Questions and Answers About Dietary Guidance Statements in Food Labeling: Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request

The American Frozen Food Institute (AFFI) appreciates the opportunity to comment on the Food and Drug Administration's (FDA's) draft guidance on "Dietary Guidance Statements" ("DG Statements") in food labeling. From manufacturers to distributors to suppliers to packagers, AFFI is proud to represent publicly traded and family-owned companies who help produce frozen foods and beverages for today's food service and retail marketplace and serve as economic pillars within their communities throughout the U.S. The frozen food industry contributes approximately $65.1 billion to U.S. GDP and accounts for 670,00 U.S. jobs. In addition to our members' strong role in economic growth, AFFI members share a commitment to food safety and transparently communicating information about the nutritional profile of the foods they produce and sell. Executive Summary AFFI supports FDA's effort to provide guidance on DG Statements, as this is a type of claim that has the potential to facilitate consumer education on the role of foods and food groups in healthy dietary patterns. We nevertheless believe many important changes are needed to ensure that the draft guidance achieves its goals of encouraging reformulation toward more healthful products and encouraging consumers to eat such products. As currently drafted, we are concerned that the draft guidance is unlikely to incentivize reformulation or change consumer behavior. The draft guidance takes an overly restrictive approach that would limit truthful and non-misleading speech that is consistent with the recommendations of the Dietary Guidelines for Americans ("DGA") and would suggest to consumers that only a very limited subset of foods have an appropriate role within a healthy diet. Much like our comments on FDA's proposed rule on "healthy" claims, eligibility for DG Statements should not be effectively limited to commodity foods such as unsweetened, low sodium fruits, vegetables, protein foods, or slightly sweetened whole grains and fat free/low fat dairy. These are not the only foods that can comprise a healthy dietary pattern, nor do most consumers eat primarily unflavored plain ingredients. The frozen food aisle represents a key opportunity to provide consumers with nutrient-dense, calorie-controlled, convenient options that will help them achieve a healthy and balanced dietary pattern. Dietary guidance has long been considered a flexible category of labeling statements that could help consumers to implement healthy dietary patterns. Given the flexibility that is offered throughout federal dietary guidance to choose a variety of foods as part of a nutritious diet, the legal standard for such claims is likewise adaptable to the particular claim and food. Rather than being subject to prescriptive criteria like those typically set for health claims and nutrient content claims, DG Statements must be "truthful and non-misleading." Yet in the draft guidance, FDA appears to be applying principles much more similar to the criteria for health claims – including a recommendation that such statements be based on a consensus report, which is similar to the standard for health claims under the FDA Modernization Act (FDAMA), and that they be subject to disqualifying levels similar to those set for health claims. Further, the recommendations in the draft guidance are very similar in nature to the criteria recently proposed by FDA for "healthy", which is regulated differently as a nutrient content claim. We ask FDA to revisit or rescind the draft guidance and revise it in a way that is more consistent with this underlying legal standard and that helps to implement the flexibility within the DGA to consume a variety of foods without excessive focus on precise food group contributions or nutrients to limit. We recognize that the Q&A is a guidance document, but this is not a license to create an overly prescriptive framework that creates barriers to discussing foods in a way that is consistent with…