The proposed study, which would examine how people respond to a variety of footnote and cueing systems, could ultimately be used to re-evaluate labeling requirements for trans fat disclosure.
Announced this week, the experimental study must first receive approval from the Office of Management and Budget (OMB). If approved, the collection of information will allow FDA's Center for Food Safety and Applied Nutrition (CFSAN) to formulate decisions and policies affecting trans fat labeling rules.
Trans fats have only been declared on product labels for the past year, following the implementation of new labeling requirements in January 2006. But although the new labeling system resulted in a sweeping effort to remove the artery-clogging fats from food products, it also inspired heated debate on consumer perception and understanding of trans fats.
This was partly because of a blank space left in the '% Daily Value' column of product labels next to the indicated level of trans fats - because unlike other fats, there is no recommended daily intake value of heart-damaging trans fats.
This inconsistency was recognized by the FDA; when it issued the final rule requiring trans fat labeling in 2003, it also issued an advance notice of proposed rulemaking to include footnotes in the labeling.
At the time, the agency sought comments about whether it should consider requiring statements about trans fat - either alone or in combination with saturated fat and cholesterol - as a footnote on the Nutrition Facts Panel (NFP). The proposal was designed to enhance consumer understanding about the cholesterol-raising lipids and about how to use information on the label to make healthy food choices.
Comments received in response to the notice contained suggested footnotes and cueing schemes, including suggestions such as "intake of trans fats should be as low as possible".
The FDA's current proposed study will evaluate the ability of several possible footnotes and cueing schemes to help consumers make heart-healthy food choices.
"FDA plans to use the consumer studies results along with comments to the trans fat ANPRM (68 FR 41507) and other information to determine a strategy for further rulemaking involving trans fat labeling. A completion date has yet to be established, but it will be dependent on when the consumer research is completed," the agency told FoodNavigator-USA.com.
"The agency often lacks empirical data about how consumers understand and respond to statements they might see in product labeling. The information gathered from this experimental study will be used to estimate consumer comprehension and the behavioral impact of various footnotes and cueing schemes intended to help consumers better understand quantitative trans fat information," it said.
The FDA received a number of comments earlier this year regarding the information collection that will take place as part of the experimental study. These resulted in the partial revision of its Full Information treatment.
Specifically, the agency added mention of calories and other sources of energy in its discussion of fat as a major source of energy. It also added mention of natural sources of trans fat, as well as the similarity between trans fat and saturated fat in terms of product shelf life and taste.
Another comment received related to the '0g' trans fat claim, an issue that has inspired heavy criticism from consumer groups over the past year. Current FDA labeling regulations allow food manufacturers to list amounts of trans fats less than 0.5g per serving as 0g on product labels. And although this provides food makers with a margin of flexibility in their formulations, it also means that people could be consuming certain levels of trans fats without being aware of it.
In the comment received, the FDA was asked to examine the use of a footnote to a product's ingredient list to explain that there may be a trans fat ingredient in the product when the NFP shows trans fat as zero.
However, the FDA rejected this suggestion, stating that "whether this causes consumer confusion is an issue outside the scope of the proposed research, which focuses on the effects of NFP footnotes and alternative presentations of trans fat information in the NFP on consumers' ability to correctly identify more healthful food products".
The agency added that the Office of Nutritional Products, Labeling and Dietary Supplements has received and responded to a separate letter on this topic from the commenter.
The FDA's study is expected to involve around one million American adults, each of whom will be randomly assigned to one of 144 experimental conditions.
To access the full FDA notice Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosure on the Nutrition Facts Panel, click here.
To access the FDA notice Proposed Experimental Study of Trans Fat Claims on Foods, click here.