A Food Labeling Guide: Appendix C - Health Claims ΓΈ Calorie Counter
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A Food Labeling Guide: Appendix C - Health Claims

A Food Labeling Guide

Health Claims


Approved Claims Food Requirements Claim Requirements Model Claim, Statements
Calcium and Osteoporosis
21 CFR 101.72
  • High in calcium
  • Assimilable (Bioavailable)
  • Supplements must disintegrate and dissolve
  • Phosphorus content cannot exceed calcium content
Indicates disease depends on many factors by listing risk factors or the disease: Gender - Female. Race - Caucasian and Asian. Age - Growing older.

Primary target population: Females, Caucasian and Asian races, and teens and young adults in their bone-forming years.

Additional factors necessary to reduce risk: Eating healthful meals, regular exercise.

Mechanism relating calcium to osteoporosis: Optimizes peak bone mass.

Foods or supplements containing more than 400 mg calcium must state that total intakes of greater than 2,000 mg calcium provide no added benefit to bone health.
Regular exercise and a healthy diet with enough calcium helps teens and young adult white and Asian women maintain good bone health and may reduce their high risk of osteoporosis later in life.
Sodium and Hypertension
21 CFR 101.74
  • Low sodium
Required terms:
  • "Sodium", "High blood pressure"
Includes physician statement (Individuals with high blood pressure should consult their physicians) if claim defines high or normal blood pressure
Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors.
Dietary Fat and Cancer
21 CFR 101.73
  • Low fat
(Fish & game meats: "Extra lean")
Required terms:
  • "Total fat" or "Fat"
  • "Some types of cancers" or "Some cancers"
Does not specify types of fats or fatty acids that may be related to risk of cancer.
Development of cancer depends on many factors. A diet low in total fat may reduce the risk of some cancers.
Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease
21 CFR 101.75
  • Low saturated fat
  • Low cholesterol
  • Low fat
(Fish & game meats: "Extra lean")
Required terms:
  • "Saturated fat and cholesterol"
  • "Coronary heart disease" or "Heart disease"
Includes physician statement (individuals with elevated blood total or LDL cholesterol should consult their physicians) if claim defines high or normal blood total and LDL cholesterol.
While many factors affect heart disease, diets low in saturated fat and cholesterol may reduce the risk of this disease.
Fiber-Containing Grain Products, Fruits, and Vegetables and Cancer
21 CFR 101.76
  • A grain product, fruit, or vegetable that contains dietary fiber
  • Low fat
  • Good source of dietary fiber (without fortification)
Required terms:
  • "Fiber", "Dietary fiber", or "Total dietary fiber"
  • "Some types of cancer" or "Some cancers"
Does not specify types of dietary fiber that may be related to risk of 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.
Fruits, Vegetables and Grain Products that contain Fiber, particularly Soluble Fiber, and Risk of Coronary Heart Disease
21 CFR 101.77
  • A fruit, vegetable, or grain product that contains fiber
  • Low saturated fat
  • Low cholesterol
  • Low fat
  • At least 0.6 grams of soluble fiber per RA (without fortification)
  • Soluble fiber content provided on label
Required terms:
  • "Fiber", "Dietary fiber", "Some types of dietary fiber", "Some dietary fibers", or "Some fibers"
  • "Saturated fat" and "Cholesterol"
  • "Heart disease" or "Coronary heart disease"
Includes physician statement ("Individuals with elevated blood total or LDL cholesterol should consult their physicians") if claim defines high or normal blood total and LDL cholesterol.
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.
Fruits and Vegetables and Cancer
21 CFR 101.78
  • A fruit or vegetable
  • Low fat
  • Good source (without fortification) of at least one of the following: Vitamin A, Vitamin C, or Dietary fiber
Required terms:
  • "Fiber", "Dietary fiber", or "Total dietary fiber"
  • "Total fat" or "Fat", - "Some types of cancer" or "Some cancers"
Characterizes fruits and vegetables as "Foods that are low in fat and may contain Vitamin A, Vitamin C, and dietary fiber."

Characterizes specific food as a "Good source" of one or more of the following: Dietary fiber, Vitamin A, or Vitamin C.

