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Guidance for Industry: A Food Labeling Guide (11. Appendix C: Health Claims)

January 2013

This document also available en Español (Spanish) , العربية  (Arabic PDF, 1.29MB), हिंदी (Hindi PDF, 1.46 MB), 简化中国 (Simplified Chinese PDF, 2.85MB), 日本人 (Japanese PDF, 1.23MB)

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The document below is available in several foreign language(s). FDA offers these translations as a service to a broad international audience. We hope that you find these translations useful. While the agency has attempted to obtain translations that are as faithful as possible to the English version, we recognize that the translated versions may not be as precise, clear, or complete as the English version. The official version of this document is the English version.


Requirements for Health Claims Made in Labeling

Approved ClaimsRequirements for the FoodClaim RequirementsModel Claim, Statements
Calcium and Osteoporosis and calcium, vitamin D, and osteoporosis

(21 CFR 101.72)

For calcium and osteoporosis claim-high in calcium

For calcium, vitamin D and osteoporosis claim-high in calcium and vitamin D

-assimilable (Bioavailable)

Supplements must disintegrate and dissolve, and

Phosphorus content cannot exceed calcium content

The claim makes clear the importance of adequate calcium intake, or when appropraite, adequate calcium and vitamin D intake, thoughout life, in healthful diet, are essential to reduce osteoporosis risk. The claim does not imply that adequate calcium intake, or when appropriate, adequate calcium and vitamin D intake, is the only recognized risk factor for the development of osteoporosis.

The claim does not attribute any degree of reduction in risk of osteoporosis to maintaining an adequate dietary calcium intake, or when appropraite, an adequate dietary calcium and vitamin D intake, thoughout life.

Calcium and Osteoporosis: Adequate calcium throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis.

Calcium, vitamin D and osteoporosis: Adequate calcium and vitamin D, as part of a well balanced diet, along with physical activity, may reduce the risk of osteoporosis.

Dietary Fat and Cancer

(21 CFR 101.73)

(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 realted to risk of cancer.

Development of cancer depends on many factors. A diet low in total fat may reduce the risk of some cancers.
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 Saturated Fat and Cholesterol, and risk of Coronary Heart Disease

(21 CFR 101.75)

Low saturated fat,

Low cholesterol, and

Low fat

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, and

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 RACC (without fortification), and,

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, and

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 dietary 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 Nutrition Label

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 Noncariogenic Carbohydrate Sweeteners and Dental Caries

(21 CFR 101.80)

Sugar free, and

When a fermentable carbohydrate is present, the food must not lower plaque pH below 5.7.

Eligible substances

1) The following sugar alcohols:xylitol, sorbitol, mannitol, maltitol, isomalt, lactitol, hydrogenated starch hydrolysates, hydrogenated glucose syrups, erythritol, or a combination of these.

2) The following sugars:D-tagatose and isomaltulose

3) The following non-nutritive sweetener:sucralose

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;

"dental caries" or "tooth decay."

"sugar alcohol" or "sugar alcohols" or the name or names of the sugar alcohols

Note: D-tagatose may be identified as "tagatose"

When the substance that is the subject of the claim is a noncariogenic sugar (i.e., D-tagatose)  the claim shall identify the substance as a sugar that, unlike other sugars, does not promote the development of dental caries.

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, and

The food product must include one or more of the following whole oat or barley foods: 1) oat bran, 2) rolled oats, 3) whole oat flour, 4) whole grain barley or dry milled barley, and the whole oat or barley foods must contain at least 0.75 g of soluble fiber per RACC of the food product; or

Oatrim that contains at least 0.75 g of beta-glucan soluble per RACC of the food product; or

Psyllium husk that contains at least 1.7 g of soluble fiber per RACC of food product.

Eligible Sources of Soluble Fiber

Beta-glucan soluble fiber from the following whole oat and barley sources:

1) Oat bran

2) Rolled Oats

3) Whole Oat Flour

4) Oatrim

5) Whole Grain Barley and Dry Milled Barley

6) Barley Beta Fiber

7) Soluble fiber from psyllium husk with purity of no less than 95%

The amount of soluble fiber per RACC must be declared in nutrition label.

