15342 Federal Register / Vol. 62, No. 61 / Monday, March 31, 1997 / Rules and Regulations

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 101 and 102

Foods and Drugs; Technical

Amendments

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; technical

amendments.

SUMMARY: The Food and Drug

Administration (FDA) is amending its

regulations to correct those portions that

pertain to foods. This action is being

taken to improve the accuracy and

clarity of the regulations.

EFFECTIVE DATE: March 31, 1997.

FOR FURTHER INFORMATION CONTACT:

Gerad L. McCowin, Center for Food

Safety and Applied Nutrition (HFS–

150), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–205–4561.

SUPPLEMENTARY INFORMATION: FDA is

amending its regulations in parts 101

and 102 (21 CFR parts 101 and 102) to

correct certain portions that pertain to

foods.

1. In the Federal Register of April 2,

1993 (58 FR 17328), FDA published

corrections to the January 6, 1993, final

rule entitled ‘‘Food Labeling; Mandatory

Status of Nutrition Labeling and

Nutrient Content Revision, Format for

Nutrition Label’’ (58 FR 2079). In the

April 2, 1993, document, FDA corrected

the word ‘‘Foods’’ at the beginning of

the fourth sentence of paragraph (j)(4) in

§ 101.9 to read ‘‘Examples of foods’’ (58

FR 17328 at 17331). However, in the

August 18, 1993, technical corrections

to § 101.9 (58 FR 44063 at 44083), the

April 2, 1993, correction to § 101.9(j)(4)

was inadvertently omitted. In this

document, the agency is correcting the

word ‘‘Foods’’ that occurs at the

beginning of the fourth sentence in

§ 101.9(j)(4) to read ‘‘Examples of

foods’’.

2. In the Federal Register of January

4, 1994 (59 FR 378), FDA published a

final rule entitled ‘‘Food Labeling;

Requirements for Nutrient Content

Claims for Dietary Supplements of

Vitamins, Minerals, Herbs, and Other

Similar Nutritional Substances.’’ In that

document, the agency amended § 101.60

by redesignating paragraphs (c)(4) and

(c)(5) as paragraphs (c)(5) and (c)(6). In

making this change, the agency

inadvertently failed to change a

reference to old § 101.60(c)(4) in the first

sentence of redesignated paragraph

(c)(6) to reflect that old paragraph (c)(4)

had been redesignated as paragraph

(c)(5). In this document, the agency is

correcting that oversight.

3. In the Federal Register of January

6, 1993 (58 FR 2665), FDA published a

final rule entitled ‘‘Food Labeling:

Health Claims; Calcium and

Osteoporosis.’’ This rule, among other

things established the requirements that

must be met for a food to bear a health

claim regarding the relationship

between calcium and osteoporosis. One

of these requirements,

§ 101.72(c)(2)(ii)(A), specifies that the

food shall meet or exceed the

requirements for a ‘‘high’’ level of

calcium. However, in

§ 101.72(c)(2)(ii)(A) when referencing

the section in which the term ‘‘high’’ is

defined in § 101.54, the agency

inadvertently referred to paragraph (c),

which defines the term ‘‘good source,’’

instead of paragraph (b), which defines

the term ‘‘high.’’ FDA is correcting this

inadvertent error.

4. In the Federal Register of January

6, 1993 (58 FR 2302), FDA published a

final rule entitled ‘‘Food Labeling:

Nutrient Content Claims, General

Principles, Definition of Terms;

Definitions of Nutrient Content Claims

for the Fat, Fatty Acid, and Cholesterol

Content of Food.’’ This final rule, among

other things, revoked § 101.25 (58 FR

2302 at 2413). In the Federal Register of

June 3, 1996 (61 FR 27771), FDA

published a final rule entitled

‘‘Revocation of Certain Regulations

Affecting Food.’’ This final rule, among

other things, revoked §§ 105.67 and

105.69 (21 CFR 105.67 and 105.69) (61

FR 27771 at 27779). However, in issuing

these two final rules, the agency

inadvertently neglected to remove the

cross references to these three sections

in § 101.108(a) and (b). In this

document, FDA is modifying

§ 101.108(a) and (b) to correct this

inadvertent omission.

5. In the Federal Register of July 2,

1991 (56 FR 30452), FDA published a

notice of proposed rulemaking entitled

‘‘Food Labeling; Declaration of

Ingredients, Common or Usual Name for

Nonstandardized Foods; Diluted Juice

Beverages.’’ In that proposed rule, FDA

proposed to, among other things,

establish common or usual name

requirements for beverages that contain

less than 100 percent and more than 0

percent fruit or vegetable juice. In

response to comments to the proposal,

in the final rule, FDA acknowledged

that the difference in phrasing that

appeared in § 102.33(b) and (c) in the

notice of proposed rulemaking of July 2,

1991; i.e., ‘‘diluted, multiple-juice’’

versus ‘‘multiple-juice beverage’’ was

inadvertent, and that both should say

‘‘diluted, multiple-juice beverage’’ (58

FR 2897 at 2918, January 6, 1993).

However, the agency inadvertently

neglected to make the change in

§ 102.33(c). Additionally, in that

proceeding, in response to a comment,

in the final rule FDA included a new

paragraph (d) in § 102.33 that contained

the phrasing ‘‘multiple-juice beverage’’

instead of the preferred phrasing

‘‘diluted, multiple-juice beverage.’’ FDA

is correcting these inadvertent errors.

Publication of this document

constitutes final action on these changes

under the Administrative Procedure Act

(5 U.S.C. 553). Notice and public

procedure are unnecessary because FDA

is merely correcting nonsubstantive

errors.

List of Subjects

21 CFR Part 101

Food labeling, Nutrition, Reporting

and recordkeeping requirements.

21 CFR Part 102

Beverages, Food grades and standards,

Food labeling, Frozen foods, Oils and

Fats, Onions, Potatoes, Seafood.

PART 101—FOOD LABELING

1. The authority citation for 21 CFR

part 101 is revised 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).

§ 101.9 [Amended]

2. Section 101.9 Nutrition labeling of

food is amended in paragraph (j)(4) by

removing the first word in the fourth

sentence, ‘‘Foods’’, and adding in its

place ‘‘Examples of foods’’.

§ 101.60 [Amended]

3. Section 101.60 Nutrient content

claims for the calorie content of foods is

amended in paragraph (c)(6) by

removing the phrase ‘‘in paragraph

(c)(4)’’ and adding in its place ‘‘in

paragraph (c)(5)’’.

§ 101.72 [Amended]

4. Section 101.72 Health claims:

calcium and osteoporosis is amended in

paragraph (c)(2)(ii)(A) by removing the

citation ‘‘§ 101.54(c)’’ and adding in its

place ‘‘§ 101.54(b)’’.

§ 101.108 [Amended]

5. Section 101.108 Temporary

exemptions for purposes of conducting

authorized food labeling experiments is

amended in paragraph (a) by removing

the phrase ‘‘§§ 101.9 and 101.25 and
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