21 CFR 101.13 Nutrient Content Claims: Thresholds and Disclosures

The general principles under 21 CFR 101.13 govern nutrient content claims on food labels: any statement that characterizes the level of a nutrient in a food, whether it is printed as “low fat,” “high in fiber,” “calorie free,” or something more subtle, must fit the definitions FDA has set and must appear on the package the way the regulation requires.¹ The rule covers what counts as a claim in the first place, the numeric thresholds a food has to meet, the disclosures a manufacturer must add when other nutrients run high, and the type size and placement of the words on the label.

What Counts as a Nutrient Content Claim

The regulation splits claims into two categories. An express claim states a nutrient level directly. “Low sodium” and “contains 100 calories” are the regulation’s own examples.¹

An implied claim describes the food or an ingredient in a way that suggests a nutrient is present or absent without naming the level outright. A package that reads “high in oat bran” implies high fiber content without ever using the word fiber. A second flavor of implied claim suggests the food may help maintain healthy dietary practices because of its nutrient profile. The word “healthy” is the classic example of that second type.¹

Both categories are governed by the same rules. A manufacturer cannot escape the definitions by implying what it is not permitted to state. Every claim, express or implied, has to match the specific definitions set out in Subpart D of Part 101.

Thresholds Behind the Common Terms

The general principles in 101.13 point to companion regulations for the actual numbers. Thresholds are measured per reference amount customarily consumed (RACC), the standardized serving size for each food category.

“Free”

“Calorie free” requires fewer than 5 calories per RACC and per labeled serving.² “Fat free” requires less than 0.5 grams of fat per RACC and per labeled serving.³ “Sodium free” means less than 5 milligrams per RACC, and the product cannot contain any ingredient that is sodium chloride or is generally understood to contain sodium unless the ingredient list flags it as adding a trivial amount.⁴

“Low”

“Low calorie” means 40 calories or fewer per RACC.² “Low fat” caps at 3 grams of fat per RACC.³ “Low sodium” caps at 140 milligrams per RACC; “very low sodium” caps at 35 milligrams.⁴ “Low saturated fat” means 1 gram or less of saturated fat per RACC and no more than 15 percent of calories from saturated fat.

“High” and “Good Source”

A food labeled “high,” “rich in,” or “excellent source of” a nutrient must contain at least 20 percent of the Reference Daily Intake (RDI) or Daily Reference Value (DRV) per RACC. A “good source,” “contains,” or “provides” claim requires between 10 and 19 percent of the RDI or DRV per RACC.⁵ A product delivering 15 percent of the DRV for vitamin C would qualify as a “good source” but could not be labeled “high in vitamin C.”

These claims are only available for nutrients that have an established RDI or DRV. Making a nutrient content claim for a substance without an official reference value violates the labeling standards.¹

Relative Claims: Reduced, Light, Less, More

Alongside absolute terms, the regulation creates a category of relative claims. Each one compares the labeled food to a reference food, and the choice of reference food is regulated.¹

For “reduced” and “light” claims, the reference food must be a similar food. A “reduced fat” potato chip has to compare itself against other potato chips. For “less” and “more” claims, the reference can be a dissimilar food in a category consumers substitute for one another, such as pretzels versus potato chips.¹

“Reduced” and “fewer” claims require at least 25 percent less of the nutrient per RACC than the reference food.² For “light” claims, the reference food’s nutrient value must be representative of a broad base of that food type, drawn from a recognized database, a market basket norm, or an average of the top national brands. That requirement prevents a manufacturer from cherry-picking the worst competitor as a reference point.¹

Any food carrying a relative claim must identify the reference food on the label and state the percentage or fraction by which the nutrient has been changed. A “reduced sodium” soup needs to tell you what it is being compared to and by how much.

Mandatory Disclosure When Other Nutrients Run High

A front-of-package claim can highlight one good trait while another less desirable nutrient sits high in the nutrition facts panel. The regulation addresses that directly. If a food making a nutrient content claim exceeds any of the following thresholds, the label must carry the statement “See nutrition information for [nutrient] content”:

Total fat above 13 grams per RACC or labeled serving
Saturated fat above 4 grams
Cholesterol above 60 milligrams
Sodium above 480 milligrams

These thresholds apply to individual foods.¹ A “high protein” claim cannot distract from sodium that runs above the trigger without the disclosure. Missing the disclosure when a threshold is exceeded makes the product misbranded.

