FDA Nutrient Content Claims: Definitions and Thresholds

The words “low fat,” “reduced sodium,” and “good source of fiber” are not marketing language, which surprises a lot of first-time founders. They are regulated terms with specific numerical definitions in federal law. Using them without meeting those definitions makes the label legally non-compliant, the same way a misstated allergen declaration or a wrong serving size does.

Most founders encounter this issue late in the label process, after the designer has already set the front panel. The product genuinely is lower in sodium than a competitor. The founder writes “low sodium” on the front. Nobody checks the number until a compliance review flags it, and the answer is either a reprint or a redesign.

What makes something a nutrient content claim

Under 21 CFR 101.13, a nutrient content claim is any statement, term, symbol, or graphic on a food label that directly or implicitly characterizes the level of a nutrient in the food. That covers explicit claims like “fat free” and “high in calcium,” but also less obvious ones: “healthy,” “light,” “lean,” phrases like “contains only 140 calories per serving,” and even the name of a product category that implies a nutrient level, like “low-calorie cookie.”

If it implies something about a nutrient, it is a nutrient content claim, and the rules in 21 CFR Part 101 Subpart D apply to it.

A food may only bear a nutrient content claim if the claim is specifically defined and authorized under those regulations. There is no permitted category of “custom” or “informal” claims. If a term is not in the rule, it cannot appear on the label as a claim.

This matters practically because founders sometimes invent claims that sound reasonable but are not defined, or use a defined term without meeting the threshold. Both problems produce non-compliance.

Absolute claims: “free” and “low”

Absolute claims describe what is in a food by itself, not in comparison to another food.

Fat free and low fat are defined in 21 CFR 101.62. “Fat free” requires less than 0.5 grams of total fat per reference amount customarily consumed (RACC) and per labeled serving. “Low fat” requires 3 grams or less of total fat per RACC, and for products with a RACC of 30 grams or less, that same threshold applies per 50 grams of food as well. A product that has 3.2 grams of fat per serving cannot be called “low fat.”

Sodium free, very low sodium, and low sodium are defined in 21 CFR 101.61 with three distinct tiers:

• “Sodium free” requires less than 5 milligrams of sodium per RACC and per labeled serving.
• “Very low sodium” requires 35 milligrams or less per RACC.
• “Low sodium” requires 140 milligrams or less per RACC.

A product with 150 mg of sodium per serving may be lower in sodium than its category average, but it cannot bear the “low sodium” claim. “Reduced sodium” is the appropriate claim in that situation, and reduced is a relative claim with its own requirements, covered below.

Calorie free and low calorie are defined in 21 CFR 101.60. “Calorie free” requires fewer than 5 calories per RACC. “Low calorie” requires no more than 40 calories per RACC. For products with a RACC of 30 grams or less, the same threshold applies per 50 grams.

The practical implication of the RACC linkage is that these thresholds always run against the regulatory serving size, not whatever serving size the label shows. If the serving size on the label is wrong for another reason, every claim built on top of it is potentially wrong too.

Positive nutrient claims: “good source” and “high”

These claims are defined in 21 CFR 101.54 and apply to vitamins, minerals, protein, dietary fiber, and potassium.

Good source requires the food to contain 10 to 19 percent of the Daily Reference Value (DRV) or Reference Daily Intake (RDI) per RACC. Equivalent terms are “contains” and “provides.”

High or excellent source requires 20 percent or more of the DRV or RDI per RACC. Equivalent terms are “rich in” and “excellent source of.”

Both claims are per-serving figures. A food that contains 15 percent of the DV for fiber per labeled serving is a “good source of fiber” in regulatory terms and may say so. A food that contains 25 percent of the DV for calcium per serving is a “high” or “excellent source of calcium” and may say so.

The relevant DVs to use for these calculations come from the FDA’s current regulatory daily values, updated as part of the 2016 Nutrition Facts rule and now fully in effect. For dietary fiber the DV is 28 grams. For calcium it is 1,300 milligrams. For vitamin D it is 20 micrograms. Building a “good source of vitamin D” claim against an outdated DV produces an incorrect percentage and a potentially non-compliant claim.

More or added claims require the food to provide 10 percent or more of the DRV or RDI per RACC above the amount in an appropriate reference food. This is a positive relative claim: the food has meaningfully more of a beneficial nutrient than a comparable product does.

Relative claims: “reduced,” “less,” and “light”

Relative claims compare the nutrient content of the product to a reference food. They require two things: a defined reference food and a defined percentage difference. Under 21 CFR 101.13, every relative claim must be accompanied by a statement identifying the reference food and the percentage or fraction by which the nutrient has been modified.

