Nutrient content claims describe the level of a nutrient in a food or supplement. Unlike structure/function claims, which describe what a nutrient does, nutrient content claims describe how much of a nutrient is present. FDA has established specific definitions for each of these claims under 21 CFR 101.54 through 21 CFR 101.65. Using them without meeting the requirements — even on a supplement label where many other claims are relatively flexible — is a misbranding violation under 21 U.S.C. 343(r).
High, Rich In, Excellent Source Of
Under 21 CFR 101.54(b), "high," "rich in," and "excellent source of" are equivalent claims. To use any of them for a nutrient, the product must contain 20% or more of the Daily Reference Value (DRV) or Reference Daily Intake (RDI) per serving.
Examples:
"High protein" requires ≥20% of the DRV for protein per serving (≥10g for a 50g DRV)
"Excellent source of fiber" requires ≥20% of the DRV for fiber per serving (≥5g for a 28g DRV)
"Excellent source of vitamin D" requires ≥20% of the RDI for vitamin D per serving (≥4mcg for a 20mcg RDI)
The DRVs and RDIs were updated with the 2016 Nutrition Facts rulemaking, effective January 1, 2020. Brands using pre-2020 Daily Values for their threshold calculations are using the wrong numbers.
Good Source Of, Contains, Provides
Under 21 CFR 101.54(c), "good source of," "contains," and "provides" are equivalent and require 10–19% of the DRV or RDI per serving. A product with 12% of the DRV for calcium can say it's a "good source of calcium" but not an "excellent source."
Low Claims
"Low" claims are defined separately for different nutrients under 21 CFR 101.56:
Low fat: ≤3g total fat per serving
Low saturated fat: ≤1g saturated fat per serving, and ≤15% of calories from saturated fat
Low sodium: ≤140mg sodium per serving
Very low sodium: ≤35mg sodium per serving
Low cholesterol: ≤20mg cholesterol per serving, and ≤2g saturated fat per serving
Low calorie: ≤40 calories per serving
"Low sugar" is not an FDA-defined nutrient content claim. There is no established threshold for "low sugar" as a standalone claim. Brands using "low sugar" on labels should understand this is not an authorized nutrient content claim under 21 CFR 101.56 — it may function as an implied nutrient content claim subject to FTC substantiation requirements.
Free Claims
"Free" claims under 21 CFR 101.60 and 101.61 require that the named nutrient be below defined thresholds:
Fat-free: <0.5g fat per serving
Saturated fat-free: <0.5g saturated fat per serving
Cholesterol-free: <2mg cholesterol per serving, and ≤2g saturated fat per serving
Sodium-free / salt-free: <5mg sodium per serving
Sugar-free: <0.5g sugars per serving
Calorie-free: <5 calories per serving
Zero: Same thresholds as "free" — "zero sugar" and "sugar-free" are equivalent under FDA's framework
"Zero sugar" and "no added sugar" are not the same claim
"Zero sugar" means <0.5g sugars per serving and falls under the "free" claim standard. "No added sugar" under 21 CFR 101.60(c) means no sugar or sugar-containing ingredients were added during processing — but the product may still contain naturally occurring sugars from ingredients. A product can be "no added sugar" and still have significant sugar content from fruit concentrates or dairy. These claims mean different things to consumers and to regulators.
More, Fortified, Enriched, Added, Extra, Plus
Under 21 CFR 101.54(e), claims that a food contains "more" of a nutrient require that the product contain at least 10% more of the DRV or RDI per serving than a reference food. For supplements, this means the claim must be comparative — "more protein than [reference food]" — with an identified reference food and documentation of the comparison.
Protein Claims: A Special Case
Protein is one of the most important nutrients in supplement marketing and one of the most frequently misclaimed. The DRV for protein is 50g per day. "High protein" requires ≥10g per serving.
But protein claims on supplement labels also interact with how protein is calculated on the Supplement Facts panel. Protein quantity on a Supplement Facts panel must reflect the corrected protein value using the PDCAAS (Protein Digestibility Corrected Amino Acid Score) methodology under 21 CFR 101.9(c)(7) for conventional foods — though for supplements, protein is listed as a dietary ingredient rather than calculated via nitrogen content. Brands making specific protein content claims must ensure the stated quantity is accurate and measurable.
Nitrogen-spiking — adding non-protein nitrogen compounds (glycine, taurine, creatine) to inflate the apparent protein content on amino acid testing — is a known fraudulent practice in the protein supplement space. It's FTC substantiation fraud and, depending on the label representation, may constitute misbranding.
Comparative Claims ("Reduced," "Less," "Fewer," "Light/Lite")
Comparative nutrient content claims under 21 CFR 101.56 require:
A stated reference food (the product being compared to)
A quantified difference (at least 25% less for most nutrients)
The comparison disclosed prominently near the claim
"Reduced sugar" requires ≥25% less sugar than the reference food per serving. "Fewer calories" requires ≥25% fewer calories. These claims cannot be made without identifying the reference product and documenting the comparison.
Every nutrient content claim has a defined threshold — "sounds about right" is not a compliance standard
Truli audits nutrient content claims on supplement labels and marketing materials against the specific thresholds in 21 CFR Part 101 — flagging "high protein" claims where the serving doesn't meet the 20% DRV threshold, "sugar-free" claims that don't meet the <0.5g standard, and undefined claims like "low sugar" that don't correspond to an authorized nutrient content claim definition.
A note from Truli: Truli is not a law firm, and this article does not constitute or contain legal advice or create an attorney-client relationship. When determining your obligations and compliance with respect to relevant laws and regulations, you should consult a licensed attorney.
