May 4, 2010 | Kelley Drye Client AdvisoryThe Food and Drug Administration (“FDA”) issued a notice last week seeking public comment and consumer research data in support of the agency’s initiative to improve the usefulness of nutrition information provided to consumers at the point-of-purchase, including through front-of-package (“FOP”) labeling and shelf tags in retail stores (“FOP initiative”). FDA’s request for information comes while a related study by the Institutes of Medicine (“IOM”) remains pending. The IOM Committee on Examination of Front-of-Package Nutrition Rating Systems and Symbols currently is evaluating scientific evidence concerning the nutrition information and ranking systems that currently are used by food manufacturers and retailers for FOP labeling, shelf tags, and other food marketing purposes.
The FDA notice states that the goal of the agency’s FOP labeling initiative is to “maximize the number of consumers who readily notice, understand, and use point-of-purchase information to make more nutritious choices for themselves and their families.” To that end, FDA is establishing a docket which will allow interested parties an opportunity to provide consumer research data concerning FOP labeling and other information that may be helpful to the agency.
In its evaluation of FOP labeling issues and options, FDA seeks to support and advance the public health and consumer education objectives established under the Nutrition Labeling and Education Act (“NLEA”), enacted in 1990. The FDA notice indicates that the NLEA was designed to inform consumers about the nutritional value of food in a manner that enables consumers to make healthy food choices as part of an overall public health promotion strategy aimed at reducing diet-related disease risks. The FDA notice reinforces the agency’s commitment to the pubic health policy objectives of the NLEA, noting Commissioner Margaret Hamburg’s recent statement suggesting that the need for consumers to have “ready access to reliable information about the calorie and nutrient content of foods” may have grown in importance in recent years, in view of U.S. trends concerning the increased prevalence of obesity and other diet-related diseases.
The notice states that FDA and USDA currently are working with public and private stakeholders to develop a voluntary FOP nutrition label that is driven by sound nutrition criteria, consumer research and design expertise. Per the notice, research should be designed to support the choice of an FOP label that will achieve the criteria for success, including to “increase the proportion of consumers who readily notice, understand, and use the available information to make more nutritious choices for themselves and their families, and thereby prevent or reduce obesity and other diet-related chronic disease.” The FDA notice specifically requests research data and other information addressing the following matters:
- Data and information on the extent to which consumers notice, use, and understand nutrition symbols on front-of-pack labeling of food packages or on shelf tags in retail stores;
- Research assessing and comparing the effectiveness of particular possible approaches to front-of-pack labeling;
- Graphic design, marketing, and advertising data and information that can inform and guide the development of better point-of-purchase nutrition information; and
- The extent to which point-of-purchase nutrition information may affect decisions by food manufacturers to reformulate products.
Click here to see the specific elements of each of these categories of interest to FDA.
The FDA notice states that the agency has conducted some research and reviewed published research concerning how consumers interpret nutrition information and symbols that appear in food labeling, but indicates that FDA’s evaluation is limited, in part, because the agency does not have access to proprietary research which may have been conducted by food companies. Specifically, the notice states,
“FDA believes the food industry has acquired extensive market experience with consumer reaction to nutrition symbols since 2005, when the voluntary use of nutrition symbols in food labeling began to proliferate in the U.S. market. FDA also is aware that many foreign governments, industry groups, food manufacturers, consumer advocacy groups, and academic researchers have conducted or are conducting consumer research on nutrition symbols. Although some of this research is publicly available, most of it remains unpublished and unavailable to the agency. Because there are limitations to the currently available published literature, we are particularly interested in obtaining access to unpublished research. For example, we are interested in research on a much wider range of nutrition symbol schemes than has been examined in the literature. In addition, studies seldom compare consumer responses to different symbol schemes. Finally, most of the publicly available research was done in European or other countries whose labeling requirements and regulatory framework are quite different from those in the United States. As a result, it is unclear whether and to what extent such findings derived from these studies are applicable to the U.S. market.”  (Emphasis added).
FDA will consider public comment submitted in response to its notice until July 28, 2010. For further information concerning the FDA notice or related submissions to FDA, please contact one of the attorneys listed below.
Kelley Drye & Warren LLPKelley Drye's team of Food and Drug lawyers strives to integrate our clients' business strategies with FDA compliance and to help resolve regulatory enforcement matters when they arise. Working side-by-side with business development and marketing professionals, we provide comprehensive regulatory counseling and assist in developing products, labels, and promotional materials that achieve our clients' goals without running afoul of regulatory requirements. With close knowledge of FDA's enforcement priorities and deep experience with the FTC's regulation of advertising, our team can provide comprehensive legal advice with an eye towards giving clients a competitive edge.
For more information about this Client Advisory, please contact:
Kristi L. Wolff
 Note that IOM’s study entitled, “Food Marketing to Kids: Threat or Opportunity?” reported that its evaluation was limited by the IOM committee’s lack of access to proprietary industry research data concerning food marketing practices that may affect children and youth. In response to these findings, Congress directed the Federal Trade Commission (“FTC”) to undertake additional research, relying on its authority under the Federal Trade Commission Act to compel disclosure of proprietary industry research data to the agency. In announcing the first phase of the study, the FTC notice emphasized the limitations of the publicly available research and the Commission’s interest in proprietary industry data. 72 Fed. Reg. 19505 (April 18, 2007).