Soy Formula Panel Caves to Industry Pressure


Another Generation of Children Condemned to
Allergies, Thyroid Disease, Learning Disorders and Infertility

ALEXANDRIA, VA. December 18, 2009: In response to soy industry revelations that a vote indicating “some concern” would be highly damaging to soy’s image and industry profits, a National Institutes of Health expert panel voted that the health risks of soy infant formula are “minimal.”

The panel also ignored requests to require warning labels on soy formula, or to make it available only by prescription with physician monitoring.

The fourteen-member committee, convened by the National Toxicology Program (NTP) Center for the Evaluation of Risks to Human Reproduction (CERHR), was swayed by representatives from the formula industry and panel member Dr. Jatinder Bhatia from the Medical College of Georgis.

Ruth Etzel, MD, PhD, from George Washington University, Department of Environmental and Occupational Health, was the only panel member to dissent from the majority, concluding that several of the studies the committee had reviewed provided enough evidence of soy toxicity to require a finding of “some concern.”

Panelist Patricia Hoyer, PhD, of the University of Arizona Department of Physiology, changed her intention to vote for “some concern” to one of “minimal concern” after her specific group of male panel members pushed for the finding of “minimal concern.”

The fourteen panelists looked at almost seven hundred studies, of which a portion were industry-funded reports, while ignoring a multitude of other unbiased published studies (as well as numerous NIEHS, NIH, and FDA negative soy reports) that repeatedly conclude soy phyto-toxicity, especially during developmental exposures.

Gail Elbek of Santa Barbara, California provided the panel with a compilation of over seven hundred additional studies showing extensive physiological, reproductive and neurological adverse effects caused by soy phyto-estrogens, especially during developmental exposures. Sally Fallon Morell, president of the Weston A. Price Foundation, noted in her written testimony that the FDA Toxic Plant Database lists almost three hundred studies showing toxicity of soy; she also provided the committee with studies showing severe thyroid and mucosal damage in infants fed soy formula.

The other speakers were all from the industry or were taking part in government-funded research, including Thomas Badger, PhD, and Martin Ronis, PhD, of the University of Arkansas for Medical Sciences, Haley Stevens, PhD, of the International Formula Council, David Bechtel, PhD, CANTOX U.S., Inc. (a consulting firm dedicated to “facilitating timely regulatory approvals”), and Larry Williams, MD, Abbott Nutrition (maker of soy infant formula). In their testimony, they assured the committee that soy infant formula was safe and did not have estrogenic effects.

Stevens of the International Formula Council insisted that there was “no new evidence” that would warrant a re-evaluation of soy formula and complained about “alarmist” literature that was scaring parents away from this “safe and healthy choice.”

In fact, many parents have been scared away. Over the last ten years, the portion of formula-fed babies has declined from 22.5 percent to 12 percent. And the CERHR panel vote of “minimal concern” compared to the vote of “no concern” handed down several years ago indeed indicates increased anxieties about the negative health effects of soy-based formula.

As Fallon Morell pointed out in her testimony, the tragic consequences of soy infant formula are falling most heavily on minority families participating in programs like Women, Infants and Children (WIC), where soy formula is routinely given to black, Hispanic, Asian and Native American mothers presumed to be “lactose intolerant.” “Educated women are not taking any chances giving soy formula to their vulnerable infants,” said Fallon Morell, “so the industry is targeting those who do not understand the dangers.”

Elbek criticized the quality of the studies the panel chose to review. “Too many of the studies reviewed are linked to industry, while at the same time the panel ignored hundreds of non-biased studies showing drastic reproductive damage, as well as interruption of neurological development, which can manifest as irreversible learning and behavior problems,” said Elbek. “Furthermore, many of the universities represented on the panel are too often industry funded.”

The only panelist to vote that soy formula was of “no concern” was Jatinder Bhatia, MD, from Medical College of Georgia. Bhatia has received extensive funding from the National Institutes of Health, foundations, and the food and pharmaceutical industries over the years. In addition to soy formula for infants, he advocates lowfat diets for infants after the age of seven months and cholesterol-lowering drugs for children ages eight and older.

Other panelists voting “minimal concern” included Katie Turner, PhD, from Merck Research Laboratories (Merck produces soy-based infant formula), Claire Sherman, PhD, of Cerus Corporation and Michael Rybak, PhD, from the Centers for Disease Control and Prevention.

According to Elbek, the soy studies carried out by the Medical College of Georgia often reveal industry bias. Furthermore, many of the studies that qualified for panel review looked at one dosage or just a few dosages of soy and not the effects of the 100 percent soy-based diet day after day in soy-fed infants.

The panel arbitrarily decided that soy causation of reproductive risk had to occur during infancy and did not look at soy damage diagnosed in the toddler or later in life, while reproductive damage is commonly not diagnosed until reproductive age. “Studies indicate that soy phyto-estrogens demonstrate estrogenic effects at doses equal to or even lower than doses of DES estrogen, and can mimic or antagonize endogenous estradiol, a process that is well-known to jeopardize developmental health,” said Elbek in her testimony.

