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FDA moves to revoke soy health claim

The US Food and Drug Administration called into question Monday the health claim that soy protein reduces heart disease risk.

“We are proposing a rule to revoke a health claim for soy protein and heart disease,” said a statement from Susan Mayne, director of the FDA Center for Food Safety and Applied Nutrition. “For the first time, we have considered it necessary to propose a rule to revoke a health claim because numerous studies published since the claim was authorized in 1999 have presented inconsistent findings on the relationship between soy protein and heart disease.”

The authorized health claim is one of 12 such claims allowed on foods. Other examples include the benefits of calcium and vitamin D to reduce risk of osteoporosis, some fruits and vegetables preventing cancer and folic acid preventing birth defects.

The FDA has been evaluating health claims on packaged foods since 1990, it said.

Mayne was careful to note that there is still evidence that shows a benefit between soy protein and heart disease, however, “the totality of currently available scientific evidence calls into question the certainty of this relationship,” she said.

The proposed rule to reverse the claim sets in motion a 75-day public comment period. The comments, along with all related research, will be reviewed to consider whether the rule will become final. If it does, the FDA said, a qualified health claim, which requires less scientific evidence, may be permitted if the agency feels there is evidence to support one.