FDA Responds to Scientists' Claims: Soy Is Safe

FDA Responds to Scientists' Claims: Soy Is Safe

WASHINGTON--Though two Food and Drug Administration (FDA) scientists made statements that questioned the safety of soy products, the FDA itself issued a comment on Aug. 14 that reiterated its original position. In late May, Drs. Daniel Doerge and Daniel Sheehan wrote a letter to the FDA saying that the soy health claim was issued without enough research into soy's adverse effects on health. However, according to the FDA, soy's benefits outweigh any potential health problems it may cause. 

In that letter, the scientists questioned soy's safety in infant formulas. They claimed soy's phytoestrogens may cause fertility problems later in life for infants weaned on soy formula. They also said that women who consumed soy regularly had an increased risk of breast cancer and men had an increased risk of brain damage. They did not say exactly how much soy must be consumed in order to cause these problems. 

Since the letter was published, the scientists have been quite vocal with their concerns. Their research was the basis of a June 9 segment for20/20. In that interview, Doerge was quoted as saying, "The animal data is a clear indication for adverse effects, [and] the potential for adverse effects in humans." At the time of its airing, the FDA had not issued a response. However, in order to offset the effects of that interview, the FDA made an official comment on Aug. 14 to reiterate that soy products are safe to consume and do indeed possess health benefits. 

An FDA official noted the recent negative spin on soy's safety brought about by Doerge and Sheehan. "We are well aware of the concerns, but we did balance those concerns with the other positive effects [when making the soy health claim]." 

After reviewing considerable scientific research, the FDA noted that those who consumed 25 g of soy protein per day would see significantly lowered cholesterol levels and could lower their risk of heart disease. The FDA set its standard [for the health claim] at 25 g of soy protein per day. When it permitted the claim, it said that reports of soy's damaging effects are based on inconclusive research. The FDA found that the phytoestrogens' actual effect is "very limited" and is actually much less powerful than that of estrogens found in the human body or synthetic estrogens. For more information, visitwww.fda.gov.