A nutrient content claim is any claim that directly or implicitly characterizes the level of a nutrient in a food. "High protein." "Low fat." "No sugar added." "Excellent source of vitamin D." Each of these is a regulated claim under 21 CFR 101.13 and the specific subparts that follow. Using any of them without meeting the applicable threshold is a misbranding violation.
The thresholds aren't suggestions. They're the line between a compliant label and a recall or warning letter.
How Nutrient Content Claims Work
FDA defines nutrient content claims in two categories:
Express claims directly state a nutrient level: "high protein," "fat free," "sodium free." Each has a specific numerical threshold that must be met per serving, per RACC (Reference Amount Customarily Consumed), or both.
Implied claims suggest a nutrient level without stating it directly: "high in the protein your body needs," "loaded with fiber," "no junk" (implying low calorie or no artificial ingredients). Implied claims are evaluated against the same standards as express claims based on the net impression they create.
Claims must be evaluated against the serving size declared on the Nutrition Facts panel — but also against the RACC. A brand cannot manipulate the declared serving size to make a claim eligibility calculation work. FDA evaluates nutrient content claim eligibility against the RACC regardless of the declared serving size.
Protein Claims
Protein claims are among the most frequently misapplied nutrient content claims in the supplement and functional food space.
"High protein" / "excellent source of protein": ≥20% of the Daily Value for protein per serving. For adults, the DV for protein is 50g, so a "high protein" serving must contain ≥10g of protein from high-quality protein sources. The DV-based calculation also requires protein quality correction — the protein content is adjusted using the Protein Digestibility-Corrected Amino Acid Score (PDCAAS). A serving with 10g of lower-quality plant protein may not meet the threshold after correction.
"Good source of protein": 10–19% DV per serving, meaning 5–9.5g of corrected protein per serving.
The violation that shows up most often: a product with 8g of protein per serving labeled "high protein." Eight grams represents 16% DV — a "good source" claim, not a "high" claim. The threshold matters.
Fat and Cholesterol Claims
"Fat free": Less than 0.5g total fat per serving. Products that contain less than 0.5g fat can also add "fat free" to the ingredient list's reference amount.
"Low fat": ≤3g total fat per serving and per 50g of food. For meals and main dishes: ≤3g per 100g and not more than 30% of calories from fat.
"Reduced fat": At least 25% less fat than the reference food, with the reduction amount and the reference food identified on the label.
"Saturated fat free": Less than 0.5g saturated fat and less than 0.5g trans fat per serving.
"Low saturated fat": ≤1g saturated fat per serving and not more than 15% of calories from saturated fat.
"Cholesterol free": Less than 2mg cholesterol per serving and ≤2g saturated fat per serving.
"Low cholesterol": ≤20mg cholesterol per serving and per 50g, and ≤2g saturated fat per serving.
All of the above are governed by 21 CFR 101.62. The saturated fat condition on cholesterol claims is a required disclosure, not optional — a food can't claim "low cholesterol" if its saturated fat content would potentially raise cholesterol levels.
Sodium Claims
Sodium claims are closely regulated and frequently misused, particularly in the functional beverage and snack categories where "low sodium" or "reduced sodium" carries significant consumer purchase influence.
"Sodium free" / "salt free": <5mg sodium per serving — 21 CFR 101.61
"Very low sodium": ≤35mg per serving and per 50g
"Low sodium": ≤140mg per serving and per 50g
"Reduced sodium": At least 25% less sodium than the reference food, with comparison disclosed
"No salt added" / "unsalted": No salt added during processing; the food the claim applies to normally contains added salt. This is a process claim, not an absolute threshold claim — a food can say "no salt added" and still contain significant sodium from naturally occurring sources in the ingredients.
"Light in sodium" / "lightly salted": At least 50% less sodium than the reference food. The label must also state "not a low sodium food" if the food doesn't meet the ≤140mg threshold — per 21 CFR 101.56.
