A PPENDIX C: H EALTH C LAIMS

11. A PPENDIX C: H EALTH C LAIMS

Requirements for Health Claims Made in Labeling

Approved Requirements Claim Model Claim

Claims for the Food

Requirements Statements

Calcium and For calcium and

Calcium and Osteoporosis: Adequate Osteoporosis

The claim makes clear the importance

calcium throughout life, as part of a and calcium,

osteoporosis

of adequate calcium intake, or when

well-balanced diet, may reduce the risk vitamin D, and

claim - high in

appropriate, adequate calcium and

calcium

vitamin D intake, throughout life, in a

of osteoporosis.

osteoporosis

healthful diet, are essential to reduce

For calcium, Calcium, vitamin D and osteoporosis:

osteoporosis risk. The claim does not

vitamin D and Adequate calcium and vitamin D, as (21 CFR 101.72)

imply that adequate calcium intake, or

osteoporosis part of a well balanced diet, along with

when appropriate, adequate calcium

claim - high in physical activity, may reduce the risk of

and vitamin D intake, is the only

calcium and

osteoporosis.

recognized risk factor for the

vitamin D

development of osteoporosis.

- assimilable

The claim does not attribute any

(Bioavailable)

degree of reduction in risk of

Supplements

osteoporosis to maintaining an

must disintegrate

adequate dietary calcium intake, or

and dissolve, and

when appropriate, an adequate dietary calcium and vitamin D intake,

Phosphorus

throughout life.

content cannot exceed calcium content

Dietary Fat Low fat

Development of cancer depends on and Cancer

Required terms:

many factors. A diet low in total fat (Fish & game

may reduce the risk of some cancers. (21 CFR 101.73)

“Total fat” or “Fat”

meats: “Extra lean”)

“Some types of cancers” or “Some cancers”

Does not specify types of fats or fatty acids that may be related to risk of cancer.

A F O O D L A B E L I N G G U I D E 95

Approved Requirements Claim Model Claim

Claims for the Food

Requirements Statements

Sodium and Low sodium

Diets low in sodium may reduce the Hypertension

Required terms:

risk of high blood pressure, a disease

associated with many factors. (21 CFR 101.74)

“Sodium”, “High blood pressure”

Includes physician statement (Individuals with high blood pressure should consult their physicians) if claim defines high or normal blood pressure

While many factors affect heart Fat and

Dietary Saturated Low saturated fat,

Required terms:

disease, diets low in saturated fat and Cholesterol

cholesterol may reduce the risk of and risk of

Low cholesterol

Saturated fat and cholesterol

and

this disease.

Coronary Heart

“Coronary heart disease”

Disease Low fat

or “heart disease”

(21 CFR 101.75)

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.

Fiber-Containing

Low fat diets rich in fiber-containing Grain Products,

A grain product,

Required terms:

fruit, or vegetable grain products, fruits, and vegetables Fruits, and

may reduce the risk of some types of Vegetables and

that contains

“Fiber”, “Dietary fiber”, or “Total

cancer, a disease associated with Cancer

dietary fiber;

dietary fiber”

many factors. Low fat, and

“Some types of cancer” or “Some

(21 CFR 101.76)

cancers”

Good source of dietary fiber

Does not specify types of dietary fiber

(without

that may be related to risk of cancer.

fortification)

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Approved Requirements Claim Model Claim

Claims for the Food

Requirements Statements

Fruits, Vegetables

Diets low in saturated fat and and Grain

A fruit, vegetable,

Required terms:

or grain product cholesterol and rich in fruits, Products that

vegetables, and grain products that contain Fiber,

that contains

“Fiber”, “Dietary fiber”, “Some types

contain some types of dietary fiber, particularly

fiber;

of dietary fiber”, “Some dietary fibers”,

particularly soluble fiber, may reduce Soluble Fiber,

or “Some fibers”

Low saturated fat, the risk of heart disease, a disease and Risk of

associated with many factors. Coronary Heart Disease

“Saturated fat” and “Cholesterol”

Low cholesterol,

“Heart disease” or “Coronary heart disease”

