Food and beverage products that promote health and well-being have proliferated. Demand has surged for foods and drinks that are loaded with nutrients and offer health benefits. Their growth is partly driven by an increased understanding of the connections between food and health outcomes. But the food industry has operated under outdated definitions of “healthy” foods. On April 28, new FDA rules on “healthy” food claims will take effect. On January 16, the FDA published a proposed rule that would impose new front-of-package nutrition labeling requirements on most packaged foods, to assist consumers in identifying healthy foods. The new rules could have a significant effect on the food industry as well as stimulate the food-as-health movement.

Growth of the Food-is-Medicine Movement

The concept of “Food is Medicine” is based on an understanding that food and diet play crucial roles in disease prevention and management. There is no single definition of “food is medicine,” but it generally refers to prioritizing food and diet in the individual’s health plan, with the goal of either preventing, reducing symptoms of, or reversing a disease state when applied in conjunction with appropriate medical treatment.

Research that examined the impact of 10 food groups—fruits, vegetables, nuts and seeds, whole grains, unprocessed red meats, processed meats, sugar-sweetened beverages, polyunsaturated fats, seafood omega-3 fats, and sodium—found that almost 20 percent of heart disease, stroke, and diabetes costs are attributable to poor diet.

In 2023, the U.S. Department of Health and Human Services developed a “Food Is Medicine” or “FIM” initiative in response to congressional action that directed HHS, in consultation with other federal agencies, to implement a federal strategy to reduce nutrition-related chronic diseases and food insecurity, in order to improve health in the United States. HHS identified several “intervention” categories centered on the relationship of healthy food to address diet-related conditions and diseases:

• Medically tailored meals: pre-prepared meals typically provided to patients with complex medical conditions who are unable to shop and prepare meals on their own. These are tailored by a Registered Dietitian Nutritionist (RDN) to meet the medical and dietary needs of the patient.
• Medically tailored groceries: perishable and nonperishable grocery items assembled in a prepackaged box or bag and designed by RDNs to address an individual’s specific needs and health conditions. They generally require additional preparation before consumption.
• Medically supportive meals: pre-prepared meals (g., heart-healthy or diabetes-friendly meals) provided to an individual to help manage or prevent diet-related disease(s) or condition(s) in people who are at a higher risk for illness.
• Medically supportive groceries: perishable and nonperishable, and generally healthy, grocery items that require additional preparation before consumption.
• Produce prescription programs: fresh, frozen, or canned produce with no added salt, sugar, or fat is given to individuals with prescriptions from their doctors, to address specific nutritional needs and food access challenges.
• Nutrition incentives: financial or nonfinancial encouragement to purchase healthier foods. These generally consist of discounts or funds to increase the ability of individuals with eligible incomes to buy healthy foods.

New FDA “Healthy” Claims Rules Come at a Crucial Time

The expansion of FIM programs is expected to drive demand for healthy food products. Many food producers seek to produce healthy, nutritional foods that cater to the growing FIM movement. This comes at a pivotal time, since the FDA recently announced an updated final rule for “healthy” claims, and has proposed mandatory nutrition disclosures on the front of product packaging. The rules foster a more holistic approach to promote dietary patterns during various consumer stages, including more flexibility to allow nutrient-dense foods to be classified as “healthy.” The rules become effective April 28. Compliance with the new rules will be voluntary until February 25, 2028, when it becomes mandatory. Food manufacturers and producers should act now to review “healthy” claims made for their products and determine whether they require changes to comply with the new rules. The health-care industry should also review the new “healthy” requirements to ensure alignment with FIM objectives.

FDA regulations that govern “healthy” claims had not been significantly updated since the 1990s. The framework for establishing “healthy” claims under the old rules was regarded as inflexible: requiring specific limits on sodium, fats, and cholesterol, and minimum levels of certain nutrients such as vitamin A, vitamin C, calcium, iron, protein, and dietary fiber. These requirements excluded some nutrient-rich foods like fish from being counted as “healthy.”

The FDA’s new rules (89 Fed. Reg. 106,064 (Dec. 27, 2024)) feature a more flexible approach to regulating “healthy” claims, and are synced with current dietary guidelines. They recognize that fruits, vegetables, whole grains, and other nutrient-dense foods should be part of a healthy diet. Nutrient-dense foods and beverages are defined as those that “provide vitamins, minerals, and other health-promoting nutrients but also have little or no added sugars, saturated fats, or sodium.” A number of these nutrient-dense foods did not qualify to bear the “healthy” claim under the old rule (e.g., salmon due to fat amounts). Foods that meet requirements for “healthy” as defined by the new rules are those that, because of their overall nutrition profiles, can be the “foundation” or “building blocks” of a healthy pattern recommended by the dietary guidelines.

