Last verified 17 Sep 2026 · Sources
Your label can say “cholesterol free” only when your product contains less than 2 milligrams of cholesterol per Reference Amount Customarily Consumed (RACC) and per labeled serving, and 2 grams or less of saturated fat per RACC (21 CFR 101.62(d)(1)). There’s no reference food and no per-50-g version: it’s an absolute claim checked on those two bases. The trap you’re most likely to hit isn’t the cholesterol number itself, which most plant-based and low-fat foods clear easily; it’s the saturated fat co-condition and, separately, the total-fat disclosure statement that kicks in once total fat passes 13 g.
| Quick facts | Cholesterol free |
|---|---|
| Regulation | 21 CFR 101.62(d)(1) |
| Threshold | <2 mg cholesterol per RACC and per labeled serving AND ≤2 g saturated fat per RACC |
| Claim type | absolute |
| Reference food needed | No |
| Disclosure statement | Yes. Total fat must be disclosed on the label when the food has more than 13 g total fat per RACC, per labeled serving, or per 50 g (small RACC), per 21 CFR 101.62(d)(1) |
| Wordings FDA allows | Free of cholesterol, No cholesterol, Zero cholesterol, Without cholesterol, Trivial/negligible source of cholesterol |
What the rule says
21 CFR 101.62(d)(1), read on eCFR: “The food contains less than 2 mg of cholesterol per reference amount customarily consumed and per labeling serving… and the food contains 2 g or less of saturated fatty acids per reference amount customarily consumed. For foods that contain more than 13 g of total fat per reference amount customarily consumed, per labeled serving, or per 50 g [where the reference amount is 30 g or less], the label must additionally disclose the level of total fat in a serving.” Allowed synonyms include “free of cholesterol,” “no cholesterol,” “zero cholesterol,” “without cholesterol,” and “trivial” or “negligible source of cholesterol.”
If your product has never contained cholesterol (most plant-based products, since cholesterol is an animal-derived compound), the claim still has to identify that fact rather than implying your brand engineered it out. eCFR’s text within 101.62(d) carries the same principle 21 CFR 101.13(e)(2) states generally: a claim on a food that “has not been specially processed, altered, formulated, or reformulated to qualify for that claim shall indicate that the food inherently meets the criteria and shall clearly refer to all foods of that type”. The rule’s illustrative wording is something like “applesauce, a cholesterol-free food,” naming the category rather than the brand.
The numbers
Cholesterol free runs on two bases only: per RACC and per labeled serving for the cholesterol number, and per RACC for the saturated fat co-condition. There’s no per-50-g variant for the free claim itself (that test belongs to “low cholesterol”; see /claims/low-cholesterol/). The 2 mg threshold sits close to where rounding could matter: under 21 CFR 101.9(c), cholesterol under 2 mg rounds to “0 mg” on the panel, so a printed zero is consistent with the claim, but the claim itself is judged against the unrounded analyzed value.
The total-fat disclosure is a separate, additive condition, not a disqualifier on its own: a food can be genuinely cholesterol free and still carry the claim while disclosing, in the same breath, that it has more than 13 g of total fat per serving. The statement has to sit in immediate proximity to the claim per 101.62(d)(1), not on a different panel or buried in the ingredient list.
On the label
Take a jar of natural peanut butter with a 2-tablespoon RACC (21 CFR 101.12): it contains 0 mg cholesterol, since peanuts, like all plant foods, contain none. Saturated fat and total fat, though, are what decide the claim. A formulation running around 3 g saturated fat per RACC would fail the ≤2 g co-condition outright; cholesterol at zero isn’t enough on its own. A lower-saturated-fat nut butter that lands at or under 2 g saturated fat per RACC, with total fat still above 13 g, could carry “Cholesterol Free” alongside the required total-fat disclosure and the naturally-occurring wording under 101.13(e)(2). See a full build for this category at /product-labels/nut-butter/.
Mistakes we see
- Checking only the cholesterol number. The saturated fat co-condition (≤2 g per RACC) is part of the same paragraph and fails the claim on its own if missed.
- Skipping the total-fat disclosure above 13 g. It’s not optional once the food crosses that line. It’s a required part of the label wherever the claim appears.
- Missing the “naturally cholesterol free” wording on plant-based foods. Nut butters, oils, and produce that never had cholesterol still need language that names the category, not the brand, per 101.13(e)(2).
- Making the claim on a label relying on a small-package or low-volume exemption. 21 CFR 101.9(j) exemptions, (j)(13)(i) and (j)(18) among them, require no nutrient content claims; adding “cholesterol free” voids that.
- Confusing cholesterol free with fat free or low fat. None of those thresholds overlap; a high-fat, high-saturated-fat-adjacent (but ≤2 g) product can still legally say cholesterol free.
Related claims
See /claims/low-cholesterol/ for the ≤20 mg threshold, /claims/saturated-fat-free/ and /claims/low-saturated-fat/ for the related fat-family claims, /claims/fat-free/, plus the general rules at /labeling-rules/nutrient-content-claims/ and /labeling-rules/rounding-rules/.
Check your label
The NutriLabels builder’s claims check runs your product’s cholesterol, saturated fat, and total fat numbers against every basis the rule names (per RACC, per labeled serving, and per 50 g where it applies) and tells you exactly which wording, and which disclosures, you need.
Catching the saturated fat co-condition and the 13 g disclosure before you print keeps your “Cholesterol Free” claim and your label in agreement. Enter your recipe, then see your label: free with no card required, you see your calories, the claims you qualify for, your allergen line and the nutrient to watch, and every other value and %DV stays hidden until you unlock it. $29 unlocks every other nutrient value and %DV, the claims check, every FDA format your product qualifies for, and the ingredient statement and allergen declaration, ready to print. Start your label or see the rest of the nutrient content claims.
Cholesterol free claim FAQ
Why does a cholesterol-free claim also check saturated fat?
Because dietary cholesterol and saturated fat both affect blood cholesterol. 21 CFR 101.62(d)(1) requires the food to contain 2 g or less of saturated fat per RACC in addition to the under-2-mg cholesterol test. A food can't hide a high-saturated-fat formulation behind a cholesterol-only claim.
My peanut butter never had cholesterol. Do I still need special wording?
Yes. Plant-based foods that never contained cholesterol have to disclose that in the claim itself, per the naturally-occurring wording read on eCFR at 21 CFR 101.62(d) (e.g., 'a cholesterol free food') rather than implying your process removed something. The general version of this rule is at 21 CFR 101.13(e)(2).
What triggers the total-fat disclosure statement?
Total fat above 13 g per RACC, per labeled serving, or per 50 g for a small RACC. 21 CFR 101.62(d)(1) requires that disclosure to appear in immediate proximity to the cholesterol-free claim itself.
Is there a per-50 g version of cholesterol free for small packages?
No. Cholesterol free is checked per RACC and per labeled serving only. The per-50-g test belongs to low cholesterol, not the free claim. See /claims/low-cholesterol/.
Does cholesterol free mean the food is automatically low fat?
No. It only limits saturated fat to 2 g or less per RACC; total fat can still be high enough to require the disclosure statement above, and the food may not qualify for a separate low-fat or fat-free claim at all.
Related claims
Low cholesterol, Saturated fat free, Low saturated fat / Reduced saturated fat, Fat free. See the full all label claims.