EWG Letter to Infant Formula Manufacturers

Background.

BPA is a toxic plastics chemical that leaches from the lining of metal food cans, including infant formula cans. Based on limited data from an FDA testing program of infant formula (14 samples) and recent tests of 6 samples by EWG, it appears that BPA may widely contaminate canned infant formula, and that formula-fed infants may be the most highly exposed population in the U.S. On July 31, 2007 EWG sent a request for data (below) on BPA levels in infant formula, to the infant formula manufacturers listed below, to learn what manufacturers know about the level of this problematic chemical in their products.

  • Wyeth Pharmaceuticals; Global Packaging
  • Wyeth Nutritions; Bernard J Poussot, President
  • Nature’s One, Inc.; Jay Highman
  • Earth’s Best; Irwin D. Simon, CEO; Consumer Relations
  • Mead Johnson Nutritionals; Steve Golsby, President; Packaging Technology Group
  • Nestle Infant Nutrition; Pete Brabeck-Letmathe, CEO; Consumer Relations
  • Ross Pediatrics; Gary E. McCullough, Senior Vice President; Consumer Relations
  • Abbott Laboratories; Miles D. White, CEO; Public Affairs

EWG request to manufacturers.

July 31, 2007
Dear [manufacturer],

The National Institutes of Health (NIH) are currently assessing the effects of exposure to bisphenol A (BPA) on human reproduction and development. Results from numerous animal studies indicate that very low doses of this compound can harm the brain and reproductive systems and may set the stage for cancer later in life. Limited test data, including studies of canned infant formula, show that BPA is able to migrate from the can liner into foods. Some measurements of BPA concentrations in formula are at levels above what many laboratory animal studies find harmful.

We are therefore writing with grave concerns about the potential for bisphenol A contamination in your canned infant formula products.

Formula-fed infants may receive the most intense exposures to BPA of any age group. The NIH review estimates that a formula-fed infant ingests between 1.6 and 8 micrograms (ug) BPA per kilogram (kg) of body weight daily. This is troubling, given that the NIH review identified studies that show toxic effects at doses lower than these, including a decline in testicular testosterone production at a daily dose of BPA of just 2.4 ug/kg per day (Akingbemi 2004).

The NIH is basing its assessment of infants’ exposures to BPA on a limited number of liquid infant formula samples. These samples cannot possibly adequately reflect BPA variability in canned infant formula nationwide, which can be influenced by many factors including the specific epoxy used in the can lining. To ensure that the best possible information is available to the NIH panel as well as parents, physicians and public health officials, we call on you to publicly disclose:

  1. The type of epoxy lining used in your steel and non-metal containers for powdered and liquid formula (i.e. epoxy-fatty acid, epoxy melamine, epoxy-castor oil, epoxy-ester, as well as the supplier/manufacturer name);
  2. The results of any tests you have conducted measuring the amount of BPA in liquid or powdered formula samples;
  3. Any analyses you have conducted on infant exposure to BPA from consumption of your products.

A number of studies suggest that BPA contamination in infant formula may be ubiquitous. In 1996, analyses by the Food and Drug Administration detected BPA in all 14 liquid infant formulas tested. Based on what was then known about BPA's toxicity, FDA considered the exposures to be acceptable (Bailey 1996). More than a decade has passed, however, and now dozens of laboratory studies show adverse effects and damage caused by BPA at increasingly low doses. We find no publicly available data to suggest whether or not your company or other formula makers have taken action to reduce BPA migration into formula in the 11 years since FDA conducted their tests, but our own recent study of a limited number of formula samples revealed contamination in some brands at levels above those the FDA detected in 1996.

To our knowledge there has been no scrutiny of BPA in powdered formulas sold in the United States. However, BPA was detected in all 6 samples of infant formula tested by researchers at the National Central University in Taiwan. Their 2004 study, which tested 3 powdered infant formulas and 3 "follow-up formulas," found “ubiquitous” BPA contamination at levels ranging from 44-113 ppb (Kuo 2004).

When parents buy formula for their children they are placing absolute trust in the company that produced it. Protecting public health demands transparency about the levels of BPA that may contaminate your products.

Thank you for your attention to this matter. Please let us know how you intend to make this critical information public. If you have any questions, please let us know.

Sincerely,

Richard Wiles
Executive Director

References:

Akingbemi BT, Sottas CM, Koulova AI, Klinefelter GR, Hardy MP. 2004. Inhibition of testicular steroidogenesis by the xenoestrogen bisphenol A is associated with reduced pituitary luteinizing hormone secretion and decreased steroidogenic enzyme gene expression in rat Leydig cells. Endocrinology 145:592–603.

Bailey AB, Food and Drug Administration. 1996. Cumulative Exposure Estimated for Bisphenol A (BPA), Individually for Adults and Infants from Its Use in Epoxy-Based Can Coatings and Polycarbonate (PC) Articles Branch, (G. Diachenki PhD, Division of Product Manufacture and Use, HGS-245).

Environmental Working Group. 2006. Bisphenol A: Toxic plastics chemical in canned food. https://www.ewg.org/reports/bisphenola

Kuo HW, Ding WH. Trace determination of bisphenol A and phytoestrogens in infant formula powders by gas chromatography-mass spectrometry. J Chromatogr A. 2004 Feb 20;1027(1-2):67-74.

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