FDA health claims and the 12 authorized food relationships
FDA health claims link substances to disease risk. Check the 12 codified relationships, food eligibility rules and model wording before using a claim.
FDA health claims describe a relationship between a substance and a disease or health-related condition. The 12 relationships in 21 CFR 101.72-101.83 meet the significant scientific agreement (SSA) standard, but other claim pathways exist. FDA lists these authorized SSA claims separately from other routes.
An authorized health claim is not FDA approval of a finished food. Before using a claim, check the specific regulation and the general conditions in section 101.14. An eligible ingredient alone is not enough. When checking an "FDA-approved health claims list", confirm both the relationship and the food's eligibility.
FDA health claims list: the 12 codified relationships
The table gives eligibility cues, not complete label specifications. RACC means reference amount customarily consumed. Read the linked section before deciding whether your food qualifies.
| Section | Authorized relationship | Main eligibility checks |
|---|---|---|
| 101.72 | Calcium, or calcium and vitamin D, and osteoporosis | High calcium; also high vitamin D when claimed. Calcium must be assimilable, and phosphorus must not exceed calcium by weight. |
| 101.73 | Dietary lipids and cancer | Low fat, with a specified fish/game alternative. The relationship concerns low-fat diets, not a particular fat type. |
| 101.74 | Sodium and hypertension | Low sodium. Wording must reflect multiple risk factors for high blood pressure. |
| 101.75 | Saturated fat and cholesterol and coronary heart disease (CHD) | Low saturated fat and cholesterol; generally low fat, with specified exceptions. |
| 101.76 | Fiber-containing grain products, fruits and vegetables and cancer | Contains a grain product, fruit or vegetable; low fat; good source of fiber without fortification. |
| 101.77 | Fruits, vegetables and grain products containing fiber, particularly soluble fiber, and CHD | Low fat, saturated fat and cholesterol; at least 0.6 g soluble fiber/RACC without fortification; soluble fiber declared. |
| 101.78 | Fruits and vegetables and cancer | Contains fruit or vegetable; low fat; good source of vitamin A, vitamin C or fiber without fortification. |
| 101.79 | Folate and neural tube defects | At least a good source of folate. Population, wording, intake and product restrictions also apply. |
| 101.80 | Noncariogenic carbohydrate sweeteners and dental caries | Listed sweeteners and sugar-content criteria; plaque-pH condition when other carbohydrates are present. |
| 101.81 | Soluble fiber from certain foods and CHD | Specified oat/barley or psyllium sources, ingredient specifications, fiber minimums and intake wording. |
| 101.82 | Soy protein and CHD | At least 6.25 g soy protein/RACC, qualifying nutrient profile and required intake wording. |
| 101.83 | Plant sterol/stanol esters and CHD | Specified forms, food categories and amounts, with twice-daily consumption conditions. |
How to check a health claim on a food label
Start with the food's composition. Section 101.14 addresses lawful, safe ingredient use and nutrition labeling. It also sets disqualifying levels for fat, saturated fat, cholesterol and sodium. Conventional foods generally need a minimum nutrient contribution before fortification, subject to exceptions.
Next, check the claim-specific section. Match the ingredient source, amount and permitted food category. Where a provision requires "high" nutrient content, the general definition is at least 20% of the RDI or DRV per RACC. Meal and main-dish provisions also apply under section 101.54.
Then review the complete presentation, including symbols and implied claims. Required information must appear together, and the claim must be truthful and nonmisleading. These requirements extend beyond choosing a model sentence from the regulation.
Calcium and sodium model wording
The calcium health claim can concern calcium alone or calcium with vitamin D. Vitamin D alone does not qualify. A food claiming both nutrients must be high in both. Specified supplement disintegration and dissolution standards also apply. Section 101.72 gives this model:
"Adequate calcium throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis."
For sodium, the claim must use "sodium" and "high blood pressure". It may also use "salt" and "hypertension". The wording must use "may" or "might", reflect multiple factors and avoid quantifying risk reduction. The section 101.74 model reads:
"Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors."
These are regulatory models, not approvals for a particular label. Check food eligibility before using either sentence.
Soluble fiber and soy protein
Fiber claims require careful source checks. Under section 101.81, eligible oat/barley sources require at least 3 g beta-glucan daily and at least 0.75 g/RACC. Eligible psyllium requires at least 7 g soluble fiber daily and at least 1.7 g/RACC. Ingredient specifications matter.
That section also requires a qualifying nutrient profile, soluble-fiber declaration and daily-intake and serving-contribution wording. Psyllium has additional labeling requirements where applicable. Do not substitute the separate section 101.77 criterion of 0.6 g soluble fiber/RACC.
The FDA soy protein health claim requires at least 6.25 g soy protein/RACC. The food must be low in saturated fat and cholesterol. It must also be low fat unless the specified whole-soybean exception applies. Its model reads:
"25 grams of soy protein a day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies ____ grams of soy protein."
FDA's SSA index lists an October 2017 proposed revocation. As of November 2, 2026, section 101.82 remained codified in the eCFR. A proposal is not an effective revocation.
Plant sterols and vitamin C
For the FDA phytosterol health claim, distinguish ester amounts from free-sterol equivalents. The codified sterol-ester provision requires at least 0.65 g/RACC and 1.3 g/day in spreads or salad dressings. Stanol esters have different amounts and food categories. Daily intake must occur in two servings at different times with other foods.
Separate enforcement-discretion options exist. Check their conditions in the relevant FDA document linked through its SSA index, rather than treating the codified categories as every available option.
Vitamin C creates another possible error. The fruit-and-vegetable cancer relationship includes qualifying foods that are good sources of vitamin C. It does not authorize vitamin C supplements to claim cancer-risk reduction.
Where whole-grain and other claims fit
The FDA whole-grain health claim belongs to the separate FDAMA authoritative-statement notification route. That route generally involves a 120-day notification period, subject to statutory conditions and FDA or court action. It is unavailable for dietary supplements. See FDA's FDAMA guidance.
The 1999 whole-grain notification uses at least 51% whole-grain ingredients by weight per RACC and a fiber-marker calculation, alongside other conditions. Its model concerns heart disease and certain cancers. The 2003 moderate-fat notification concerns heart disease only. Do not combine their wording and eligibility rules.
Qualified health claims rely on credible evidence that does not meet SSA. FDA may issue enforcement-discretion letters with qualifying language and product conditions. Another manufacturer can use a claim only when meeting the letter's conditions. These are not claims authorized under an SSA regulation, as FDA explains.
Structure/function claims describe normal functions rather than a substance-disease relationship. FDA's examples include "Calcium builds strong bones" and "Fiber maintains bowel regularity". Supplement claims have substantiation, notification and statutory-disclaimer requirements. Conventional-food claims do not require that notification or disclaimer and concern nutritive effects. A disclaimer does not legalize a disease-treatment claim. See FDA's label-claims explanation.
RegAffairs AI's answer on FDA health claims links the regulatory sources behind these relationships.