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Bill Would Require FDA to Regulate Baby Products

Apr 29, 2009 | Parker Waichman Alonso LLP

Last month we wrote about the possibility that carcinogens had made their way into a variety of baby products. Following the study that broke that news, U.S. Senator Kirsten Gillibrand is taking steps to protect the nation’s children, said the Hudson Valley Press.

Baby shampoos, bubble baths, and lotions were reviewed by the nonprofit health advocacy group, Campaign for Safe Cosmetics (CSC) and over half of the products tested came back positive for cancer-causing toxins, said the Washington Post in March. Now, Senator Gillibrand has taken steps with new legislation she wrote entitled “The Safe Baby Products Act,” said the Hudson Valley Press. The Act “directs” the U.S. Food and Drug Administration (FDA) to “investigate and regulate … chemicals in cosmetics and personal care products marketed to and used by children,” said the Hudson Valley Press.

According to the CSC, Johnson & Johnson Baby Shampoo and Baby Magic lotion both tested positive for either 1,4-dioxane or formaldehyde, or both, said the prior Washington Post article. Web MD noted at that time that the chemicals will likely not be listed on baby product labels, but not appearing on a label does not indicate the products are free of the dangerous chemicals; because the toxins are not intentional ingredients, the manufacturers do not have to list them, even when present.

Although restrictions do not exist for permissible levels of the chemicals in body care products in the United States, the new legislation will mandate the FDA to investigate product safety, report its findings, and establish production processes to minimize or eliminate the toxins, said the Hudson Valley Press. “Like many other mothers in New York, when I read the list of these products, I immediately began to worry that I had been using some of these same products for my own children,” said Senator Gillibrand adding, “This common sense legislation will ensure that we have all the facts about the baby soap and lotions that we use on our children,” quoted the Hudson Valley Press.

The study found that the majority of products tested contained 1,4-dioxane or formaldehyde and about half tested positive for both. 1,4 dioxane is a known “eye and respiratory tract irritant,” said the Hudson Valley Press, and is “classified as a Group 2B carcinogen by the International Agency for Research on Cancer (IARC)”; formaldehyde is a known skin irritant a “probable carcinogen.”

Many critics claim that the amounts of toxins and carcinogens are trace, thus creating negligible effects for children; however, Stacy Malkan, a CSC spokeswoman, pointed last month that regardless of how low the level, there are low levels of carcinogens in a wide variety of products, which increases actual aggregate exposures, reported the Washington Post, adding that no studies ever actually examined the effects of these chemicals on the susceptible and developing bodies of babies and children. The Hudson Valley press said that Environmental Protection Agency (EPA) estimates indicate that infants are anywhere from 10 to a staggering 65 times more vulnerable to cancer-causing toxins than adults.

In other countries, the chemicals are simply not allowed in such products: Formaldehyde is banned in cosmetics sold in Japan and Sweden; 1,4-dioxane is banned from cosmetic products in the European Union (EU), reported WebMD last month.

Senator Gillibrand has since written to Acting FDA Commissioner, Frank M. Torti, urging action on this issue, said the Hudson Valley Press.