We reported on FDA’s May 7, 2021 announcement of plans to conduct quantitative research studies to explore consumer responses to draft Front of Pack (FOP) symbols that manufacturers could voluntarily use on a food product as a graphic representation of the nutrient content claim ‘‘healthy.’’  FDA proposed an experimental study to be followed by two surveys.  FDA was required to collect comments on this proposal before submitting the plan for approval by the Office of Management and Budget (OMB) as required under the Paperwork Reduction Act (PRA).  The comment period on FDA’s plans closed July 6, 2021.

Today, March 28, 2022, FDA provided notice that plans to collect information have been submitted to OMB for approval of two consecutive quantitative research studies of consumer responses to the draft FOP symbols that companies could voluntarily use on packaged food as a graphic representation of the nutrient content claim “healthy.”  In response to comments on the plan put forth almost a year ago, FDA will reorder the research to perform the experimental study component first and will now conduct one survey with a larger sample size (instead of two surveys with smaller sample sizes).  FDA declined to make other changes in the experimental studies (suggested in 27 comments that were considered) including the use of images of real products, as opposed to mock images, and the use of online store settings or other naturalistic study environments.  FDA noted that later research may be necessary to address additional issues raised in the comments, such as the effect of other FOP symbols that may appear on the same package.

FDA maintains that the research proposal (OMB Control Number 0910-NEW) is not dependent on specific criteria for “healthy.”  Thus, while FDA’s Constituent Update promises that FDA intends to propose a revised definition “soon,” FDA contends there is no need to postpone the planned research on a “healthy” symbol until after the regulatory definition at 21 CFR 101.65(d) is updated.