[Federal Register Volume 62, Number 15 (Thursday, January 23, 1997)]
[Rules and Regulations]
[Pages 3584-3601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-1598]



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Part III





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



_______________________________________________________________________



21 CFR Part 101



Food Labeling: Health Claims; Oats and Coronary Heart Disease; Final 
Rule

  Federal Register / Vol. 62, No. 15, Thursday, January 23, 1997 / 
Rules and Regulations  

[[Page 3584]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 95P-0197]
RIN 0910-AA19


Food Labeling: Health Claims; Oats and Coronary Heart Disease

AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its 
decision to authorize the use, on food labels and in food labeling, of 
health claims on the association between soluble fiber from whole oats 
and a reduced risk of coronary heart disease (CHD). Based on its review 
of evidence submitted with comments to the proposal, as well as of the 
evidence described in the proposal, the agency has concluded that the 
type of soluble fiber found in whole oats, i.e., beta ()-
glucan soluble fiber, is primarily responsible for the association 
between consumption of whole oats, including oat bran, rolled oats, and 
whole oat flour, and an observed lowering of blood cholesterol levels. 
The agency has concluded that, based on the totality of the scientific 
evidence, there is significant scientific agreement among qualified 
experts to support the relationship between soluble fiber in whole oats 
and CHD. Therefore, FDA has decided to make the subject of the health 
claim ``soluble fiber from whole oats'' and has concluded that claims 
on foods relating the onsumption of soluble fiber from whole oats to 
reduced risk of heart disease are justified. FDA is announcing this 
action in response to a petition filed by the Quaker Oats Company (the 
petitioner).

DATES: The regulation is effective January 23, 1997. The Director of 
the Office of the Federal Register approves the incorporation by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of a 
certain publication in 21 CFR 101.81(c)(2)(ii)(A), effective January 
23, 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, 202-205-5916.

SUPPLEMENTARY INFORMATION

I. Background

    In the Federal Register of January 4, 1996 (61 FR 296), the agency 
proposed to authorize the use, on food labels and in food labeling, of 
health claims on the association between oat bran and oatmeal and 
reduced risk of CHD. The proposed rule was issued in response to a 
petition filed under section 403(r)(3)(B)(i) of the Federal Food, Drug, 
and Cosmetic Act (the act) (21 U.S.C. 343(r)(3)(B)(i)). Section 
403(r)(3)(B)(i) of the act states that the Secretary of Health and 
Human Services (and, by delegation, FDA) shall promulgate regulations 
authorizing health claims only if he or she determines, based on the 
totality of publicly available scientific evidence (including evidence 
from well-designed studies conducted in a manner which is consistent 
with generally recognized scientific procedures and principles), that 
there is significant scientific agreement, among experts qualified by 
scientific training and experience to evaluate such claims, that the 
claim is supported by such evidence (see also Sec. 101.14(c)).
    FDA considered the relevant scientific studies and data presented 
in the petition as part of its review of the scientific literature on 
oat bran and oatmeal, i.e., rolled oats, and heart disease. The agency 
summarized this evidence in the proposed rule (61 FR 296).
    The proposed rule included qualifying and disqualifying criteria 
for the purpose of identifying foods eligible to bear the proposed 
health claim. The proposed qualifying criteria were that a food provide 
13 grams (g) of oat bran or 20 g of oatmeal, and that the oat bran and 
oatmeal contain, without fortification, at least 1 g of -
glucan soluble fiber. The proposal also specified mandatory content and 
label information for health claim statements and provided model health 
claims.
    As part of the requirements for the claim, the agency proposed to 
allow a shortened version of the claim describing the relationship 
between diets high in oat bran and oatmeal and risk of heart disease 
that included a referral statement to the location of the full claim. 
The proposed version of the full claim described the relationship 
between diets low in saturated fat and cholesterol and high in oat bran 
and oatmeal and heart disease. FDA requested data on whether permitting 
a shortened claim will affect whether consumers will also read the full 
claim.
    The agency also proposed to make the phrase ``depends on many 
factors'' optional information. The agency agreed with the petitioner's 
arguments that, based on an ever increasing background of health 
information made available through various media, consumers already 
understand that foods are not drugs, and that health enhancement 
depends not only on consumption of a particular food but also on other 
dietary practices, exercise, heredity, lifestyle, and a host of other 
factors. The agency also agreed with the petitioner that the 
requirement that the claim use the term ``may'' or ``might'' to relate 
the ability of oat bran or oatmeal to reduce the risk of heart disease 
is intended to reflect the multifactorial nature of the disease. The 
agency requested written comments on the proposed rule, including 
comments on the agency's tentative decision to make the phrase 
``depends on many factors'' optional information.

II. Summary of Comments and the Agency's Responses

    In response to the proposal, the agency received approximately 
1,450 letters, each containing one or more comments, from consumers, 
professional organizations, government agencies, industry, trade 
associations, and health care professionals.
    The majority of the comments that the agency received agreed with 
one or more provisions of the proposed rule without providing grounds 
for this support other than those provided by FDA in the preamble to 
the proposal. Many of these comments also requested modification of one 
or more provisions of the proposed rule. A few comments disagreed with 
the proposed rule and provided specific support for their positions. 
The agency has summarized and addressed the relevant issues raised in 
all comments in the sections of this document that follow.

A. Food Substance Associated with Reduced Risk of CHD

    Health claims have two essential elements: a food substance and a 
disease or health-related condition (Sec. 101.14). The agency proposed 
to authorize a health claim that diets high in oat bran and oatmeal and 
low in saturated fat and cholesterol may reduce the risk of CHD. 
Further, in the proposal, the agency tentatively agreed with the 
petitioner's position that, while current research may not demonstrate 
that -glucan soluble fiber is the only component of oats that 
affects blood total- and low density lipoprotein (LDL)-cholesterol 
levels, potentially reducing the risk of CHD, -glucan soluble 
fiber can serve as a marker for the food substance that is the subject 
of the claim. Therefore, FDA tentatively concluded that the 
relationship is based on a daily intake of not less than 40 g oat bran 
or 60 g oatmeal, without fortification, that provide 3 g or more per 
day -glucan soluble fiber. The disease element of the claim is 
CHD, as

[[Page 3585]]

assessed by changes in serum total- and LDL-cholesterol levels in 
response to the consumption of specified levels of oatmeal or oat bran. 
A number of comments dealt with what should be the appropriate 
description of the food substance that is part of the health claim 
relationship.
1. Terminology
(Comment 1)
    Some comments stated that the proposed claim seemed to be limited 
to hot cereals because the agency used the term ``oatmeal'' to describe 
one of the qualifying foods. A few comments suggested that the agency 
inappropriately used the term ``oatmeal'' for the more technically 
correct term ``rolled oats,'' the dry form of the food before cooking 
or processing.
    The agency did not intend to limit the proposed claim to hot 
cereals. As suggested by the comments, the agency was using the term 
``oatmeal'' to be synonymous with the term ``rolled oats,'' i.e., the 
dry oat product.
    Likewise, the agency did not intend that use of the terms 
``oatmeal'' and ``oat bran'' would mean that only hot, cooked cereals 
could bear the claim. The proposed claim was intended to describe the 
relationship between oat bran and rolled oats which can be used as 
single ingredients, such as in hot or ready-to-eat cereals, or as 
components of other foods that are served either hot or cold. Under the 
proposal, any oat product meeting the eligibility requirements for the 
claim could bear the claim. Because the term ``rolled oats'' is the 
technical term more commonly used to describe the dry form of the food, 
the agency has replaced the term ``oatmeal'' with ``rolled oats'' 
throughout this final rule.
2. Component of Oat Bran and Rolled Oats Responsible for the Effect
(Comment 2)
    Some comments stated that the proposed claim inappropriately 
focused on oat bran and rolled oats as providing an effect on CHD risk. 
These comments suggested that it was the type of soluble fiber in oat 
products, specifically -glucan, that was the primary component 
responsible for the relationship between the oat products and CHD. FDA 
had noted in its proposal that -glucan soluble fiber was 
closely associated with the observed effect, but at the time, the 
agency tentatively concluded that -glucan soluble fiber served 
as a marker for the food with potential to reduce the risk of CHD. 
Comments offered support for the view that -glucan soluble 
fiber is more than just a marker in whole oats by referencing studies 
that demonstrated effects of -glucan independent of the food. 
These comments cited references in FDA's proposed rule (Refs. 12, 15, 
33, 35, 38) and also provided additional references (Refs. 60 through 
74) in support of their argument. According to these comments, this 
evidence suggests that -glucan soluble fiber can provide an 
independent and meaningful effect and, in turn, supports that 
-glucan is the primary component in whole oat products 
responsible for that effect on CHD risk factors. A few comments also 
noted that studies suggest a dose-response relationship between 
-glucan soluble fiber and the effect on blood total- and LDL-
cholesterol levels because the degree of effect is linearly related to 
the amount of -glucan consumed (Ref. 66). Conversely, some 
comments supported the agency's proposed treatment of -glucan 
soluble fiber as a marker for identifying a useful food product rather 
than as the active component.
    In addition, several comments cited references to demonstrate that 
processing of oat products in ways that alter the physical structure of 
the -glucan soluble fiber component (e.g., alter molecular 
structure and hence viscosity) results in a loss of effect on blood 
total- and LDL-cholesterol levels (Refs. 63 through 64). Several 
comments also noted that FDA's proposal cited the Torrenen et al. study 
(Ref. 38), showing that a special processing technique, when used with 
oat bran concentrate, appeared to reduce its effect on serum lipid 
levels. These comments cited the loss of effect with changes in the 
physical structure of -glucan soluble fiber as evidence that 
there is a direct effect attributable to the presence of -
glucan soluble fiber, and that this effect is dependent not only on the 
chemical characteristics of the -glucan soluble fiber but also 
on the retention of important physical characteristics such as 
viscosity.
    Moreover, several comments cited references to show that it is the 
presence of a highly viscous soluble fiber in the intestinal tract that 
is determinative of the desired effect on CHD risk factors, and that, 
holding all other factors constant, changes in viscosity of intestinal 
contents alone result in significant effects on blood total- and LDL-
cholesterol levels (Refs. 72 through 74). These comments, which were 
submitted by fiber experts, suggested that the ability of -
glucan soluble fiber to produce viscosity in the intestinal contents, 
while not the only mechanism by which soluble fibers have an effect on 
CHD risk, can be a clinically meaningful and independent factor 
affecting CHD risk. Other comments cited studies that showed that oat 
-glucan soluble fiber has viscous properties that are 
responsible for physiological effects on the glycemic response (i.e., 
changes in blood sugar levels following ingestion of foods) and 
suggested that the same viscous properties may also play a role in 
affecting blood total cholesterol levels (Refs. 60 and 69).
    On the other hand, some comments stated that, while -
glucan soluble fiber is an important factor, other components in the 
oat products, including certain chemical characteristics and the 
tocotrienols that are part of the lipid fraction of whole oats, also 
contribute to the association with CHD risk reduction. Thus, according 
to these comments, specifying requirements for only -glucan 
soluble fiber in the proposed regulation is not appropriate.
    The agency has carefully reviewed the comments and evidence 
submitted on the issue of the significance of the -glucan in 
the oat products and is persuaded that -glucan soluble fiber 
is the primary, but not the only, component in whole oats that affects 
serum lipids. -glucan thus plays a significant role in the 
relationship between whole grain oats and the risk of CHD. The agency 
reached this conclusion based on evidence that there is a dose response 
between the level of -glucan soluble fiber from whole oats and 
the level of reduction in blood total- and LDL-cholesterol (Refs. 15 
and 33), and that intakes of -glucan soluble fiber at or above 
3 g per day were more effective in lowering serum lipids than lower 
intake levels. These results are consistent with the results of the 
individual human studies reviewed in the proposal.
    FDA, therefore, concludes that it is appropriate to change the food 
substance that is the subject of this authorization for claims from oat 
bran and rolled oats to -glucan soluble fiber from whole oats.
3. Eligibility of Whole Oat Flour
(Comment 3)
    A number of comments suggested that products containing whole oat 
flour made from 100 percent oat groats should be eligible to bear the 
health claim. The reasons given, some supported by data, included: (a) 
Evidence suggests that -glucan soluble fiber is the primary 
contributor to the observed effect of oat bran and rolled oats, and 
whole oat flour contains -glucan; (b) whole oat flour is 
derived from the same starting material as rolled oats (i.e., whole oat 
groats) and, other

