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DuPont Challenges FDA’s Proposal to Revoke Soy-Heart Health Claim

  • As reported on this blog in October 2017, the U.S. Food and Drug Administration (FDA) proposed a rule to revoke a regulation authorizing the use of a health claim on the relationship between soy protein and coronary heart disease (CHD) (21 CFR 101.82) on the label or in the labeling of foods. FDA estimates that 200 to 300 products currently use that health claim.

  • By way of background, FDA authorized the health claim about the relationship between soy protein and reduced risk of CHD in 1999 in response to a petition from Protein Technologies International, Inc. (now DuPont Nutrition & Health). In 2007, FDA announced its intent to re-evaluate the scientific evidence for certain health claims, including the authorized health claim for soy protein and risk of CHD. After considering new research conducted over the last 18 years, FDA tentatively determined that “the strength of the totality of the publicly available data does not meet the SSA [significant scientific agreement] standard for a relationship between soy protein intake and CHD risk.

  • FDA received 994 comments on that proposal (click here to access the comments). Most of the comments were from individuals supporting revocation of the heart health claim for soy protein. However, DuPont Nutrition & Health suggested in comments that, “by modifying the existing status of the soy heart health claim, FDA is not meeting [its] mandate for providing clear, evidence-based guidance that is practical and actionable.” Dupont agreed with FDA’s approach to limit or omit many of the 709 publication on the relationship between soy and heart health but questioned the criteria used. For example, noted Dupont, over half of the studies considered by FDA were conducted outside North America and, therefore, are not relevant to the U.S. population. Dupont also stated that FDA didn’t include studies that potentially better reflected the dietary patterns and health status of the current population.

  • “Soy protein can be included in the diet along with other recognized components that have a beneficial effect on heart health, in alignment with current Dietary Guideline, suggesting a greater shift toward plant-based eating,” Dupont concluded.

© 2020 Keller and Heckman LLPNational Law Review, Volume VIII, Number 23
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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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