November 3, 2017

2 Min Read
FDA Mulls Changes to Rules on Soy Protein Health Claims
Unloading soybeans. Image courtesy of USDA

Citing recent research indicating that soy protein does not lower risk levels for coronary heart disease (CHD), the U.S. Food and Drug Administration moved to revise its rules on health claims in food labeling linking the food ingredient to a reduced risk of the heart ailment.

“We have tentatively concluded that there is no longer significant scientific agreement among qualified experts that a health claim regarding the relationship between soy protein and reduced risk of coronary heart disease is scientifically valid,” the agency wrote in a Preliminary Regulatory Impact Analysis report published in the Federal Register on Oct. 31.                                                                                                          

The FDA posits that the rule change is necessary to ensure that those buying products with soy protein can read accurate health information on food packaging to make informed decisions. If the proposed rule moves forward, food producers would be required to remove the health claims from their packaging.

Agency analysts estimate that some 200 to 300 products would have to be relabeled under the proposed rule change, with one-time costs for food companies to make the shift ranging from $400,000 to $890,000. The FDA pointed out that some smaller food companies may find the change burdensome.

“Because up to 40 small businesses could be required to relabel one or more products, we find that the proposed rule may have a significant economic impact on a substantial number of small entities,” the Preliminary Regulatory Impact Analysis said.

If approved, the FDA said that it estimates the final rule will be published in late 2017 with a Uniform Compliance Date set for January 2020.

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