(21 CFR 101.77) Low fat, At least 0.6 grams

of soluble fiber per RACC (without fortification), and,

Soluble fiber content provided on label

Low fat diets rich in fruits and Vegetables

Fruits and

A fruit or

Required terms:

vegetables (foods that are low in fat and Cancer

vegetable,

“Fiber”, “Dietary fiber”, or “Total

and may contain dietary fiber, Low fat, and

dietary fiber”;

Vitamin A, or Vitamin C) may reduce (21 CFR 101.78)

the risk of some types of cancer, a Good source

“Total fat” or “Fat”,

disease associated with many factors. (without

Broccoli is high in vitamin A and C, fortification) of

“Some types of cancer” or “Some

and it is a good source of dietary fiber. at least one of the following:

cancers”

Characterizes fruits and vegetables as

• Vitamin A,

“Foods that are low in fat and may

• Vitamin C, or

contain Vitamin A, Vitamin C, and

• Dietary fiber

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.

A F O O D L A B E L I N G G U I D E 97

Approved Requirements Claim Model Claim

Claims for the Food

Requirements Statements

Folate and Neural “Good source”

Healthful diets with adequate folate Tube Defects

Required terms:

of folate (at least may reduce a woman's risk of having

Nutrient: a child with a brain or spinal cord (21 CFR 101.79)

40 mcg folate

per serving)

“Folate”, “folic acid”, “folacin”, “folate,

defect.

a B vitamin”, “folic acid, a B vitamin,”

Dietary

“folacin, a B vitamin.”

supplements, or foods in

Condition:

conventional food “neural tube defects”, “birth defects, form that are

spinal bifida, or anencephaly”,

naturally good

“birth defects of the brain or spinal cord,

sources of folate

anencephaly or spinal bifida”, “spinal

(i.e., only non-

bifida and anencephaly, birth defects of

fortified food in

the brain or spinal cord”;

conventional food “brain or spinal cord birth defects.” form)

Must also include information on the

The claim shall

multifactorial nature of neural tube

not be made on

defects, and the safe upper limit of

products that

daily intake.

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 on Nutrition Label

98 G U I D A N C E F O R I N D U S T R Y

Approved Requirements Claim Model Claim

Claims for the Food

Requirements Statements

Dietary Non- Sugar free, and

Full claim: Frequent between-meal cariogenic

Required terms:

consumption of foods high in sugars Carbohydrate

and starches promotes tooth decay. Sweeteners and

When a fermen-

“does not promote,” “may reduce the

table carbohydrate risk of,” “useful [or is useful] in not The sugar alcohols in [name of food] Dental Caries

do not promote tooth decay. food must not

is present, the

promoting” or “expressly [or is

expressly] for not promoting” dental

(21 CFR 101.80) lower plaque pH

caries;

Shortened claim (on small packages

below 5.7. only): Does not promote tooth decay.

“dental caries” or “tooth decay.”

Eligible substances

“sugar alcohol” or “sugar alcohols”

1) The following

or the name or names of the sugar

sugar alcohols:

alcohols

xylitol, sorbitol, mannitol, maltitol, Note: D-tagatose may be identified isomalt, lactitol,

as “tagatose”

hydrogenated starch hydrolysates, When the substance that is the subject hydrogenated

of the claim is a noncariogenic sugar

glucose syrups,

(i.e., D-tagatose) the claim shall identify

erythritol, or a

the substance as a sugar that, unlike

combination of

other sugars, does not promote the

these.

development of dental caries.

2) The following

Includes statement that frequent

sugars:

between meal consumption of foods

D-tagatose and

high in sugars and starches can

isomaltulose

promote tooth decay.

3) The following

Packages with less than 15 square

non-nutritive

inches of surface area available for

sweetener:

labeling may use a shortened claim

sucralose

A F O O D L A B E L I N G G U I D E 99

Approved Requirements Claim Model Claim Claims for the Food

Requirements Statements

Soluble Fiber Low saturated fat

Soluble fiber from Certain

Required terms:

from foods such Foods and Risk

as [name of of Coronary

Low cholesterol

“Heart disease” or “coronary heart

soluble fiber Heart Disease

disease.”

