U.S. FDA greenlights 'healthy' label for seafood under new nutrition rules

THE U.S. Food and Drug Administration (FDA) has officially recognized seafood’s essential role in a healthy diet, granting it automatic qualification for the "healthy" claim under its newly updated labeling criteria. This change, effective February 25, 2028, marks a shift in how nutritional claims are regulated. It allows seafood products to carry the designation without additional scrutiny as long as these contain no added ingredients except water. With this new rule, consumers can identify seafood as a beneficial choice based on today’s dietary recommendations. Industry leaders and nutrition experts said this update will not only advance transparency in food marketing, but encourage healthy eating.

In the following interview, Anna Benevente, Director of Regulatory Affairs, Registrar Corp, further explains the new norm and its impact on manufacturers and consumers.

Anna Benevente, Director of Regulatory Affairs, Registrar Corp

Could you provide a quick background on FDA’s “healthy” labeling criteria?

FDA's new regulation for the "healthy" claim represents a significant shift towards promoting overall healthy dietary patterns rather than focusing on individual nutrients within a food. The previous rule had required most foods to meet the nutrient content claim requirements for “low fat” and “low in saturated fat”, contain 60 mg or less of cholesterol, contain 480 mg or less of sodium, and have at least 10% of the daily value from a specific list of nutrients. Single ingredient raw seafood had a modified list but were still required to contain low levels of fat, saturated fat, and cholesterol. Foods such as shrimp and salmon were often not able to meet the requirement given these limitations. 

The new rule reflects a better understanding of human nutrition and emphasizes nutrient-dense foods recommended by the Dietary Guidelines for Americans (DGA), encouraging consumption of whole foods that contribute to a balanced diet.

Certain foods will now automatically qualify to make the claim, such as seafood, lean meats, fruits, and vegetables that have no added ingredients other than water. Bottled water, tea, and coffee with fewer than 5 calories also will automatically qualify. Certain oils that are relatively low in saturated fat like olive oil may also qualify.

For all other foods, qualification will depend on whether the product has a specific number of “food group equivalents” (FGE) while also not exceeding certain levels of sodium, saturated fat, and added sugars. The food groups are: vegetable, fruit, grains, dairy, and protein foods (including seafood). The regulation establishes FGEs such as ½ cup equivalent vegetable and 1 oz equivalent seafood. The conditions under which a food can make the claim will vary depending on whether it is an individual food, mixed product, main dish, or meal product. For example, a main dish product must have two total FGEs with no less than 1⁄2 food group equivalent from at least two food groups, and not exceed 15% DV for added sugars, 20% DV for sodium, and 15% DV for saturated fat excluding the amount inherent in seafood.

Companies should begin to familiarize themselves with the new requirements as there is some complexity with the FGEs. They vary depending on the type of food and the form. For example, ½ cup of equivalent vegetable may mean ½ cup of cooked green beans but would correspond to 1 cup of raw spinach leaves. Dried powders of fruits or vegetables may also qualify to be a FGE, but it’s not entirely clear at this point how much of a dried powder would correspond to ½ cup of equivalent vegetable. FDA has stated that the agency intends to provide further guidance regarding determining FGEs leading up to the compliance deadline.

How important is it to have healthy claims on packaged seafood?

While “healthy” is a voluntary claim, it would seem to be highly beneficial from a marketing standpoint. Manufacturers should evaluate their offerings not only to see which products are currently making the claim (to verify if they still qualify) but also to see which products may be able to make the claim under the new rule.

The compliance date for the new rule is February 25, 2028, so companies have time to make sure that their labeling is correct. FDA will allow for foods that qualify under the new conditions to begin making the claim now. Foods that no longer qualify will have until the stated compliance date to update their labeling, but companies should begin the evaluation process now to ensure that no mislabeled products are in the marketplace once that date passes.

It is also important to note that even if a food does not qualify for “healthy”, other nutrient claims such as “low in fat” or “high in iron” may still be made if products contain specific levels of those nutrients and meet any other conditions described in regulation.

Will the new FDA criteria impact seafood exporters to the US significantly?

According to USDA, as much as 80% of the seafood consumed in the U.S. is imported from abroad (see https://www.ers.usda.gov/data-products/charts-of-note/chart-detail?chartId=108472 ). As they make up a very large portion of the companies’ marketing seafood here, exporters should pay close attention to the new regulations; they are subject to them just as domestic firms are. Any exporter will need to ensure that their labeling is compliant, but particularly if they are shipping seafood that has already been packaged for retail. Imported goods are subject to increased scrutiny as they arrive in port and are often inspected for compliance. If a product’s label is not compliant, FDA can detain the product on misbranding charges and refuse entry unless the products can be brought into compliance with a reconditioning proposal. Reconditioning noncompliant seafood packaging, particularly if refrigerated or frozen, is extremely difficult and should be avoided at all costs. Exporters should verify the status of their labeling prior to shipping to avoid the risk of detention and refusal.

Are there additional insights you’d like to share? What key information should food manufacturing businesses keep in mind?

We believe that the change in the regulation presents an excellent opportunity for the seafood industry to highlight the health benefits of many of its products. In 2016, FDA modified its stance on the “healthy” claim by publishing a guidance document that allowed for enforcement discretion for certain seafood products.

The guidance document allowed products that did not meet the low-fat requirement to make the healthy claim if the amounts of mono- and polyunsaturated fats were declared on the label, and those amounts were the majority of the products’ fat content. It also allowed for the 10% DRV value to be met by the food’s levels of potassium or vitamin D. This opened the door for some higher fat fish such as salmon to make the healthy claim. However, it was dependent on a non-binding guidance document, which was not ideal. With the new regulation in place, companies can feel confident that they may rely on it to make the claim on their label, with no risk of import refusal or other enforcement action by FDA.