Reduced and less claims generally require at least 25 percent less of the named nutrient per RACC compared to the reference food. So “reduced sodium” means the product has at least 25 percent less sodium than the reference food. That reduction has to be stated: “reduced sodium, 30% less sodium than [reference product]” or a similar disclosure adjacent to the claim.

The reference food for a reduced claim must be a similar food, not a different product category. You cannot establish a “reduced fat” claim for a granola bar by comparing it to a higher-fat food in a different category. The comparison has to be meaningful, and FDA’s rules require the reference food to be representative of the type of food that includes the product.

Light or lite is defined in 21 CFR 101.56 and operates differently depending on where the calories in the product come from. If the food derives 50 percent or more of its calories from fat, the “light” claim requires the fat content to be reduced by at least 50 percent per RACC compared to the reference food. If the food derives less than 50 percent of its calories from fat, the “light” claim requires a calorie reduction of at least one-third (33 percent) per RACC compared to the reference food.

The disclosure requirement for “light” claims is specific: the label must state the amount of calories and fat in the light product and in the reference food, either adjacent to the most prominent claim or adjacent to the Nutrition Facts panel. A “light” claim standing alone, without that comparative disclosure, does not satisfy the regulation.

One restriction on “light” worth knowing: it cannot be used if the reference food already meets the definition of “low fat” and “low calorie.” In that case, the claim is not meaningful under the regulatory framework.

The disqualifying nutrient issue

Under 21 CFR 101.13(h), a food may not bear a nutrient content claim if it contains more than the specified level of any disqualifying nutrient. The disqualifying levels per RACC are: 13 grams of total fat, 4 grams of saturated fat, 60 milligrams of cholesterol, or 480 milligrams of sodium.

For meal products the thresholds are higher; for products with a RACC of 30 grams or less, a per-50-gram calculation also applies. But the basic rule is that a food high in fat, saturated fat, cholesterol, or sodium cannot simultaneously make a positive nutrient content claim about something else without specific disclosures.

In practical terms, this means a high-fat product with a meaningful source of fiber cannot simply declare “good source of fiber” on the front panel. The fat content disqualifies the claim unless the label includes the required disclosure statement: “See nutrition information for [fat/saturated fat/cholesterol/sodium] content.” That disclosure must appear adjacent to the claim, in type at least half the size of the claim itself.

This provision catches founders who focus on the nutrient being claimed and miss what the panel already shows on the other side. A thorough label review checks both directions.

What Canada requires

In Canada, nutrient content claims are governed by Health Canada’s Table of Permitted Nutrient Content Statements and Claims, incorporated by reference into the Food and Drug Regulations (FDR) following section B.01.513. The table is a different document from FDA’s rules, with different terms and different thresholds.

The most important difference in day-to-day practice: Canada’s daily values differ from FDA’s in several nutrients, and the DV is the base for calculating percentage claims. Fat has a DV of 75 grams in Canada versus 78 grams in the US. Those differences shift the %DV on every fat-containing product and affect whether a “good source” threshold is met.

Fiber claims in Canada follow the table as well. Three tiers exist: “source of fibre” requires a minimum of 2 grams of dietary fiber per serving; “high source of fibre” requires 4 grams; and “very high source of fibre” requires 6 grams. The terms and the gram thresholds differ from the FDA framework, which uses 10 percent and 20 percent of DV. A product that qualifies as a “good source of fiber” under FDA rules may or may not satisfy the Canadian “source of fibre” threshold, depending on the serving size and gram content.

Canada’s rules for sodium claims and fat claims follow permitted claim terms in the table, which are not identical to FDA’s tier labels. Before assuming a US claim translates directly to a Canadian label, the specific conditions in the Canadian table need to be checked against the product’s actual nutrient values per Canadian serving size.

Why this comes up at review

The most common nutrient content claim problems at review are not usually fabricated claims. They are claims that were meant in good faith, based on what the product genuinely delivers, but that do not meet the specific threshold.

A bar with 3.1 grams of fat described as “low fat.” A beverage with 150 mg of sodium described as “low sodium” when the threshold is 140 mg. A product with 8 percent of the DV for fiber described as a “good source” when 10 percent is the floor. Each of these is a real product claim that fails the definition by a small margin, and each one has to be removed or corrected before the label can go to print.

The secondary issue is the disclosure requirement on relative claims. A label that says “reduced sodium” without the required comparative statement is non-compliant in a different way: the claim is factually supportable, but the label is missing a required disclosure. Both types of error add up to the same outcome: a revision cycle between the founder and the designer, and a delayed print date.

At Complion, nutrient content claims are verified against the applicable FDA thresholds and Health Canada permitted claim conditions as part of the full label build. If you are building a first label and want to make sure the front panel reflects what the product can legally say, book a free call to start.