Health Law Update

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The Food and Drug Administration (FDA) recently issued a final rule updating the definition of the term “healthy” for use on food labels. This change aims to align with modern nutrition science and the latest Dietary Guidelines for Americans, marking the first major revision to the term on packaging since the 1990s. While the update has its merits, it has also sparked concerns from stakeholders, particularly in the food industry and among free speech advocates. Here’s what you need to know about the new definition and its potential implications.

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What’s New in the Definition of Healthy?

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Under the updated rule, foods can carry the healthy label only if they meet stringent criteria based on food group equivalents and nutrient limits. Specifically, products must:

Contain a minimum amount of food from at least one key group (e.g., fruits, vegetables, whole grains or low-fat dairy) and

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Stay within specific thresholds for saturated fat, sodium and added sugars.

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For example, cereals labeled as healthy must include a certain amount of whole grains and meet the limits for saturated fat, sodium and added sugars. Foods including nuts, seeds, salmon and certain oils, previously excluded, can now qualify. Manufacturers have until February 2028 to comply but may adopt the new criteria sooner.

The FDA intends the new definition to help consumers quickly identify foods that support healthier dietary patterns. By updating the criteria, the agency hopes to reduce diet-related chronic diseases, such as heart disease and diabetes, and address health inequities experienced by certain racial and socioeconomic groups.

While the updated definition seeks to provide clarity, it has raised concerns in the food industry. Many industry representatives argue that the criteria are overly restrictive, potentially disqualifying nutrient-dense packaged foods from bearing the healthy label. For example, some whole-wheat bread and yogurt products – long considered staples of a balanced diet – may now fail to meet the thresholds for added sugars or sodium.

Critics also warn that the complexity of the new standards might hinder innovation in creating new products. Furthermore, compliance costs for reformulating existing products could pose economic challenges for manufacturers, potentially driving up prices for consumers.

Moreover, the FDA’s rule emphasizes its reliance on current nutrition science. However, critics have questioned the validity and uniformity of the evidence used to establish these guidelines. Nutrition science evolves rapidly, and some argue that rigid definitions could quickly become outdated, especially as personalized nutrition gains prominence.

The new rule also faces criticism on First Amendment grounds. Stakeholders commented in response to the proposed rule that restricting the use of the term healthy infringes on manufacturers’ ability to communicate truthful information about their products. The FDA maintains that the rule aligns with its statutory mandate to prevent misleading labeling, but ongoing debates suggest this issue may not be resolved anytime soon.

Lastly, there are concerns surrounding consumer impact. While the rule aims to guide healthier choices, its practical impact on consumer behavior remains uncertain. Critics worry that disqualifying familiar products from carrying the healthy label could confuse rather than enlighten consumers. Additionally, the economic burden of reformulation might lead to higher prices, potentially limiting access to healthier options for lower-income families.

The FDA’s updated definition of healthy represents a well-intentioned effort to improve public health and reduce chronic diseases. However, the concerns about its economic, scientific and constitutional implications cannot be ignored. As the food industry adapts, it remains to be seen whether these changes will empower consumers or create unintended challenges.

For now, both manufacturers and consumers will need to navigate this evolving landscape carefully. The FDA may issue additional guidance to clarify the implementation of the new standards, which are set to become effective in February 2028. However, impending political shifts add uncertainty to the future of this rule, including potential withdrawal of this rule by the new administration. With continued dialogue and potential refinements, the FDA’s initiative could strike the right balance between clarity and flexibility, benefiting public health without unduly burdening the food industry.

The FDA’s New Definition of ‘Healthy’: A Step Forward, or a Step Too Far?