[[Page 3586]]

than the smaller particle size of whole oat flour, possesses a chemical 
and physical composition virtually identical to rolled oats (Ref. 57); 
(c) animal studies demonstrate that, like the -glucan soluble 
fiber from oat bran and rolled oats, whole oat flour -glucan 
soluble fiber retains important physical characteristics during 
digestion (Ref. 68); and (d) data from a human study (Ref. 70) and 
several animal studies (Refs. 57, 66, and 71) show a positive effect of 
ready-to-eat cereals made with whole oat flour on risk factors for CHD. 
One comment submitted a recent, unpublished human clinical trial in 
which a ready-to-eat cereal made from whole oat flour was used as the 
test product (Ref. 70). Results showed that consumption of the cereal 
had a significant effect on blood total- and LDL-cholesterol levels as 
compared to the placebo cereal.
    In considering the comments concerning the inclusion of whole oat 
flour in this rulemaking, the agency has reviewed the evidence 
referenced in these comments, including the additional data submitted. 
The agency noted the similarity of whole oat flour to rolled oats in 
terms of chemical and physical properties and type of processing. After 
careful consideration of the scientific evidence and the nature of the 
proposed health claim, FDA has concluded that products made with whole 
oat flour from 100 percent oat groats should be eligible to bear a 
claim.
    FDA originally proposed the health claim that is the subject of 
this rulemaking for oat bran and oatmeal (i.e, rolled oats) because 
this was the claim requested in the petition that began this 
proceeding, and because the submitted evidence supported the 
relationship between the consumption of these foods and a reduced risk 
of CHD. However, the agency did not conclude in its proposal that the 
effect was uniquely that of oat bran and rolled oats, but rather that 
the evidence submitted by the petitioner supported the relationship for 
these foods. The comments argued, and pointed to evidence in the record 
as well as to evidence that they submitted that supported their claim, 
that whole oat flour has a similar composition, and had similar effects 
on blood cholesterol levels, as oat bran and rolled oats. They argued 
that, given these facts, it was the logical outgrowth of the proposal 
to enlarge the substances that could be the subject of a claim as part 
of this final rule to include whole oat flour.
    FDA notes that one study submitted with a comment examined the 
effect of whole oat flour-based cereal on serum lipids in mildly 
hypercholesterolemic subjects. Forty-three patients, aged 27 to 68 
years, with mild to moderate hypercholesterolemia participated in this 
placebo-controlled study. The study consisted of three parts: a 4-week 
run-in on a Step 1 diet (i.e., a diet with less than 30 percent 
calories from fat, less than 10 percent calories from saturated fat, 
and less than 300 mg cholesterol), a 2-week baseline, and a 4-week 
treatment period. During the treatment period, subjects in the oat 
group continued to adhere to the Step I diet and consumed one 
prepackaged portion (1.5 oz.) of cereal twice a day, resulting in an 
estimated total daily intake of 3 g -glucan from whole oat 
flour. Body weights were maintained at a constant level throughout the 
treatment period. Although there were differences in total-, high 
density lipoprotein (HDL)-, and LDL-cholesterol levels between the 
groups at baseline, the authors used an analysis of covariance to 
adjust data to a common baseline.
    The results of the study showed that subjects consuming the whole 
grain oat cereal experienced a significant decrease in total 
cholesterol (4.4 percent or 10.0 milligrams (mg)/deciliter (dL)) and 
LDL-cholesterol (4.9 percent or 7.8 mg/dL), and no significant 
difference in HDL-cholesterol, compared to the placebo group. These 
results are consistent with the findings for oat bran and rolled oats, 
i.e., positive effects on blood total- and LDL-cholesterol levels in 
mildly hypercholesterolemic subjects adhering to a diet low in 
saturated fat and cholesterol. Therefore, this study, along with 
evidence submitted by comments showing compositional similarities 
between whole oat flour and rolled oats, provides sufficient evidence 
for the agency to conclude that whole oat flour has the same effects 
relative to reduced risk of CHD as do oat bran and rolled oats. 
Further, there is evidence that corroborates this conclusion that is 
provided by animal studies (Ref. 68). These animal studies addressed 
the issue of retention of viscosity characteristics during processing 
and digestion. Because viscosity of intestinal contents is known to be 
a critical factor in determining the ability of soluble fibers to 
reduce the risk of CHD (Refs. 56, 72, and 73), and because viscosity is 
known to be affected by food processing procedures or, following 
ingestion, by the digestive system in ways that are unpredictable 
(Refs. 56 and 65), evidence to demonstrate that the -glucan 
soluble fiber from whole oat flour retains the same level of viscosity 
in the digestive tract as does that from rolled oats is crucial to the 
question of whether whole oat flour can provide the same benefits as 
rolled oats.
    The animal studies cited by one comment (Ref. 68) demonstrate that 
there is bioequivalence relative to these important physical 
characteristics between whole oat flour and rolled oats. When taken 
together, the available evidence provides a basis for concluding that 
it is appropriate to make whole oat flour, as well as oat bran and 
rolled oats, the subject of the authorized substance-disease 
relationship.
    Therefore, for the purposes of Sec. 101.81, the term ``whole oats'' 
includes oat bran, rolled oats, and whole oat flour. Changes to the 
codified sections of this rule to reflect the inclusion of whole oat 
flour are discussed in section II.B. of this document.
    While FDA has added whole oat flour as a subject of the health 
claim in this proceeding, it must caution that it has done so here only 
because of the close relationship of whole oat flour to the substances 
that were the subject of the proposal and the very narrow increment of 
evidence necessary to broaden the claim to include this substance. 
Given the very tight timeframes that are established by the statute, 
and the agency's interest in ensuring that scientifically valid claims 
are authorized as quickly as possible, the agency cautions that it will 
not frequently be in a position to authorize claims about additional 
substances during the comment period. Thus, interested people would be 
well advised, if they are aware of a substance that should be the 
subject of a health claim, to petition for authorization for a claim 
about the substance rather than relying on the comment process to 
achieve that end.
4. -glucan Soluble Fiber From Other Sources
(Comment 4)
    Some comments, in noting the evidence to suggest that -
glucan soluble fiber is the component in oat bran and rolled oats 
responsible for their effect, further noted that the evidence suggests 
that -glucan soluble fiber from other sources, such as barley 
and oat gums, affects the risk of CHD in the same way as -
glucan from the oat bran and rolled oats (Refs. 61 through 65, and 67). 
These comments requested that the proposed health claim be extended to 
any food product containing a specified level of -glucan 
soluble fiber from any source including processed or novel sources of 
-glucan soluble fiber.

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    Several comments suggested that one type of evidence to demonstrate 
that -glucan soluble fiber from other food sources can affect 
the risk of CHD is the studies showing similar effects on blood total- 
and LDL-cholesterol levels among different -glucan containing 
foods, including barley and oats (Refs. 61 through 65, and 67). Another 
comment cited a study showing that variability in effects on serum 
cholesterol levels among different barley cultivars is associated with 
differences in amounts of -glucan soluble fiber (Ref. 64).
    While acknowledging that there is evidence suggesting that 
consumption of -glucan soluble fiber from a variety of food 
sources may help to lower blood total- and LDL-cholesterol levels, and 
thus reduce the risk of CHD, the agency disagrees that the claim should 
be extended at this time to all foods that contain a specified amount 
of -glucan soluble from any source. The agency's decision to 
limit eligibility to bear a claim to oat bran, rolled oats, and whole 
oat flour is based on several considerations.
    First, the proposed subject of this rulemaking was oatmeal and oat 
bran and their effect on the risk of CHD. FDA has examined in detail 
only the evidence for these oat products and whole oat flour. Other 
food sources of -glucan soluble fiber (oat and non-oat 
sources) have not been carefully reviewed by FDA, 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.
    Nonetheless, the agency recognizes that it is likely that 
consumption of other sources of -glucan soluble fiber in 
addition to those that are the subject of this rulemaking will affect 
blood cholesterol levels. For this reason, and for reasons described 
elsewhere in this document in response to related comments about other 
soluble fibers, FDA is adopting a final rule that is structured so that 
it can be amended to establish a framework that will accommodate claims 
for other sources and types of soluble fibers and the risk of CHD.
    Second, there currently are no generally accepted or validated 
criteria for predicting which sources or processed forms of -
glucan soluble fiber, beyond oat bran, rolled oats, and whole oat 
flour, are capable of reducing blood total- and LDL-cholesterol levels. 
FDA, therefore, lacks criteria for differentiating among those sources 
that provide such effects and those that do not. This lack of evidence 
is of concern to the agency because, as discussed previously, certain 
types of processing may decrease the ability of the fiber to have the 
desired effect for reasons that are unpredictable and that vary from 
source to source. At the same time, it is known that certain physical 
characteristics related to the fiber's ability to maintain the 
viscosity of the intestinal contents must be present. However, the 
extent to which this capacity can be influenced by different food 
sources or by processing is unclear. Validated and accepted in vitro or 
animal methods for identifying this characteristic are not part of the 
administrative record for this rulemaking.
    Human clinical trials can be used to resolve these issues. However, 
in the absence of clinical or other appropriate types of data in the 
administrative record, assumptions about the bioequivalence of all 
sources of -glucan soluble fiber cannot be made at this time.
    In authorizing the claim for whole oat flour as a result of 
comments to the proposal, FDA is relying on in vivo (animal) studies as 
evidence of the bioequivalence of whole oat flour relative to rolled 
oats. The agency feels comfortable in doing so because there is a human 
study to demonstrate the effectiveness of whole oat flour in reducing 
the risk of CHD, as well as information on the similarity in 
composition of whole oat flour to rolled oats. It is unclear to what 
extent such in vivo data from animal studies can be relied upon in the 
absence of corroborating human data. FDA will make decisions on this 
issue based on the totality of the available evidence. Thus, future 
petitions for other sources of -glucan soluble fiber to be 
added as subjects of a health claim, which the agency anticipates 
receiving, should specifically address the appropriateness, the 
protocol used to develop, and the interpretation of, in vivo data from 
animal studies in demonstrating bioequivalence among soluble fibers.
5. Claims for Other Soluble Fibers
(Comment 5)
    Some comments stated that by proposing the oat bran and rolled oats 
health claim, the agency has acknowledged that soluble fibers 
themselves are an important functional component that affect serum 
lipid levels and thereby reduce the risk of CHD. These comments 
suggested that other soluble fibers have been shown to have the same 
effects as that of -glucan soluble fiber from whole oats on 
the risk of CHD. One comment discussed the evidence for psyllium and 
its capacity to affect serum lipid levels and thereby reduce the risk 
of CHD. These comments stated that, because other soluble fibers and 
purified gums can demonstrate cholesterol-lowering effects, the agency 
should authorize a broad claim for soluble fibers and reduced risk of 
CHD.
    Several comments suggested that consumers would benefit from a 
soluble fiber and CHD claim in that it would be consistent with dietary 
recommendations to consume diets high in fiber and low in fat. However, 
some of the comments noted that differences in the source and method of 
processing whole oat -glucan result in varied and 
unpredictable effects on the physical characteristics of the fiber, and 
that these differences may apply to other types of soluble fibers as 
well. The comments stated that, therefore, a claim for soluble fiber 
and heart disease should only be extended to those soluble fibers that 
have been demonstrated to reduce the risk factors related to CHD.
    Another comment noted that, from a regulatory standpoint, a single 
claim on the relationship between certain soluble fibers and heart 
disease would be more manageable for the agency than would be 
attempting to authorize individual health claims for all the different 
soluble fiber sources that might be eligible to bear a CHD claim. The 
comment explained that, as other soluble fibers are shown to qualify to 
bear a soluble fiber/CHD claim, the regulation could be amended to 
include the additional substance.
    FDA agrees with the comments that stated that there is evidence to 
suggest that consumption of a number of soluble fibers, in addition to 
-glucan, affect blood total- and LDL-cholesterol levels and 
thus affect the risk of CHD. The agency reviewed evidence to this 
effect in evaluating the relationship between total dietary fiber and 
CHD in the final regulation published in the January 6, 1993 Federal 
Register (58 FR 2552). The agency noted, however, that there was some 
evidence that soluble fiber from different foods has different effects, 
and that the analytical measure of soluble fiber may not be adequately 
predictive of its physiological effects (58 FR 2552 at 2562). 
Therefore, FDA encouraged manufacturers to petition for a claim for 
their soluble fiber product if there was evidence to demonstrate that 
the particular soluble fiber-containing product is effective in 
lowering serum lipid levels (58 FR 2552 at 2562).

