Nutrient Content Claims: What You May Legally Say
The rules in 21 CFR 101.13 run the opposite way to most labeling law: nothing is allowed unless FDA has defined it. The closed list, the thresholds behind each family of claims, the per-RACC basis and the disclosure statement.
A phrase like "low sodium" or "excellent source of fiber" is not marketing copy in the eyes of a regulator. It is a nutrient content claim, and the rules for nutrient content claims FDA enforces sit in 21 CFR 101.13 with the definition sections in subpart D. The structure runs the opposite way to most labeling rules: it does not list forbidden phrases. It defines a closed set of terms, each with a numeric threshold, and anything outside that set either cannot be printed or has to be rewritten as a bare factual statement.
One consequence is worth stating up front: under 101.13(n), nutrition labeling must be provided for any food that bears a nutrient content claim, so making a claim can remove an exemption you were 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 to be 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. Two words do the work: expressly and implicitly.
An express claim, under 101.13(b)(1), is any direct statement about the level or range of a nutrient, and the regulation gives "low sodium" and "contains 100 calories" as examples. Everybody knows to check those. An implied claim, under 101.13(b)(2), is the category that catches people out. The first limb covers any claim describing the food or an ingredient in it in a manner suggesting a nutrient is absent or present in a certain amount, the regulation's own example being "high in oat bran." No number, no nutrient named, and it is still a claim about fiber content, subject to the fiber thresholds in 101.54. The second limb covers a claim suggesting the food, because of its nutrient content, may be useful in maintaining healthy dietary practices, where there is also implied or explicit information about the nutrition content. The example given is "healthy," with its own criteria in 101.65. The updated "healthy" rule is final but voluntary until the 25 February 2028 compliance date, and its criteria are set out in the FDA healthy claim requirements.
One more trap sits in 101.13(c), and it is purely about placement. Information that 101.9 requires or permits you to declare, appearing as part of the nutrition label, is not a claim. The same information anywhere else on the label is a claim, with every requirement in this section attached. "0 g trans fat" inside the panel is a mandatory declaration. The same characters on the front panel are a claim.
Which nutrient content claims FDA allows: the closed list
The operative principle: you may use a term the regulation defines, as it defines it, and nothing else. There is no general permission to describe nutrient levels in your own words. To say something about the level of fat, sodium, calories, sugar, cholesterol, fiber, protein, a vitamin or a mineral, you go to the definition section, take a term listed there, and meet its number. Three provisions soften that edge without breaking it.
- Spelling variations. 101.13(b)(4) permits reasonable variations in the spelling of defined terms and their synonyms, provided they are not misleading. The examples given are "hi" and "lo."
- Bare amount statements. 101.13(i) lets you state an amount or percentage of a nutrient in three situations. If the statement characterizes the level and is consistent with a subpart D definition, it is allowed: "less than 3 g of fat per serving." If it characterizes the level but is not consistent with a definition, it needs an adjacent disclaimer: "only 200 mg sodium per serving, not a low sodium food." If it does not characterize the level at all, no disclaimer is needed: "100 calories" or "5 grams of fat." Note 101.13(i)(4): "percent fat free" is not authorized by this route and must comply with 101.62(b)(6), which requires the food to meet "low fat" first.
- Inherently qualifying foods. 101.13(e)(1) says "free" or "low" before the name of a food implies it differs from others of the same type, so only foods specially processed, altered, formulated or reformulated to lower the nutrient may bear such a claim. If your food qualifies naturally, 101.13(e)(2) requires the claim to refer to all foods of that type rather than your brand: "corn oil, a sodium-free food."
The main families and the thresholds behind them
The defined terms group into families. Within a family the logic is identical across nutrients and only the number changes, so the structure is worth learning once rather than memorising a grid. The table below gives enough worked thresholds to check a typical front panel. For your own nutrient, read the paragraph cited in the last column: several definitions carry extra conditions a table cannot hold.
| 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 terms pull in their own extra text: a saturated fat claim must disclose total fat and cholesterol in immediate proximity under 101.62(c), and 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 at no less than half the size of the claim. Our claim validator checks a proposed term against the definition sections and reports which statements it pulls in.
The per-RACC basis, and the extra per-50 g test
Every threshold above is measured on the reference amount customarily consumed, not on your declared serving size. Section 101.13(p)(1) is explicit: unless otherwise specified, the RACC in 101.12(b) through (f) determines whether a product meets the criteria for a claim. When the labeled serving differs from the RACC and the nutrient amount in that serving does not meet the criterion, the claim must be followed by the criteria for the claim 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: 101.13(p)(2) puts it immediately adjacent to the most prominent claim, at the type size set by 101.13(h)(4)(i).
A second test applies to small reference amounts. Where a food has a RACC of 30 g or less, or 2 tablespoons or less, several definitions add a per 50 g criterion on top of the per RACC one, and the food must satisfy both. Low fat under 101.62(b)(2) is 3 g or less on both bases, low sodium under 101.61(b)(4) is 140 mg or less, very low sodium under 101.61(b)(2) is 35 mg or less, and low calorie under 101.60(b)(2) is not more than 40 calories per RACC and, except for sugar substitutes, per 50 g.
The reason is arithmetic. A seasoning with a 5 g reference amount clears almost any per-serving ceiling, so the 50 g test asks what the food looks like at a weight where the comparison means something. Condiments, spice blends, crackers and drink mixes are where a claim that passes per RACC fails per 50 g. For dehydrated foods reconstituted with water, the per 50 g criterion refers to the "as prepared" form.
