On Monday, March 28, 2022, the United States Food and Drug Administration (FDA) published in the Federal Register a 30-day procedural notice on the Agency’s consumer research concerning the development of a front-of-pack (FOP) symbol that would show whether a product meets the agency’s “healthy” criteria.
In the last few years, industry has been keenly interested in revamping FDA’s definition of healthy, originally codified as an implied nutrient content claim in 1994 (59 FR 24232, May 10, 1994; 21 CFR 101.65(d)(2)) and currently undergoing review. The Constituent Update announcing the 30-day procedural notice states: “The agency intends to publish the proposed rule with the [healthy] definition update soon.” Concurrently, FDA will pursue the development of a healthy symbol to reflect current nutritional standards and American eating habits.
FDA’s initiative to develop a “healthy” symbol stems from the Agency’s 2018 Nutrition Innovation Strategy to reduce the burden of chronic disease through improved nutrition. Two years earlier, FDA requested information to redefine healthy to reflect current dietary recommendations and nutrition science after stakeholders noted that the current definition limited the ability to label foods that contained nuts, whole grains, seafood, fruits, and vegetables as healthy, all of which are currently recommended as key components of a healthful diet. Then, in 2019 and 2020, FDA reviewed literature on FOP nutrition-related symbols and held a series of focus groups to test symbol concepts and draft FOP symbols.
In May 2021, FDA issued a procedural notice announcing that it would conduct the preliminary quantitative research described below and requested stakeholder comments on FDA’s proposed approach to data gathering and study design. FDA received comments related to, among many other things, the practical utility of the information being collected, the validity of the methodology and assumptions used in the studies, alternatives to a symbol such as a QR code, and the criteria for the use of a “healthy” symbol. In the current notice, FDA largely responded by reiterating that it is moving forward with the studies as designed and reemphasizing the goal was to research general consumer perceptions and impressions of a healthy symbol, and not the definition underlying the symbol. FDA does not usually receive substantive comments to procedural notices nor does FDA provide responses to comments received. The fact that both occurred with this issue shows broad interest by everyone involved. The Notice represents the next procedural step in moving forward with the healthy symbol studies.
FDA will conduct two consecutive quantitative research studies to assess consumer responses to draft FOP symbols that companies could voluntarily use on food products as a graphic representation of the “healthy” nutrient content claim: (1) an online survey of 2,000 adult consumers each who self-identify as primary food shoppers to assess clarity, relevance and appeal of a set of proposed symbols and (2) a controlled, randomized experiment that will use a 15-minute web-based questionnaire to collect information from 5,000 U.S. adult members of an online consumer panel.
The studies are a part of FDA’s efforts to enable consumers to make informed dietary choices in order to help reduce the burden of diet-related chronic diseases and advance health equity.
FDA’s Nutrition Initiatives
FDA’s work to develop a healthy symbol and revamp the term’s definition aligns with FDA’s focus on its Nutrition Initiatives to help ensure Americans have greater access to healthier foods and nutrition information that can be used to more readily facilitate healthier eating decisions. FDA has stressed the role poor nutrition plays in diet-related chronic diseases, which disproportionately affects racial and ethnic minority groups, those with lower socioeconomic status and those living in rural areas. FDA believes it can play a role in reducing the burden of chronic diseases and advancing health equity through its nutrition initiatives. Key elements of FDA’s Nutrition Initiatives include:
- Labeling and Claims: In addition to updating the definition of healthy and developing a healthy symbol, FDA is developing guidance on Dietary Guidance Statements which could be used on food packages to help consumers understand how a food or food group can contribute to a healthy eating pattern consistent with the Dietary Guidelines. Further, FDA will continue to engage with stakeholders on recommendations for nutrition labeling for online grocery shopping.
- Sodium Reduction: FDA issued voluntary sodium reduction targets in October 2021.
- Maternal and Infant Health and Nutrition: FDA updated its fish consumption advice for those who might become pregnant, are pregnant or are breastfeeding, and for parents and caregivers who are feeding children. FDA is examining novel infant formula ingredients, including new “bioactive” ingredients that are similar to components of human milk. FDA will also promote nutritious and safe food choices, including implementing its Closer to Zero Action plan on heavy metals in food for babies and young children.
- Standards of Identity (SOI) and Labeling of Plant-based Food Alternatives: FDA and USDA are working to reissue a proposed rule on SOI principles. FDA is working to amend all relevant SOIs so that they would no longer list partially hydrogenated oils (PHOs) as an optional ingredient in standardized foods. In addition, FDA will be issuing draft guidances on the labeling of plant-based milk and meat alternatives.
- Consumer Education: FDA will continue educational efforts on labeling and nutrition by developing educational materials for various audiences.
If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drugs, and Devices practice.
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