On October 1, 2024, the U.S. Food and Drug Administration (FDA or the Agency) implemented its unified Human Foods Program (HFP). The Agency established the HFP – which represented the single largest reorganization in FDA’s modern history – to more effectively deliver on the Agency’s mission to protect and promote public health through science-based approaches to prevent foodborne illness, reduce diet-related chronic disease, and ensure the safety of chemicals in food. One of the program’s most critical deliverables is to “empower consumers to build nutritious diets that support health and wellness.” As part of this goal, FDA plans to promulgate additional regulations governing food labeling, at least some of which could have serious implications on the way manufacturers market their products. This article will focus on perhaps the most consequential of these initiatives—the changed definition of what constitutes “healthy” food, as well as what is to come in the world of food labeling and how that could affect your business.
What You Need to Know
- FDA Human Foods Program launched in October of 2024 to improve food safety and nutrition.
- The new “Healthy” rule finalized in December of 2024 and compliance is expected by February 2028.
- Nutrient limits now apply for sugar, sodium, and saturated fat.
- Front-of-package nutrition labels may soon be required.
- Brands will potentially need to grapple with rebranding and/or reformulation in order to come into compliance with these new changes.
What does “healthy” mean, really?
In December of 2024, FDA issued its final rule to update the “healthy” nutrient content claim. Historically, the term was used widely but was never defined—the new rule changes that, and now there are specific requirements with which marketers must adhere in order to claim that their products are, by definition, healthy. FDA’s rationale in promulgating the “healthy” rule is that the Agency wants to “help consumers identify foods that are particularly useful as the foundation of a diet that is consistent with dietary recommendations.”
In order to be “healthy,” a food product needs to contain a certain amount of food from at least one of the proscribed food groups or subgroups (such as fruit, vegetables, grains, fat-free and low-fat dairy and protein foods) contained within the Dietary Guidelines for Americans, and be at or below the limits for added sugars, saturated fat, and sodium. Some healthy foods might be obvious, such as vegetables, fruits, and whole grains. However, other foods that are higher in calories but nutrient dense, such as fatty fish and olive oil, may now qualify to use the “healthy” claim. FDA has established specific sugar, sodium, and fat limits for each food group that can be viewed in more detail here. This means that, for example, yogurts that vary by just a couple grams of sugar could have different labeling allowances.
Proposed Upcoming Rules
In the same vein of promoting nutritious diets, the Agency is also pursuing a drastic change to the formatting of required food labeling. FDA has proposed a front-of-package (FOP) nutrition labeling scheme which would make each food item’s nutrition facts much harder for consumers to ignore. As part of this change, the nutrition label would also include a simple “Low,” “Med,” or “High” in reference to fat, sugar, and sodium levels. Similarly, the Agency is also considering the idea of a “healthy” symbol which could be optionally placed on the front of food packaging.
What do these changes mean for you?
Although the “healthy” rule was published in December of 2024, full compliance is not required until February of 2028. However, as with most things, getting ahead of these changes will help your operations run more smoothly.
Those in the food industry should start thinking about how the new definition will affect not just labeling, but also formulations and overall brand image. The establishment of the sodium, sugar, and fat thresholds means that manufacturers need to be very intentional about developing new products or even potentially altering existing ones. Brands previously perceived as “healthy,” may no longer benefit from that reputation under the new standards.
For example, Chobani Greek Yogurt is generally accepted to be “healthy.” However, under the new definition, at least some Chobani products would not be allowed to be labeled as “healthy” snack because they contain more than the allowed threshold of added sugar per serving. Taking just one product as an example, their Strawberry Greek Yogurt contains 9 grams of added sugars per 5.3 ounce serving (roughly 2/3 cup). Most people would consider this a guilt-free food because it’s high in protein and is fairly satiating. However, the Agency would not allow Chobani to lean into this perception because FDA’s new threshold states that only 2.5 grams (or 5 percent Daily Value) of added sugar is allowed per 2/3 cup of any dairy product.
While implementation and changes in consumer perception may happen slowly, it will almost certainly happen with this new definition. Pretty soon, many consumers will only be able to shop in terms of the black and white parameters of the imposed definition of “healthy.” This imposed definition is somewhat arbitrary, as items that are only one gram of fat apart will have completely different branding. No matter what the effects of this new FDA rule, brands are going to have to find ways to navigate and manage the fallout.
Should you have any questions about the recent FDA updates or how it may affect your company, please contact the authors or your regular Saul Ewing attorneys.