Elbek criticized the panel for rushing through the evidence of soy genistein’s phyto-toxicity and for largely disregarding damaging effects caused by daidzein (metabolite equol) and glycitein, individually or in combination with other estrogenic endocrine disruptors. “Even in some of the industry-funded studies, genistein was shown to cause reproductive toxicity,” said Elbek, “but the panel chose to focus on perceived flaws in these studies as a way of dismissing them.”

Elbek also noted that the panel avoided discussion of negative effects on digestion, thyroid function and brain development. “Soy formula is full of toxins including phytates, trypsin, tyrosine, and topoisomerase II inhibitors, saponins, nitrites, lysinalanine, and toxic metals such as aluminum, cadmium, manganese, thallium, lead and arsenic, all known to be especially harmful during developing brain and body exposures.”

In her testimony, Fallon Morell explained that an infant on soy formula receives as a function of body weight a dose of estrogenic isoflavones over ten times greater than the dose that caused thyroid suppression in Japanese subjects receiving adequate iodine after three months, and over eight times greater than the dose that caused hormonal changes in American women after one month. “Surely with these numbers, the panel should urge the precautionary principle and warn mothers about the potential dangers of giving soy formula to their infants.”

Industry representatives argued that humans do not convert soy isoflavones to equol, the most active form of estrogen, as efficiently as animal do. “But with the high doses of isoflavones in soy formula, even a conversion of 10 percent puts the infant at risk,” said Fallon Morell, “and some infants convert isoflavones to equol very efficiently. Studies by Kenneth Setchell show that babies on soy formula have levels of serum estrogens at levels 13,000-22,000 times greater than those in infants who have been breastfed or given milk-based formula. Even if only a small percentage of these estrogens is in the active form, the exposure to the vulnerable infant is huge. While the industry concentrates on damage control, we hear from the heart-broken mothers reporting breast development in their young female children, arrested or delayed puberty in their soy-fed male children, and severe learning and behavior problems in both sexes.”

According to Fallon Morell, a baby on soy formula receives about six grams of soy protein per day, which on a body-weight basis is equivalent to 60 grams in an adult. “Soy industry scientist and lobbyer Mark Messina, PhD, warns against consumption of more than 20 grams of soy protein per day in adults. The American Dietetic Association recommends no more than two servings of soy per day. Yet we are feeding our infants six or more servings of soy per day.”

In her testimony, Fallon Morell also pointed out the high levels of oxalates in soy formula. “Oxalates can build up in any tissue, not just in the kidneys, with painful and long-lasting effects. Soy contains ten times more oxalates than spinach.” She also noted the lack of cholesterol in soy-based formulas. “Babies need cholesterol for the development of their brains and intestinal tracts. Mother’s milk is very rich in cholesterol and contains a special enzyme to ensure that all the cholesterol is absorbed. Without cholesterol in the infant diet, the baby is at risk for altered brain development and poor gut integrity, both of which are frequent in soy-fed children.”

Elbek and Fallon Morell both urged the panel to explore the connection between soy formula and autism. “We are hearing from therapists that a disproportionate number of autistic children received soy formula as infants,” said Fallon Morell.

Elbek reports that “Soy is proven to damage several neurotransmitter systems, and autism is known to be caused by disruptions in these neurotransmitters. Interestingly, soy damage caused to the thyroid and thymus further damages the immune system and the cerebral cortex of the brain, the same region related to the cause of autism. Based upon the multitude of existing published studies, I doubt very much that any of the panelists would risk feeding their infants and grandchildren soy formula. I intend to request that the expert panel provide a questionnaire to children’s hospitals, clinics and doctors’ offices to compile damage caused by soy formula, because the excuse based upon ‘lack-of-study information in infants and children’ must not continue. Morally, scientists are extremely hesitant to deliberately place infants in a soy toxicity study, although it remains unknown to parents that the infants who are fed soy formulas or foods are participating in an undocumented experiment.”

“In the face of such intense industry pressure, our only recourse is the court of public opinion,” said Fallon Morell. “If you believe that one of your children or grandchildren has been damaged by soy formula, please write to your elected representatives and government officials such as Kathleen Sebelius of HHS or Kristina Thayer, administrator of the CERHR panel. You can also post adverse effects from soy at”

Kristina Thayer, PhD,
NEIHS/NTP, NTP Center for the evaluation of Risks to Human Reproduction (CERHR)
530 Davis Drive, Room 2154/Mail Drop K2-04
Morrisville, NC 27560

Kathleen Sebelius, Secretary
The U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201

Medwatch reports:

CONTACT: Kimberly Hartke, Publicist
The Weston A. Price Foundation
(703) 675-5557

Sally Fallon Morell is the founding president of the Weston A. Price Foundation and founder of A Campaign for Real Milk. She is the author of the best-selling cookbook, Nourishing Traditions (with Mary G. Enig, PhD) and the Nourishing Traditions Book of Baby & Child Care (with Thomas S. Cowan, MD). She is also the author of Nourishing Broth (with Kaayla T. Daniel, PhD, CCN).

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