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FDA Imposes Strict Requirements for Healthy Claim Used by Food Manufacturers

Posted in Food Policy,Our Blog on February 25, 2025

Food manufacturers have new healthy claim requirements to continue use of the phrase in their products. In an effort to fight misinformation and promote healthier lifestyles, the U.S. Food and Drug Administration (FDA) has updated the existing requirements for food manufacturers to make a healthy claim on their products.

How has this claim status changed over the years, and what exactly does it mean now?

Let’s explore!

Historical Healthy Claim Rules

This healthy claim rule is not a new one. But an update of previous rules. In fact, this rule was set in 1994.

On the 1994 rule, certain limits for total fat, saturated fat, cholesterol, and sodium were included. As was the qualification that the food had to provide at least 10% of the Daily Value (DV) for at least one of the following nutrients: vitamin A, vitamin C, calcium, iron, protein, and fiber.

Movement in 2016 began with the FDA’s published guidance and “intent to exercise enforcement discretion” for products bearing a label with a “healthy” claim.

In 2022 the proposed rule was updated and a request for information and comments on the matter was issued.

New Healthy Claim Requirements

The updated criteria must be met in order for a food product to include the word, “healthy” on its packaging.

The primary criteria includes:

  • It must contain a certain amount of food from at least one of the food groups (or subgroups) recommended by the Dietary Guidelines for Americans.
    • For example, fruits, vegetables, grains, fat-free and low-fat dairy, and protein foods.
  • It must meet certain limits for added sugars, saturated fat, and sodium.

Does this seem vague to you?

If the blanket rule seems vague, it is because there is no longer a blanket rule.

These criteria change based on the specific food being labeled.

“The criteria for how much food from a particular food group is required (called food group equivalents) and the specific limits for the three individual nutrients vary for individual food products, mixed products (which contain certain amounts of more than one food group), main dishes and meal, and are based on a Reference Amount Customarily Consumed, which is the basis for determining a serving size.”

Complicated. But necessary.

This is the most specific healthy claim rule yet.

So, what does that look like?

Automatically Eligible for Healthy Claim

Certain foods are given an automatic eligibility green flag. This includes “nutrient-dense” foods encouraged by the Dietary Guidelines.

Provided that they have no other ingredient except water, these foods include:

  • Vegetables
  • Fruits
  • Whole grains
  • Fat-free and low-fat dairy
  • Lean game meat
  • Seafood
  • Eggs
  • Beans
  • Peas
  • Lentils
  • Nuts
  • Seeds

Specifically, the updated requirements now allow water, avocados, nuts and seeds, higher fat fish (like salmon), and olive oil.

Even frozen or canned varieties now qualify.

Complete List of Healthy Claim Limits

As you can see from the table below, sodium limits are standard across the board. With the exception of oil. Which, why would oil need sodium anyway.

As for the other requirements, different limits are set for certain foods with respect to added sugar and saturated fats.

Food Groups Food Group
Equivalent Minimum
Added Sugar Limit Sodium Limit Saturated Fat Limit
Grains product 3/4 oz whole-grain equivalent 10% DV (5 g) 10% DV (230 mg) 5% DV (1 g)
Dairy product 2/3 cup equivalent 5% DV (2.5 g) 10% DV (230 mg) 10% DV (2 g)
Vegetable product 1/2 cup equivalent 2% DV (1 g) 10% DV (230 mg) 5% DV (1 g)
Fruit product 1/2 cup equivalent 2% DV (1 g) 10% DV (230 mg) 5% DV (1 g)
Protein Foods 
Game meat 1 ½ oz equivalent 2% DV (1 g) 10% DV (230 mg) 10% DV (2 g)
Seafood 1 oz equivalent 2% DV (1 g) 10% DV (230 mg) 5% DV (1 g)*
Egg 1 egg 2% DV (1 g) 10% DV (230 mg) 10% DV (2 g)
Beans, peas, and
lentils
1 oz equivalent 2% DV (1 g) 10% DV (230 mg) 5% DV (1 g)
Nuts, seeds, and soy products 1 oz equivalent 2% DV (1 g) 10% DV (230 mg) 5% DV (1 g)*
Oils 
100% Oil N/A 0% DV 0% DV 20% of total fat
Oil-based
Spreads
N/A 0% DV 10% DV (230 mg) 20% of total fat
Oil-based
Dressing**
N/A 2% DV (1 g) 10% DV (230 mg) 20% of total fat
* Excluding saturated fat inherent in nuts, seeds, soy products, and seafood
** Must contain at least 30% oil

Foods Removed from Qualification

While some foods were added to the qualified list, others have been removed.

For example, under previous guidelines, fortified white bread, highly sweetened yogurt, and highly sweetened cereal were eligible. Now they are not.

What is Driving This Movement?

Misinformation is everywhere. Especially in the Internet era. It is difficult for consumers to get a straight answer when it comes to what is healthy.

For example, you can Google: “Is oat milk good for someone with diabetes?” and it will give you a list of websites explaining that yes. Oat milk is good for people with diabetes.

Then you can Google, “Is oat milk bad for someone with diabetes?” and it will give you a list of websites explaining that yes. Oat milk is bad for people with diabetes.

With the U.S. facing a growing epidemic of diet-related chronic diseases like cardiovascular disease, type 2 diabetes, and obesity, improving nutrition has become a necessary public health intervention tool. A tool consumers can use to make better, more informed choices.

A New Symbol Could Be Coming Soon

The agency is also working to develop a new symbol that manufacturers could use on food packages to notate that they have met the criteria.

This at-a-glance symbol, like others currently being used for gluten-free and heart-healthy, will help consumers immediately recognize foods that are categorized as “healthy.”

The first official notice for this proposed symbol started way back in May 2021. The FDA’s research was approved on the subject and development of the symbol continues to be a work in progress.

Other Initiatives to Help Consumers

In addition to the new healthy claim requirements and proposed symbol to make it easier for consumers to identify it, another FDA initiative is making its way to grocery store shelves.

You are likely familiar with the nutritional facts label on the back of the package. Some of that information will be moving to the front. This front-of-package nutrition label will feature saturated fat, sodium, and added sugars, along with a low, medium, or high tag.

What Are You Thoughts on These Label Changes?

So, what do you think about these changes to labels.

Will they influence your buying decisions?

Personally, I like the transparency these labels bring. I have always been a person who reads the backs of labels. As someone with a food allergy and low-glycemic diet, it is a necessity. Having certain information front and center speeds this process along.

Stay in Touch with Make Food Safe!

If you’d like to know more about food safety topics in the news, like “FDA Imposes Strict Requirements for Healthy Claim Used by Food Manufacturers,” check out the Make Food Safe Blog. We regularly update trending topics, foodborne infections in the news, recalls, and more! Stay tuned for quality information to help keep your family safe, while The Lange Law Firm, PLLC strives to Make Food Safe!

By: Heather Van Tassell (contributing writer, non-lawyer)