Does not specify types of fats or fatty acids or types of dietary fiber that may be related to risk of cancer.
Low fat diets rich in fruits and vegetables (foods that are low in fat and may contain dietary fiber, Vitamin A, or Vitamin C) may reduce the risk of some types of cancer, a disease associated with many factors. Broccoli is high in vitamin A and C, and it is a good source of ditary fiber.
Folate and Neural Tube Defects
21 CFR 101.79
"Good source" of folate (at least 40 mcg folate per serving)
  • Dietary supplements, or foods in conventional food form that are naturally good sources of folate (i.e., only non-fortified food in conventional food form)
  • The claim shall not be made on products that contain more than 100% of the RDI for vitamin A as retinol or preformed vitamin A or vitamin D
  • Dietary supplements shall meet USP standards for disintegration and dissolution or otherwise bioavailable
  • Amount of folate required in N.L.
Required terms:
  • Terms that specify the relationship (e.g., women who are capable of becoming pregnant and who consume adequate amounts of folate) "Folate", "folic acid", "folacin","folate a B vitamin", "folic acid, a B vitamin," "folacin, a B vitamin," "neural tube defects", "birth defects, spinal bifida, or anencephaly", "birth defects of the brain or spinal cord - anencephaly or spinal bifida", "spinal bifida or anencephaly, birth defects of the brain or spinal cord".
Must also include information on the multifactorial nature of neural tube defects, and the safe upper limit of daily intake.
Healthful diets with adequate folate may reduce a woman's risk of having a child with a brain or spinal cord defect.
Dietary Sugar Alcohol and Dental Caries
21 CFR 101.80
  • Sugar free
  • The sugar alcohol must be xylitol, sorbitol, mannitol, maltitol, isomalt, lactitol, hydrogenated starch hydrolysates, hydrogenated glucose syrups, erythritol, or a combination
  • When a fermentable carbohydrate is present, the food must not lower plaque pH below 5.7
Required terms:
  • "Does not promote," "may reduce the risk of," "useful [or is useful] in not promoting" or "expressly [or is expressly] for not promoting" dental caries
  • "Sugar alcohol" or "sugar alcohols" or the name or names of the sugar alcohols, e.g., sorbitol
  • "Dental caries" or "tooth decay."
  • Includes statement that frequent between meal consumption of foods high in sugars and starches can promote tooth decay.
  • Packages with less than 15 square inches of surface area available for labeling may use a shortened claim.
Full claim: 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. Shortened claim(on small packages only): Does not promote tooth decay.
Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease
21 CFR 101.81
  • Low saturated fat
  • Low cholesterol
  • Low fat
  • Include either (1) one or more eligible sources of whole oats, containing at least 0.75 g whole oat soluble fiber per RA; or (2) psyllium seed husk containing at least 1.7 g of psyllium husk soluble fiber per RA
  • Amount of soluble fiber per RA declared in nutrition label.

Eligible Source of Soluble Fiber

Beta (β) glucan soluble fiber from oat bran, rolled oats (or oatmeal), and whole oat flour. Oat bran must provide at least 5.5% β-glucan soluble fiber, rolled oats must provide at least 4% β-glucan soluble fiber, and whole oat flour must provide at least 4% β-glucan soluble fiber or Psyllium husk wih purity of no less than 95%
Required terms:
  • "Heart disease" or "coronary heart disease."
  • "Soluble fiber" qualified by either "psyllium seed husk" or the name of the eligible source of whole oat soluble fiber
  • "Saturated fat" and "cholesterol."
  • "Daily dietary intake of the soluble fiber source necessary to reduce the risk of CHD and the contribution one serving of the product makes to this level of intake."

Additional Required Label Statement

Foods bearing a psyllium seed husk health claim must also bear a label statement concerning the need to consume them with adequate amounts of fluids; e.g., "NOTICE: This food should be eaten with at least a full glass of liquid. Eating this product without enough liquid may cause choking. Do not eat this product if your have difficulty in swallowing." (21 CFR 101.17(f))
Soluble fiber from foods such as [name of soluble fiber source, and, if desired, 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 product] supplies __ grams of the [necessary daily dietary intake for the benefit] soluble fiber from [name of soluble fiber source] necessary per day to have this effect.
Soy Protein and Risk of Coronary Heart Disease
21 CFR 101.82
  • At least 6.25 g soy protein per RA
  • Low saturated fat
  • Low cholesterol
  • Low fat (except that foods made from whole soybeans that contain no fat in addition to that inherent in the whole soybean are exempt from the "low fat" requirement)
Required terms:
  • Heart disease" or "coronary heart disease"
  • "Soy protein"
  • "Saturated fat" and "cholesterol"
Claim specifies daily dietary intake levels of soy protein associated with reduced risk

