Health Claims Guidelines

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FDA Regulatory Requirements for Nutrient Content Claims 

Nutrient Content Claims

Please contact our friendly and knowledgeable technical sales colleagues to help guide you to the best ingredients to allow you to achieve these recommended levels on your products.

Claim Category Pre-Approved Health Claims Requirements RACC: Reference Amounts Customarily Consumed
DV: Daily Values		 Comments
Dietary Lipids and Cancer
 Development of cancer depends on many factors. A diet low in total fat may reduce the risk of some cancers The food must meet the requirement for a “low fat food” 3 g or less per RACC (and per 50 g if RACC is small). Meals and main dishes: 3 g or less per 100 g and not more than 30% of calories from fat. You may only use the terms “low” or “free” (i.e. “fat free” or “low sodium”) when you have specifically processed the food to lower the amount of that nutrient or you not included that nutrient in the formulation of the food.
Eating a healthful diet low in fat may help reduce the risk of some types of cancers. Development of cancer is associated with many factors, including a family history of the disease, cigarette smoking, and what you eat      
Fiber-Containing Grain products, Fruits, Vegetables and Cancer
 Low fat diets rich in fiber-containing grain products, fruits, and vegetables may reduce the risk of some types of cancer, a disease associated with many factors. The food must be OR contain a fruit, grain, or vegetable    
Development of cancer depends on many factors. Eating a diet low in fat and high in grain products, fruits, and vegetables that contain dietary fiber may reduce your risk of some cancers The food must meet the requirements for a “low fat food” 3 g or less per RACC (and per 50 g if RACC is small). Meals and main dishes: 3 g or less per 100 g and not more than 30% of calories from fat. You may only use the terms “low” or “free” (i.e. “fat free” or “low sodium”) when you have specifically processed the food to lower the amount of that nutrient or you not included that nutrient in the formulation of the food. You may only use the terms “low” or “free” (i.e. “fat free” or “low sodium”) when you have specifically processed the food to lower the amount of that nutrient or you not included that nutrient in the formulation of the food.
  The food must meet the requirements for a “good source of fiber” without fortification Contains 10–19% of the DV per RACC. May be used on meals or main dishes to indicate that the product contains a food that meets the definition.  
Fruits, Vegetables, and Cancer
 Low fat diets rich in fruits and vegetables (foods that are low in fat and may contain dietary fiber, vitamin A, and vitamin C) may reduce the risk of some types of cancer, a disease associated with many factors. Broccoli is high in vitamins A and C, and it is a good source of dietary fiber The food must be OR contain a fruit or a vegetable.    
Development of cancer depends on many factors. Eating a diet low in fat and high in fruits and vegetables, foods that are low in fat and may contain vitamin A, vitamin C, and dietary fiber, may reduce your risk of some cancers. Oranges, a food low in fat, are a good source of fiber and vitamin C. The food must meet the requirements for a “low fat” food. 3 g or less per RACC (and per 50 g if RACC is small). Meals and main dishes: 3 g or less per 100 g and not more than 30% of calories from fat.

You may only use the terms “low” or “free” (i.e. “fat free” or “low sodium”) when you have specifically processed the food to lower the amount of that nutrient or you not included that nutrient in the formulation of the food.
Dietary Saturated Fat, Cholesterol and the Risk of Coronary Heart Disease
 While many factors affect heart disease, diets low in saturated fat and cholesterol may reduce the risk of this disease The food must meet the requirements for a “low saturated fat food” 1 g or less per RACC and 15% or less of calories from saturated fat.

Meals and main dishes: 1 g or less per 100 g and less than 10% of calories from saturated fat.

Must declare the amount of cholesterol if 2 mg or more per RACC, and the amount of total fat if more than 3 g per RACC (or, for meals and main dishes, the amount of cholesterol if 2 mg or more per labeled serving, and the amount of total fat if more than 3 g per 100 g or more than 30% of calories from fat).		 You may only use the terms “low” or “free” (i.e. “fat free” or “low sodium”) when you have specifically processed the food to lower the amount of that nutrient or you not included that nutrient in the formulation of the food.
Development of heart disease depends upon many factors, but its risk may be reduced by diets low in saturated fat and cholesterol and healthy lifestyles The food must meet the requirements for a “low cholesterol food” 20 mg or less per RACC (and per 50 g of food if RACC is small).

