WASHINGTON, Oct. 30, 2017 – The Food and Drug Administration plans to revoke a health claim that consumption of soy protein can help reduce the risk of coronary heart disease (CHD).

In a proposed rule to be published in Tuesday's Federal Register, FDA lays out the case for why the health claim should be removed from food labeling, saying there is no longer “significant scientific agreement” (SSA) on the relationship between soy protein consumption and CHD. The SSA standard is contained in the Food, Drug & Cosmetic Act and accompanying FDA regulations.

FDA estimates that 200 to 300 food products bear this health claim. The main food categories with products bearing this claim include soy milk, protein supplements, snacks, tofu, frozen soybeans, and canned soup.

“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,” said Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition.

“While some evidence continues to suggest a relationship between soy protein and a reduced risk of heart disease – including evidence reviewed by the FDA when the claim was authorized – the totality of currently available scientific evidence calls into question the certainty of this relationship,” Mayne said. “For example, some studies, published after the FDA authorized the health claim, show inconsistent findings concerning the ability of soy protein to lower heart-damaging low-density lipoprotein (LDL) cholesterol. Our review of that evidence has led us to conclude that the relationship between soy protein and heart disease does not meet the rigorous standard for an FDA-authorized health claim.”

The American Soybean Association responded quickly to the announcement. ASA President Ron Moore (pictured above) said that “in a time when heart disease is the number-one cause of death both in the United States and the world, we can’t afford to discourage people from taking steps to improve their diets with heart-healthy ingredients.”

Moore said “there is still evidence that shows eating soy protein can help reduce the risk of heart disease, and while we are of course disappointed that FDA is looking at moving the health claim for these products from ‘unqualified’ to ‘qualified,’ it’s important for consumers to remember that soy protein can be an important part of a heart-healthy diet. Even in today’s announcement, FDA still refers customers to the agency’s 2015-2020 Dietary Guidelines, which state that healthy eating patterns include soy beverages and a variety of protein foods, including soy products. Moving forward, we hope that in its upcoming reevaluation of the available data, FDA will focus on the many studies that show the heart-healthy benefits of a diet that includes soy protein.”

FDA said in the proposal that it “may consider whether there is credible evidence to support a ‘qualified’ health claim and what qualifying statements and other information should accompany the claim to ensure that it is truthful and not misleading.”

Also in its proposal, FDA said it looked at two types of studies: observational and intervention studies. “Well-conducted intervention studies provide the strongest evidence of an effect and are the most reliable category of studies for determining a cause-and-effect relationship,” FDA said, explaining that in those studies, “subjects similar to each other are randomly assigned to either receive the intervention or not to receive the intervention, whereas in an observational study, the subjects (or their medical records) are observed for a certain outcome (i.e., disease).”

“We could not draw scientific conclusions about the relationship between soy protein consumption and risk of CHD from 154 intervention studies due to significant design flaws,” FDA’s proposal said. Seventeen of those studies “did not include a control group or provide an appropriate control for the comparison to the relative effects of soy protein.”

“Seventy-six studies, described in 84 publications, that substituted soy protein for animal protein or were feeding studies, reported large differences in or did not report information on other dietary components that have an effect on blood cholesterol (e.g., dietary fiber, saturated fat, dietary cholesterol),” FDA said. “Such large differences in nutrient intakes of dietary fiber, saturated fat, or dietary cholesterol make it difficult to clearly delineate what may be causing a change in serum cholesterol levels. Therefore, the results of these studies could not be interpreted, and we could not draw scientific conclusions about the relationship between soy protein consumption and risk of CHD from these studies.”

The public will have 75 days to comment on the proposal after it is published Oct. 31.

FDA has authorized 12 health claims for food, "such as the effect of calcium and vitamin D in helping to lower the risk of osteoporosis or certain fruits and vegetables to lower the risk of cancer," Mayne said in her statement.


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