Under the new rules, claims that foods are “healthy,” “healthful,” or “healthier” must be substantiated by evidence that: (1) the product contains a certain amount of food (described as a “food group equivalent”) from at least one of the food groups recommended by the Dietary Guidelines for Americans (such as vegetables, fruits, whole grains, fat-free or low-fat dairy, lean meat, seafood, eggs, beans, peas, lentils, nuts, or seeds); and (2) the product meets specific limits for added sugars, saturated fats, and sodium. Certain food categories, including vegetables, fruits, seafood, lentils, nuts, and seeds, automatically qualify as “healthy” due to their nutrient density, provided they do not contain additional ingredients.

In its summary, the FDA noted that foods that do not meet the requirements to bear the “healthy” claim could, however, have beneficial nutritional attributes, and these attributes may be communicated to consumers in different ways. For example, use of other nutrient content claims, such as “low” (e.g., “low saturated fat”) or “high”, can inform consumers interested in their intake of specific nutrients. A food label could include health claims that are different from nutrient content claims, such as showing how a food or food component may reduce the risk of a disease or health-related condition. Still other claims (e.g., structure/ function claims) might describe, for example, the role of a nutrient intended to support the normal structure or function of the body. In addition, dietary guidance statements are a type of voluntary labeling statement that can be used to suggest an individual food or food group may contribute to or help maintain a nutritious dietary pattern. Dietary guidance statements provide manufacturers with a broad range of messages beyond characterizing the nutrient content of the food (compared with nutrient content claims such as “healthy”), and can communicate to consumers that a food may help to maintain a nutritious dietary pattern.

The FDA notes that certain statements may constitute more than one type of claim, depending on the context in which they are used, and interpreted with the labels or labeling as a whole. That a food may qualify for another type of claim does not automatically make the food eligible for the “healthy” claim, however.  Similarly, if a food qualifies for the “healthy” claim, that does not mean it meets the requirements for other claims. The criteria for each  claim must be met, and manufacturers are free to use any applicable claims for which they qualify and can make truthful and non-misleading statements on food labels or labeling.

Except in limited situations, manufacturers of foods that make “healthy” claims are required to make and keep written records (e.g., analyses of databases, recipes, formulations, information from recipes or formulations, or batch records) that substantiate the claims. These records must be kept for a period of at least two years after introduction or delivery of the food into interstate commerce. Such records must be provided to the FDA upon request, during an inspection, for official review and photocopying, or through other means of reproduction. Failure to make and keep records and provide the records to the FDA may result in a determination that the food has been misbranded.

New Proposed Rule Would Alter Nutrition Labeling Requirements

On January 16, the FDA published a proposed rule which, if finalized, would mandate front-of-package nutrition labels on most foods that require a Nutrition Facts label. This action would require the display of a compact informational box that contains nutrient information on the principal display panel. The box would provide consumers with standardized, interpretive nutrition information that quickly and easily identifies how the contents can be part of a healthy diet by disclosing the relative amounts of saturated fat, sodium, and added sugars in a serving, and identification of whether those amounts are low, medium, or high. The rule would also amend certain nutrient content claim regulations to align with current nutrition science and avoid within-label inconsistencies.

The FDA believes the ranges it proposes for the interpretive descriptions (i.e., its designation of 5% DV or less as “low” and 20% DV or more as “high”) are consistent with its past regulatory approach. However, the FDA invites comment on its conclusions and analysis through May 16.

Costs to the packaged foods industry of relabeling to satisfy requirements of the proposed rules are expected to range between $66 million and $154 million per year over a ten-year period. Product reformulation is not a stated goal of the proposed rule; however, the FDA recognizes the rule may result in some food producers choosing to undertake voluntary reformulation efforts. The FDA estimates the annualized costs of reformulation might range between $125 million and $377 million over a ten-year time horizon.

If the proposed rule is finalized, businesses that have $10 million or more in annual food sales will be required to comply with these requirements within three years of the rule’s effective date. Businesses with less than $10 million in annual food sales will be required to comply within four years. The FDA is accepting comments on the proposed rule through May 16.

Food producers face a potential sea of upcoming changes related to healthy food claims and nutrition labeling. The time to plan and budget for them is now.

This article summarizes aspects of the law and opinions that are solely those of the author. This article does not constitute legal advice. For legal advice regarding your situation, you should contact an attorney.