Meals and main dishes: 20 mg or less per 100 g.

Cholesterol claims only allowed when food contains 2 g or less saturated fat per RACC, or, for meals and main dishes, per 100 g.
Must declare the amount of total fat next to claim when fat exceeds 13 g per RACC and per labeled serving (or per 50 g if RACC is small), or when fat exceeds 19.5 g per labeled serving for main dishes or 26 g for meal products.		 You may only use the terms “low” or “free” (i.e. “fat free” or “low sodium”) when you have specifically processed the food to lower the amount of that nutrient or you not included that nutrient in the formulation of the food.
Development of heart disease depends upon many factors, including a family history of the disease, high blood LDL-cholesterol, diabetes, high blood pressure, being overweight, cigarette smoking, lack of exercise, and the type of dietary pattern. A healthful diet low in saturated fat, total fat, and cholesterol, as part of a healthy lifestyle, may lower blood cholesterol levels and may reduce the risk of heart disease      
Many factors, such as a family history of the disease, increased blood- and LDL-cholesterol levels, high blood pressure, cigarette smoking, diabetes, and being overweight, contribute to developing heart disease. A diet low in saturated fat, cholesterol, and total fat may help reduce the risk of heart disease      
Diets low in saturated fat, cholesterol, and total fat may reduce the risk of heart disease. Heart disease is dependent upon many factors, including diet, a family history of the disease, elevated blood LDL-cholesterol levels, and physical inactivity.      
Fruits, Vegetables, and Grain Products that Contain Fiber, and the Risk of Coronary Heart Disease
 Diets low in saturated fat and cholesterol and rich in fruits, vegetables, and grain products that contain some types of dietary fiber, particularly soluble fiber, may reduce the risk of heart disease, a disease associated with many factors The food must be OR contain a fruit, grain, or vegetable    
Development of heart disease depends on many factors. Eating a diet low in saturated fat and cholesterol and high in fruits, vegetables, and grain products that contain fiber may lower blood cholesterol levels and reduce your risk of heart disease The food must meet the requirements for a “low saturated fat” food, “low cholesterol” food, or a “low fat” food See above See above
  The food must contain 0.6g of soluble fiber per serving (without fortification).    
  The soluble fiber content must de displayed in the nutrition panel.    
Soluble Fiber and the Risk of Coronary Heart Disease
 Soluble fiber from foods such as [*Insert name of applicable soluble fiber]) of this section and, if desired, the name of food product], 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 the [grams of soluble fiber applicable soluble fiber specified] soluble fiber from [*Insert name of applicable soluble fiber] necessary per day to have this effect.


