[Federal Register Volume 62, Number 61 (Monday, March 31, 1997)]
[Rules and Regulations]
[Pages 15343-15344]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7972]


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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.

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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 
(Sec. 101.81 (21 CFR 101.81)). Since then, questions have been raised 
regarding the meaning of the regulation. Therefore, FDA is amending 
Sec. 101.81 to correct and clarify the regulation.

II. Nature of the Claim (Sec. 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 Sec. 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 Sec. 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 
Sec. 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 
Sec. 101.81(c)(2)(i)(C) to make clear that the food source of the beta 
()-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 
Sec. 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 
(Sec. 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 -glucan soluble 
fiber: Oat bran (Sec. 101.81(c)(2)(ii)(A)(1)), rolled oats or oatmeal 
(Sec. 101.81(c)(2)(ii)(A)(2)), and whole oat flour 
(Sec. 101.81(c)(2)(ii)(A)(3)).
    Questions have been raised regarding whether an extract of whole 
oat -glucan soluble fiber, such as an extract of -
glucan from oat bran, could be used to fortify a product and thus 
qualify for the health claim.
    FDA intended to make clear in Sec. 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 -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 -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 -
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 
Sec. 101.81(c)(2)(iii)(A) define the nature of the whole oat foods that 
are eligible sources of -glucan soluble fiber, and not to 
suggest that -glucan 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 Sec. 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 Sec. 101.81(c)(2)(ii), and the

[[Page 15344]]

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 (Sec. 101.81(e))

    In light of the revision to Sec. 101.81(c)(2)(i)(C) in section II 
of this document, the agency is making minor changes to the model 
claims in Sec. 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 Sec. 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 
Sec. 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 
Sec. 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:


Sec.  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