[[Page 3588]]

    Further, FDA agrees that its decision to authorize claims on the 
association between oat bran, rolled oats, and whole oat flour and CHD 
represents acceptance that one type of soluble fiber, i.e., -
glucan soluble fiber from whole oats, has been adequately shown 
scientifically to have this effect. However, while the agency agrees 
with the comments that there is considerable likelihood that a similar 
showing will be made for certain other soluble fibers, based on the 
record now before the agency, it cannot take the steps suggested by the 
comments and broaden this claim. As the agency explained in the 1993 
dietary fiber final rule, the effect of individual soluble fibers needs 
to be documented on a case-by-case basis. A concern about the ability 
of particular soluble fibers to affect CHD risk was expressed in 
several comments to the oat bran and oatmeal proposal. As mentioned 
previously, those comments stated that only soluble fibers that have 
been demonstrated to reduce serum lipids should qualify to bear a 
claim. The agency notes that a petition for soluble fiber from psyllium 
and risk of CHD is currently under consideration by the agency.
    As mentioned previously, in the 1993 dietary fiber final rule, the 
agency encouraged manufacturers to petition for a health claim if the 
manufacturer could present scientific evidence to support the 
relationship between its soluble fiber product and risk of CHD (58 FR 
2552 at 2567). By encouraging manufacturers to petition for a more 
specific health claim, the agency implied that it would consider a new 
claim for those soluble fiber products that had been shown to affect 
the risk of CHD. However, the agency did not commit to any particular 
course for how it would authorize health claims about a specific fiber 
source should it find them to be justified.
    One way of doing so would be a regulation about each particular 
ingredient source of soluble fiber. This model is essentially the one 
that the agency utilized in the proposal. An alternative approach would 
be to adopt an umbrella regulation authorizing a claim for diets 
containing soluble fiber from certain foods and CHD but authorize the 
use of the claim for specific food sources of soluble fiber only when 
consumption of those foods has been demonstrated to help reduce the 
risk of heart disease. FDA agrees with comments that this alternative 
mechanism would provide flexibility, and that this flexibility may 
ultimately provide efficiency. However, based on the fact that it was 
not the agency's charge, in responding to this petition to review the 
totality of evidence from other, non-oat sources of -glucan 
soluble fiber or other types of soluble fiber, the agency finds that it 
is premature to authorize a broader claim for ``soluble fiber from 
certain foods.''
    The agency may, at some point, decide to amend Sec. 101.81 to cover 
types of soluble fiber other than -glucan from whole oats. If 
a manufacturer can document, through appropriate studies, that a 
soluble fiber product has an effect on blood total- and LDL-cholesterol 
levels, and thereby the product can be useful in reducing the risk of 
CHD, the manufacturer may petition to amend Sec. 101.81 to include that 
type of soluble fiber-containing product among the substances about 
which claims are authorized. This case-by-case approach is necessary 
because, as discussed in the oat bran and oatmeal proposal, soluble 
fiber is a family of very heterogeneous substances that vary greatly in 
their effect on the risk of CHD (61 FR 296).
    In summary, in its proposal, the agency was responding to a 
specific petition to authorize claims about the relationship between 
oat bran and rolled oats and the reduced risk of CHD. In response to 
comments, however, FDA is now authorizing claims that describe the 
relationship between consumption of only a specific type of soluble 
fiber, -glucan from whole oats, and reduced risk of CHD.
    As suggested by comments, on-going research efforts are likely to 
build support for the relationship between CHD and consumption of other 
soluble fibers not addressed in this rulemaking. While the narrow focus 
of this rulemaking, and limitations on agency time and resources, 
preclude review of all such soluble fibers as part of this rulemaking, 
FDA will consider amending Sec. 101.81 to establish a framework that 
will allow the agency to readily add the list of soluble fibers that 
can be the subject of a claim, as the evidence warrants.
    Therefore, in this final rule, FDA has revised the title of 
Sec. 101.81 to read: ``Health claims; soluble fiber from whole oats and 
coronary heart disease.'' For this health claim, the statement 
``soluble fiber from whole oats'' is intended to mean -glucan 
soluble fiber from whole oats. Based on information provided in the 
petition and in some comments, the soluble fiber content of whole oats 
is predominantly (approximately 87 percent or more) -glucan 
(Ref. 1, p. 22). Thus, the total soluble fiber content of whole oats 
significantly reflects the -glucan present. Moreover, the term 
``soluble fiber'' is more familiar to consumers than `` -
glucan'' because soluble fiber can be used on the nutrition label under 
Sec. 101.9(c)(6)(i)(A). -glucan is a technical term that 
presumably is not widely understood.
    Further, the agency has modified the regulation to reflect its 
decision to describe specifically the food substance that is the focus 
of the claim and to list the sources of -glucan soluble fiber 
that have been shown to affect the risk of CHD. Thus, the agency has 
replaced the discussion in proposed section (c)(2)(ii) on the 
presentation of the claim with a new discussion, ``Nature of the 
substance: Eligible sources of soluble fiber.'' This provision 
describes those sources of -glucan soluble fiber that qualify 
for this claim. This section will be discussed in detail in section 
II.B., of this document.
    Given the change in focus from oat bran and rolled oats to soluble 
fiber from whole oats, the agency is revising several sections of the 
proposed regulation. First, the words ``diets high in oatmeal and oat 
bran'' has been deleted from Sec. 101.81(c)(2)(i) and reference to 
soluble fiber from whole oats is being added, so that 
Sec. 101.81(c)(2)(i) will read, relevant part, ``diets low in saturated 
fat and cholesterol that include soluble fiber from whole oats.'' The 
agency notes that the statement ``diets low in saturated fat and 
cholesterol and high in soluble fiber from * * *'' cannot be used at 
this time because the term ``high'' and its synonyms have been defined 
under Sec. 101.54(b) as meaning that the food contains 20 percent or 
more of the Daily Reference Value (DRV) per reference amount 
customarily consumed (RACC) for a particular substance. There is no DRV 
for soluble fiber. While the agency recognizes that it would be helpful 
to encourage consumption of a specific amount of soluble fiber from 
whole oats, it cannot do so in the absence of a DRV for this nutrient. 
Therefore, the agency is wording Sec. 101.81(c)(2)(i) to state that the 
diet ``include'' soluble fiber from whole oats, until such time that a 
DRV for soluble fiber is established. The agency intends to propose to 
establish a DRV for soluble fiber, and, once that rulemaking is 
completed, assuming it results in a DRV, it plans to revisit the 
requirements in Sec. 101.81 and propose appropriate changes in the 
requirements for the wording of the claim. Other sections of the 
regulation that are affected by these changes include Sec. 101.81(a), 
(b), and (c)(2)(i)(D). Additionally, FDA has deleted the phrase ``oat 
bran and oatmeal'' in paragraphs (c)(2)(i)(A), (c)(2)(i)(E), (d)(2), 
(d)(3), and (e) and replaced it with the statement ``diets low in

[[Page 3589]]

saturated fat and cholesterol that include soluble fiber from whole 
oats.''
    Other changes to the proposed regulation, in order of appearance, 
include the following: the second sentence of proposed 
Sec. 101.81(a)(2) states ``* * * These populations also tend to have 
dietary patterns that are not only low in total fat, especially 
saturated fat and cholesterol, but are also relatively high in fiber-
containing fruits, vegetables, and grain products, such as oatmeal and 
oat bran.'' The agency is revising the last part of that sentence to 
read ``* * * but are also relatively high in fiber-containing fruits, 
vegetables, and grain products, such as whole oat products.''
    Proposed Sec. 101.81(a)(3) described oat bran and rolled oats as 
good sources of soluble fiber and stated that scientific evidence 
demonstrates that these products are associated with reduced blood 
total- and LDL-cholesterol levels. In light of the changes in this 
final rule intended to focus on the relationship between soluble fiber 
from whole oats and CHD, FDA has deleted the first sentence in proposed 
Sec. 101.81(a)(3) and revised the second sentence to state, 
``Scientific evidence demonstrates that diets low in saturated fat and 
cholesterol may reduce the risk of CHD. Other evidence demonstrates 
that the addition of soluble fiber from whole oats to a diet that is 
low in saturated fat and cholesterol may also help to reduce the risk 
of CHD.'' Again, the agency notes that it realizes that information 
about the amount of soluble fiber from whole oats to consume would be 
helpful information for consumers, but until a DRV is established, such 
information cannot be provided. The agency has concluded that the 
statements in paragraph (a)(3) accurately represent the relationship 
between diets low in saturated fat and cholesterol and CHD and between 
soluble fiber from whole oats and CHD.
    Proposed Sec. 101.81(c)(2)(i)(C) described what the claim could 
state in terms of a diet high in oat bran and oatmeal (paragraph 
(c)(2)(i)(C)(1)), and that the effect of a dietary intake of oat bran 
and oatmeal on risk of CHD was particularly evident when consumed as 
part of a diet low in saturated fat and cholesterol (paragraph 
(c)(2)(i)(C)(2)). In light of the change to a claim for soluble fiber 
from whole oats and the risk of CHD, FDA is deleting paragraph 
(c)(2)(i)(C) and adding two new paragraphs, (c)(2)(i)(C) and (D). These 
new paragraphs list the terms for use in specifying the soluble fiber 
and fat components of the claim (paragraphs (c)(2)(i)(C) and (D), 
respectively) and are discussed further in this section of this 
document. With the addition of paragraphs (c)(2)(i)(C) and (D), FDA has 
redesignated proposed paragraphs (c)(2)(i)(D) and (E) as paragraphs 
(c)(2)(i)(E) and (F), respectively.
    Section 101.81(d) contains optional information that may be 
included in the claim. In paragraph (d)(4) of the proposal, the agency 
proposed to permit manufacturers the option of describing oat bran and 
oatmeal as good sources of soluble fiber. For the reason given 
previously for the revision in paragraph (a)(3), the agency is deleting 
proposed paragraph (d)(4). FDA is replacing it with new paragraph 
(d)(4), which states ``The claim may specify the name of the eligible 
soluble fiber.'' Thus, the manufacturer may refer to ``beta-glucan 
soluble fiber'' in the health claim. The use of a specific soluble 
fiber name is appropriate as optional information but is likely too 
technical to be of interest to many consumers, and thus to require its 
inclusion in the claim would be contrary to the agency's desire to 
provide for claims that are simple, concise, and easy for consumers to 
understand. The rationale for this change is discussed in more detail 
under section II.D.4. of this document.
6. Amounts of -glucan Soluble Fiber Useful in Reducing the 
Risks of CHD
(Comment 6)
    One comment reexamined the data from the Davidson et al., study 
(Ref. 15) concerning the level of -glucan consumption per day 
that is needed to affect blood total cholesterol levels and thereby 
reduce the risk of CHD. The results of the Davidson et al. study 
suggested a dose-response relationship between the level of -
glucan intake and the amount of change in blood total cholesterol. The 
petitioner presented the data from this study in a linear regression 
model to show the change in blood total cholesterol as a function of 
soluble fiber intake (Ref. 1, p. 26). The linear regression model 
showed that an estimated intake of 3 g per day soluble fiber (i.e., 
-glucan soluble fiber) is associated with a reduction in blood 
total cholesterol of about 5 percent. The petitioner submitted the 
results of its analysis as support for the conclusion that 3 g per day 
of -glucan soluble fiber is useful in affecting risks for CHD.
    The comment stated that a nonlinear model fits the data better than 
the simple linear regression model. The comment stated that, based on 
the nonlinear model, 2.5 g/d -glucan soluble fiber is 
necessary to lower blood total cholesterol 5 percent.
    The agency does not agree that there is sufficient evidence to 
conclude that 2.5 g per day is more appropriate than 3 g per day, or 
that the nonlinear model is a better statistical approach than is the 
linear model. The data available from the Davidson et al. study are 
insufficient to determine superiority of the linear model compared to 
the curvilinear model. The results of the studies that showed an effect 
of soluble fiber from oat bran, rolled oats, and whole oat flour, and 
the results of the meta-analysis demonstrate that intakes of 3 g or 
more -glucan are more likely to be effective. Thus, to use 2.5 
g would be speculative, at best, and not supported by actual data. In 
contrast, the use of 3 g per day is. Therefore, the agency has 
concluded that, without further data, there is no justification for 
concluding that 2.5 g per day is a more appropriate estimate of the 
amount of -glucan useful in reducing the risk of CHD than is 3 
g per day.
7. Issues Related to a Food-specific Health Claim
(Comment 7)
    Some comments stated that the proposed claim for oat bran and 
oatmeal should not be authorized because it will portray specific 
foods, i.e., oat products, as ``magic bullets.'' The comments suggested 
that the claim would mislead consumers in that it creates the 
impression that consumption of certain foods (oat bran and oatmeal) 
alone will protect against CHD, and in that it would not convey the 
concept that it is diets, not foods, that are important in risk 
reduction. The comments suggested that, as a result, consumers will be 
discouraged from making other important, and perhaps more effective, 
life-style changes to help reduce their risk of CHD. Some comments 
suggested that including reference to the diet in the claim will help 
prevent oat bran and rolled oats from appearing as ``magic bullets.'' 
However, there were many comments that stated that consumers are aware 
that no one food is a ``magic bullet'' in reducing the risk of disease.
    Other comments stated that a claim for an individual food, such as 
that proposed for oat bran and oatmeal, is appropriate and would also 
be helpful to consumers because it would identify products that 
contribute to healthy dietary practices. A few comments expressed 
concern that consumers would inappropriately extrapolate from the 
effects of consuming oat bran and rolled oats set out in the health 
claim and assume a similar effect for all foods containing oat 
products, whether the foods are consistent with a total dietary pattern 
for risk reduction of heart disease or not. The comments likened this 
situation to the one that developed before the passage of the 1990

