Overview

On 28 March 2022, FDA issued a notice in the Federal Register summarizing and responding to comments FDA received on a 60-day procedural notice the Agency issued last year. 1 As a reminder, in May 2021, FDA first announced its intention to conduct consumer testing in conjunction with the development of a proposed rule that would update when manufacturers may use the “healthy” nutrient content claim on food packages. 2 Although there were few details about the planned testing provided in the initial notice, FDA explained that it planned to conduct a series of consumer perception studies designed to evaluate the effectiveness of a potential symbol. Stakeholders had the opportunity to comment on the basic methodology and draft “healthy” symbols to be used in the testing.³ (The images of the draft symbols are included at the end of this update.) In this recent notice, FDA provides additional details regarding the planned research—such as elaborating on the types of mock food labels that will bear the proposed symbols and clarifying the relatively narrow scope of the research and its results. The agency also responds to comments provided in 2021. These developments are summarized below.

Relationship between consumer research on the symbol to the forthcoming proposed “healthy” definition

In the recent notice, FDA announced that it will proceed with research on the symbol now, rather than waiting until the Agency takes regulatory action to finalize the new “healthy” definition. In the Constituent Update announcing the availability of the notice, FDA stated that it intends to publish the proposed rule on the healthy definition “soon.”⁴

Depending on the results of the research, FDA may decide to test additional symbols or revise the symbols currently under consideration. The agency notes that “while the symbol is intended to represent the nutrient content claim ‘healthy,’ our research on the symbol is not dependent on any specific criteria for ‘healthy.’” FDA also noted that it will continue to coordinate with the United States Department of Agriculture (USDA) Food Safety Inspection Service (FSIS) as the Agency continues its work on a “healthy” symbol.

What the consumer research will evaluate

FDA will conduct two consecutive quantitative research studies designed to explore consumer responses to the draft front-of-pack (FOP) “healthy” symbols. Study 1 is a web-based survey focusing on the aesthetic features of the symbols, such as clarity, relevance, and appeal. Study 2 is 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. Once assigned to a random condition, consumers will view label images on mock food products and respond to various measures of the symbols effectiveness. The conditions include:

• a set of draft FOP symbols, including “no-symbol” controls;
• three types of mock food products (e.g., a breakfast cereal, a frozen meal, and a canned soup);
• “no-information” condition where no explanation of the symbol is provided; and
• a URL condition, in which a URL is tested alongside the symbol.

FDA explains that the study is designed to test general consumer responses to the symbols themselves. Measures of response include product perceptions (e.g., healthfulness and contribution to a healthy diet), label perceptions (e.g., believability, trustworthiness, message effects), and purchase/choice questions. FDA will add an open-ended question asking what the symbol brings to mind to help determine if any symbols should be removed from consideration or revised on this basis.

Some noteworthy aspects of the research include:

• Mock products: FDA has provided greater detail on the types of mock products that will be used in the testing, which will represent “broad and basic food categories,” including vegetables and whole grains with limited nutrients of concern (e.g., sodium or saturated fat) that would meet the current “healthy” definition. FDA will not separately use a beverage or fresh vegetables as mock products as requested by commenters. Moreover, FDA rejected the recommendation to use images of real food labels rather than mock product images, as FDA concluded that the use of mock images will remove the potential for brand biases.
• Symbol design: FDA will assess the symbols in full rather than separating out the various aspects of the symbols for assessment (e.g., the term FDA vs. the graphic). Additionally, FDA noted that it will test the inclusion of a URL as part of the symbol (specifically a URL ending in “.gov”), but is not considering other technology like a QR code.

What the consumer research will NOT evaluate

FDA notes a number of issues the research will not assess, including:

• consumer perceptions of the term “healthy,”
• long-term behavior (i.e., consumption) changes or health effects,
• purchasing behavior,
• the relative healthfulness of any product,
• the placement of the symbol on the package or elements that would be required if a company uses the label, or
• the effect of other FOP labels on the efficacy of the healthy symbol.

Additionally, FDA stated that it would not view findings from this research as applicable to other FOP labeling systems.

Comments on the notice are due Wednesday, 27 April 2022.

References

1 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Quantitative Research on a Voluntary Symbol Depicting the Nutrient Content Claim “Healthy” on Packaged Foods 87 Fed. Reg.17300 (Mar. 28, 2022).

2 See Martin Hahn, Joseph Levitt, Veronica Colas, & Anneke Altieri, FDA to test voluntary “healthy” symbols through consumer research, Hogan Lovells (7 May 2021).

3 See Martin Hahn, Joseph Levitt, Veronica Colas, & Anneke Altieri, Reminder: Opportunity to comment on draft “healthy” symbols for FDA’s planned consumer research (21 June 2021).

4 FDA Constituent Update, FDA Issues Additional Procedural Notice on Consumer Research on “Healthy” Symbol (Mar. 25, 2022)