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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Mandatory DEHP labeling?: Health Care Without Harm, a coalition of public advocacy organizations, is petitioning FDA to require manufacturers to label for the presence of di(2-ethylhexyl) phthalate, or DEHP, in their medical devices and the potential risks of the material. The July 24 1petition was sent to the agency along with a letter of support signed by groups including the American Medical Association and the American Nurses Association. DEHP is used as a plasticizing (softening) agent with polyvinyl chloride, a common material in medical tubing, IV bags and other hospital storage containers. Some data has linked the substance, which has been shown in some cases to leach in small amounts from the devices into contained fluids, to reproductive effects on male infants. FDA issued a public health notification in 2002 recommending precautions to limit exposure in certain populations including neonates and pregnant and nursing women, but it has declined to require labeling and has rejected previous HCHW petitions to do so. Meanwhile, hospital product manufacturers including B Braun, Hospira and Baxter have increased their DEHP-free offerings in response to market demand (2"The Gray Sheet" April 24, 2006, p. 16)...

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