Lead in Women’s and Children’s Vitamins

Abstract

A survey was conducted to determine the extent of lead (Pb) contamination in vitamins labeled for use by women and children. The Pb content of 324 multivitamin-mineral products was determined using microwave assisted nitric acid digestion and inductively coupled plasma mass spectrometry. Cryogenic grinding was used to composite soft samples such as oil filled capsules and candy-like products such as gummies and jelly beans. Estimates of Pb exposures from consumption of these products were derived for four population groups: young children (0-6 yrs), older children (7+ yrs), pregnant or lactating women, and adult women. The estimated median and maximum Pb exposures were 0.123 and 2.88 microg/day for young children, 0.356 and 1.78 microg/day for older children, 0.845 and 8.97 microg/day for pregnant and lactating women, and 0.842 and 4.92 microg/day for adult women. The overall median value for Pb exposure was 0.576 microg/day. Five samples would have provided exposures that exceeded 4 microg/day. Estimates of exposures were assessed with respect to safe/tolerable exposure levels that have been developed for the specific age and sex groups. These safe/tolerable levels are referred to as the provisional total tolerable intake levels (PTTI) and are 6, 15, 25, and 75 microg Pb/day for young children, older children, pregnant or lactating women, and adult women, respectively. Estimates of Pb exposures were below the PTTI levels for the four population groups. Median and maximum values were used instead of the mean and standard deviation because of the skewed distribution of results toward lower mass fraction and exposure.

Inorganic elemental compositions of commercial multivitamin/mineral dietary supplements: Application of collision/reaction cell inductively coupled-mass spectroscopy

“…In the USA, commercially available vitamins and dietary supplements are regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA) by the US Food and Drug Administration (FDA). Recently published FDA regulations hold supplement manufacturers or distributors responsible for the content of the dietary supplement which should only contain what they are labelled and not any harmful or undesirable substances, including pesticides and heavy metals (Mindak, Cheng, Canas, & Bolger, 2008).…”

“…There has been an increasing number of studies focusing on elemental compositions of multivitamin/dietary supplements in order to assess their safety for public consumption (Dolan, Nortrup, Bolger, & Capar, 2003;Mindak et al, 2008;Raman, Patino, & Nair, 2004). The safety of the multivitamin/dietary supplements depends on various factors including, but not limited to, growing conditions of the raw material and its extraction, formulation, and manufacturing processes (Raman et al, 2004).…”

“…The safety of the multivitamin/dietary supplements depends on various factors including, but not limited to, growing conditions of the raw material and its extraction, formulation, and manufacturing processes (Raman et al, 2004). Several studies documented that these supplementary materials may contain high levels of certain elements, especially Pb and As (Amster, Tiwary, & Schenker, 2007;Mindak et al, 2008) compared to their safe/tolerable exposure levels (provisional total tolerable intake level, PTTI) (Amster et al, 2007;Mindak et al, 2008). Therefore, determining elemental compositions of multivitamin/dietary supplements is crucial.…”

LIBS: A Quality Control Tool for Food Supplements

“…Codex Alimentarius Commission [an organization that is sponsored by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO)] has included dietary minerals as a category of food supplement. There have been a lot of studies focusing on elemental compositions of food and dietary supplements to assess their quality for public consumption [1][2][3][4] . Traditionally, dietary supplements such as cod liver oil, iron tablets and multivitamins were taken to ensure the adequacy of the diet.…”

The U.S. Food and Drug Administration Risk Assessment on Lead in Women’s and Children’s Vitamins Is Based on Outdated Assumptions

“…To estimate the range of Pb exposures that might result from consumption of each vitamin product in the study, the FDA multiplied the amount of Pb in each product (the mass fraction) by the maximum recommended daily consumption, as indicated on the package label instructions (Mindak et al 2008). …”