Claim specifies amount of soy protein in a serving of food
  • 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.
  • 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.
Plant Sterol/stanol esters and Risk of Coronary Heart Disease
21 CFR 101.83
  • At least 0.65 g plant sterol esters per RA of spreads and salad dressings
  • At least 1.7 g plant stanol esters per RA of spreads, salad dressings, snack bars, and dietary supplements
  • Low saturated fat
  • Low cholesterol
  • Spreads and salad dressings that exceed 13 g fat per 50 g must bear the statement "see nutrition information for fat content"
Salad dressings are exempted from the minimum 10% DV nutrient requirement (see General Criteria below)
Required terms:
  • "May" or "might" reduce the risk of CHD
  • "Heart disease" or "coronary heart disease"
  • "Plant sterol esters" or "plant stanol esters"; except "vegetable oil" may replace the term "plant" if vegetable oil is the sole source of the sterol/stanol ester
Claim specifies plant stero/stanol esters are part of a diet low in saturated fat and cholesterol.

Claim does not attribute any degree of CHD risk reduction.

Claim specifies the daily dietary intake of plant sterol or stanol esters necessary to reduce CHD risk, and the amount provided per serving.

Claim specifies that plant sterol or stanol esters should be consumed with two different meals each a day.

  • Foods containing at least 0.65 gram per serving of vegetable oil sterol esters, eaten twice a day with meals for a daily total intake of at least 1.3 grams, 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 vegetable oil sterol esters.
  • Diets low in saturated fat and cholesterol that include two servings of foods that provide a daily total of at least 3.4 grams of plant stanol esters in two meals may reduce the risk of heart disease. A serving of [name of food] supplies __ grams of plant stanol esters.


CLAIMS AUTHORIZED BASED ON AUTHORITATIVE STATEMENTS BY FEDERAL SCIENTIFIC BODIES


Approved Claims Food Requirements Claim Requirements Model Claim, Statements
Whole Grain Foods and Risk of Heart Disease and Certain Cancers
Docket No. 99P-2209
  • Contains 51 percent or more whole grain ingredients by weight per RA
  • Dietary fiber content at least:
    • 3.0 g per RA of 55 g
    • 2.8 g per RA of 50 g
    • 2.5 g per RA of 45 g
    • 1.7 g per RA of 35 g
  • Low fat
Required wording of the claim:
  • "Diets rich in whole grain foods and other plant foods and low in total fat, saturated fat, and cholesterol may reduce the risk of heart disease and some cancers."
N/A
Potassium and the Risk of High Blood Pressure and Stroke
Docket No. 00Q-1582
  • Good source of potassium
  • Low sodium
  • Low total fat
  • Low saturated fat
  • Low cholesterol
Required wording for the claim:
  • "Diets containing foods that are a good source of potassium and that are low in sodium may reduce the risk of high blood pressure and stroke."
N/A


General Criteria All Claims Must Meet

  • All information in one place without intervening material (Reference statement permitted).
  • Only information on the value that intake or reduced intake, as part of a total dietary pattern, may have on a disease or health-related condition.
  • Enables public to understand information provided and significance of information in the context of a total daily diet.
  • Complete, truthful, and not misleading.
  • Food Contains, without fortification, 10% or more of the Daily Value for one of six nutrients (dietary supplements excepted):

    Vitamin A 500 IU Calcium 100 mg
    Vitamin C 6 mg Protein 5 g
    Iron 1.8 mg Fiber 2.5 g

  • Not represented for infants or toddlers less than 2 years of age.
  • Uses "may" or "might" to express relationship between substance and disease.
  • Does not quantify any degree of risk reduction.
  • Indicates disease depends on many factors.
  • Food contains less than the specified levels of four disqualifying nutrients:

    Disqualifying Nutrients Foods Main Dishes Meal Products
    Fat 13 g 19.5 g 26 g
    Saturated Fat 4 g 6 g 8 g
    Cholesterol 60 mg 90 mg 120 mg
    Sodium 480 mg 720 mg 960 mg

Abbreviations: RA = reference amount, IU = International Units


Updated Information:


March 20, 2001: Claims That Can Be Made for Conventional Foods & Dietary Supplements

October 2, 2002: Oatrim (amylase-hydrolyzed whole oat flour or oat bran) was added to the eligible sources of oat soluble fiber. Interim Final Rule - Food Labeling: Health Claims; Soluble Dietary Fiber From Certain Foods and Coronary Heart Disease

December 23, 2005: Barley was added as an additional eligible source of β-glucan soluble fiber. Interim Final Rule - Food Labeling: Health Claims; Soluble Dietary Fiber From Certain Foods and Coronary Heart Disease




A Food Labeling Guide



Food and Drug Administration Center for Food Safety and Applied Nutrition
A Food Labeling Guide, September 1994 (Editorial revisions June, 1999)

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