[[Page 3590]]

amendments, when some high-fiber food products bore a message from the 
National Cancer Institute suggesting that there was a relationship 
between fiber and risk of cancer. There was a proliferation of 
ingredient claims on products with trivial amounts of fiber.
    A few comments stated that the proposed claim for oat bran and 
oatmeal should be folded into the authorized claim for fruits, 
vegetables, and grain products and heart disease (i.e., Sec. 101.77). 
The comments stated that Sec. 101.77 could be modified to permit the 
terms ``oat bran'' and ``oatmeal'' in the health claim. The comments 
explained that Sec. 101.77 already establishes the specific 
requirements for foods that contain soluble fiber. The comments added 
that this would help prevent individual foods, such as rolled oats, 
from appearing to be ``magic bullets.''
    The agency disagrees with the comments that stated that it should 
incorporate this health claim into the authorization for claims on the 
relationship between fruits, vegetables, and grain products and CHD 
(Sec. 101.77). Under Sec. 101.77, soluble fiber is a marker for 
identifying useful foods, but no specific effect is attributed to the 
fiber. The claim that FDA is authorizing in this proceeding is based on 
the demonstrated effect of a certain type of soluble fiber (-
glucan soluble fiber) from a specific food source (whole oats). 
Therefore, the eligibility criteria and the scientific criteria set 
forth in Sec. 101.81 are different from those set out in Sec. 101.77. 
The agency concludes, consequently, that the two claims should not be 
combined.
    The agency notes that, in this final rule, the relationship of 
whole oats to reduced risk of heart disease is being described in terms 
of the total diet. As discussed in more detail in response to comment 
13 in section II.D.1. of this document, diets low in saturated fat and 
cholesterol are considered by expert groups to be the most effective 
dietary means of reducing heart disease risk (Ref. 5). While soluble 
fiber from whole oats can contribute to this effect, its role is 
generally recognized as being of smaller magnitude (Refs. 4 and 5). 
Describing the relationship of a total diet low in saturated fat and 
cholesterol that includes whole oats to the risk of CHD will prevent 
the oat-containing foods eligible to bear the claim from appearing to 
be ``magic bullets.''

B. Specifications for the Nature of the Food Substance Eligible to Bear 
the Claim

    In the proposal, the food substances that were the subject of the 
claim were oat bran and rolled oats and the products that contain them. 
The agency stated that the -glucan soluble fiber content of 
these products is an appropriate marker for identifying the 
cholesterol-reducing potential of these products (61 FR 296 at 308) and 
established levels for -glucan in foods that would qualify for 
the claim.
    Based on its review of the comments, however, the agency has 
concluded that -glucan is the primary component of whole oats 
that is responsible for the effect that consuming these foods has on 
the risk of CHD. Therefore, the agency has concluded that the 
substance-disease relationship that is appropriately the subject of a 
claim is that between -glucan soluble fiber from whole oats 
and CHD. To reflect this judgment, the agency has modified the 
authorizing regulation to specify the sources of -glucan that 
are appropriately the subject of a claim.
    Section Sec. 101.81(c)(2)(ii)(A) lists -glucan soluble 
fiber and the whole oat sources of this substance. It also sets out the 
official Association of Official Analytical Chemists International 
(AOAC) method to be used to determine the -glucan content of 
the food. Paragraph (c)(2)(ii)(A) states that the eligible source of 
-glucan soluble fiber is from the whole oat sources specified 
in paragraphs (c)(2)(ii)(A)(1) through (3). Paragraph (c)(2)(ii)(A)(1) 
lists oat bran, paragraph (c)(2)(ii)(A)(2) lists rolled oats, and 
paragraph (c)(2)(ii)(A)(3) lists whole oat flour. The totality of the 
evidence establishes that consumption of these three sources of 
-glucan soluble fiber as part of a diet that is low in 
saturated fat and cholesterol can reduce blood lipids and thus help 
reduce the risk of CHD.
1. Definition of Whole Oat Products
    In the proposal, the agency set out a specific qualifying level of 
oat bran or rolled oats and -glucan soluble fiber, i.e., 13 g 
of oat bran or 20 g or rolled oats that provide 1 g of -glucan 
soluble fiber per RACC.
(Comment 8)
    Some comments noted that the variability in -glucan 
soluble fiber content of oat products may affect whether these products 
qualify to bear this claim. Several comments stated that to ensure that 
products contain the appropriate amount of -glucan soluble 
fiber, FDA needs to define oat bran because -glucan soluble 
fiber levels vary among cultivars. Most of these comments encouraged 
adoption of the existing American Association of Cereal Chemists' 
(AACC) definition for oat bran.
    The comments pointed out that the AACC definition requires that for 
a product to be oat bran, it must have a total -glucan content 
of at least 5.5 percent (dry weight basis (dwb)). As a result of 
processing oat groats to oat bran, -glucan soluble fiber is 
more concentrated. Therefore, oat bran contains higher levels of this 
soluble fiber than rolled oats or oat flour.
    Some comments explained that the level of -glucan soluble 
fiber in rolled oats and oat flour more closely approximates the level 
of -glucan in oat groats. This level may range from 3 to 5 
percent, depending on the specific oat cultivar and on seasonal 
variation between crop years. One comment stated that the AACC had not 
adopted a definition of rolled oats because the product, oatmeal, has 
been on the market for over 100 years and is known to be a product made 
by rolling whole grain oats that have had 100 percent of the hull 
removed.
    The agency is persuaded by the comments that, based on the 
variability in -glucan soluble fiber content of oat cultivars, 
a definition of the eligible whole oat products that includes the 
-glucan soluble fiber content will help ensure that a source 
of whole oats that bears a claim is consistent with those shown in 
clinical studies to lower blood lipids. In its review of studies in the 
proposal (61 FR 296 at 314), FDA observed that the results of most of 
the studies that failed to show a significant effect of oat bran on 
serum lipids used oat bran that provided less than 5.5 percent (dwb) of 
-glucan soluble fiber (Refs. 13, 26, 27, 28, 36, and 41). For 
example, New Zealand oat bran was described to contain -glucan 
soluble fiber within a range of 3.7 to 4.4 percent (Ref. 26). In the 
studies that showed an effect of oat bran on serum lipid levels, the 
oat bran provided more than 5.5 percent (the exact amount cannot be 
determined in all studies) -glucan (Refs. 8, 11, 12, 15, 17, 
20, 23 through 25, 29, 35, 39, and 42).
    Thus, the agency agrees that adoption of the AACC definition of oat 
bran (Ref. 52), which requires that a product have a total -
glucan content of at least 5.5 percent (dwb) to qualify as oat bran, is 
appropriate. This definition was developed to respond to the confusion 
among oat processors, as well as others in industry and among home 
consumers, about a uniform identity of the product that was receiving 
widespread publicity with regards to its health benefits. Oat bran 
cannot be cleanly separated from the endosperm of oat groats (Ref. 52). 
Consequently, oat bran contains some flour and is rich in -
glucan soluble fiber, and debranned oat flour contains some bran but 
contains significantly less -glucan.

[[Page 3591]]

Consequently, it became essential that the industry define what could 
be called ``oat bran.'' It was the ``rich'' oat bran that has been used 
in clinical trials and that has been shown to lower serum lipids.
    Therefore, FDA is adding the AACC definition of oat bran (Ref. 52) 
to Sec. 101.81(c)(2)(ii)(A)(1). It states that oat bran is produced by 
grinding clean oat groats or rolled oats and separating the resulting 
oat flour by suitable means into fractions, such that the oat bran 
fraction is not more than 50 percent of the original starting material 
and provides at least 5.5 percent (dwb) -glucan soluble fiber 
and a total dietary fiber content of 16 percent (dwb), and such that at 
least one-third of the total dietary fiber is soluble fiber.
    As discussed previously, there have been no formally accepted 
definitions of the terms rolled oats and whole oat flour. However, 
based on data provided in comments from fiber experts (Refs. 55 through 
58), data from the U.S. Department of Agriculture National Nutrient 
Data Base (Ref. 75), and data provided in the petition (Ref. 1, p. 22 
and Appendix II), the agency is providing general definitions for these 
terms that reflect the type of whole oat products used in clinical 
trials. As part of each definition, the agency is specifying the 
-glucan soluble fiber and total dietary fiber contents of 
rolled oats and whole oat flour that are required for a product to 
qualify for this claim.
    In light of the evidence presented in the proposal that some oat 
groats naturally contain low levels of -glucan soluble fiber 
and, as a result, may not have hypocholesterolemic properties, the 
agency finds it important to set a minimum -glucan content to 
ensure the effectiveness of these oat products. In new 
Sec. 101.81(c)(2)(ii)(A)(2), the agency defines rolled oats, also known 
as oatmeal, as a product produced from 100 percent dehulled clean oat 
groats by steaming, cutting, rolling, and flaking, and that provides at 
least 4 percent (dwb) of -glucan soluble fiber with a total 
dietary fiber content of at least 10 percent (Refs. 1, 55 through 58, 
and 75).
    In new Sec. 101.81(c)(2)(ii)(3), the agency is defining whole oat 
flour as a product that is produced from 100 percent dehulled, clean 
oat groats by steaming and grinding, such that there is no significant 
loss of oat bran in the final product, and that provides at least 4 
percent (dwb) of -glucan soluble fiber and 10 percent (dwb) 
total dietary fiber.
    FDA agrees with the comments that definitions to identify of the 
whole oat substances that have been shown in clinical studies to help 
reduce serum lipids are important in light of the fact that there are 
other whole oat substances, e.g., oat husks and fine oat flour, that 
have not been shown to provide this effect.
2. Testing of Oat Products to Ensure Retention of Characteristics
(Comment 9)
    Some comments suggested that the effect on blood lipids from 
consumption of -glucan soluble fiber from whole oat products 
is related to the molecular weight and the solution viscosity of the 
-glucan. The comments stated that processing methods can alter 
the size and molecular weight of the -glucan molecule and may 
cause it to lose its effect on blood cholesterol levels. The comments 
suggested that to ensure that the processed oat-containing food product 
will provide the effects associated with the -glucan soluble 
fiber in the starting material, i.e., oat bran, rolled oats, and whole 
oat flour, the finished oat product should be tested to determine 
whether its -glucan soluble fiber has retained the physical 
properties, such as molecular weight, that it had in the starting 
material.
    The agency is not persuaded that there is a need for testing for 
the molecular weight and solution viscosity of the -glucan in 
products that contain oat bran, rolled oat, or whole oat flour. 
Although processing can produce extensive depolymerization of the 
-glucan, oat bran and rolled oats were fed to subjects in a 
variety of processed foods as part of the scientific studies that 
evaluated the effects of these ingredients on blood cholesterol levels 
(see Table 1, 61 FR 296). Regardless of whether the whole oats were 
processed into cereals, muffins, breads, or other foods, or whether 
they were consumed hot or cold, the majority of oat products 
significantly lowered blood lipids when consumed as part of an 
appropriate diet.
    The agency noted that, in the few studies that did not demonstrate 
cholesterol-lowering effects from the consumption of oat bran or rolled 
oats, the authors attributed the lack of an effect to either the source 
of the oat cultivar, specifically a New Zealand cultivar that had a low 
content of soluble fiber (one case), or to an effect of processing to 
purify an extract of the -glucan soluble fiber (one case) (61 
FR 296 at 305). Thus, the lack of an effect in one of these cases was 
associated with an unusually low level of -glucan in the oats. 
This problem is protected against by the -glucan content 
requirement in Sec. 101.81(c)(2)(ii)(A)(1), (2), and (3). In the other 
case, the lack of effect was associated with the use of a highly 
processed oat gum extract. This result does not represent a problem 
under Sec. 101.81 because FDA is only authorizing claims on whole oat 
products.
    Therefore, the agency finds that there is no need for testing the 
physical properties of the -glucan soluble fiber in processed 
products containing whole grain oats.

