Soy groups respond to F.D.A. proposal to revoke health claim

by Jeff Gelski
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Heart-healthy soy
The Soy Nutrition Institute and the American Soybean Association point out evidence of soy protein’s heart-health benefits.
 

ST. LOUIS — The Soy Nutrition Institute and the American Soybean Association pointed out evidence of soy protein’s heart-health benefits after the Food and Drug Administration on Oct. 30 said it was proposing to revoke a health claim related to soy protein and the reduced risk of heart disease.

Soy protein lowers blood cholesterol levels, according to years of scientific evidence and the conclusions of the F.D.A. and health agencies in Canada and 11 other countries, the Soy Nutrition Institute said.

Ron Moore, American Soybean Association
Ron Moore, president of the American Soybean Association

“In a time when heart disease is the No. 1 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,” added Ron Moore, president of the American Soybean Association and Illinois farmer. “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 F.D.A. 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.”

The F.D.A. authorized a health claim for soy protein in the Oct. 26, 1999, issue of the Federal Register, saying soy protein included in a diet low in saturated fat and cholesterol may reduce the risk of coronary heart disease by lowering blood cholesterol levels. Soybean use soon increased. Total U.S. disappearance of soybeans was 3,944 million bus in 2015, which was up from 2,716 million bus in 1999, according to the U.S. Department of Agriculture.

In a re-evaluation, which included investigating studies published after 1999, the F.D.A. tentatively concluded the evidence does not support its previous determination that there is significant scientific agreement among qualified experts for a health claim regarding the relationship between soy protein and reduced risk of coronary heart disease. The proposal to revoke the health claim was published in the Oct. 31 issue of the Federal Register and may be found here.

Should the F.D.A. finalize the proposed rule to revoke the health claim, the agency intends to allow the use of a qualified health claim as long as sufficient evidence supports a link between eating soy protein and a reduced risk of heart disease.

“The possible change to a ‘qualified’ health claim indicates that while the F.D.A. believes the scientific evidence still supports consumption of soy protein as a means of lowering blood cholesterol levels, it recognizes there is some inconsistency in the results of recent clinical trials,” the Soy Nutrition Institute said. “However, no adverse effects were observed in these studies. Such inconsistency is not at all unexpected as there is no nutrition research area where clinical studies have produced entirely consistent findings. This is true even for the effects of sodium on blood pressure and calcium on bone mineral density, and yet reducing the intake of sodium is routinely recommended by nutritionists as a means of reducing risk of heart disease and increasing calcium intake as a means of preventing osteoporosis.”

The F.D.A. will accept public comments on its proposal for 75 days after it was published in the Federal Register. Electronic comments may be submitted at www.regulations.gov. Written/paper submissions may be sent to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All submissions must include the Docket No. FDA-2017-N-0763 for “Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease.”

The Soy Nutrition Institute plans to submit comments. The Soy Nutrition Institute began in 2004 through the initiative of the United Soybean Board, Chesterfield, Mo., and soy industry leaders. The institute seeks to identify soy and health research priorities, provide evidence-based information on the impact of soybeans and soy components on human health through a variety of education and outreach efforts, and facilitate the development and funding of targeted research projects.

The St. Louis-based American Soybean Association (ASA) represents all U.S. soybean farmers on domestic and international policy issues important to the soybean industry. 
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