Federal Register / Vol. 62, No. 61 / Monday, March 31, 1997 / Rules and Regulations 15343

with §§ 105.66, 105.67, and 105.69’’ and

adding in its place ‘‘§§ 101.9 and

105.66’’ and in paragraph (b) by

removing the phrase ‘‘§§ 101.9 and

101.25 and §§ 105.66, 105.67, and

105.69’’ and adding in its place

‘‘§§ 101.9 and 105.66’’.

PART 102—COMMON OR USUAL

NAME FOR NONSTANDARDIZED

FOODS

6. The authority citation for 21 CFR

part 102 continues to read as follows:

Authority: Secs. 201, 403, 701 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 343, 371).

§ 102.33 [Amended]

7. Section 102.33 Beverages that

contain fruit or vegetable juice is

amended in paragraphs (c) and (d) by

adding the word ‘‘diluted,’’ before the

phrase ‘‘multiple-juice beverage’’.

Dated: March 24, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–7973 Filed 3–28–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 101

[Docket No. 95P–0197]

RIN 0910–AA19

Food Labeling: Health Claims; Soluble

Fiber From Whole Oats and Risk of

Coronary Heart Disease

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

regulation that authorizes health claims

about the relationship between soluble

fiber from whole oats and coronary

heart disease (CHD) to clarify and

correct its provisions. This action is

being taken in response to inquiries that

FDA has received since it issued this

regulation.

EFFECTIVE DATE: March 31, 1997.

FOR FURTHER INFORMATION CONTACT:

Joyce J. Saltsman, Center for Food Safety

and Applied Nutrition (HFS–165), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204,202–205–5483.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of January 23,

1997 (62 FR 3584), FDA published a

final rule announcing its decision to

authorize the use of health claims on the

relationship between soluble fiber from

whole oats (i.e., oat bran, rolled oats,

and whole oat flour) and the risk of CHD

(§ 101.81 (21 CFR 101.81)). Since then,

questions have been raised regarding the

meaning of the regulation. Therefore,

FDA is amending § 101.81 to correct and

clarify the regulation.

II. Nature of the Claim (§ 101.81(c)(2)(i))

Section 101.81(c)(2)(i)(C) states that

‘‘in specifying the substance, the claim

uses the term ‘soluble fiber’ qualified by

either the use of the name of the eligible

source of whole oat soluble fiber

(provided in paragraph (c)(2)(ii) of this

section) or the name of the food

product.’’ The agency is amending

§ 101.81(c)(2)(i)(C) to clarify that the

claim must state the name of the source

of eligible soluble fiber, and that it may

state the name of the food product that

contains the source of the soluble fiber.

In the preamble to the whole oats final

rule (62 FR 3584 at 3595), the agency

gave examples of statements that

complied with § 101.81(c)(2)(i)(C).

Those examples were: ‘‘Soluble fiber

from whole oats * * *’’ and ‘‘Soluble

fiber from oatmeal

* * *.’’ The agency stated that:

In each case, the inclusion of information

about the source or the product qualifies the

term soluble fiber so that the consumer is not

misled to believe that all soluble fiber may

reduce the risk of CHD. The manufacturer

may also clarify the information for those

product names that do not indicate the name

of the soluble fiber source, for instance:

‘‘Soluble fiber from the oat bran in this

product * * *.’’

62 FR 3584 at 3595

As the discussion of this provision in

the final tried to make clear, it was the

agency’s intention that the claim use the

name of the whole oat food, i.e., oat

bran, rolled oats, or whole oat flour, that

is the source of soluble fiber, so that the

consumer would not be misled to

believe that all soluble fibers that may

be present in the food may reduce the

risk of CHD. However, the agency has

come to recognize that a claim such as

‘‘Soluble fiber from Today’s Cereal as

part of a diet low in saturated fat and

cholesterol may reduce the risk of heart

disease,’’ which does not identify the

source of the soluble fiber that provides

the basis for the claim, satisfies

§ 101.81(c)(2)(i)(C) in that it uses the

term ‘‘soluble fiber’’ qualified by the

name of the product. Thus, the

regulation does not set out the rule the

agency intended to embody in the

regulation. Consequently, FDA finds it necessary

to amend § 101.81(c)(2)(i)(C) to make

clear that the food source of the beta (β)-

glucan soluble fiber in the product that

bears the claim must be identified in the

health claim, and that use of the product

name is optional. Therefore, in this

document, the agency is correcting

§ 101.81(c)(2)(i)(C) to state:

In specifying the substance, the claim uses

the term ‘soluble fiber’ qualified by the name

of the eligible source of soluble fiber

(provided in paragraph (c)(2)(ii) of this

section). Additionally, the claim may use the

name of the food product that contains the

eligible source of soluble fiber.