Low fat, and source, and, if

desired, name of (21 CFR 101.81) The food product must include one

“Saturated fat” and “cholesterol.”

food product], or more of the following whole oat or

as part of a diet barley foods: 1) oat bran, 2) rolled oats,

In specifying the substance the claim

uses the term “soluble fiber” qualified low in saturated

fat and barley or dry milled barley, and the

3) whole oat f lour, 4) whole grain

by the name of the eligible source of

cholesterol, may whole oat or barley foods must contain

by the name of the eligible source of

the soluble fiber, which is either whole reduce the risk at least 0.75 g of soluble fiber per

heart disease. RACC of the food product; or

oat or barley or psyllium seed husk.

A serving of

[name of food Oatrim that contains at least 0.75 g of

Claim specifies the daily dietary

product] beta--glucan soluble per RACC of the

intake of the soluble fiber source

supplies _ grams food product; or

necessary to reduce the risk of CHD

of the [necessary Claim specifies the amount of soluble

daily dietary Psyllium husk that contains at least

fiber in one serving of the product.

intake for the

benefit] soluble product.

1.7 g of soluble fiber per RACC of food

Additional Required Label Statement

fiber from [name of

Eligible Sources of Soluble Fiber

Foods bearing a psyllium seed husk

soluble fiber

source] necessary Beta-glucan soluble fiber from the

health claim must also bear a label

per day to have following whole oat and barley sources:

statement concerning the need to

consume them with adequate amounts this effect.

1) Oat bran

of f luids; e.g., “NOTICE: This food

protein.

2) Rolled Oats

should be eaten with at least a full

3) Whole Oat Flour

glass of liquid. Eating this product

4) Oatrim

without enough liquid may cause

5) Whole Grain Barley and Dry

choking. Do not eat this product if

Milled Barley

your have difficulty in swallowing.

6) Barley Betafiber

7) Soluble fiber from psyllium husk

(21 CFR 101.17(f))

with purity of no less than 95% The amount of soluble fiber per

RACC must be declared in nutrition label.

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Approved Requirements Claim Model Claim

Claims for the Food

Requirements Statements

Soy Protein and At least 6.25 g

(1) 25 grams of soy protein a day, as Risk of Coronary

Required terms:

soy protein per part of a low in saturated fat and Heart Disease

RACC

“Heart disease” or “coronary heart

cholesterol, may reduce the risk of

heart disease. A serving of [name of (21 CFR 101.82)

disease”

Low saturated food] supplies __ grams of soy protein. fat,

“Soy protein”

(2) Diets low in saturated fat and Low cholesterol,

cholesterol that include 25 grams of and

“Saturated fat” and “cholesterol”

soy protein a day may reduce the risk

of heart disease. One serving of [name Low fat (except

Claim specifies daily dietary intake

of food] provides __ grams of soy that foods made

levels of soy protein associated with

reduced risk

protein.

from whole soybeans that

Claim specifies amount of soy protein

contain no fat

in a serving of food

in addition to that inherent in the whole soybean are exempt from the “low fat” requirement)

A F O O D L A B E L I N G G U I D E 101

Approved Requirements Claim Model Claim

Claims for the Food

Requirements Statements

*Plant Sterol/ At least 0.65 g

(1) Foods containing at least 0.65 stanol esters and

Required terms:

plant sterol esters gram per of vegetable oil sterol esters, Risk of Coronary

eaten twice a day with meals for a Heart Disease

per RACC of

“May” or “might” reduce the risk of

spreads and salad

daily total intake of least 1.3 grams, dressings, or

CHD

as part of a diet low in saturated fat (21

CFR 101.83) and cholesterol, may reduce the risk

“Heart disease” or “coronary heart

At least 1.7 g

of heart disease. A serving of [name plant stanol esters

disease”

of food] supplies __ grams of per RACC of

vegetable oil sterol esters. spreads, salad

“Plant sterol esters” or “plant stanol

esters”; except “vegetable oil” may

dressings, snack

(2) Diets low in saturated fat and bars, and dietary

replace the term “plant” if vegetable

cholesterol that include two servings supplements.

