Nutrient Content Claims: FDA Rules and Examples

A phrase such as "low sodium" or "excellent source of fiber" is a regulated nutrient content claim, not simply marketing copy. The rules for nutrient content claims FDA enforces are in 21 CFR 101.13, with the individual claim definitions in subpart D.

The system works differently from many other labeling rules. FDA does not provide a list of prohibited marketing phrases. Instead, it defines a closed set of terms with specific numeric thresholds. If your wording characterizes the level of a nutrient, it generally needs to use a defined term and satisfy its conditions, or be presented as a factual amount statement under the applicable rules.

One consequence matters before you add any claim to a package: under 101.13(n), nutrition labeling must be provided for any food bearing a nutrient content claim. A claim can therefore remove an exemption the product was relying on. That interaction is covered in nutrition label compliance.

What makes a phrase a nutrient content claim

Section 101.13(b) draws the line. A claim that expressly or implicitly characterizes the level of a nutrient of the type required in nutrition labeling under 101.9 or 101.36 may not be made unless it complies with 101.13 and the applicable regulations in subpart D.

The important words are expressly and implicitly.

An express claim under 101.13(b)(1) directly states something about the level or range of a nutrient. The regulation gives "low sodium" and "contains 100 calories" as examples.

An implied claim under 101.13(b)(2) is easier to miss.

The first type describes a food or an ingredient in a way that suggests a nutrient is absent or present at a particular level. The regulation's example is "high in oat bran." The statement does not give a nutrient amount, but it still implies something about fiber content and is subject to the fiber requirements in 101.54.

The second type suggests that a food may be useful in maintaining healthy dietary practices because of its nutrient content, while also giving explicit or implied information about that content. FDA's example is "healthy," which has separate criteria under 101.65.

The updated "healthy" rule is final but voluntary until its 25 February 2028 compliance date. Its criteria are covered in the FDA healthy claim requirements.

Another important distinction appears in 101.13(c), and it depends entirely on placement.

Nutrition information required or permitted under 101.9 is not a nutrient content claim when it appears as part of the Nutrition Facts label. Put the same information somewhere else on the package and it becomes a claim subject to 101.13.

For example, "0 g trans fat" inside the Nutrition Facts panel is a nutrient declaration. The same "0 g trans fat" statement on the front of the package is a claim.

FDA nutrient content claims use a closed list of defined terms

The basic rule is that you may use a term FDA defines, according to the conditions FDA gives it. There is no general permission to invent your own wording to characterize nutrient levels.

If you want to describe the amount of fat, sodium, calories, sugar, cholesterol, fiber, protein, a vitamin or a mineral, start with the applicable definition in subpart D and determine whether the food meets its threshold.

Three provisions give you some flexibility without changing that principle.

• Spelling variations. 101.13(b)(4) permits reasonable spelling variations of defined terms and their synonyms when the variation is not misleading. The regulation gives "hi" and "lo" as examples.
• Bare amount statements. 101.13(i) permits nutrient amounts or percentages in three situations. A statement that characterizes the level and is consistent with a subpart D definition is permitted, such as "less than 3 g of fat per serving." If it characterizes the level but does not meet a definition, an adjacent disclaimer is required, such as "only 200 mg sodium per serving, not a low sodium food." If the statement does not characterize the level, no disclaimer is required, such as "100 calories" or "5 grams of fat." Under 101.13(i)(4), "percent fat free" cannot use this route and instead must comply with 101.62(b)(6), which first requires the food to meet the definition of low fat.
• Inherently qualifying foods. Under 101.13(e)(1), placing "free" or "low" before a food name implies the product differs from other foods of that type. Only a food specially processed, altered, formulated or reformulated to reduce the nutrient may use the claim that way. When a food naturally qualifies, 101.13(e)(2) requires wording that applies to the whole food category, such as "corn oil, a sodium-free food."

Nutrient content claim examples and their thresholds

The defined terms fall into several families. Within each family, the underlying logic is similar across nutrients, while the numeric threshold changes.

The table below provides worked thresholds for common front-of-package claims. For the nutrient you are evaluating, check the paragraph cited in the final column because several definitions include additional requirements that cannot be captured by a threshold alone.