Meal Products and Main Dish Products

Frozen dinners, entrées, and similar multi-component products get their own treatment. A “meal product” must weigh at least 10 ounces per labeled serving and contain portions from at least two of four food groups (grains, fruits and vegetables, dairy, and meat or protein). A “main dish product” must weigh at least 6 ounces and meet a similar multi-group test.¹

Because these products are larger, the disclosure thresholds scale up. A meal product triggers the disclosure requirement above 26 grams of fat, 8 grams of saturated fat, 120 milligrams of cholesterol, or 960 milligrams of sodium per labeled serving. A main dish product triggers above 19.5 grams of fat, 6 grams of saturated fat, 90 milligrams of cholesterol, or 720 milligrams of sodium.¹

When a Brand Name Is Itself a Claim

The regulation reaches into brand names. If the brand incorporates a word like “light” or “lean,” FDA treats the brand name as a nutrient content claim subject to the same rules as any other claim on the label.¹

There is a grandfathering provision. Brand names in use before October 25, 1989, that contain undefined nutrient content claims may continue to be used, provided they are not false or misleading. Soft drinks that used “diet” before that date and complied with the then-current regulation may keep the term; soft drinks introduced after that date must comply with the current requirements.¹ Any new implied nutrient content claim in a brand name requires FDA authorization through a formal petition.

Type Size and Placement

The regulation controls the appearance of the words, not just the words themselves. When a nutrient content claim appears outside the statement of identity (the food’s name), it cannot be printed in a type size larger than twice the height of the statement of identity. If the claim appears within the statement of identity, it must match the same type size as the food’s name.⁶ The rule keeps “LOW FAT” from dominating a package while the product name sits in fine print beneath it.

Disclosure statements have their own sizing rules. The disclosure must appear in easily legible boldface print, in distinct contrast to other printed matter, and no smaller than the size required for the net quantity of contents statement. When the claim itself is small, the disclosure must be at least half the size of the claim but no smaller than one-sixteenth of an inch. It must sit immediately adjacent to the nutrient content claim with no intervening material other than legally required information.¹

The “Healthy” Claim Is Changing

FDA finalized a major overhaul of the “healthy” nutrient content claim in December 2024, with a compliance date of February 25, 2028. Under the new rule, a food must contain a meaningful amount from at least one food group recommended by the Dietary Guidelines for Americans and must meet specific limits for added sugars, saturated fat, and sodium.⁷ Most individual foods must stay at or below 10 percent of the Daily Value for sodium (230 milligrams) and 5 percent of the DV for saturated fat (1 gram), with slightly higher saturated fat allowances for dairy and some protein foods.⁸ Nutrient-dense foods such as whole fruits, vegetables, whole grains, and seafood automatically qualify as “healthy” if they contain no added ingredients beyond water.

Restaurants and Retail Food Establishments

Nutrient content claims are not limited to packaged food. Restaurants and retail food establishments can make these claims on menus and signage, but the regulation adjusts the requirements. Restaurant foods bearing nutrient content claims are exempt from the disclosure statement requirements. In place of laboratory testing, a restaurant may rely on a reasonable basis for concluding the food meets the claim’s definition, such as recognized nutrient databases, standardized recipes, or calculated nutrient levels.¹

Some menu terms that look like nutrient claims are treated differently in a restaurant context. A menu heading “lite fare” followed by a clear note explaining it refers to smaller portions rather than fewer calories would not be treated as a nutrient content claim. The test is whether the term characterizes the level of a nutrient. If it does, the full requirements apply regardless of the setting.¹

What Happens When a Claim Does Not Comply

A food carrying a nutrient content claim that does not meet the regulation is misbranded under the Federal Food, Drug, and Cosmetic Act. FDA’s enforcement toolkit includes warning letters, product seizures, injunctions, and criminal prosecution.⁹ Criminal penalties for misbranding a food product can reach $1,000 per violation and one year of imprisonment.¹⁰ In practice, FDA usually starts with a warning letter, giving the company a chance to correct its labels before escalating to seizure or an injunction that halts production.

1
eCFR. 21 CFR 101.13 – Nutrient Content Claims, General Principles
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eCFR. 21 CFR 101.60 – Nutrient Content Claims for the Calorie Content of Foods
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eCFR. 21 CFR 101.62 – Nutrient Content Claims for Fat, Fatty Acid, and Cholesterol Content of Foods
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eCFR. 21 CFR 101.61 – Nutrient Content Claims for the Sodium Content of Foods
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eCFR. 21 CFR 101.54 – Nutrient Content Claims for Good Source, High, More, and Other Claims
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Government Publishing Office. 21 CFR 101.13 – Nutrient Content Claims, General Principles
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U.S. Food and Drug Administration. Use of the “Healthy” Claim on Food Labeling
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Federal Register. Food Labeling: Nutrient Content Claims; Definition of Term Healthy
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Food and Drug Administration. Compliance and Enforcement (Food)
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Office of the Law Revision Counsel. 21 USC 333 – Penalties