III. Nature of the Food Eligible to Bear

the Claim (§ 101.81(c)(2)(iii))

Section 101.81(c)(2)(iii)(A) states that,

‘‘the food shall contain at least 0.75

gram (g) per reference amount

customarily consumed of whole oat

soluble fiber from the eligible sources

listed in paragraph (c)(2)(ii) of this

section.’’ Section 101.81(c)(2)(ii) lists

three whole oat foods that are eligible

sources of β-glucan soluble fiber: Oat

bran (§ 101.81(c)(2)(ii)(A)(1)), rolled oats

or oatmeal (§ 101.81(c)(2)(ii)(A)(2)), and

whole oat flour (§ 101.81(c)(2)(ii)(A)(3)).

Questions have been raised regarding

whether an extract of whole oat βglucan soluble fiber, such as an extract

of β-glucan from oat bran, could be used

to fortify a product and thus qualify for

the health claim.

FDA intended to make clear in

§ 101.81 that an extract of an eligible oat

food could not justify the use of the

authorized health claim. In the

preamble to the whole oat final rule, the

agency stated that the β-glucan soluble

fiber in whole oat products is the

primary, but not the only, component in

whole oats that affects serum lipids (62

FR 3584 at 3585). The agency also stated

that:

Other food sources of β-glucan soluble

fiber (such as oat gum and non-oat sources)

have not been carefully reviewed by the

agency, nor has the totality of the evidence

on these other sources of the fiber been

submitted to the agency for review. Thus, the

basis for including a wider range of food

sources of β-glucan beyond whole oats in the

regulation authorizing health claims is not

presented by the administrative record, and

consideration of these other sources is

beyond the scope of this rulemaking.

62 FR 3584 at 3587

It was the agency’s intention that the

provisions in § 101.81(c)(2)(iii)(A)

define the nature of the whole oat foods

that are eligible sources of β-glucan

soluble fiber, and not to suggest that βglucan soluble fiber by itself could be

used to fortify a product for purposes of

making a claim.

The inquiries that FDA has received,

however, stated that FDA needs to make

its meaning even clearer in

§ 101.81(c)(2)(iii)(A). Therefore, in this

document, the agency is amending this

provision to state: ‘‘The food product

shall include one or more of the whole

oat foods from § 101.81(c)(2)(ii), and the
15344 Federal Register / Vol. 62, No. 61 / Monday, March 31, 1997 / Rules and Regulations

whole oat foods shall contain at least

0.75 gram (g) of soluble fiber per

reference amount customarily

consumed of the food product.’’

IV. Model Health Claim (§ 101.81(e))

In light of the revision to

§ 101.81(c)(2)(i)(C) in section II of this

document, the agency is making minor

changes to the model claims in

§ 101.81(e)(1) and (e)(2). In current

paragraphs (e)(1) and (e)(2) in the model

claims, the name of the soluble fiber

source from § 101.81(c)(2)(ii) or the

name of the food product may be

provided. In this document, the agency

is revising the model claims to clarify

that the name of the soluble fiber source

from § 101.81(c)(2)(ii) must be presented

and, if desired, the name of the food

product may also be provided. For

example, FDA is amending

§ 101.81(e)(1) to state, ‘‘Soluble fiber

from foods such as [name of soluble

fiber source from section (c)(2)(ii) 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.’’ Therefore, a claim for an oat

bran-containing food may state,

‘‘Soluble fiber from foods such as oat

bran in Brand Name Cereal, as part of

a diet low in saturated fat and

cholesterol, may reduce the risk of heart

disease.’’

List of Subjects in 21 CFR Part 101

Food labeling, Nutrition, Reporting

and recordkeeping requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 101 is

amended as follows:

PART 101—FOOD LABELING

1. The authority citation for 21 CFR

part 101 continues to read as follows:

Authority: Secs. 4, 5, 6 of the Fair

Packaging and Labeling Act (15 U.S.C. 1453,

1454, 1455); secs. 201, 301, 402, 403, 409,

701 of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 321, 331, 342, 343, 348, 371).

2. Section 101.81 is amended by

revising paragraphs (c)(2)(i)(C),

(c)(2)(iii)(A), (e)(1), and (e)(2) to read as

follows:

§ 101.81 Health claims: Soluble fiber from

whole oats and risk of coronary heart

disease (CHD).

* * * * *

(c) * * *

(2) * * *

(i) * * *

(C) In specifying the substance, the

claim uses the term ‘‘soluble fiber’’

qualified by the name of the eligible

source of soluble fiber (provided in

paragraph (c)(2)(ii) of this section).

Additionally, the claim may use the

name of the food product that contains

the eligible source of soluble fiber;

* * * * *

(iii) * * *

(A) The food product shall include

one or more of the whole oat foods from

paragraph (c)(2)(ii) of this section, and

the whole oat foods shall contain at

least 0.75 gram (g) of soluble fiber per

reference amount customarily

consumed of the food product;

* * * * *

(e) * * *

(1) Soluble fiber from foods such as

[name of soluble fiber source from

paragraph (c)(2)(ii) 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.

(2) Diets low in saturated fat and

cholesterol that include soluble fiber

from [name of soluble fiber source from

paragraph (c)(2)(ii) of this section and,

if desired, the name of food product]

may reduce the risk of heart disease.

Dated: March 25, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–7972 Filed 3–28–97; 8:45 am]

BILLING CODE 4160–01–F