| The U.S. Food and Drug Administration Risk Assessment on Lead in Women’s and Children’s Vitamins Is Based on Outdated Assumptions Amir Miodovnik1,2,3 and Philip J. Landrigan1,2,3 1Children’s Environmental Health Center, 2Department of Community and Preventive Medicine, and 3Department of Pediatrics,
Mount Sinai School of Medicine, New York, New York, USA Abstract
Background: Following a recent report of lead in certain commercial vitamin products, the U.S. Food and Drug Administration (FDA) conducted a nationwide survey to determine the Pb content in 324 multivitamin/mineral products labeled for use by women and children. The FDA compared estimated Pb exposures from each product with safe/tolerable exposure levels, termed provisional total tolerable intake (PTTI) levels, previously developed for at-risk population groups in 1992. Objective: We investigated the FDA’s conclusions that Pb concentrations in all vitamin products examined do not pose a hazard to health because they are below the PTTI levels for all groups considered. Discussion: For their initial estimations of PTTI levels, the FDA used a blood lead level (BLL) of 10 µg/dL as the threshold for adverse effects in children and in pregnant or lactating women. Studies have repeatedly linked chronic exposure to BLLs < 10 µg/dL with impairments in cognitive function and behavior in young children despite the absence of overt signs of toxicity. The FDA analysis also omitted any consideration of nonfood sources of Pb exposure, which is inconsistent with our current understanding of how most children develop elevated BLLs. Conclusion: We feel that based on these oversights, the FDA’s conclusions are unduly reassuring and that reconsideration of their current recommendations appears warranted. Key words: fetal and child neurobehavioral development, Food and Drug Administration, lead, provisional total tolerable intake levels, vitamins. Environ Health Perspect 117:1021–1022 (2009) . doi:10.1289/ehp.0900573 available via http://dx.doi.org/ [Online 25 March 2009]
Address correspondence to A. Miodovnik, Children’s Environmental Health Center, Department of Community and Preventive Medicine, Mount Sinai School of Medicine, One Gustave L. Levy Place, Box 1057, New York, NY 10029 USA. Telephone: (212) 241-5756. Fax: (212) 996-0407. E-mail: amir.miodovnik@mssm.edu The authors declare they have no competing financial interests. Received 14 January 2009 ; accepted 25 March 2009.
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