21 CFR 101.60 defines the specific conditions under which calorie content claims — "calorie free," "low calorie," "reduced calorie," "light," "diet," and related terms — may appear on food and dietary supplement labels. These are nutrient content claims governed by the general principles of 21 CFR 101.13 and the specific thresholds in this section.
"Calorie Free" Claims
Under 21 CFR 101.60(b)(1), a food may be labeled "calorie free," "free of calories," "no calories," "zero calories," "without calories," or "trivial source of calories" if it contains less than 5 calories per reference amount customarily consumed (RACC) and per labeled serving.
Common synonyms covered:
"Calorie free"
"Free of calories"
"No calories"
"Zero calories"
"Negligible source of calories"
"Dietarily insignificant source of calories"
A product that contains exactly 5 calories per serving does not qualify for a "calorie free" claim — the threshold is fewer than 5 calories.
"Low Calorie" Claims
Under 21 CFR 101.60(b)(2), a food may be labeled "low calorie," "few calories," "contains a small amount of calories," "low source of calories," or "diet" if it contains:
40 calories or fewer per RACC and per labeled serving, and
For foods with a RACC of 30 g or less, or 2 tablespoons or less, the food must contain 40 calories or fewer per 50 g of food
Exception: Foods with a RACC that has been established as ≥ 50 g use the per-RACC threshold only.
"Reduced Calorie" and "Fewer Calories" Claims
Under 21 CFR 101.60(b)(4), "reduced calorie," "reduced in calories," "calorie reduced," "fewer calories," and "lower in calories" claims require:
The food must contain at least 25% fewer calories than an appropriate reference food
The label must identify the reference food and the percentage difference (e.g., "40% fewer calories than [reference food]")
The comparison is made on a per-RACC basis
The reference food must be a similar food — not an arbitrary comparison. "Reduced calorie" claims cannot be made on foods that already qualify as "low calorie."
"Light" or "Lite" — Calorie Basis
Under 21 CFR 101.56, "light" or "lite" on a calorie basis requires:
The food derives more than 50% of its calories from fat: must reduce fat by 50% or more per RACC vs. the reference food
The food derives 50% or less of its calories from fat: must reduce calories by at least one-third per RACC vs. the reference food
Note: "Light" claims may also be made on a sodium or fat basis under different thresholds. The label must specify the basis of the "light" claim if it could be interpreted as referring to more than one nutrient.
Summary of Calorie Claim Thresholds
Claim | Per Serving Threshold | Comparison Requirement |
|---|---|---|
Calorie free | < 5 calories | None |
Low calorie | ≤ 40 calories | None (for most foods) |
Reduced calorie | ≥ 25% fewer | vs. reference food, must disclose |
Light (calorie basis, ≤ 50% fat calories) | ≥ 1/3 fewer calories | vs. reference food, must disclose |
Light (calorie basis, > 50% fat calories) | ≥ 50% fat reduction | vs. reference food, must disclose |
Disclosure Statement for Relative Claims
When a "reduced calorie," "fewer calories," or calorie-basis "light" claim is made, the label must include a disclosure that identifies:
The name of the reference food used for comparison
The percentage difference in calories
Example: "Reduced Calorie — 35% fewer calories than Original [Product Name]"
This disclosure must appear adjacent to the claim, in type size no less than that of the claim. It cannot appear only in a footnote or on the information panel away from the claim.
Disqualifying Nutrients and Disclosure Requirements
Under 21 CFR 101.13(h), calorie content claims may trigger a disclosure statement if the food contains more than specified levels of total fat, saturated fat, cholesterol, or sodium per RACC:
Nutrient | Disclosure Trigger |
|---|---|
Total fat | > 13 g |
Saturated fat | > 4 g |
Cholesterol | > 60 mg |
Sodium | > 480 mg |
If the food exceeds any of these thresholds, the label must bear: "See [panel] for nutrition information" or a similar statement directing consumers to the Nutrition Facts panel.
Calorie Claims on Dietary Supplements
Dietary supplements typically use calorie content claims in one of two contexts:
Protein powders and meal replacement products: Often bear "low calorie" or "calorie reduced" claims compared to conventional meal options
Weight management supplements: May not use implied calorie claims (e.g., "helps you eat fewer calories") without ensuring the claim is truthful and substantiated
The calorie thresholds in 21 CFR 101.60 apply to supplement labels in the same way as conventional food labels. Supplements that include "low calorie" on the Supplement Facts panel must meet the ≤ 40 calorie threshold.
How Truli Helps with Calorie Claim Compliance
Threshold verification: Truli compares the declared calorie content per serving against the applicable thresholds for "calorie free," "low calorie," and "reduced calorie" claims
Reference food comparison audit: Truli verifies that relative claims ("reduced calorie") are supported by a valid comparison to an appropriate reference food with the required percentage and reference food disclosure
Disqualifying nutrient check: Truli identifies calorie claims on products that may require a disclosure statement due to excess fat, saturated fat, cholesterol, or sodium levels
"Light" claim basis analysis: Truli determines whether a "light" claim is being made on a calorie or fat basis and verifies the applicable reduction threshold is met
Related Regulations
21 CFR 101.13 — Nutrient Content Claims — General principles for all nutrient content claims
21 CFR 101.61 — Sodium Content Claims — Sodium thresholds for "sodium free," "low sodium" claims
21 CFR 101.62 — Fat and Cholesterol Content Claims — Fat content claim thresholds
21 CFR 101.9 — Nutrition Facts Panel — Where calorie content is declared per serving
Frequently Asked Questions
Our product has 42 calories per serving. Can we call it "low calorie"?
No. "Low calorie" requires 40 calories or fewer per serving. At 42 calories, the product does not meet the threshold. You could potentially reformulate to 40 calories or fewer, or use a "reduced calorie" claim if the product has at least 25% fewer calories than an appropriate reference food.
We want to say "only 20 calories" on our label — is that a nutrient content claim?
Yes. "Only 20 calories" functions as an implied nutrient content claim about calorie content. It would likely be evaluated as a "low calorie" claim (since it implies the calorie level is low) and must meet the ≤ 40 calorie threshold, or as a factual statement if the context makes clear it is not a comparative or implied claim. Working with a labeling attorney to evaluate specific language is advisable.
Can we make calorie claims in advertising without meeting these thresholds?
The FTC requires substantiation for advertising claims, and FDA's misbranding standards apply to labeling. Advertising a food as "low calorie" when it doesn't meet 21 CFR 101.60 thresholds may constitute both an FDA misbranding violation (if the advertising is considered "labeling") and an FTC deceptive advertising violation.
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.
Last updated: April 2026. Reflects 21 CFR 101.60 as of April 2026. Book a demo to see how Truli monitors food label compliance.
