On June 15, 2023, FDA issued a 30-day procedural notice1 regarding its planned study “Quantitative Research on Front of Package Labeling on Packaged Foods.” The study will be a step forward in FDA’s FOP initiative to develop standardized labeling aimed at helping consumers more easily identify the nutritional attributes of foods. It will also complement the insight FDA gained from focus groups convened in 2022 to gauge consumer responses to sample FOP labeling formats.
As FDA announced in January of this year, the study will include a set of draft FOP schemes and three types of mock food products (breakfast cereal, frozen meal, and canned soup).2 The six draft FOP schemes and mock labels to be tested are available here. None of the schemes to be tested include “nutrients to encourage”; rather, they all focus on three nutrients to limit: saturated fat, sodium, and added sugars. The schemes to be tested are largely “interpretive” rather than strictly informational. The sole informational scheme includes quantitative information on the three nutrients. (Of note, FDA is not proposing to test an informational scheme that mirrors the existing voluntary Facts Up Front program.) The other schemes characterize the three nutrient levels as low, medium, or high. The notice explains that the proposed “low,” “medium,” and “high” levels are based on the percent Daily Value (DV) of a nutrient, and that “low” refers to 5% or less of the DV while “high” refers to 20% or more of the DV per serving. Some of the schemes list the %DV for each nutrient while others do not. One scheme would only require disclosure of any of the three nutrients where the food is high in that nutrient. FDA notes it plans to test both color and black-and-white labeling schemes.
The study will be carried out in two parts, where in part one, participants will see three different “levels of healthfulness” (described by FDA as “most healthful,” “middle,” and “least healthful”) on a single FOP labeling scheme and be asked to identify the most and least healthful profiles. Each participant in part 1 will evaluate three different sets of FOP labeling schemes. In the second part, participants will answer questions about a single labeling scheme and mock product, related to product perceptions (e.g., healthfulness and contribution to a healthy diet) and label perceptions (e.g., believability and trustworthiness). The survey will also collect information from participants about their history of purchasing or consuming similar products, nutrition knowledge, dietary interests, motivation regarding label use, health status, and demographic characteristics. To assess study participant reactions to the products and labels, no explanatory information will be provided on the FOP schemes.
Included in the recent notice are FDA’s responses to the twenty substantive comments the agency received regarding its January announcement on the proposed study. Of note, the agency will be increasing the planned sample size from 3,000 to 9,000 participants. FDA is also making available its April 2023 review of literature on FOP labeling schemes.
Next steps
Comments are due July 17, 2023. We are available to assist in drafting comments regarding the proposed research.
