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Editor’s Note: The new soybean oil health claim was allowed in response to a petition submitted by Bunge Limited and is available on the FDA website. A letter of enforcement discretion from the FDA authorizing the new claim is also available on that site.
The new QHC for soybean oil is among the strongest of such claims approved by the FDA to date. This outcome reflects the strength of the scientific evidence attesting to the cardioprotective protective properties of this commonly used oil, and is consistent with recommendations in the 2015-2020 Dietary Guidelines for Americans and those from other public health authorities. The availability of this claim allows soybean oil and certain soybean oil-containing foods to use heart-shaped vignettes in labeling and promotional materials, and offers incentives for the food industry and other stakeholders to educate consumers about the benefits of this heart-healthy oil.
By Guy Johnson, PhD,
The U.S. Food and Drug Administration (FDA) vouched for the heart-health benefits of soybean oil in 2017 by acknowledging that there is sufficient “supportive scientific evidence” to authorize a new Qualified Health Claim (QHC) for soybean oil and certain foods made from it. Exact wording of the new claim reads: “Supportive but not conclusive scientific evidence suggests that eating about 1 ½ tablespoons (20.5 grams) daily of soybean oil, which contains unsaturated fat, may reduce the risk of coronary heart disease. To achieve this possible benefit, soybean oil is to replace saturated fat and not increase the total number of calories you eat in a day. One serving of this product contains [x] grams of soybean oil.”
By Mark Messina, PhD, MS,
Meta-analyses of the clinical data consistently show that soy protein lowers circulating LDL-cholesterol (LDL-C) levels. The most recent meta-analysis demonstrating this finding to be the case was published in 2015. The first one was published in 1995. Four years later, after conducting its own analysis of the literature, the U.S. Food and Drug Administration (FDA) authorized a health claim for soy protein and reduced risk of coronary heart disease. Since 1999, similar claims have been approved in 11 other countries; the most recent country to do so was Canada in 2015.
The Soy Nutrition Institute (SNI) is now a co-sponsor of The Soy Connection newsletter, helping to bring the latest news about soy research to health professionals both in this newsletter and on the SNI web site.