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Guidance for Industry: Letter Regarding Point of Purchase Food Labeling October 2009

Docket Number:
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.

Dear Industry:

Point of purchase labeling including Front of Package (FOP) labeling is voluntary information that is intended to convey to consumers the nutritional attributes of a food. Point of purchase labeling often includes symbols that are typically linked to a set of nutritional criteria developed by food manufacturers, grocery stores, trade organizations, and health organizations. Two major categories of FOP symbol systems are "summary" and "nutrient-specific" systems. The summary symbols use logos, numerical scores, or graphic schemes to communicate the overall nutritional quality of a food product to consumers and facilitate comparisons between products based on the food's nutritional quality. Nutrient-specific symbols provide quantitative, evaluative, or both kinds of information on selected nutrients in a product without comparing the product's overall nutritional quality to that of its counterparts.

Although all symbol programs intend to indicate that the food products with their symbol are healthful choices, each symbol program has different nutritional criteria. The selected nutrients and the nutrient levels required for eligibility vary among the different symbol programs in use. FDA recognizes that point of purchase labeling can be a way of promoting informed food choices and helping consumers construct healthier diets in accordance with the Dietary Guidelines for Americans. FOP or shelf labeling that provides consumers with readily accessible information about a product's nutritional profile, in a manner that is consistent with and linked to the required Nutrition Facts panel, responds to today's marketplace realities and can be part of the education and outreach consumers need to understand and act on nutrition information at the point of purchase.

However, FDA's research has found that with FOP labeling, people are less likely to check the Nutrition Facts label on the information panel of foods (usually, the back or side of the package). It is thus essential that both the criteria and symbols used in front-of-package and shelf-labeling systems be nutritionally sound, well-designed to help consumers make informed and healthy food choices, and not be false or misleading. The agency is currently analyzing FOP labels that appear to be misleading. The agency is also looking for symbols that either expressly or by implication are nutrient content claims. We are assessing the criteria established by food manufacturers for such symbols and comparing them to our regulatory criteria.

It is important to note that nutrition-related FOP and shelf labeling, while currently voluntary, is subject to the provisions of the Federal Food, Drug, and Cosmetic Act that prohibit false or misleading claims and restrict nutrient content claims to those defined in FDA regulations. Therefore, FOP and shelf labeling that is used in a manner that is false or misleading misbrands the products it accompanies. Similarly, a food that bears FOP or shelf labeling with a nutrient content claim that does not comply with the regulatory criteria for the claim as defined in Title 21 Code of Federal Regulations (CFR) 101.13 and Subpart D of Part 101 is misbranded. We will consider enforcement actions against clear violations of these established labeling requirements.

FDA is also developing a proposed regulation that would define the nutritional criteria that would have to be met by manufacturers making broad FOP or shelf label claims concerning the nutritional quality of a food, whether the claim is made in text or in symbols. FDA's intent is to provide standardized, science-based criteria on which FOP nutrition labeling must be based.

We also intend to continue to improve our understanding of how consumers view and use such labels. Research suggests that the proliferation of divergent FOP approaches is likely to be confusing to consumers and ultimately counter-productive. We want to work with the food industry - retailers and manufacturers alike - as well as nutrition and design experts and the Institute of Medicine, to develop an optimal, common approach to nutrition-related FOP and shelf labeling that all Americans can trust and use to build better diets and improve their health.

The recent experience with FOP labeling in the United Kingdom demonstrates the potential of voluntary initiatives to provide consumers helpful FOP labeling. In that instance, the government set certain criteria for the use of such labeling, and retailers took the initiative to implement FOP labeling in their stores. The agency wants to explore the potential of that approach. If voluntary action by the food industry does not result in a common, credible approach to FOP and shelf labeling, we will consider using our regulatory tools toward that end. This effort will include research to assess through consumer studies the likely effects of FOP symbols on information search behavior related to the Nutrition Facts label, which in turn can affect consumer understanding of the full nutrition profile of a product. The foundation of that approach should be a common set of mandatory nutritional criteria that consumers can rely on when they view FOP labels, even if no one symbol is ultimately selected as superior.

Accurate food labeling information can assist consumers in making healthy nutritional choices. FDA intends to monitor and evaluate the various FOP labeling systems and their effect on consumers' food choices and perceptions. FDA recommends that manufacturers and distributors of food products that include FOP labeling ensure that the label statements are consistent with FDA laws and regulations. FDA will proceed with enforcement action against products that bear FOP labeling that are explicit or implied nutrient content claims and that are not consistent with current nutrient content claim requirements. FDA will also proceed with enforcement action where such FOP labeling or labeling systems are used in a manner that is false or misleading.

FDA intends to work in collaboration with our sister public health agencies and the Department of Agriculture, which has authority over the labeling of meat and poultry, to pursue these efforts on FOP labeling. We will base our initiative on sound consumer research to ensure that we move toward an approach that will help consumers in selecting a healthy diet.



Barbara O. Schneeman, Ph.D.
Office of Nutrition, Labeling and Dietary Supplements
Center for Food Safety and Applied Nutrition
Food and Drug Administration

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