Family	How it works, with worked thresholds	Defined in
Free	A trivial amount, per RACC and per labeled serving. Calorie free, under 5 calories. Sodium free, under 5 mg. Fat free and sugar free, under 0.5 g each. Cholesterol free, under 2 mg. Saturated fat free, under 0.5 g saturated fat and under 0.5 g trans fat.	101.60(b)(1), 101.61(b)(1), 101.62(b)(1), 101.60(c)(1), 101.62(d)(1), 101.62(c)(1)
Low	A ceiling per RACC. Low calorie, 40 calories or less. Low sodium, 140 mg or less. Low fat, 3 g or less. Low saturated fat, 1 g or less and not more than 15 percent of calories from saturated fatty acids. Low cholesterol, 20 mg or less. Sodium alone adds "very low sodium" at 35 mg or less.	101.60(b)(2), 101.61(b)(4), 101.62(b)(2), 101.62(c)(2), 101.62(d)(2), 101.61(b)(2)
Reduced, less, fewer, lower	At least 25 percent less per RACC than an appropriate reference food. The same 25 percent covers calories, sugars, sodium, fat and saturated fat.	101.60(b)(4), 101.60(c)(5), 101.61(b)(6), 101.62(b)(4), 101.62(c)(4)
High, rich in, excellent source of	20 percent or more of the RDI or the DRV per RACC.	101.54(b)(1)
Good source, contains, provides	10 to 19 percent of the RDI or the DRV per RACC.	101.54(c)(1)
More, fortified, enriched, added, extra, plus	At least 10 percent more of the RDI or DRV per RACC than a reference food, for protein, vitamins, minerals, dietary fiber and potassium only.	101.54(e)(1)
Light, lite	Turns on the fat share of calories. At 50 percent or more of calories from fat, fat must be cut by 50 percent or more per RACC against the reference. Below that, either calories fall by at least one-third or fat by 50 percent or more.	101.56(b)

Some nutrient content claims also trigger additional statements.

A saturated fat claim must disclose total fat and cholesterol in immediate proximity under 101.62(c).

A fiber claim on a food that is not low in total fat must disclose total fat per labeled serving under 101.54(d). Both disclosures must appear at no less than half the size of the claim.

Our claim validator checks a proposed claim against the applicable definition and identifies the additional statements it triggers.

Nutrient content claims are measured per RACC, not your chosen serving

The thresholds above are generally measured against the Reference Amount Customarily Consumed, not simply the serving size you print on the label.

Section 101.13(p)(1) states that, unless otherwise specified, the RACC established in 101.12(b) through (f) determines whether a product satisfies the criteria for a claim.

When the labeled serving differs from the RACC and the nutrient amount in that serving does not meet the claim criterion, the claim must be followed by the applicable criteria as required by 101.12(g).

The regulation's example is "very low sodium, 35 mg or less per 240 milliliters (8 fl oz)."

That qualifier is not a footnote. Under 101.13(p)(2), it must appear immediately adjacent to the most prominent claim at the type size specified by 101.13(h)(4)(i).

The additional per-50 g test

A second test applies to foods with small reference amounts.

When the RACC is 30 g or less, or 2 tablespoons or less, several definitions require the food to meet a threshold both per RACC and per 50 g.

Examples include:

• Low fat: 3 g or less under 101.62(b)(2), on both applicable bases.
• Low sodium: 140 mg or less under 101.61(b)(4).
• Very low sodium: 35 mg or less under 101.61(b)(2).
• Low calorie: no more than 40 calories per RACC and, except for sugar substitutes, per 50 g under 101.60(b)(2).

The reason becomes clear with a small serving.

A seasoning with a 5 g reference amount can satisfy many per-RACC ceilings simply because very little food is being measured. The 50 g test evaluates the same food at a weight where its nutrient concentration becomes meaningful.

Condiments, spice blends, crackers and drink mixes are common examples where a claim can pass per RACC but fail per 50 g.

For dehydrated foods reconstituted with water, the per-50 g test applies to the "as prepared" form.

FDA nutrient content claims can require a disclosure statement

A valid claim can still trigger additional text on the package.

Under 101.13(h)(1), a food bearing a nutrient content claim must carry a disclosure when it contains more than:

• 13.0 g total fat
• 4.0 g saturated fat
• 60 mg cholesterol
• 480 mg sodium

The applicable amount is tested per RACC, per labeled serving, or per 50 g when the RACC is 30 g or less or 2 tablespoons or less.

The required statement identifies the nutrient exceeding the threshold, using wording such as "See nutrition information for sodium content."

Meal products and main dish products, defined in 101.13(l) and 101.13(m), have separate thresholds per labeled serving.

For a meal product, the levels are 26 g total fat, 8.0 g saturated fat, 120 mg cholesterol and 960 mg sodium.

For a main dish product, they are 19.5 g total fat, 6.0 g saturated fat, 90 mg cholesterol and 720 mg sodium.

The formatting requirements in 101.13(h)(4) are specific. The disclosure must:

• Appear in easily legible boldface.
• Contrast distinctly with other printed material.
• Be no smaller than the type required for the net quantity declaration under 101.7(i).
• When the claim is less than twice that size, be at least half the size of the claim and never below one-sixteenth inch.
• Appear immediately adjacent to the claim with no intervening material.
• Repeat on every panel carrying the claim except the panel containing the nutrition information.

