Last verified 17 Sep 2026 · Sources
Your product can carry “low cholesterol” when it contains 20 milligrams or less of cholesterol per Reference Amount Customarily Consumed (RACC) (and, if the RACC is 30 g or less or 2 tablespoons or less, per 50 g as well), plus 2 grams or less of saturated fatty acids per RACC (21 CFR 101.62(d)(2)). There’s no reference food required; it’s an absolute claim on two co-conditions and, for small RACCs, two bases. The trap you’re most likely to hit is treating cholesterol as the only number that matters: the saturated fat ceiling is part of the same paragraph, and missing it fails the claim even with a comfortably low cholesterol figure.
| Quick facts | Low cholesterol |
|---|---|
| Regulation | 21 CFR 101.62(d)(2) |
| Threshold | ≤20 mg cholesterol/RACC (and per 50 g if RACC ≤30 g/2 tbsp) AND ≤2 g sat fat/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, per 21 CFR 101.62(d)(2) |
| Wordings FDA allows | Low in cholesterol, Contains a small amount of cholesterol, Low source of cholesterol, Little cholesterol |
What the rule says
21 CFR 101.62(d)(2), read on eCFR: “The food contains 20 mg or less of cholesterol per reference amount customarily consumed [and per 50 g where the reference amount is 30 g or less]; and the food contains 2 g or less of saturated fatty acids per reference amount customarily consumed. Where total fat exceeds 13 g, the label must also disclose the level of total fat in a serving.” Allowed synonyms include “low in cholesterol,” “contains a small amount of cholesterol,” “low source of cholesterol,” and “little cholesterol.”
For meal and main dish products, 21 CFR 101.62(d)(3) substitutes a per-100-g basis: cholesterol limited to 20 mg or less per 100 g, and saturated fat to 2 g or less per 100 g: the same numbers as the standard test, just on a different denominator suited to composite dishes.
If your product is inherently low in cholesterol without reformulation, the same naturally-occurring principle in 21 CFR 101.13(e)(2) applies: the claim has to make clear that the whole category is this way, not that your brand specifically achieved it, referring to “all foods of that type” rather than the particular product.
The numbers
The per-50-g test is the piece that trips people up: it only applies when the RACC itself is small: 30 g or less, or 2 tablespoons or less. A food with a larger RACC, say a 55 g cereal portion, only has to clear the 20 mg-per-RACC test; a food with a 15 g RACC has to clear both 20 mg per RACC and 20 mg per 50 g, which is a materially different (and sometimes harder) bar since 50 g is over three times the RACC size in that example.
Rounding matters at the edges here too: under 21 CFR 101.9(c), cholesterol rounds to the nearest 5 mg increment above 5 mg, and values under 2 mg round to zero. A panel showing “20 mg” could reflect anywhere from roughly 17.5 mg to 22.5 mg unrounded, so if your product sits right at the boundary, confirm the underlying analyzed value, not just the rounded panel figure, before relying on the claim.
The total-fat disclosure trigger (total fat above 13 g per RACC, per labeled serving, or per 50 g for small RACCs) is the same condition that applies to cholesterol free, stated in the same paragraph of 101.62(d) for the low-cholesterol claim.
On the label
Take a reduced-fat plain yogurt with a 170 g RACC (21 CFR 101.12): an analyzed cup shows 15 mg cholesterol and 1.2 g saturated fat. Since the RACC is well above 30 g, only the per-RACC test applies; no per-50-g check is required. Both the 20 mg cholesterol ceiling and the 2 g saturated fat ceiling clear, so the label can read “Low Cholesterol,” and because the yogurt was genuinely reformulated to reduced-fat rather than being inherently this way, no “naturally occurring” wording is required. See a full build for this category at /product-labels/yogurt/.
Mistakes we see
- Ignoring the saturated fat co-condition. Your product can have low cholesterol and still fail the claim if saturated fat exceeds 2 g per RACC.
- Applying the per-50-g test to a large-RACC food that doesn’t need it, or skipping it on a small-RACC food that does. The 30 g / 2 tablespoon line is the deciding factor, not the product category.
- Skipping the total-fat disclosure above 13 g. It’s required in the same paragraph as the threshold itself, not a separate optional step.
- Confusing “low cholesterol” with “cholesterol free.” They’re different claims with different thresholds (20 mg vs. under 2 mg) and different basis rules. See /claims/cholesterol-free/.
- 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; “low cholesterol” voids that.
Related claims
See /claims/cholesterol-free/ for the under-2-mg threshold, /claims/saturated-fat-free/ and /claims/low-saturated-fat/ for the related fat-family claims, /claims/low-fat/, 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 and saturated fat numbers against every basis the rule names (per RACC, per labeled serving, and per 50 g where your RACC size requires it) and tells you exactly which wording, and which disclosures, you need.
Checking both co-conditions up front lets you print “Low Cholesterol” knowing the saturated fat number backs it too. Enter your recipe, then see your label: its shape and calorie count, the claims you qualify for and your allergen line are free, no card required, 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 compare it with cholesterol free.
Low cholesterol claim FAQ
When does the per-50 g test apply to low cholesterol?
Only when the RACC is 30 g or less, or 2 tablespoons or less. 21 CFR 101.62(d)(2) requires the food to meet the 20 mg threshold per RACC and per 50 g in that case; larger-RACC foods are tested per RACC alone.
Does low cholesterol also limit saturated fat?
Yes. The same paragraph, 21 CFR 101.62(d)(2), requires 2 g or less of saturated fatty acids per RACC in addition to the cholesterol limit. A high-saturated-fat food can't carry a low-cholesterol claim even if its cholesterol number is low.
What's different for a meal or main dish product?
It's tested per 100 g instead of per RACC: 20 mg or less of cholesterol per 100 g, and 2 g or less of saturated fat per 100 g, per 21 CFR 101.62(d)(3).
Does low cholesterol require the same total-fat disclosure as cholesterol free?
Yes. Total fat above 13 g per RACC, per labeled serving, or per 50 g (small RACC) triggers the same disclosure requirement, stated in the same paragraph as the low-cholesterol threshold itself.
Can a reduced-fat dairy product use 'low cholesterol' even though dairy naturally has some cholesterol?
Yes, if it's genuinely reformulated below 20 mg and 2 g saturated fat per RACC. That's a real reformulation claim, not one requiring the 'naturally occurring' wording that applies to foods that never had cholesterol to begin with.
Related claims
Cholesterol free, Low saturated fat / Reduced saturated fat, Saturated fat free, Low fat. See the full all label claims.