C. Nature of the Food Eligible to Bear the Claim

    Proposed section Sec. 101.81(c)(2)(iii)(A) stated that for a food 
to be eligible to bear the claim, it must contain 13 g of oat bran or 
20 g oatmeal, and that the oat bran or oatmeal must contain, without 
fortification, at least 1.0 g of -glucan soluble fiber per 
RACC. The agency noted that consumption of 3 or more g of oat 
-glucan soluble fiber per day was associated with significant 
reductions in blood total- and LDL-cholesterol levels. It tentatively 
concluded that it is reasonable to assume that a person could consume a 
total of at least 40 g oat bran, 60 g oatmeal, or a combination of the 
two, to provide 3 g -glucan soluble fiber in the course of 
three eating occasions a day.
1. Qualifying Criteria for Foods
(Comment 10)
    Some comments agreed with the proposal and emphasized that foods 
should contain a significant amount of oat bran or oatmeal in order to 
qualify for this claim. A few comments stated that the claim should be 
allowed only on foods for which a customary serving enables consumers 
to achieve the desired effect on the risk of disease (i.e., 3 g 
-glucan per serving of food). However, a number of comments 
suggested that it is unrealistic to assume consumers will eat enough 
oat bran or oatmeal daily for the rest of their lives to lower their 
risk of cardiovascular disease.
    Some comments suggested that the proposed qualifying levels of 
oatmeal, oat bran, and -glucan were overly restrictive and 
prevented a number of important oat-containing foods from bearing the 
claim. These comments requested that the qualifying levels of oat bran, 
oatmeal, or -glucan be lowered so that more products could 
qualify to bear the claim. Several suggested that Americans are more 
likely to increase their consumption of soluble fiber if they are 
presented with a wide variety of whole-grain oat-containing foods that 
may be eaten over the course of the day. The comments suggested various 
qualifying levels for a food to bear the claim, ranging from 6 to 15 g 
of oatmeal or from 4 to 11 g of oat bran.

[[Page 3592]]

    Some comments recommended setting only a level of -glucan 
soluble fiber that must be contained in the food to qualify for this 
claim, rather than a level of oat bran or oatmeal as well as a level of 
-glucan soluble fiber. These comments argued that the level of 
the -glucan soluble fiber in the product is a marker of the 
product's usefulness in reducing the risk of CHD, and that if a product 
contains the appropriate amount of -glucan soluble fiber, it 
should qualify to bear the claim no matter how much oat bran or oatmeal 
it contains. The comments suggested a range of qualifying -
glucan levels from 0.5 g -glucan to 3 g -glucan per 
serving. A number of different rationales where presented in the 
comments to justify these varying qualifying levels of -glucan 
per serving.
    One comment recommended a level of 0.6 g -glucan soluble 
fiber per serving as the qualifying level instead of the proposed 1 g 
-glucan soluble fiber because 0.6 g is more readily achievable 
and thus would encourage the development of new soluble fiber-
containing products. According to the comment, this level is at least 
twice the level of existing oatmeal-based bakery products such as 
cookies and crackers. Some comments suggested that a qualifying level 
of 0.6 g -glucan per serving would make the qualifying 
criteria for this claim consistent with the authorized health claim for 
fruits, vegetables, and grain products and CHD.
    Many comments stated that the qualifying level of -glucan 
soluble fiber per serving should not be based on three servings of oat 
products per day but rather on FDA's usual basis of four eating 
occasions (three meals and a snack) a day. The comments stated that the 
agency did not adequately justify its reliance on three eating 
occasions per day, rather than on four. A few comments questioned 
whether consumers would consume oatmeal and other oat products three or 
four times a day. One comment asked for evidence that consumers will 
eat oat products three times a day every day.
    As discussed earlier in this final rule, FDA has been persuaded 
that the subject of the claim is appropriately -glucan soluble 
fiber from whole oats. Thus, to be eligible to bear the claim, a food 
must contain the requisite amount of -glucan soluble fiber 
from whole oat sources, rather than a specified amount of oat bran or 
rolled oats that provide a specific amount of -glucan soluble 
fiber.
    Given the changed focus of the final regulation, the issues raised 
in the comments that addressed the levels of oat bran and oatmeal are 
moot. FDA has deleted the requirement in proposed 
Sec. 101.81(c)(2)(iii)(A) that the food must contain no less than 20 g 
oatmeal or 13 g of oat bran that provides, without fortification, at 
least 1.0 g of -glucan soluble fiber and replaced it with a 
requirement that focuses on the -glucan level.
    The agency has reviewed the discussions from the comments 
concerning the levels of -glucan in a food. The agency 
disagrees with the comments that suggested that the qualifying level of 
-glucan soluble fiber be low as 0.5 or 0.6 g per RACC to 
permit many more oat-containing products, e.g., crackers and cookies, 
to qualify to bear the claim. As discussed previously, an intake of 3 
or more g of -glucan soluble fiber from whole oat products is 
necessary to make a significant impact on serum lipid levels. Using the 
minimum levels of -glucan soluble fiber for oat bran (5.5 
percent) and rolled oats and whole oat flour (4 percent) that the 
agency now specifies in new Sec. 101.81(c)(ii)(A)(1) through (3) (see 
comment 8 in section II.B.1. of this document), products that contain a 
minimum of 0.5 g -glucan soluble fiber would contain about 9 g 
of oat bran or 12.5 g rolled oats or whole oat flour, or a level 
between 9 and 12 g if a blend of whole oats is used. To obtain a daily 
intake of 3 g -glucan from whole oats, it would require the 
consumption of six or more servings. Similarly, if the oat products 
qualified with 0.6 g -glucan soluble fiber, consumers would 
have to consume five or more servings of oat-containing products daily. 
The agency finds that these levels of consumption, five or six or more 
servings per day, highly unlikely. As mentioned in some of the 
comments, consumers should be able to consume a beneficial amount of 
the nutrient based on typical American eating patterns, i.e., four 
eating occasions per day.
    In the proposal, the agency considered the number of eating 
occasions at which consumers might consume oat bran and rolled oats. 
The agency tentatively agreed with the petitioner's arguments that it 
was unlikely that consumers would eat oat bran or rolled oats 4 times a 
day, in order to consume a daily intake of about 40 g oat bran or 60 g 
rolled oats, but that consumers should be able to consume this amount 
over three eating occasions a day (61 FR 296 at 309). Based on the 
petitioner's submission, the agency considered that -glucan 
soluble fiber would come from only two sources, oat bran and rolled 
oats, which would limit the number and types of products available.
    In this final rule, however, the agency has expanded the sources of 
whole oats to include whole oat flour. Thus, many more whole oat-
containing products will be available to qualify to bear this claim. 
This development increases the likelihood that whole oat products will 
be consumed at four, instead of three, eating occasions. Moreover, 
based on consumption data provided in a comment submitted by the 
petitioner, whole oat products (including all oat cereals, baked 
products, and snack foods) are consumed at four eating occasions a day, 
with breakfast being the most popular time to consume oat products (see 
Sup-1 to Docket No. 95P-0197). Therefore, based on the expanded focus 
of this final regulation (to include whole oat flour) and on the 
additional evidence from comments, the agency is persuaded that the 
determination of the qualifying level of -glucan for a food to 
bear a claim should be based on four eating occasions a day (three 
meals plus a snack) rather than on the proposed three.
    The agency proposed a qualifying level of 1 g -glucan 
soluble fiber per serving based on the consumption of 3 g per day (see 
comment 6 in section II.A.6. of this document) distributed over three 
eating occasions per day. Based on the same approach as that used in 
the proposal, but adjusting it for the increase in the number of 
servings consumed per day, the intake of 3 g of -glucan is 
distributed over four servings per day as part of four eating occasions 
(3 g divided by 4) and results in a criterion of 0.75 g per serving 
(i.e., RACC).
    In providing for this qualifying level, the agency wishes to point 
out that the approach used to derive the qualifying level is somewhat 
different from that used in authorizing other health claims. 
Specifically, the guiding principle for other health claims is to use 
the established definitions for ``good source'' or for ``high'' which 
characterize the amount of a nutrient based on a percentage of the 
Daily Value (DV) for the nutrient in a serving of food. In this way, 
products that qualify to bear the claim contain a meaningful level of 
the substance per serving compared to the recommended intake of the 
substance from all food sources. In the case of this final rule, there 
is no DV for -glucan soluble fiber or for soluble fiber.
    FDA has revised Sec. 101.81(c)(2)(iii)(A) to state ``[T]he 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.'' The statement in proposed

[[Page 3593]]

Sec. 101.81(c)(2)(iii)(A) regarding the method for determining 
-glucan soluble fiber has been deleted because it now appears 
under section new section Sec. 101.81(c)(2)(ii)(A) of this final rule, 
as discussed previously.
    No comments were received on proposed Sec. 101.81(c)(2)(iii)(B) 
which requires that the food meet the nutrient content requirements of 
Sec. 101.62 for a ``low saturated fat,'' ``low cholesterol,'' and ``low 
fat'' food. Therefore this paragraph is adopted without change, 
although it has been renumbered as Sec. 101.81(c)(2)(iii)(C).
2. Mixtures of Oat Products
(Comment 11)
    Some comments stated that the agency should allow a mixture of oat 
products that together within a single food product provide the total 
qualifying level of -glucan soluble fiber to bear this claim. 
The comments stated that as long as the requisite amount of -
glucan soluble fiber is present, it should not matter if it is derived 
from a mixture.
    The agency agrees with this suggestion and notes that it never 
intended not to allow a mixture of whole oats to qualify for the 
proposed claim. To clarify this fact, the agency has revised 
Sec. 101.81(c)(2)(iii) (Nature of the food eligible to bear the claim) 
to state that the product must provide the required level of soluble 
fiber per RACC from the eligible sources of whole oat soluble fiber 
listed in Sec. 101.81(c)(2)(ii). Therefore, a mixture of oat bran, 
rolled oats, and whole oat flour may be used in a product that bears a 
claim so long as the product contains the requisite amount of 
-glucan soluble fiber per RACC.
3. Nutrient Declaration for Soluble Fiber and -glucan Soluble 
Fiber
    The agency proposed in Sec. 101.81(d)(4) that if the claim uses the 
term ``soluble fiber,'' which was to be optional, the total soluble 
fiber content must be declared in the nutrition label, consistent with 
Sec. 101.9(c)(6)(i)(A).
(Comment 12)
    One comment suggested that the final rule require that the soluble 
fiber and -glucan contents of a food product bearing the 
health claim be declared in nutrition labeling. The comment stated 
that, because -glucan is the marker nutrient in a qualifying 
product, it should be included in the nutrition label. The comment 
cited other health claim regulations specific to foods (rather than 
nutrients) (Secs. 101.76 to 101.78) as precedents for requiring 
declaration of the amount of the marker nutrient in the nutrition 
label. In suggesting that -glucan be declared as a 
subcomponent of soluble fiber, the comment also cited as precedent the 
regulation permitting -carotene to be declared as a 
subcomponent of vitamin A (Sec. 101.9(c)(8)(vi)). In addition, the 
comment stated that the final regulation should also permit optional 
declaration of these nutrients elsewhere on the label, consistent with 
Sec. 101.13(i)(3).
    The agency has considered this comment in view of the previously 
discussed conclusions concerning the food substance that is the subject 
of this claim, specifically -glucan soluble fiber from whole 
oats. The suggestion in the comment that soluble fiber be declared 
within the nutrition label is consistent with the change in focus of 
the claim from oat bran and oatmeal to -glucan soluble fiber 
from whole oats. Since -glucan is a soluble fiber, and the 
claim requires use of the term ``soluble fiber,'' FDA is requiring the 
declaration of the amount of soluble fiber per RACC or labeled serving 
(which would include the declaration of the amount of -glucan) 
in the nutrition label in accordance with Sec. 101.9(c)(6)(i)(A). In 
this document, FDA is adding Sec. 101.81(c)(2)(iii)(B), which reflects 
this requirement. As a result of this action, FDA, as stated 
previously, is redesignating proposed Sec. 101.81(c)(2)(iii)(B) as 
Sec. 101.81(c)(2)(iii)(C).
    FDA does not agree with the comment that the specific amount of 
-glucan should also be declared in the nutrition label. 
Declarations for -carotene, which the comment uses as an 
analogy, are made in terms of a percentage of the DV for vitamin A. In 
this case, there is no DV for soluble fiber or for -glucan 
soluble fiber. More importantly, use of the term ``beta-glucan'' as a 
subcategory of soluble fiber would likely be confusing to the consumer 
as ``-glucan'' is primarily a technical term with which 
consumers are not familiar. Therefore, FDA is not providing for the 
declaration of -glucan on the nutrition label.
    It should be noted that the agency is making provision for optional 
label statements in the claim relative to the amount of -
glucan considered useful in reducing the risk of CHD (i.e., 3 g per 
day) and to the contribution that one serving of the food makes toward 
reaching the specified amount. As explained in section II.D.4. of this 
document, provision of this information is optional because of the 
agency's concerns about requiring long messages and the possibility of 
consumer information overload. Moreover, given the potential for the 
broad range of soluble fibers that may be eligible to bear the claim in 
the future, it is questionable whether requiring that the consumers' 
attention be drawn to a specific type of soluble fiber would be 
helpful. The comment provided no information on how consumers would use 
and interpret such a declaration for -glucan. In the absence 
of such data, it is difficult to conclude that declaration of 
-glucan soluble fiber in the nutrition label would assist 
consumers to any greater degree than the declaration of soluble fiber.
    Further, FDA notes that, as suggested in the comment, declaration 
of soluble fiber and -glucan soluble fiber on the label other 
than in the Nutrition Facts panel, is permitted by Sec. 101.13(i)(3). 
No additional authorization is needed for such declarations.

