By Jake Rossen
By Jesse Marx
By Michelle LeBow
By Alleen Brown
By Maggie LaMaack
By CP Staff
By Jesse Marx
U.S. government officials first became aware of phthalates in infant formula in 1985, when a study found that phthalate levels were higher than desired but not at "dangerous levels," according to Elizabeth Yetley, director of the Office of Special Nutritionals (CFSAN) at the Food and Drug Administration (FDA), who was quoted in a June 3, 1996 issue of Food Chemical News. At the time of the testing in Britain, Yetley said, "Based on the best information we have now, the levels in U.S. formulas are much, much lower than the apparent levels were in the British products." The FDA hasn't taken any action on phthalates in formula because, according to Dr. Michael Bolger, head of the Contaminants division at the FDA, "it was felt that the most effective way to get at this particular issue was to identify controllable sources and to minimize or discontinue use of this kind of plasticizer."
After reading the article in Food Chemical News, I decided to contact Bolger directly. In email correspondence, he told me, "Unlike the manufacturers in the U.K. in the latter part of the 1980s, U.S. manufacturers eliminated the use of phthalates in their packaging materials because of concerns of possible carcinogenic effects observed in lab animal bioassays [tests]." However, in a subsequent phone conversation, he said he assumed manufacturers had voluntarily made process changes; it was never mandated by the agency and he hadn't followed up to see whether formula manufacturers ever actually eliminated phthalates from their packaging. He also said that any testing for phthalates now would be done voluntarily by the companies.
Following up with the Infant Formula Council, the trade association for manufacturers of baby formula, proved fruitless. Despite repeated contact attempts--two phone calls, one fax, and a letter from me to them--I never got any answers. The staff person with whom I actually spoke had no idea what phthalates were. She promised to get back to me after contacting their member companies, but so far, no information has been forthcoming.
The customer service representative at Ross Products (the division of Abbott Laboratories that makes Similac) had no idea what I was talking about; she took my name and number. No one has gotten back to me. Sandy Willett of Mead Johnson (the division of Bristol-Myers Squibb that makes Enfamil) told me that to her knowledge, there is no DEHP in their packaging materials, and that stainless steel equipment is used during the production process. She also said that, to her knowledge, Mead Johnson has not tested its infant formula products for phthalates.
I played "voice-mail tag" with Pam Aldrian of Nestle, a company with a record of customer concern over formula. She reported that Nestle's Carnation products are all tested for phthalates "on a regular basis," and the levels have been found to be below the detection limits (five to ten parts per billion). Nestle does not believe phthalates pose a "health risk" to infants, but claims to have certification from suppliers that their products, both soy and dairy, are "phthalate-free" or below detection using EPA methods.
What Could Infant Formula Makers Do Differently?
U.S. formula makers should begin by testing their products for phthalates and publicizing the results (as well as reporting them to the FDA). Currently, consumers have no simple way of accessing this information.
If phthalates are found at levels above the limits of detection, manufacturers should undergo a thorough analysis of their production processes to identify sources of phthalate contamination and take immediate action to eliminate phthalates from those sources. This process should be supervised by the FDA.
And any and all chemicals used in the packaging or processing of infant formula should be screened for their potential to cause cancer, birth defects, or disrupt the hormone system.
What Can Our Government Do?
Other nations that have already acted on phthalates provide leads for our government to follow: Denmark's environment minister, Svend Auken, has called on the Danish Environmental Protection Agency to ban the use of toxic substances, including phthalates, in toys because of concerns over health risks.
The Toronto, Ontario Public Health Department issued a report in September, 1997 to the Board of Health, calling on the Canadian Food Inspection Agency to make sure: 1) that phthalate levels in formula and fluid milk "are kept as low as technologically attainable and within relevant guidelines"; 2) that Health Canada (their federal agency on health matters) continue testing for phthalates in formula, milk, and other foods and keep levels as low as technologically possible; and 3) that Health Canada review and revise, if necessary, the "Tolerable Daily Intake" (TDI) for DEHP to make certain that it protects all age groups [emphasis mine] in the general population as well as vulnerable groups. Independent testing for phthalates to corroborate the manufacturers' findings is also critical.
What Can Consumers Do?
Breastfeed if you can. Even though phthalates are probably present in breast milk, too, the health benefits of breastfeeding are numerous and powerful.
Contact infant-formula manufacturers, and ask them to test their products, release test results to consumers, and change their production processes, if necessary. (Ask Nestle to get verification that Carnation products are indeed phthalate-free, and then put that information on their formula cans.)