 Applicable Soluble Fibers: oat bran, rolled oats, whole wheat flour, oatrim, whole grain barley, dry milled barley, barley betafiber, psyllium husk    
Diets low in saturated fat and cholesterol that include ____ grams of soluble fiber per day from [*Insert name of applicable soluble fiber] may reduce the risk of heart disease. One serving of [name of food] provides ____ grams of this soluble fiber. The food product must include at least 0.75g (per amount of the food typically consumed) of one of the following:
o Oat Bran
o Rolled oats
o Whole wheat flour
o Whole grain barley and dry milled barley		    
  The food containing oatrim must contain ≥0.75g of beta-glucan soluble fiber per amount of the food typically consumed.    
  The amount of soluble fiber must be claimed in the nutrition information label.    
  The food must meet the requirement for a “low saturated fat” The only acceptable exception is if the food exceeds the requirement for “low fat” food due to fat derived from the whole oat sources. See above See above
  The food must meet the requirement for a “low cholesterol food”. See above See above
Soy Protein and the Risk of Coronary Heart Disease
 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. The food must meet the nutrient requirements for a “low fat” food unless it comes from soybeans and contains no additional fat than the fat inherent in those soybeans. See above See above
Diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease. One serving of [name of food] provides __ grams of soy protein The food must meet the requirements for a “low saturated fat” food and a “low cholesterol” food. See above See above
Plant Sterol Esters and the Risk of Coronary Heart Disease
 Foods containing at least 0.65 g per serving of plant sterol esters, eaten twice a day with meals for a daily total intake of at least 1.3 g, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of the food] supplies ___grams of vegetable oil sterol esters. The food must contain ≥ 0.65g of applicable plant sterol* esters per amount typically consumed.    
Diets low in saturated fat and cholesterol that include two servings of foods that provide a daily total of at least 1.3 g of vegetable oil sterol esters in two meals may reduce the risk of heart disease. A serving of [name of the food] supplies ___grams of vegetable oil sterol esters. The food must contain ≥ 1.7g of plant stanol esters per amount typically consumed. Note that only certain food products are eligible to make this claim, including spreads, salad dressings, snack bars, and dietary supplements.    
  The food must meet the nutrient requirements for a “low saturated fat” food and a “low cholesterol” food. See above See above
  The food must meet the limit for total fat per 50g — except for spreads and salad dressings, which can exceed this limit if they have a disclosure statement such as, “see nutrition information for fat content”    
  Except for salad dressing, the food must meet the minimum nutrient requirement    
  Applicable Plant Sterols: prepared by esterifying a mixture of plant sterols from edible oils with food-grade fatty acids. The plant sterol mixture shall contain at least 80% beta-sitosterol, campesterol, and stigmasterol (combined weight).    
Plant Stanol Esters and the Risk of Coronary Heart Disease
 Foods containing at least 1.7 g per serving of plant stanol esters, eaten twice a day with meals for a total daily intake of at least 3.4 g, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of the food] supplies ___grams of plant stanol esters. The food must contain ≥ 0.65g of applicable plant sterol* esters per amount typically consumed.    
Diets low in saturated fat and cholesterol that include two servings of foods that provide a daily total of at least 3.4 g of vegetable oil stanol esters in two meals may reduce the risk of heart disease. A serving of [name of the food] supplies ___grams of vegetable oil stanol esters. The food must contain ≥ 1.7g of plant stanol esters per amount typically consumed. Note that only certain food products are eligible to make this claim, including spreads, salad dressings, snack bars, and dietary supplements.    
  The food must meet the nutrient requirements for a “low saturated fat” food and a “low cholesterol” food. See above See above
  The food must meet the limit for total fat per 50g — except for spreads and salad dressings, which can exceed this limit if they have a disclosure statement such as, “see nutrition information for fat content”    
  Except for salad dressing, the food must meet the minimum nutrient requirement    
  Applicable Plant Stanol Esters: Plant stanol esters prepared by esterifying a mixture of plant stanols derived from edible oils or byproducts of the kraft paper pulping process with food-grade fatty acids. The plant stanol mixture shall contain at least 80 percent sitostanol and campestanol (combined weight).    
Sodium and Hypertension
 Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors. The sodium must me the requirements for a “low sodium” food 140 mg or less per RACC (and per 50 g if RACC is small).
Meals and main dishes: 140 mg or less per 100g.
“Very Low Sodium”: 35 mg or less per RACC (and per 50 g if RACC is small); for meals and main dishes: 35 mg or less per 100 g.		 See above
Development of hypertension or high blood pressure depends on many factors. [This product] can be part of a low sodium, low salt diet that might reduce the risk of hypertension or high blood pressure.      
Calcium, Vitamin D and Osteoporosis
 Adequate calcium throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis. If the claim references Vitamin D, then the food must exceed the requirements for a “high” level of vitamin D Contains 20% or more of the DV per RACC.
May be used on meals or main dishes to indicate that the product contains a food that meets the definition.		 You may use these terms if the food contains 20% or more of the Daily-Recommended-Value (DRV) in the amount that is typically consumed.