D. Provisions for Abbreviated and Full Claims

    In addition to providing for a full claim on the relationship 
between oat bran and rolled oats as part of a diet low in saturated fat 
and cholesterol and risk of CHD, the agency proposed an optional 
abbreviated claim. FDA proposed in Sec. 101.81(c)(2)(ii), 
``Presentation of the claim,'' to provide that if a full statement of 
the claim appears on a label or in labeling, other presentations of the 
claim may appear on the label or in labeling that do not include the 
information required in proposed Sec. 101.81(c)(2)(i)(C)(2) as long as 
there is a referral statement from the shortened to the full claim. The 
agency was concerned, however, about the possibility that consumers may 
not read the complete claim, and thus that they will not have all the 
facts necessary to fully understand the significance of the claim and 
to comprehend the claim in the context of the daily diet. FDA asked for 
data on whether the shortened claim will affect the extent to which 
consumers read the full claim (61 FR 296 at 307). The agency also 
requested comments on whether consumers will be misled if the 
multifactorial nature of CHD is not stated as part of the claim (61 FR 
296 at 307). The agency proposed making optional the statement ``a 
disease caused by many factors.''
1. Appropriateness of Abbreviated Claim and Wording of Full Claim
(Comment 13)
    Many comments expressed concern about the omission of reference to 
the diet in the proposed abbreviated claim. Some comments suggested 
that the proposed abbreviated claim, which stated that ``Diets high in 
[oat bran/oatmeal] may reduce the risk of heart disease,'' will mislead 
consumers to think that the oat products will

[[Page 3594]]

compensate for a diet that is high in saturated fat and cholesterol. 
The comments stated that other authorized health claims reinforce that 
overall diets, not individual foods, can reduce the risk of disease. 
Many comments stated that the abbreviated claim is misleading without 
the reference to a total diet that is low in saturated fat and 
cholesterol. A few of the comments stated that the effects of oat bran 
or rolled oats on reducing the risk of CHD, in the absence of a low 
saturated fat and cholesterol diet, is modest, so the abbreviated claim 
may mislead consumers to think that eating oat products daily, without 
consuming a low saturated fat and cholesterol diet, will significantly 
effect their risk of CHD.
    Some of the comments discussed diet as one of the more important 
modifiable risk factors for CHD. Many stated that a reference to the 
total diet should be a mandatory part of the abbreviated claim. The 
comments suggested that including reference to the diet in the claim 
will help prevent oat bran and rolled oats from appearing to be ``magic 
bullets.'' However, there were comments that stated that consumers are 
aware that no one food is a ``magic bullet'' in reducing the risk of 
disease.
    Some of the comments stated that the agency did not present any 
data to show that consumers will read the full claim, which includes 
the statement on the total diet, when it is located elsewhere on the 
food label relative to the abbreviated claim. They concluded that 
consumers would be misled by the limited information in the abbreviated 
claim. Several comments stated that by removing the qualifying portion 
of the health claim (i.e., information about total diet) from the most 
prominent location on the label, there was less likelihood this 
critical information would be read by consumers.
    Some comments supported FDA's proposal to permit use of an 
abbreviated health claim because it provided flexibility and consumer-
friendly language. Several comments in support of the shortened claim 
mentioned its advantages in communicating information to consumers 
because it was easily readable, compelling, and direct. The shortened 
claim was seen as playing the role of a reminder to consumers about the 
core diet-disease relationship that is the subject of the health claim. 
One comment cited findings from FDA health claims focus groups (Ref. 
53), which reported that consumers perceived full health claims as 
``too wordy, too vague, too academic, and much too long.'' One comment 
stated the use of the abbreviated claim as a referral (see 
Sec. 101.14(d)(2)(iv)) to the full claim would serve both consumer 
information needs and the motivational goals of the 1990 amendments to 
encourage industry to use health claims on appropriate food products.
    The agency proposed the abbreviated claim because the petitioner 
requested it, and because the agency tentatively concluded that the 
information could be more effectively communicated with an abbreviated 
claim in a prominent place with a referral to the full claim. The 
agency did not intend for the abbreviated message to suggest to 
consumers that adding oats to the diet was the only dietary 
modification necessary to help them reduce the risk of CHD.
    The agency agrees with the comments that the dietary component of 
this health claim is important for a complete understanding of the 
relationship between the type of soluble fiber from whole oats and 
reduced risk of heart disease. FDA has been persuaded that there is the 
possibility that consumers may be misled if reference to the total diet 
were to be omitted in an abbreviated version of this claim. Diets low 
in saturated fat and cholesterol are considered by expert groups to be 
the most effective dietary means of reducing heart disease risk (Ref. 
5). While soluble fiber from whole oats can contribute to this effect, 
its role is generally recognized as being of smaller magnitude (Refs. 4 
and 5). Selection of foods with soluble fiber from whole oats is seen 
as a useful adjunct to selection of diets low in saturated fat and 
cholesterol (Ref. 5). Therefore, the agency concludes that it would not 
be in the best interest of public health or consistent with the 
scientific evidence to imply that selecting diets with soluble fiber 
from whole oats is a substitute for consuming diets low in saturated 
fat and cholesterol, and has FDA revised Sec. 101.81 to emphasize the 
importance of the diet.
    Proposed Sec. 110.81(b)(2) stated, ``* * * Scientific evidence 
demonstrates that diets high in oat bran and oatmeal and low in 
saturated fat and cholesterol are associated with lower blood total- 
and LDL-cholesterol levels.'' FDA has revised that sentence to state:
    * * * Scientific evidence demonstrates that diets low in 
saturated fat and cholesterol are associated with lower blood total 
and LDL-cholesterol levels. Soluble fiber from whole oats, when 
added to a low saturated fat and cholesterol diet, also helps to 
lower these blood levels and thus the risk of CHD.
The revised statement emphasizes that consumption of a diet low in 
saturated fat and cholesterol is an important factor in reducing the 
risk of CHD and is consistent with FDA's conclusions in authorizing the 
health claim for dietary saturated fat and cholesterol and heart 
disease (58 FR 2739, January 6, 1993).
    Relative to the concerns about the appropriateness of the 
abbreviated claim, the agency was mindful of those comments that 
focused on concerns about health claims being too wordy and too 
lengthy. This concern has been raised to the agency in various ways, 
including by a petition submitted by the National Food Processors 
Association (NFPA) (Docket No. 94P-0390). In response to the NFPA 
petition, the agency proposed several changes to the requirements for 
health claims in the Federal Register of December 21, 1995 (60 FR at 
66206) (the 1995 proposal). At that time, FDA stated that it had no 
desire for its regulations to unnecessarily stand in the way of the use 
of health claims and the presentation of the important information 
contained therein. The agency stated that, while health claims are 
being used on the label and in labeling, they could be used more 
extensively. The agency, therefore, proposed to provide for shorter 
health claims by making optional some of the elements that are 
presently required. If FDA finalizes the 1995 proposal as it was 
proposed, many of the current full claims will be brief enough to 
permit their use on the principal display panel.
    FDA is reviewing the comments received in response to the 1995 
proposal on changing the requirements for health claims, but it has not 
completed its work on the final rule. Given that this proposal is 
pending, and given its relevance to many of the issues raised as a 
result of the proposal that is the subject of this rulemaking, FDA has 
decided to defer a decision on allowing for an abbreviated claim on 
-glucan soluble fiber from whole oats and the risk of CHD. The 
agency intends to resolve this matter in the context of the rulemaking 
based on the NFPA petition. Thus, at this time, the agency is making 
provision only for a full claim. Thus, FDA has deleted proposed 
Sec. 101.81(c)(2)(ii), ``Presentation of the claim,'' which provided 
for an abbreviated claim, in this final rule.
2. Research Study on the Abbreviated Claim
(Comment 14)
    A comment from the petitioner included results from a consumer 
research study that compared an abbreviated oatmeal claim (``A diet 
high in oatmeal may help reduce the risk of heart disease'') with a 
full fiber-heart disease health claim (``Diets low in

[[Page 3595]]

