21 CFR 101.62 — Fat and Cholesterol Content Claims on Food Labels
21 CFR 101.62 sets the specific thresholds for fat and cholesterol content claims on food labels — defining what calorie percentages and gram amounts qualify for 'fat free,' 'low fat,' 'reduced fat,' 'saturated fat free,' 'low saturated fat,' 'cholesterol free,' and 'low cholesterol' claims. Fat claims interact with saturated fat and cholesterol declarations and can trigger mandatory disclosure statements when a food is high in certain types of fat.
21 CFR 101.62 defines the conditions under which fat and cholesterol content claims may appear on food labels. The regulation separately addresses total fat, saturated fat, and cholesterol — each with distinct thresholds and requirements.
Total Fat Claims
"Fat Free"
Under 21 CFR 101.62(b)(1), "fat free," "free of fat," "no fat," "zero fat," "without fat," "trivial source of fat," or "dietarily insignificant source of fat" requires:
Less than 0.5 g of total fat per RACC and per labeled serving
No added ingredients containing fat (lipids may not be added even in amounts that would fall below the threshold)
"Low Fat"
Under 21 CFR 101.62(b)(2), "low fat," "low in fat," "contains a small amount of fat," or "low source of fat" requires:
3 g or fewer of total fat per RACC and per labeled serving
For foods with a RACC of 30 g or less or 2 tablespoons or less: 3 g or fewer per 50 g
"Reduced Fat" or "Less Fat"
Under 21 CFR 101.62(b)(4), "reduced fat," "reduced in fat," "less fat," or "lower in fat" requires:
At least 25% less total fat per RACC than an appropriate reference food
Must identify the reference food and state the percentage difference
Saturated Fat Claims
"Saturated Fat Free"
Under 21 CFR 101.62(c)(1), "saturated fat free" requires:
Less than 0.5 g of saturated fat per RACC and per labeled serving
Less than 0.5 g of trans fat per RACC and per labeled serving
Both saturated fat and trans fat must be below the threshold. A product cannot claim "saturated fat free" if it contains significant trans fat even if saturated fat is negligible.
"Low Saturated Fat"
Under 21 CFR 101.62(c)(2), "low saturated fat," "low in saturated fat," or "little saturated fat" requires:
1 g or fewer of saturated fat per RACC and per labeled serving
15% or fewer of calories from saturated fat
Both conditions must be met.
"Reduced Saturated Fat"
At least 25% less saturated fat per RACC than an appropriate reference food, with the required reference food and percentage disclosure.
Cholesterol Claims
"Cholesterol Free"
Under 21 CFR 101.62(d)(1), "cholesterol free," "free of cholesterol," "no cholesterol," "zero cholesterol," or "without cholesterol" requires:
Less than 2 mg of cholesterol per RACC and per labeled serving
2 g or fewer of saturated fat per RACC — a cholesterol claim cannot be made if the food is high in saturated fat
The saturated fat condition exists because dietary saturated fat has a significant effect on blood cholesterol levels — allowing "cholesterol free" claims on high-saturated-fat foods would be misleading.
"Low Cholesterol"
Under 21 CFR 101.62(d)(2), "low cholesterol," "low in cholesterol," or "contains a small amount of cholesterol" requires:
20 mg or fewer of cholesterol per RACC and per labeled serving
2 g or fewer of saturated fat per RACC and per labeled serving
Again, both thresholds must be met.
Summary of Fat and Cholesterol Claim Thresholds
Claim | Threshold |
|---|---|
Fat free | < 0.5 g total fat/serving |
Low fat | ≤ 3 g total fat/serving |
Reduced fat | ≥ 25% less total fat vs. reference |
Saturated fat free | < 0.5 g sat fat AND < 0.5 g trans fat/serving |
Low saturated fat | ≤ 1 g sat fat/serving AND ≤ 15% calories from sat fat |
Reduced saturated fat | ≥ 25% less sat fat vs. reference |
Cholesterol free | < 2 mg cholesterol AND ≤ 2 g sat fat/serving |
Low cholesterol | ≤ 20 mg cholesterol AND ≤ 2 g sat fat/serving |
Reduced cholesterol | ≥ 25% less cholesterol vs. reference |
Required Disclosure When Making Cholesterol Claims
Under 21 CFR 101.62(d)(1)(ii)(B), when a cholesterol claim is made on a food that contains more than 13 g of total fat per RACC and per 50 g (if the RACC is 30 g or less), the label must include:
"See [panel] for total fat content" or equivalent statement directing consumers to the Nutrition Facts panel.
This disclosure prevents a "cholesterol free" label from obscuring the fact that a product is still high in total fat.
Fatty Acid Disclosure for Fat Claims on Meat and Poultry Products
For meat and poultry products making fat claims (regulated by USDA FSIS for most products), additional labeling requirements apply that overlap with FDA's framework for the same products when dual jurisdiction exists.
"% Fat Free" Claims
Under 21 CFR 101.62(b)(6), "% fat free" statements (e.g., "97% fat free") may only be used on foods that qualify as "low fat" (≤ 3 g total fat per serving). The percentage must accurately reflect the fat content of the food. A "98% fat free" claim on a food with 5 g total fat per serving is a misbranding violation.
How Truli Helps with Fat and Cholesterol Claim Compliance
Threshold verification: Truli checks declared fat and cholesterol values against the applicable claim thresholds for each claim type used on the label
Trans fat inclusion for sat fat free: Truli verifies that "saturated fat free" claims account for trans fat content, which must also be below threshold
Cholesterol claim sat fat check: Truli flags cholesterol claims on foods where saturated fat exceeds the 2 g limit required to make the cholesterol claim
"% Fat free" accuracy: Truli verifies that percentage fat-free claims are mathematically accurate and that the underlying product qualifies as "low fat"
Related Regulations
21 CFR 101.13 — Nutrient Content Claims — General principles and disclosure requirements for nutrient content claims
21 CFR 101.60 — Calorie Content Claims — Calorie claim thresholds
21 CFR 101.61 — Sodium Content Claims — Sodium claim thresholds
21 CFR 101.9 — Nutrition Facts Panel — Where total fat, saturated fat, trans fat, and cholesterol are declared
Frequently Asked Questions
Our product has 0.4 g of saturated fat. Can we claim "saturated fat free"?
Yes — 0.4 g is less than 0.5 g, so the saturated fat threshold is met. However, you must also verify that trans fat is less than 0.5 g per serving. If your product contains more than 0.5 g trans fat, the "saturated fat free" claim is not permitted regardless of the saturated fat level.
Can we make a "cholesterol free" claim on a high-fat food like olive oil?
Only with the required disclosure. Olive oil that contains less than 2 mg cholesterol per serving may technically meet the cholesterol threshold, but if it contains more than 13 g total fat per serving (which it does), the label must include a statement directing consumers to the Nutrition Facts panel for total fat content. Many brands use "contains 0 mg cholesterol" as a factual statement (not a nutrient content claim) to avoid triggering these requirements.
What counts as a "reference food" for reduced fat claims?
The reference food must be a similar food — typically the regular or original version of the same product, or the average of the three leading brands in the same category. The reference food must be appropriate so the comparison is meaningful and not misleading.
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 101.62 as of April 2026. Book a demo to see how Truli monitors food label compliance.
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