If the product is a “meal product” containing multiple foods, then you must identify which food is the subject of this claim (i.e. the serving of cauliflower in this product is high in vitamin C)
Adequate calcium as part of a healthful diet, along with physical activity, may reduce the risk of osteoporosis in later life. The calcium in the food must be absorbable as a nutrient.    
Adequate calcium and vitamin D throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis. There may not be more phosphorus than calcium in the food (by weight.)    
Adequate calcium and vitamin D as part of a healthful diet, along with physical activity, may reduce the risk of osteoporosis in later life      
Folate and Neural Tube Defects
 Model health claim appropriate for foods containing 100 percent or less of the DV for folate per serving or per unit. The example contains all required elements plus optional information: Women who consume healthful diets with adequate folate throughout their childbearing years may reduce their risk of having a child with a birth defect of the brain or spinal cord. Sources of folate include fruits, vegetables, whole grain products, fortified cereals, and dietary supplements The food must meet the minimum requirements for a “good source of folate” Contains 10–19% of the DV per RACC.
May be used on meals or main dishes to indicate that the product contains a food that meets the definition.		 You may use the terms “good source” “contains” or “provides” if the food contains 10-19% of the Daily-Recommended-Value (DRV) in the amount that is typically consumed.

If the product is a “meal product” containing multiple foods, then you must identify which food is the subject of this claim (i.e. the serving of yams in this product is a ‘good source’ of fiber)
Model health claim appropriate for foods intended for use by the general population and containing more than 100 percent of the DV of folate per serving or per unit: Women who consume healthful diets with adequate folate may reduce their risk of having a child with birth defects of the brain or spinal cord. Folate intake should not exceed 250% of the DV (1,000 mcg). The foods must not contain more than 100% of the daily recommended intake for vitamin A as retinol per serving.    
The following health claims may be used if the food contains 100% or less of the daily value for the serving per-unit.

” Healthful diets with adequate folate may reduce a woman’s risk of having a child with a brain or spinal cord birth defect.”
“Adequate folate in healthful diets may reduce a woman’s risk of having a child with a brain or spinal cord birth defect.”		 The foods must not contain more than 100% of the daily recommended intake of preformed vitamin A or D per serving.    
  The nutrition information label must include information about folate.    
  *Note there are additional requirements for dietary supplements    
       
Dietary Sweeteners and Dental Tooth Decay
 Frequent eating of foods high in sugars and starches as between-meal snacks can promote tooth decay. The sugar alcohol [name, optional] used to sweeten this food may reduce the risk of dental caries. The product must meet the requirement for sugar content claims SUGAR FREE
Less than 0.5 g sugars per RACC and per labeled serving (or, for meals and main dishes, less than 0.5 g per labeled serving).
Contains no ingredient that is a sugar or generally understood to contain sugars except as noted below.*
Disclose calorie profile (e.g., “low calorie” or “not a low calorie food”).
“No added sugars” and “Without added sugars” are allowed if no sugar or sugar containing ingredient such as jam, jelly, or concentrated fruit juice is added during processing. Must state if food is not “low” or “reduced calorie.”		  
Frequent between-meal consumption of foods high in sugars and starches promotes tooth decay. The sugar alcohols in [name of food] do not promote tooth decay   REDUCED/LESS
At least 25% less sugars per RACC than an appropriate reference food (or, for meals and main dishes, at least 25% less sugars per 100 g).		  
Frequent eating of foods high in sugars and starches as between-meal snacks can promote tooth decay. [*insert the applicable sweetener from the list below], the sugar used to sweeten this food, unlike other sugars, may reduce the risk of dental caries.”      
Frequent between-meal consumption of foods high in sugars and starches promotes tooth decay. [*insert the applicable sweetener from the list below], the sugar in [name of food], unlike other sugars, does not promote tooth decay      
Frequent eating of foods high in sugars and starches as between-meal snacks can promote tooth decay. Sucralose, the sweetening ingredient used to sweeten this food, unlike sugars, does not promote tooth decay.      
Shortened Claims for Use on Small Packages:
“Does not promote tooth decay.”

“May reduce the risk of tooth decay.”

“[*insert the applicable sweetener from the list below] sugar does not promote tooth decay.”

“[*insert the applicable sweetener from the list below] sugar may reduce the risk of tooth decay.”		      
Applicable Sweeteners: xylitol, sorbitol, mannitol, maltitol, isomalt, lactitol, hydrogenated starch hydrolysates, hydrogenated glucose syrups, erythritol, D-tagatose, isomaltulose, sucralose.