saturated fat and cholesterol and high in grains, fruits and vegetables 
that contain fiber, particularly soluble fiber, may reduce the risk of 
heart disease, a condition associated with many factors.'') The data 
were from a national shopping mall intercept study of 826 consumers. 
Participants saw one of three mocked-up cereal packages that contained 
either the abbreviated claim, the long claim, or no claim (control 
condition).
    The comment suggested that results showed that the presence of 
either health claim, compared to the control condition, increased the 
number of participants who recognized that a diet high in oatmeal may 
help reduce the risk of heart disease. There were no significant 
differences in terms of the impact of the claims on consumers' 
perceptions of the product or their beliefs about the diet-disease 
relationship.
    The data submitted by the petitioner address issues related to the 
interpretation of a specific abbreviated claim and are intended to 
provide support for an abbreviated claim on the relationship that is 
the subject of this rulemaking. Because the FDA rulemaking that 
responds to the NFPA petition is pending, the agency is deferring a 
final decision on whether to make provisions for an abbreviated claim 
to describe this relationship. FDA finds that there is nothing in this 
evidence that is sufficiently compelling to persuade the agency that it 
is not appropriate to defer this decision. Therefore, the agency is 
forwarding the petitioner's comment and supporting data as a comment to 
the 1995 proposal (i.e., to Docket No. 94P-0390) so that FDA can 
consider these results as part of that rulemaking.
3. Use of ``Low Fat'' to Replace ``Low in Saturated Fat and 
Cholesterol''
(Comment 15)
    Two comments suggested that the statement ``low in saturated fat 
and cholesterol'' might be shortened to ``low fat'' for the abbreviated 
claim only. These comments did not provide any data to show that 
consumers interpret the statement ``low fat'' to mean ``low in 
saturated fat and cholesterol.''
    Another comment cautioned against referring to a ``low fat'' diet 
because the scientific evidence showed that a low fat diet was not 
associated with reduced blood total cholesterol levels and hence a 
reduced risk of CHD, while a diet low in saturated fat and cholesterol 
did affect cholesterol levels.
    The agency finds that there is not sufficient evidence to support 
simplifying the term ``low saturated fat and cholesterol'' to the term 
``low fat.'' No data were submitted to show that consumers would not be 
misled by such a simplification, and, as pointed out by comments, there 
is evidence that low fat diets do not necessarily result in the 
benefits of low saturated fat diets. The term ``low fat'' is defined in 
Sec. 101.62(b)(iii)(2) as low in total lipid fatty acids. It therefore 
takes into account not only saturated fat but also polyunsaturated and 
monounsaturated fat. Further, the term does not include cholesterol. 
Therefore, the term ``low fat'' is not be sufficiently specific.
4. Modifications of Sec. 101.81
    In light of the changes in this final rule to authorize a claim for 
diets low in saturated fat and cholesterol that include soluble fiber 
from whole oats, a number of additional modifications to the proposed 
requirement for the claim are required.
    The agency is revising Sec. 101.81(c)(2)(i)(A) to state that: ``The 
claim states that diets low in saturated fat and cholesterol that 
include soluble fiber from whole oats `may' or `might' reduce the risk 
of heart disease.''
    New Sec. 101.81(c)(2)(i)(C) states: ``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 
(c)(2)(ii)) or the name of the food product.'' Examples of such 
statements are: ``Soluble fiber from whole oats * * *'' and ``Soluble 
fiber from oatmeal * * *'' 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 * * *.''
    The agency is also adding new paragraph (c)(2)(i)(D), which states: 
``In specifying the fat component, the claim uses the terms 'saturated 
fat' and 'cholesterol'.'' This terminology is consistent with the 
authorized CHD health claims, Secs. 101.75 and 101.77, regarding diets 
low in saturated fat and cholesterol and risk of disease.
    After careful consideration of the comments about claim wording and 
in view of the change in focus of the claim in response to comments, 
FDA has modified the model health claim statements in Sec. 101.81(e) to 
reflect the changes it is making. Thus, FDA has deleted proposed 
paragraph (e)(1), which provided an example of a full claim, and 
replaced it with the following model claim: ``Soluble fiber from foods 
such as [name of soluble fiber source from paragraph (c)(2)(ii) of this 
section or name of food product], as part of a diet low in saturated 
fat and cholesterol, may reduce the risk of heart disease.'' FDA has 
also deleted proposed Sec. 101.81(e)(2) and (e)(2)(A) and (B), which 
provided examples of the shortened claim with the referral statement, 
and replaced it with new paragraph (e)(2), which gives another example 
of a full claim.
    Section 101.81(d) provides for optional information that the 
manufacturer may use to elaborate on the substance-disease 
relationship. New Sec. 101.81(d)(4) states that the manufacturer may 
identify the specific type of soluble fiber that is the subject of 
claim. For instance, the claim may state: ``Beta-glucan soluble fiber 
from whole oats, as part of a diet low in saturated fat and 
cholesterol, may reduce the risk of coronary heart disease.'' The 
agency believes that the specification of -glucan soluble 
fiber in the wording of the claim is appropriate as an option for the 
manufacturer but need not be a required component of the claim, because 
while scientifically correct, it may be information that is too 
technical for many consumers and thus contrary to the agency's desire 
to keep the claim simple, concise, and easy for consumers to 
understand.
    Proposed Sec. 101.81(b)(2) stated, ``Intakes of saturated fat 
exceed recommended levels in the diets of many people in the United 
States. Intakes of cholesterol are, on average, at or above recommended 
levels * * *.'' Based on recent data on cholesterol intakes reported in 
the ``Third Report on Nutrition Monitoring in the United States'' (Ref. 
77), which shows a reduction in some cholesterol intake levels, the 
agency has reconsidered including of the second sentence and has 
decided to delete it.
5. Multifactorial Nature of Disease
(Comment 16)
    Several comments responded to FDA's question as to whether 
consumers will be misled if the multifactorial nature of CHD is not 
stated in the claim. These comments supported the proposal to make 
optional the statement ``a disease caused by many factors.'' Several 
comments cited FDA Health and Diet Survey data that showed ``American 
consumers understand that serious diseases like cancer and heart 
disease have multiple causes, including factors such as diet, heredity, 
smoking and stress'' (Ref. 54). One comment stated that consumers are

[[Page 3596]]

sufficiently knowledgeable to appreciate that many factors affect risk 
of CHD, and that a mandatory statement of this fact would detract from 
the communication of the core message because it would make the claim 
longer, which would in turn deter manufacturers from using the claim.
    For the reasons set out in the proposal and in the absence of any 
objections to the agency doing so, FDA has concluded that the statement 
``a disease caused by many factors'' should remain optional. FDA is 
adopting proposed paragraph (d)(1) without change.
6. Dietary ``Context'' of Claim
(Comment 17)
    Some comments stated that the proposed claim would be misleading to 
consumers because it provided no indication of how much of the oat-
containing food would have to be consumed to reduce the risk of CHD. 
One comment stressed the need for explicit information in the health 
claim about how much oat bran or oatmeal to eat daily to affect the 
risk of disease, for example in terms of number of servings. The 
comment emphasized the need to make it clear that the consumer should 
eat a certain amount every day in order to benefit from consumption of 
these foods.
    The agency agrees that consumers may find ``contextual'' 
information, as well as additional information that specifies the 
nature of the relationship, helpful. However, in the absence of a DRV 
for soluble fiber, the agency cannot identify an amount of whole oat 
soluble fiber that represents a ``good source'' or that is ``high'' in 
soluble fiber. Until the agency takes action to establish a DRV for 
soluble fiber, it considers such information to be more appropriate as 
optional information.
    The agency does not agree that consumers would be misled if such 
information were not provided, and the mandatory inclusion of such 
optional information would be inconsistent with the approach taken for 
other claims. For the other authorized health claims, Secs. 101.72 
through 101.80, the agency has not required the level of detail 
suggested by these comments in the wording of the claim. For example, 
the regulation authorizing health claims on the relationship between 
diets low in saturated fat and cholesterol and CHD does not require 
that the claim statement specify that saturated fat should be less than 
10 percent of calories on a daily basis, or that cholesterol should be 
limited to less than 300 mg per day. FDA allows for the optional 
provision of this information.
    FDA, therefore, concludes that the information described in 
proposed Sec. 101.81(d)(8) be retained as optional information, but the 
agency is modifying the statement to reflect the change in the focus of 
the claim to -glucan soluble fiber from whole oats. Proposed 
paragraph (d)(8) has been replaced with new Sec. 101.81(d)(6), which 
states:
    A claim based on -glucan soluble fiber from whole oats 
may state that 3 g or more per day of -glucan soluble fiber 
from whole oats may reduce the risk of CHD, provided that the claim 
also states the contribution one serving of the product makes to 
this specified intake level for -glucan soluble fiber.
The amount of -glucan per serving is required here because 
without it, consumers may be misled to believe that the food 
contributes 3 g of -glucan soluble fiber per serving. In 
making this provision, FDA wishes to point out that if a variety of 
soluble fibers become eligible to make this claim, it may be necessary 
to review and revise the appropriateness of such ``contextual.''
    As a result of this change, FDA has renumbered proposed paragraphs 
(d)(6) and (d)(7) in the final regulation as paragraphs (d)(7) and 
(d)(8), respectively. In the absence of comments on paragraphs (d)(7) 
and (d)(8), FDA has adopted these paragraphs without change.
    Proposed paragraph (d)(5) states: ``The claim may state that a diet 
low in saturated fat and cholesterol and high in oatmeal or oat bran is 
consistent with `Nutrition and Your Health, Dietary Guidelines for 
Americans,'
* * *.'' In light of the change in focus of this claim to soluble fiber 
from whole oats and in the absence of dietary guidelines specific for 
soluble fiber, the agency is revising this statement to keep it 
consistent with ``Dietary Guidelines for Americans.'' Therefore, 
Sec. 101.81(d)(5) now states ``* * * a diet low in saturated fat and 
cholesterol that includes soluble fiber from whole oats'' is consistent 
with the dietary guidelines.

E. Other Comments

1. Implied Claims
(Comment 18)
    Some comments expressed concern that, if FDA authorizes a health 
claim that specifically mentions an oat ingredient, e.g., oat bran, 
oatmeal, or whole oats, these terms will imply, wherever they appear, 
that the food provides the effect described in the claim. One comment 
suggested specific limitations on how label statements about oat 
ingredients in a food could be used, depending on the nature and amount 
of soluble fiber in the food.
    Another comment noted that in the regulation on implied nutrient 
content claims (Sec. 101.65(c)(3)) and FDA's discussion of implied 
claims in the January 6, 1993, final rule on nutrient content claims 
(58 FR at 2374), the agency had provided that in some contexts terms 
like ``made with oat bran'' or ``oat bran muffins'' would be considered 
to imply that the food was a good source of dietary fiber. This comment 
stated that once the health claim appears on food labels, consumers 
will interpret the terms as implying the presence of a significant 
amount of -glucan soluble fiber consistent with the message of 
the claim. The comment stated that, therefore, any such oat ingredient 
implied nutrient content claim should be regulated as a claim about the 
amount of -glucan soluble fiber rather than as a more general 
claim about dietary fiber.
    Recognizing that current FDA regulations do not permit ``good 
source'' or ``high in'' claims about soluble fiber in general or about 
-glucan in particular, the comment suggested that FDA provide 
advice in this final rule that such claims could be made using the 
soluble fiber intake recommendations cited in the regulation 
authorizing health claims about soluble-fiber containing fruits, 
vegetables, and grain products and CHD (Sec. 101.77). In the preamble 
to the final rule establishing Sec. 101.77 (58 FR 2573 through 2574), 
FDA had explained that the 0.6 g soluble fiber eligibility criterion 
for bearing the claim derives from 10 percent of the Life Science 
Research Organization (LSRO) recommended daily intake of soluble fiber, 
i.e., about 6 g (Ref. 7).
    Another comment disagreed with this suggestion, however, stating 
that it would require decisions that are outside the scope of this 
proposal. The comment stated that the proposal made no mention of the 
possibility of a nutrient content claim regulation arising from the 
proposed health claim rule. In addition, the comment stated that it 
would be speculative to conclude that any declaration (outside the 
ingredient list) on the label of the whole oat substance identified in 
the health claim regulation would constitute a nutrient content claim. 
The comment stated that the impact of label references to oats will 
depend on a variety of factors: The extent of the market penetration of 
the oats/CHD claim; the manner in which consumers who became aware of 
the claim perceive that claim; whether the claim leads consumers to 
become aware of -glucan at all; and whether they consider it 
beyond its role as a marker for measuring the effectiveness of oats