If one panel contains multiple claims, one disclosure is sufficient when it appears next to the claim printed in the largest type.

Separately, 101.13(f) limits the visual prominence of the claim itself. A claim may not appear in type larger than twice the size of the statement of identity and cannot be unduly prominent in type style compared with that statement.

This requirement often affects packaging design after claim copy has been approved. A nutrient claim used as a dominant headline above a much smaller product name can violate the rule even when the nutrient threshold itself is satisfied.

Relative nutrient content claims require two additional statements

Section 101.13(j) treats "light," "reduced," "less" or "fewer," and "more" as relative claims because they compare the labeled food with another food.

The reference food must be identified and the difference must be quantified.

Which reference food you may use depends on the claim.

Under 101.13(j)(1)(i)(A), "less" and "more" may use a dissimilar food within a product category that can generally substitute for the labeled food in the diet. The regulation allows, for example, potato chips to serve as a reference for pretzels.

Under 101.13(j)(1)(i)(B), "light," "reduced," "added," "extra," "plus," "fortified" and "enriched" must use a similar reference food.

For "light," 101.13(j)(1)(ii)(A) requires the reference value to represent a broad base of foods of that type. It may come from a valid database, the average of the top three national or regional brands, a market basket norm, or a representative market leader. You must provide the basis for the value on request.

Section 101.13(j)(2) then requires two statements.

First, identify the reference food and state the percentage or fraction by which the nutrient differs. For example:

"50 percent less fat than (reference food)."

That statement must appear immediately adjacent to the most prominent claim at the type size required by 101.13(h)(4)(i).

Second, provide clear and concise quantitative information comparing the nutrient amount per labeled serving in your product with the reference food. This can appear adjacent to the most prominent claim or next to the nutrition label.

For example:

"Sodium content has been lowered from 300 to 150 mg per serving."

101.13(j)(2)(iii) determines which claim is considered most prominent. A claim on the principal display panel next to the statement of identity ranks first, followed by a claim elsewhere on that panel, then one on the information panel, and finally one appearing elsewhere.

There is also a limit on decreased-level relative claims.

Under 101.13(j)(3), you cannot make a relative claim for a decreased nutrient level if the reference food already satisfies the "low" requirement for that nutrient. The regulation uses a food containing 3 g fat or less as an example.

So "reduced fat" compared with a food that is already low fat is prohibited rather than merely unnecessary.

The same restriction appears in 101.60(b)(4)(iii) for calories, 101.61(b)(6)(iii) for sodium and 101.62(b)(4)(iii) for fat. Section 101.56(b)(4) also prohibits "light" when the reference food meets both the low fat and low calorie definitions.

Build the Nutrition Facts panel and front-of-package claims from the same nutrient data so they cannot drift apart. The nutrition label generator calculates the per-RACC values against which your claim is evaluated while building the panel.

Nutrient content claims frequently asked questions

Can I invent my own nutrient content claim if it is technically true?

Not when the wording characterizes the level of a nutrient. Section 101.13(b) requires such claims to comply with 101.13 and the definitions in subpart D. You can instead use a bare factual statement under 101.13(i)(3), such as "100 calories," or a statement with the required disclaimer under 101.13(i)(2), such as "only 200 mg sodium per serving, not a low sodium food."

Is an ingredient callout on the front of the package a nutrient content claim?

It can be. Section 101.13(b)(2)(i) covers statements describing a food or ingredient in a way that suggests a nutrient is absent or present at a particular level. The regulation's example is "high in oat bran." A front-panel ingredient callout can therefore become an implied nutrient claim even when it gives no number and does not name the nutrient directly.

Why does my low fat snack fail when it passes the 3 g test?

Because small reference amounts can trigger a second test. Under 101.62(b)(2)(i)(B), a food with a RACC of 30 g or less or 2 tablespoons or less must contain 3 g or less fat both per RACC and per 50 g. A 28 g amount containing 2.8 g fat passes the first test but fails the second because 50 g contains 5 g fat.

My product qualifies for a claim but is high in sodium. Can I still print the claim?

Yes, with the required disclosure statement. Under 101.13(h)(1), a claimed food containing more than 480 mg sodium per RACC, per labeled serving, or per 50 g when the RACC is small must state "See nutrition information for sodium content" immediately adjacent to the claim in boldface. Similar disclosure requirements apply above 13.0 g fat, 4.0 g saturated fat or 60 mg cholesterol.

Can I say “reduced sodium” compared with a product that is already low sodium?

No. Section 101.13(j)(3) prohibits a decreased-level relative claim when the reference food already satisfies the applicable "low" definition, and 101.61(b)(6)(iii) specifically repeats that restriction for sodium. The reference food must not already qualify as low sodium, and the label must identify it, state the percentage difference and provide the quantitative comparison per labeled serving.