FDA Looks At Whole Grain Health Claims

June 02, 2011

A proposed new study from the Food & Drug Administration may lay the groundwork for renewed enforcement action in the whole grain area.

A proposed new study from the Food & Drug Administration may lay the groundwork for renewed enforcement action in the “whole grain” area, according to The Food Institute.  Last month, FDA published a Federal Register notice requesting public comments on a proposed study entitled: “Experimental Study on Consumer Responses to Whole Grain Labeling Statements on Food Packages.” 

The proposed study is significant because the results, depending on the outcome, could form the basis for regulatory action. FDA received a Citizen Petitions for rulemaking in the area, and complaints requesting enforcement action against label claims, such as “made with whole wheat,” for products that are primarily made with enriched wheat flour.

The results of the FDA study might also be used by private class action litigants who have challenged “whole wheat” claims under state Unfair and Deceptive Acts and Practices statutes noted Food Institute counsel OFW Law.  In the Fed Reg notice, FDA indicates that whole grain consumption is being promoted by government agencies and the public health community as an important part of a healthy diet, citing the U.S. 2010 Dietary Guidelines for Americans, published jointly by the Department of Agriculture and the Department of Health and Human Services. That publication advises Americans to strive to make half their total grain consumption whole grains. Appendix 4 of the Dietary Guidelines alludes to possible consumer confusion with “whole grain” statements. 

FDA confirms this view in its Federal Register notice stating, “Several studies indicate that consumers may have difficulties in understanding the meaning of whole grains or recognizing whole-grain foods.” The agency plans to specifically examine: 
Consumer perceptions about differences between various statements, such as “Made with Whole Grain,” “Contains Whole Grain,” and “Whole Grain”;

Consumer extrapolation of whole grain statements beyond the scope of the statements themselves.

Thus, the agency’s new study, depending on the results, could lead to renewed enforcement action in the “whole grain” area. The FDA’s Federal Register notice states “the study is part of the agency’s continuing effort to engage consumers to make informed dietary choices and construct healthful diets” and that “results of the study will be used primarily to enhance the agency’s understanding of how whole grain claims” may affect dietary choices. However, studies such as this one can provide the agency with evidence to justify regulatory action in the form of rulemaking, guidance statements or enforcement actions, and be used by private litigants in cases challenging “whole grain” claims.

The Food Institute will be monitoring this process in its weekly report and in its daily e-mail updates.


For more, check out this recent article in Food Navigator: Colour may be key to consumer acceptance of whole grain foods: Study