The disclosure statement, and the limit on how big a claim can be
A legitimate claim can still force extra text onto the panel. Under 101.13(h)(1), a food bearing a claim and containing more than 13.0 g of fat, 4.0 g of saturated fat, 60 mg of cholesterol or 480 mg of sodium per RACC, per labeled serving, or per 50 g where the RACC is 30 g or less or 2 tablespoons or less, must bear a statement naming the nutrient that exceeds the level: "See nutrition information for ____ content."
Meal products and main dish products, defined in 101.13(l) and 101.13(m), have their own levels per labeled serving: 26 g of fat, 8.0 g of saturated fat, 120 mg of cholesterol and 960 mg of sodium for a meal product, 19.5 g, 6.0 g, 90 mg and 720 mg for a main dish.
The formatting rules in 101.13(h)(4) are specific. The statement is in easily legible boldface, in distinct contrast to other printed matter, and no smaller than the type 101.7(i) requires for the net quantity of contents; where the claim is less than twice that size, at least half the size of the claim and never below one-sixteenth of an inch. It sits immediately adjacent to the claim with no intervening material, and repeats on every panel carrying the claim except the one bearing the nutrition information. Where a panel carries several claims, one disclosure is enough, next to the claim printed in the largest type.
Separately, 101.13(f) caps how loud a claim can be: it must be in type no larger than two times the statement of identity, and not unduly prominent in type style compared to it. This is the rule that sends front panels back to the designer after the copy is approved, because a claim set as the dominant headline over a small product name breaks it.
Relative claims carry two extra pieces of text
Section 101.13(j) treats "light," "reduced," "less" (or "fewer") and "more" as relative claims, because each compares your food to something else. That something else has to be identified on the label, and the comparison 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 be substituted in the diet, such as potato chips as a reference for pretzels. Under 101.13(j)(1)(i)(B), "light," "reduced," "added," "extra," "plus," "fortified" and "enriched" must use a similar food. For "light," 101.13(j)(1)(ii)(A) requires a value representative of a broad base of foods of that type: a valid database, an average of the top three national or regional brands, a market basket norm, or a representative market leader, and you must supply the basis for that value on request.
Then 101.13(j)(2) adds two mandatory statements. First, the label must state the identity of the reference food and the percentage or fraction by which the nutrient differs, for example "50 percent less fat than (reference food)," immediately adjacent to the most prominent claim at the type size set by 101.13(h)(4)(i). Second, it must bear clear and concise quantitative information comparing that nutrient per labeled serving with the reference food, adjacent to the most prominent claim or to the nutrition label. Which use is most prominent is settled by the ordered list in 101.13(j)(2)(iii): a claim on the principal display panel next to the statement of identity outranks one elsewhere on that panel, then the information panel, then anywhere else.
One limit closes the loop. Under 101.13(j)(3), a relative claim for a decreased level may not be made if the reference food already meets the "low" requirement for that nutrient, and the regulation gives 3 g fat or less as the example. "Reduced fat" against a food that was already low fat is not a smaller number, it is a prohibited claim. The rule repeats in 101.60(b)(4)(iii) for calories, 101.61(b)(6)(iii) for sodium and 101.62(b)(4)(iii) for fat, and in 101.56(b)(4), which bars "light" where the reference food meets both "low fat" and "low calorie."
Build the panel and the front-panel copy together so the claim and the nutrition information cannot drift apart: the nutrition label generator calculates the per RACC values your claim is measured against while it builds the panel.
Frequently asked questions
Can I invent my own phrase if it is technically true?
Not if it characterizes the level of a nutrient. Section 101.13(b) permits such a claim only when it complies with 101.13 and the definitions in subpart D, which are a closed list. What you can do instead is a bare factual statement under 101.13(i)(3), such as "100 calories," or a statement that does characterize the level but carries the disclaimer required by 101.13(i)(2), such as "only 200 mg sodium per serving, not a low sodium food."
Is an ingredient callout on the front a claim?
It can be. Section 101.13(b)(2)(i) defines an implied claim as one describing the food or an ingredient in it in a manner suggesting a nutrient is absent or present in a certain amount, the example being "high in oat bran." A callout naming an ingredient consumers associate with a nutrient can fall inside that definition with no number and no nutrient named, so it has to meet the threshold for the nutrient it implies.
Why does my low fat snack fail when it passes the 3 g test?
Because of the second test for small reference amounts. Under 101.62(b)(2)(i)(B), a food whose RACC is 30 g or less or 2 tablespoons or less must contain 3 g or less of fat per RACC and per 50 g. A 28 g portion with 2.8 g of fat passes the first and fails the second, since the same food at 50 g carries 5 g. Low sodium, very low sodium and low calorie run the same double test.
My product qualifies but it is high in sodium. Can I still print the claim?
Yes, with the disclosure statement. Section 101.13(h)(1) requires a food carrying a claim and containing more than 480 mg of sodium per RACC, per labeled serving, or per 50 g where the RACC is small, to bear "See nutrition information for sodium content" immediately adjacent to the claim in boldface. The same applies above 13.0 g of fat, 4.0 g of saturated fat or 60 mg of cholesterol. The claim is not blocked, it just cannot travel alone.
Can I say "reduced sodium" against a competitor that is already low sodium?
No. Section 101.13(j)(3) bars a relative claim for a decreased level where the reference food itself meets the "low" requirement for that nutrient, and 101.61(b)(6)(iii) repeats it for sodium. You would need a reference food that does not meet "low sodium," named on the label with the percentage difference and a quantitative comparison per labeled serving.