oil is the sole source of the sterol/

stanol ester

of foods that provide a daily total of at least 3.4 grams of plant stanol esters

Low saturated fat,

Claim specifies plant stero/stanol

in two meals may reduce the risk of

heart disease. A serving of [name of Low cholesterol,

esters are part of a diet low in saturated

food] supplies __ grams of plant and

fat and cholesterol.

stanol esters

Claim does not attribute any degree

Spreads and salad

of CHD risk reduction.

dressings that exceed 13 g fat

Claim specifies the daily dietary intake

per 50 g must

of plant sterol or stanol esters

bear the statement

necessary to reduce CHD risk, and

“see nutrition

the amount provided per serving.

information for

Claim specifies that plant sterol or

fat content”

stanol esters should be consumed with two different meals each a day.

Salad dressings are exempted from the minimum 10% DV nutrient requirement

* 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/LabelingNutrition/LabelClaims/HealthClaimsMeetingSignificantScientificAgreementSSA/ucm074779.htm?utm_campaign =Google2&utm_source=fdaSearch&utm_medium=website&utm_term=phytosterols&utm_content=8 and

3) A proposed rule for the health claim that published on December 8, 2010 (75 FR 76526).

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

Approved Food Claim Model Claim

Claims Requirements Requirement Statements

Whole Grain Contains 51 percent or more whole

NA Foods and Risk

Required wording of the claim:

grain ingredients by weight per RACC,

“Diets rich in whole grain foods and

of Heart Disease and

other plant foods and low in total fat,

and Certain

Cancers Dietary fiber content at least:

saturated fat, and cholesterol may

reduce the risk of heart disease and

• (Docket 3.0 g per RACC of 55 g No.

some cancers.”

• 1999P-2209) 2.8 g per RACC of 50 g •

2.5 g per RACC of 45 g

1.7 g per RACC of 35 g

Whole Grain Contains 51 percent or more whole

NA Foods with

Required wording of the claim:

grain ingredients by weight per RACC,

“Diets rich in whole grain foods and

Moderate Fat and

other plant foods, and low in total fat,

Content and Dietary fiber content at least:

saturated fat, and cholesterol may help Risk of Heart

reduce the risk of heart disease.”

Disease •

3.0 g per RACC of 55 g

• (Docket 2.8 g per RACC of 50 g No.

• 03Q-0547) 2.5 g per RACC of 45 g •

1.7 g per RACC of 35 g

Potassium and Good source of potassium

NA the Risk of High

Required wording of the claim:

Low sodium

“Diets containing foods that are a

Blood Pressure good source of potassium and that are and Stroke

Low total fat

low in sodium may reduce the risk of

(Docket No. Low saturated fat

high blood pressure and stroke.”

2000Q-1582) Low cholesterol

Fluoridated Bottled water meeting the standards of

NA Water and

Required wording of the claim:

identity and quality set forth in

“Drinking f luoridated water may

Reduced Risk of

21 CFR 165.110

reduce the risk of [dental caries or

Dental Carries Meet all general requirements for

tooth decay]”.

(Docket No. health claims in (21 CFR 101.14) with 2006Q-0418) the exception of the minium 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

A F O O D L A B E L I N G G U I D E 103

Approved Food Claim Model Claim

Claims Requirements Requirement Statements

Saturated Fat, Low saturated fat

NA Cholesterol, and

Required wording of the claim:

Trans Fat, and Low cholesterol cholesterol, and as low as possible in

“Diets low in saturated fat and

Reduced Risk of Bear quantitative trans fat labeling trans fat, may reduce the risk of heart Heart Disease

Contains less than 0.5 g trans fat per

disease.”

(Docket No. RACC 2006Q-0458)

Contains less than 6.5 g total fat Substitution of

NA Saturated Fat in

Low fat

Required wording of the claim:

“Replacing saturated fat with similar the Diet with

Low cholesterol amounts of unsaturated fats may

Unsaturated Meets all general requirements for reduce the risk of heart disease. To Fatty Acids and

health claims in 21 Reduced Risk of

achieve this benefit, total daily calories should not increase.”

CFR 101.14

Heart Disease (Docket No.

2007Q-0192)

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