Required terms:

"Heart disease" or "coronary heart disease."

"Saturated fat" and "cholesterol."

In specifying the substance the claim uses the term "soluble fiber" qualified by the name of the eligible source of the soluble fiber, which is either whole oat or barley or psyllium seed husk.

Claim specifies the daily dietary intake of the soluble fiber source necessary to reduce the risk of CHD

Claim specifies the amount of soluble fiber in one serving of the product.

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 RACC

Low saturated fat,

Low cholesterol, and

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

(1) 25 grams of soy protein a day, as part of a low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies __ grams of soy protein.

(2) 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 RACC of spreads and salad dressings, or

At least 1.7 g plant stanol esters per RACC of spreads, salad dressings, snack bars, and dietary supplements.

Low saturated fat,

Low cholesterol, and

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

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.

(1) Foods containing at least 0.65 gram per of vegetable oil sterol esters, eaten twice a day with meals for a daily total intake of 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.

(2) 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.

*FDA regulates the plant sterol/stanol esters and risk of coronary heart disease health claim according to the following requirements:
1) An interim final rule for the health claim that published on September 8, 2000 (65 FR 54686),
2) An enforcement discretion letter about expanded use of the interim final rule for the health claim, http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm074779.htm
3) A proposed rule for the health claim that published on December 8, 2010 (75 FR 76526).


FDAMA (FDA Modernization Act) Health Claims (Health Claims Authorized Based on an Authoritative Statement by Federal Scientific Bodies)

Approved ClaimsFood RequirementsClaim RequirementModel Claim Statements

Whole Grain Foods and Risk of Heart Disease and Certain Cancers

(Docket No. 1999P-2209)

Contains 51 percent or more whole grain ingredients by weight per RACC, and

Dietary fiber content at least:

  • 3.0 g per RACC of 55 g
  • 2.8 g per RACC of 50 g
  • 2.5 g per RACC of 45 g
  • 1.7 g per RACC of 35 g

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."

NA

Whole Grain Foods with Moderate Fat Content and Risk of Heart Disease

(Docket No. 03Q-0547)

Contains 51 percent or more whole grain ingredients by weight per RACC, and

Dietary fiber content at least:

  • 3.0 g per RACC of 55 g
  • 2.8 g per RACC of 50 g
  • 2.5 g per RACC of 45 g
  • 1.7 g per RACC of 35 g

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 help reduce the risk of heart disease."

NA

Potassium and the Risk of High Blood Pressure and Stroke

(Docket No. 2000Q-1582)

Good source of potassium

Low sodium

Low total fat

Low saturated fat

Low cholesterol

Required wording of 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."

NA

Fluoridated Water and Reduced Risk of Dental Carries

(Docket No. 2006Q-0418)

Bottled water meeting the standards of identity and quality set forth in 21 CFR 165.110

Meet all general requirements for health claims in 21 CFR 101.14) with the exception of the minimum nutrient contribution (21 CFR 101.14(e)(6)),

Total Fluoride: >0.6 to 1.0 mg/L

Excluding bottled water products specifically marketed for use by infants

Required wording of the claim:

"Drinking fluoridated water may reduce the risk of [dental caries or tooth decay]".

NA

Saturated Fat, Cholesterol, and Trans Fat, and Reduced Risk of Heart Disease

(Docket No. 2006Q-0458)

Low saturated fat

Low cholesterol

Bear quantitative trans fat labeling

Contain less than 0.5 g trans fat per RACC

Contain less than 6.5 g total fat

Required wording of the claim:

"Diets low in saturated fat and cholesterol, and as low as possible in trans fat, may reduce the risk of heart disease."

NA

Substitution of Saturated Fat in the Diet with Unsaturated Fatty Acids and Reduced Risk of Heart Disease

(Docket No. 2007Q-0192)

Low fat

Low cholesterol

Meets all general requirements for health claims in 21 CFR 101.14

Required wording of the claim:

"Replacing saturated fat with similar amounts of unsaturated fats may reduce the risk of heart disease. To achieve this benefit, total daily calories should not increase."

NA


For questions regarding this document, contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-2371.