of triclosan since it was first initiated in the early 1970s, and most recently amended in the 1990s. Beyond Pesticides is urging FDA to move expeditiously with its review on the human health impacts of triclosan.

FDA also notes in its factsheet that it does not have sufficient safety evidence to recommend changing consumer use of products. The agency is ignoring a wealth of evidence in the scientific literature, and those submitted to the agency in Beyond Pesticides’ 2009 and 2004 petitions which show that triclosan poses a public health risk by way of endocrine disruption, and increased antibacterial resistance, as well as environmental contamination of surface waters and food. However, the agency does advise concerned consumers to check product labels to determine whether products contain triclosan and to wash with regular soap and water.

FDA has come under intense scrutiny recently over the use of triclosan in consumer products. Triclosan is used in a wide range of products including soaps, sanitizers, cosmetics etc. (See the list of commonly used triclosan-containing products). In February, the agency responded to a congressional letter authored by Rep. Markey (D-MA), stating that “existing data raise valid concerns about the [health] effects of repetitive daily human exposure to these antiseptic ingredients,” and announced plans to address the use of triclosan in cosmetics or other products. The agency has not formally responded to Beyond Pesticides’ petition.

Both FDA and EPA share jurisdiction over the regulation of triclosan, and to date neither agency has moved to restrict this hazardous chemical. EPA conducted a risk assessment of triclosan in 2008 and found it eligible for continued use despite evidence of endocrine disruption and widespread water contamination. The U.S. Geological Survey reports that triclosan is one of the most detected pharmaceuticals substances in the nation’s waters. Triclosan impacts the hormone systems of amphibians, accumulates in fish and destroys algal communities. A study conducted by researchers at the CDC detected triclosan in 75 percent of the U.S. population. It has also been found in human breast milk.

Since the 2004 publication of “The Ubiquitous Triclosan,” Beyond Pesticides has been exposing the dangers of this toxic chemical. Now, along with Food and Water Watch and over 80 environmental and public health groups, Beyond Pesticides is leading a national grassroots movement calling for the ban of triclosan from consumer products. Beyond Pesticides is calling on manufacturers, retailers, school districts, local businesses and communities to wash their hands of triclosan and protect our nation’s waters and public health from this toxic pesticide. To learn more about this grassroots campaign and the join the movement, visit our triclosan homepage.

Source: FDA Consumer Updates


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