Calorie Claims
"Calorie free": <5 calories per serving — 21 CFR 101.60
"Low calorie": ≤40 calories per serving and per 50g
"Reduced calorie": At least 25% fewer calories than the reference food, with comparison disclosed
"Light" (calorie basis): At least 1/3 fewer calories than the reference food, or at least 50% less fat (if the food derives less than 50% of its calories from fat)
The required disclosures that come with calorie claims are easy to miss: a "reduced calorie" or "fewer calories" claim must include the calorie content of both the product and the reference food. "33% fewer calories than regular [product]" is not sufficient on its own — the actual calorie counts must be disclosed.
Sugar Claims
"Sugar free": <0.5g total sugars per serving. Products bearing a "sugar free" claim that are not also low calorie or reduced calorie must include one of the following: "not a reduced calorie food," "not a low calorie food," or "not for weight control" — 21 CFR 101.60(c)(1)(i)(B).
"No sugar added" / "no added sugar": No sugars added during processing or packing; no ingredients added that contain added sugars (jam, jelly, concentrated fruit juice used for sweetening); no processes that increase sugar content above what naturally occurs. The food must also normally contain added sugars in its standard form — a product that never contains added sugars (like plain sparkling water) doesn't qualify for "no sugar added" because the claim implies a departure from a standard that doesn't apply.
If a "no sugar added" food is not also low calorie, the label must state: "not a reduced calorie food" or equivalent.
Fiber and Vitamin/Mineral Claims
"Excellent source of" / "high in" [nutrient]: ≥20% DV per serving — 21 CFR 101.54
"Good source of" [nutrient]: 10–19% DV per serving
"More" / "added" / "enriched" / "fortified": At least 10% more DV than the reference food per serving, from fortification or addition
These thresholds apply to fiber, vitamins, minerals, and protein. "High fiber" requires ≥20% DV for dietary fiber, which is 28g at 2,000 calories — meaning ≥5.6g of fiber per serving. "Good source of calcium" requires at least 130mg of calcium per serving (10% of the 1,300mg DV).
The "Healthy" Claim
"Healthy" is treated as an implied nutrient content claim under 21 CFR 101.65. The definition was updated in a final rule effective February 25, 2025. The new definition requires:
The food must contribute a meaningful amount from at least one food group (vegetables, fruits, grains, dairy, or protein foods)
Added sugars must be within category-specific limits (2–10% DV depending on food type)
Sodium must be ≤10% DV for most individual foods (higher for mixed dishes and meals)
Saturated fat must be ≤5–10% DV depending on category
The old definition — which disqualified avocados and nuts due to total fat content — is no longer valid for new products after February 25, 2025, though a safe harbor through February 24, 2028 allows products that qualified under the old criteria to continue the claim while transitioning.
Required Accompanying Disclosures
Many nutrient content claims require additional disclosures that are frequently omitted:
"Light in sodium": must include "not a low sodium food" if sodium >140mg/serving
"Sugar free" on non-low-calorie foods: must include "not a low calorie food" or equivalent
"Reduced [nutrient]" and "less [nutrient]": must identify the reference food and the amount of reduction
"Light": must disclose the basis of the claim (light in sodium vs. light in calories) if not self-evident, and must reference the comparison food
"More" / "added": must identify the reference food and the amount added per serving
Missing a required accompanying disclosure is a violation even if the underlying claim itself is supported.
Nutrient Content Claims Are Verifiable — Before the Label Ships
The specific thresholds are in the regulations. The nutrition data is in the Nutrition Facts panel. A compliant nutrient content claim is a matter of matching the two — and catching the mismatches before a label is printed.
Truli's AI compliance platform checks every nutrient content claim on a label against current FDA thresholds — flagging claims that don't meet their threshold, missing required accompanying disclosures, and serving size manipulations that affect claim eligibility. Each finding cites the specific CFR section. Book a demo to see how Truli verifies nutrient content claims across your product catalog.
