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FDA’s “Healthy” Label Proposal Continues to Stir Debate

Defining “healthy foods” has been a hot topic for years, and while consumers generally want to consume foods that are healthy, trying to put precise definitions on what is healthy is a challenge. The implication that if a food is not designated as healthy then it must be unhealthy is clearly a misnomer that can have significant consequences on the ability for consumers to purchase affordable food. Thus the debate continues and although the comment period for FDA’s proposed rule to update the definition of Healthy on label claims closed in December 2022, the proposal and submitted comments are continuing to stir controversy.

In March, The Washington Post published an article noting manufacturers’ concern that “almost no packaged foods would qualify under the agency’s new rules,” citing a joint comment from the Consumer Brands Association’s (CBA) and FMI. While supporting FDA’s work to revise the healthy claim, CBA and FMI cited the proposed rule as overly restrictive and “would violate the First Amendment by prohibiting truthful, non-misleading labeling claims in an unjustified manner.” In April 2023, however, the Center for Science in the Public Interest (CSPI) published a rebuttal to the CBA/FMI comment  disputing the “unconvincing legal arguments” and downplaying of “the scientific evidence supporting front-of-package nutrition labeling.”

The rule would revise the 1994 definition of the nutrient content claim, with requirements that, to be labeled as Healthy, a food product would need to (1) contain a certain amount of food from at least one of the food groups or subgroups (e.g., fruit, vegetables, grains, dairy and protein foods) recommended by the DGA; (2) adhere to specific limits for certain nutrients, such as saturated fat, sodium and added sugars, with a threshold based on a percent of the Daily Value (DV) for the nutrient and the food/food group (e.g., the limit for sodium is 10% of the 230 mg DV per serving).

On the one side: As stated in their comments on the rule and on the CSPI citizen petition which, at least in part, led to the FDA proposal, CBA/FMI believe the proposed rule’s interpretation of “healthy” is overly restrictive and results in a regulatory framework that would automatically disqualify a vast majority of packaged foods, including those that are nutrient dense and/or are recognized as “healthy” choices based on the Dietary Guidelines for Americans. Additionally, the associations feel that FDA did not sufficiently market test its proposed regulatory framework, leading to unintended consequences.

The primary concern of CBA is “the overly stringent proposed added sugars thresholds,” believing it to be “unwarranted and outside FDA’s authority given the lack of scientific consensus on the relationship between sugar intake and diet related disease.”

In addition to the comment from CBA (which represents 1,700 major food brands), a number of companies and food associations, including those representing the sugar, snack, dairy, and other industries, took exception with the FDA’s proposed definition. Among these were dissension on the sugar, salt and/or fat limits; its lack of alignment with other established nutritional policies and professional recommendations; and its overall restrictiveness. Some even stated that “the proposed rule probably would lead to an unintended exclusion of some nutrient-rich products.”

To provide an alternative, the CBA/FMI drafted a framework that would align with the Dietary Guidelines and inform consumers, but be less onerous on the industry. A few of the suggested alternatives are revising added sugars and sodium nutrient thresholds to “modestly higher levels”; adding a small RACC individual/mixed foods category with specific recommendations; factoring composite contributions of food groups; and qualifying a food as healthy based on thresholds for dietary fiber, protein, vitamin D, calcium, potassium, or iron as an alternative to meeting food group requirements.

Counter to that: CSPI supports its rebuttal with a statement that “the overwhelming majority” of the 7,700 comments to its citizen petition, submitted to FDA in August 2022, backed the petition’s request for such front-of-package nutrition labeling (FOPNL) of added sugar, sodium, and saturated fat. With a focus on both the CBA/FMI legal and scientific foci, the CSPI arguments dispute the CBA/FMI assertion of FDA’s lack of authority to mandate the labeling, stating that “mandatory FOPNL is a natural outgrowth of the nutrition labeling that FDA already regulates” and that the CBA/FMI “arguments only affirm that FDA has both authority and a sound scientific basis to move forward expeditiously with a rulemaking to require such labeling.”

Responding to the science cited by CBA/FMI, CSPI countered the CBA/FMI’s “few studies,” that an FOPNL would have no meaningful effect on consumers’ overall diet, with the CSPI petition’s inclusion of a “systematic review of more than 300 experimental studies.”

Concluding that “FDA has clear authority to require FOPNL” and that the “expansive body of scientific evidence [demonstrates] the efficacy of interpretive, nutrient-specific FOPNL at improving food choices and informing consumers,” CSPI closed with “FDA is on solid ground and should proceed with this bold effort to support consumer education and public health.”

With CSPI’s stance being supported by responses to a recent poll, along with a number of public health and consumer organizations, it will be interesting to continue to watch this space, how the two sides play out, and where FDA takes it from here. We will continue to track this debate and provide updates as applicable in the future.


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