U.S. · Food labeling · 21 CFR 101.75
Saturated fat and heart disease health claim.
21 CFR 101.75 permits a claim tying diets low in saturated fat and cholesterol to heart disease risk only on foods that are low in saturated fat, cholesterol and fat.
21 CFR 101.75(c)(2) allows a health claim linking diets low in saturated fat and cholesterol to a reduced risk of coronary heart disease only on a food that meets the 101.62 requirements for "low saturated fat" (1 g or less per reference amount and no more than 15 percent of calories from saturated fat), "low cholesterol" (20 mg or less) and "low fat" (3 g or less, with a raw fruit or vegetable exception). The claim must say "may" or "might," list both nutrients, attribute no degree of risk reduction and state that heart disease depends on many factors.
Check the food-side numbers
Result
What 21 CFR 101.75 covers
Section 101.75 is the authorized health claim for "dietary saturated fat and cholesterol and risk of coronary heart disease." It follows the same four-part pattern as the other claims: the regulation's own findings in (a) and (b), the requirements in (c), optional information in (d), and model claims in (e). The text on this page is the eCFR version current through October 29, 2026, with a history of 58 FR 2757 (January 6, 1993) as amended at 81 FR 91722 (December 19, 2016). It is reported as printed and does not say what FDA has since said about the underlying science.
The regulation's own numbers
Paragraph (a)(1) gives total-cholesterol levels of 240 mg/dL (6.21 mmol/L) or above and LDL-cholesterol levels of 160 mg/dL (4.13 mmol/L) or above as levels where high coronary heart disease rates occur, and borderline-high levels of 200 to 239 mg/dL total and 130 to 159 mg/dL LDL. Paragraph (b)(3) restates public health recommendations to consume less than 10 percent of calories from saturated fat, an average of 30 percent or less of calories from all fat, and 300 mg or less of cholesterol per day. These figures are in the section as printed. They are not a medical reference.
Nature of the claim: paragraph (c)(2)(i)
- (A) The claim states that diets low in saturated fat and cholesterol "may" or "might" reduce the risk of heart disease.
- (B) The disease is named "heart disease" or "coronary heart disease."
- (C) The nutrients are named "saturated fat" and "cholesterol," and both are listed.
- (D) No degree of risk reduction is attributed to such diets.
- (E) The claim states that coronary heart disease risk depends on many factors.
Nature of the food: paragraph (c)(2)(ii)
The food must meet the 101.62 nutrient content requirements for both "low saturated fat" and "low cholesterol." In 101.62, "low saturated fat" means 1 g or less saturated fatty acids per reference amount customarily consumed and not more than 15 percent of calories from saturated fatty acids (c)(2)(i). "Low cholesterol" for a food with a reference amount over 30 g and 13 g or less total fat means 20 mg or less cholesterol and 2 g or less saturated fatty acids per reference amount (d)(2)(i); smaller reference amounts add a per 50 g test (d)(2)(ii). The food must also meet "low fat" (3 g or less per reference amount, b(2)), unless it is a raw fruit or vegetable. Fish and game meats (deer, bison, rabbit, quail, wild turkey, geese and ostrich) may instead meet "extra lean" in 101.62. Paragraph (c)(1) additionally requires 101.14, except 101.14(e)(6) for a raw fruit or vegetable.
Optional information: paragraph (d)
The claim may name other risk factors with general scientific agreement (family history, elevated blood cholesterol, excess weight, high blood pressure, smoking, diabetes, physical inactivity), may mention the intermediate link of "blood cholesterol," may add the phrase "total fat," may give a sourced count of people with coronary heart disease, may say it is consistent with the Dietary Guidelines, and may advise people with elevated cholesterol to consult physicians; if it defines high or normal levels, that advice is mandatory.
Model claims: paragraph (e)
Five model claims are printed. The first reads: "While many factors affect heart disease, diets low in saturated fat and cholesterol may reduce the risk of this disease." The others expand on risk factors, a healthful diet low in saturated fat, total fat and cholesterol as part of a healthy lifestyle, and the dependence of heart disease on many factors. Each uses "may," and none says by how much.
Worked example
A reduced fat product has 2.5 g total fat, 0.5 g saturated fat, 8 percent of calories from saturated fat and 10 mg cholesterol per reference amount. It is at or under 3 g, 1 g, 15 percent and 20 mg, so the entered numbers clear the three food tests. Change saturated fat to 1.5 g and the "low saturated fat" test fails, which removes the product from the claim. The calculator above reproduces these comparisons. It does not run the 30 g / 50 g companion tests for small reference amounts or the meal and main dish branches.
Limits of this page
This page compares four numbers with the thresholds quoted. It does not run 101.14, does not evaluate small reference amount rules, "extra lean" alternatives, or label design, and it is not dietary or medical advice.
Sources
Sources opened and read November 2, 2026.
Frequently asked questions
Which foods can carry the saturated fat and heart disease claim?
Foods that meet the 101.62 requirements for "low saturated fat" and "low cholesterol," and "low fat" unless a raw fruit or vegetable (21 CFR 101.75(c)(2)(ii)).
What is "low saturated fat"?
1 g or less saturated fatty acids per reference amount customarily consumed and not more than 15 percent of calories from saturated fatty acids (101.62(c)(2)(i)).
What is "low fat"?
3 g or less of fat per reference amount, with an additional per 50 g test when the reference amount is 30 g or less (101.62(b)(2)).
Does the claim have to say both nutrients?
Yes. It must use the terms "saturated fat" and "cholesterol" and list both (101.75(c)(2)(i)(C)).
Can fish or game meat use another standard?
Yes. Fish and game meats may meet "extra lean" in 101.62 instead of "low fat" (101.75(c)(2)(ii)(B)).
What is the regulation's saturated fat recommendation?
Paragraph (b)(3) states a public health recommendation of less than 10 percent of calories from saturated fat and 300 mg or less cholesterol per day, as printed in 1993 and amended in 2016.
Is this medical advice?
No. It reports a labeling regulation; ask a clinician about heart health.
Not legal or compliance advice
This page is general information drawn from the sources listed, not legal, tax or compliance advice, and it is not run by any government agency. Rules, forms and dates change and your agency, base jurisdiction or enforcement officer decides your case, so confirm with the office named on this page before you rely on it. Everything runs in your browser; nothing you enter is sent anywhere.