[[Page 3597]]

in improving serum cholesterol levels. On the basis that this kind of 
information is not available at this time, the comment opined that FDA 
should not adopt any final rules until it has more information on these 
issues.
    The agency agrees that a final regulation defining a nutrient 
content claim is outside the scope of the proposal. FDA also agrees 
with the comment that it would be premature for the agency to conclude 
that all declarations of relevant oat ingredients on a food label 
(other than in the ingredient list) are implied claims. The regulation 
establishing general principles for health claims states that implied 
health claims ``include those statements, * * * that suggest, within 
the context in which they are presented, that a relationship exists 
between the presence or level of a substance in the food and a disease 
or health-related condition'' (Sec. 101.14(a)(1)). In the preamble for 
that regulation (58 FR 2478 at 2483), FDA stated that it could not 
establish a bright line definition of implied health claims, and that 
labeling claims needed to be considered in their entirety and in 
context to determine whether the elements of a health claim are 
present. The agency took a similar position in the preamble of the 
final rule establishing regulations for nutrient content claims (58 FR 
2370 through 2374). In that document, FDA stated that whether a label 
statement is a nutrient content claim will depend on the context in 
which it is presented, taking the entire label into consideration.
    To change this position and find that terms such as ``oat bran,'' 
``rolled oats,'' or ``whole oat flour'' are always in a context that 
constitutes a nutrient content or health claim, FDA would need 
information that it does not have. The agency would need data showing 
that consumers consistently interpret these terms as implying the 
presence of a significant amount of -glucan, or that 
consumption of the food will affect the risk of CHD. The comments did 
not provide this or any other kind of information that FDA could use as 
a basis for the requested policy.
    While FDA remains concerned that label statements not be 
misleading, it agrees with the comment that its policy of evaluating 
label statements on a case-by-case basis provides adequate control. The 
agency reviews the entire label to assess what emphasis is being placed 
on the specific ingredients named. However, if experience with label 
statements about oat ingredients or other information persuades FDA 
that additional regulatory controls are needed, the agency can take 
action to establish appropriate regulations.
    In addition, FDA advises that, as discussed previously in response 
to comment 5 in section II.A.5. of this document, the agency intends to 
propose to establish a DRV for soluble fiber, which will provide the 
basis for nutrient content claims like ``good source of soluble fiber'' 
and ``high in soluble fiber.'' The information in the comment 
recommending use of 6 g as the DV can be fully evaluated in the 
rulemaking to establish the DV for soluble fiber.
2. Reference to Authoritative Bodies
(Comment 19)
    One comment suggested permitting reference to third party 
authoritative bodies, including FDA, as part of the health claim. It 
was noted that in the FDA health claims study (Ref. 53), consumers 
expressed skepticism about health claims on food packages, in large 
part because they did not realize health information on the front of 
the package was regulated.
    The agency advises that issues related to making specific provision 
for reference to authoritative bodies as part of health claims 
statements is outside the scope of this rulemaking. Under the statute, 
FDA evaluates the relationship between a nutrient or food and a disease 
being advanced as the subject of a health claim. FDA authorization 
reflects a determination that there is significant scientific agreement 
that the relationship is supported by the totality of publicly 
available data. Once a health claim has been authorized by the agency, 
specific claims on labels are not subject to prior review or approval 
because the agency does not approve specific claims (see section 
3(b)(1)(A)(vii) of the 1990 amendments). Therefore, the agency does not 
agree that citing FDA as an authoritative body is appropriate. Under 
the general principles for health claims, Sec. 101.14(a)(1), the agency 
defines a health claim as including ``third party'' references, so it 
does not object to the use of other third party endorsements, provided 
the food complies with all requirements of the claim, and the statement 
of endorsement is not false or misleading.
3. RACC
(Comment 20)
    One comment requested that FDA reevaluate its established RACC for 
flavored instant oat products. The comment suggested that the RACC for 
flavored sweetened hot cereals should be lowered from 55 g to 40 g 
which is the RACC for regular rolled oats.
    This issue is outside the scope of this rulemaking. This rulemaking 
addresses the question of whether to authorize a claim regarding the 
association between oat bran and rolled oats and the risk of CHD. The 
process for amending a reference amount is set forth in Sec. 101.12.
4. Oat Gum Product
(Comment 21)
    One comment stated that, in the proposal, the agency incorrectly 
concluded that the oat gum product used in the study by Braaten et al. 
(Ref. 12), had not been characterized. The comment stated that the gum 
was thoroughly described and characterized in other studies that were 
cited in the Braaten et al. study, and requested that FDA correct this 
statement to make clear that the gum had in fact been characterized. 
The comment included a copy of the studies but made no other request 
relative to consideration of these data.
    The agency acknowledges that the oat gum used in the study by 
Braaten and coworkers was characterized in the information and studies 
submitted with the comment (Refs. 56, 59, and 76). The agency notes, 
however, that this additional information was not submitted with the 
petition and was, therefore, not part of the administrative record 
available to the agency at the time of the proposal. The studies 
submitted with the comment do not alter the outcome of this final 
rulemaking because oat gum, a purified extract of oat bran, is not a 
whole grain oat product and was not one of the substances that was the 
subject of the petition. Although whole oat flour was not one of the 
substances in the petition, the agency has included it in this final 
rule because it is a whole grain oat product with similar nutritional 
properties to rolled oats, and there were sufficient data in the 
administrative record from which to evaluate its physiological 
effectiveness. This type of evidence for purified oat gum is not 
available in the administrative record. A manufacturer may petition to 
amend Sec. 101.81 to include oat gum by submitting such data.

III. Decision to Authorize a Health Claim on the Relationship 
Between Soluble Fiber From Whole Oats and CHD

    FDA has considered all of the comments that it received in response 
to its proposal to authorize a claim to describe the relationship 
between oat bran and rolled oats and the risk of CHD. The agency is 
authorizing this claim although, based on comments, FDA has been 
persuaded to make a

[[Page 3598]]

number of changes in the proposed provisions for the health claim.
    FDA concludes that, rather than oat bran and rolled oats, the food 
substance that is the subject of the claim is -glucan soluble 
fiber from whole oats. FDA further determines that the relationship is 
scientifically valid in that there is significant scientific agreement 
based on the totality of publicly available scientific evidence that 
-glucan soluble fiber from whole oats, as part of a diet low 
in saturated fat and cholesterol, may reduce the risk of CHD. Decisions 
relating to provisions for an abbreviated version of the claim have 
been deferred and will be handled in a separate rulemaking.

IV. Environmental Impact

    The agency has previously considered the environmental effects of 
this rule as announced in the proposed rule (61 FR 296). At that time, 
the agency determined under 21 CFR 25.24(a)(11) that this action is of 
a type that does not individually or cumulatively have a significant 
effect on the human environment. No new information or comments have 
been received that would affect the agency's previous determination 
that there is no significant impact on the human environment and that 
an environmental impact statement is not required.

V. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select the regulatory approach that maximizes net benefits 
(including potential economic, environmental, public health and safety 
effects; distributive impacts; and equity).
    Executive Order 12866 classifies a rule as significant if it meets 
any one of a number of specified conditions, including having an annual 
effect on the economy of $100 million or adversely affecting in a 
material way a sector of the economy, competition, or jobs, or if it 
raises novel legal or policy issues. If a rule has a significant 
economic impact on a substantial number of small entities, the 
Regulatory Flexibility Act requires agencies to analyze regulatory 
options that would minimize the economic impact of that rule on small 
entities. FDA finds that this final rule is not a significant rule as 
defined by Executive Order 12866 and finds under the Regulatory 
Flexibility Act that the final rule will not have a significant impact 
on a substantial number of small entities.
    The authorization of health claims about the relationship between 
-glucan soluble fiber from whole oats and CHD results in 
benefits and in costs only to the extent that food manufacturers elect 
to take advantage of the opportunity to use the claim. This rule will 
not require that any labels be redesigned, or that any product be 
reformulated.
    The benefit of authorizing this type of health claim is to provide 
for new information in the market in the form of a claim linking 
consumption of soluble fiber from whole oats to the risk of CHD.
    Costs will be incurred by small entities only if they opt to take 
advantage of the marketing opportunity presented by this regulation. 
FDA cannot predict the number of small entities that will choose to use 
the claim. However, no firm, including small entities, will choose to 
bear the cost of redesigning labels unless they believe the claim will 
result in increased sales of their product. Therefore, this rule will 
not result in either a decrease in revenues or a significant increase 
in costs to any small entity. Accordingly, under the Regulatory 
Flexibility Act, 5 U.S.C. 605(b), the Secretary certifies that this 
final rule will not have a significant economic impact on a substantial 
number of small entities.

VI. Paperwork Reduction Act

    This final rule contains no information collection or recordkeeping 
requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
et seq.).

VII. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a. m. and 4 p. m., Monday through Friday.
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Products and Coronary Heart Disease,'' March 22, 1995 [CP1].
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Technology, 2:85-91, 1978.

[[Page 3599]]

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[[Page 3600]]

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Scale Preparation and Properties of Oat Fractions Enriched in (1 
3)(1 4)--D-Glucan,'' Cereal Chemistry, 66:97-103, 1989.
    77. LSRO, FASEB, ``Third Report on Nutrition Monitoring in the 
United States--Executive Summary,'' U.S. Government Printing Office, 
Washington, DC, pp. ES-1-ES-5, 1995.

List of Subjects in 21 CFR Part 101

    Food labeling, Incorporation by reference, 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 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, 501, 
502, 505, 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321, 342, 343, 348, 351, 352, 355, 371).

    2. New Sec. 101.81 is added to subpart E to read as follows:


Sec. 101.81  Health claims: Soluble fiber from whole oats and risk of 
coronary heart disease (CHD).

    (a) Relationship between diets low in saturated fat and cholesterol 
that include soluble fiber from whole oats and risk of coronary heart 
disease--(1) Cardiovascular disease means diseases of the heart and 
circulatory system. Coronary heart disease (CHD) is one of the most 
common and serious forms of cardiovascular disease and refers to 
diseases of the heart muscle and supporting blood vessels. High blood 
total cholesterol and low density lipoprotein (LDL)-cholesterol levels 
are associated with increased risk of developing coronary heart 
disease. High CHD rates occur among people with high total cholesterol 
levels of 240 milligrams per deciliter (mg/dL) (6.21 (mmol/L)) or above 
and LDL-cholesterol levels of 160 mg/dL (4.13 mmol/L) or above. 
Borderline high risk total cholesterol levels range from 200 to 239 mg/
dL (5.17 to 6.18 mmol/L) and 130 to 159 mg/dL (3.36 to 4.11 mmol/L) of 
LDL-cholesterol. The scientific evidence establishes that diets high in 
saturated fat and cholesterol are associated with increased levels of 
blood total- and LDL-cholesterol and, thus, with increased risk of CHD.
    (2) Populations with a low incidence of CHD tend to have relatively 
low blood total cholesterol and LDL-cholesterol levels. These 
populations also tend to have dietary patterns that are not only low in 
total fat, especially saturated fat and cholesterol, but are also 
relatively high in fiber-containing fruits, vegetables, and grain 
products, such as whole oat products.
    (3) Scientific evidence demonstrates that diets low in saturated 
fat and cholesterol may reduce the risk of CHD. Other evidence 
demonstrates that the addition of soluble fiber from whole oats to a 
diet that is low in saturated fat and cholesterol may also help to 
reduce the risk of CHD.
    (b) Significance of the relationship between diets low in saturated 
fat and cholesterol that include soluble fiber from whole oats and risk 
of CHD--(1) CHD is a major public health concern in the United States. 
It accounts for more deaths than any other disease or group of 
diseases. Early management of risk factors for CHD is a major public 
health goal that can assist in reducing risk of CHD. High blood total 
and LDL-cholesterol are major modifiable risk factors in the 
development of CHD.
    (2) Intakes of saturated fat exceed recommended levels in the diets 
of many people in the United States. One of the major public health 
recommendations relative to CHD risk is to consume less than 10 percent 
of calories from saturated fat and an average of 30 percent or less of 
total calories from all fat. Recommended daily cholesterol intakes are 
300 milligrams (mg) or less per day. Scientific evidence demonstrates 
that diets low in saturated fat and cholesterol are associated with 
lower blood total and LDL-cholesterol levels. Soluble fiber from whole 
oats, when added to a low saturated fat and cholesterol diet, also 
helps to lower blood total and LDL-cholesterol levels.
    (c) Requirements--(1) All requirements set forth in Sec. 101.14 
shall be met.
    (2) Specific requirements--(i) Nature of the claim. A health claim 
associating diets low in saturated fat and cholesterol that include 
soluble fiber from whole oats with reduced risk of heart disease may be 
made on the label or labeling of a food described in paragraph 
(c)(2)(iii) of this section, provided that:
    (A) The claim states that diets low in saturated fat and 
cholesterol that include soluble fiber from whole oats ``may'' or 
``might'' reduce the risk of heart disease;
    (B) In specifying the disease, the claim uses the following terms: 
``heart disease'' or ``coronary heart disease'';
    (C) 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

[[Page 3601]]

soluble fiber (provided in paragraph (c)(2)(ii)) of this section or the 
name of the food product;
    (D) In specifying the fat component, the claim uses the terms 
``saturated fat'' and ``cholesterol'';
    (E) The claim does not attribute any degree of risk reduction for 
CHD to diets low in saturated fat and cholesterol that include soluble 
fiber from whole oats; and
    (F) The claim does not imply that consumption of diets low in 
saturated fat and cholesterol that include soluble fiber from whole 
oats is the only recognized means of achieving a reduced risk of CHD.
    (ii) Nature of the substance. Eligible sources of soluble fiber.
    (A) Beta () glucan soluble fiber from the whole oat 
sources listed below. -glucan soluble fiber will be determined 
by method No. 992.28 from the ``Official Methods of Analysis of the 
Association of Official Analytical Chemists International,'' 16th ed. 
(1995), which is incorporated by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. Copies may be obtained from the Association 
of Official Analytical Chemists International, 481 North Frederick 
Ave., suite 500, Gaithersburg, MD 20877-2504, or may be examined at the 
Center for Food Safety and Applied Nutrition's Library, 200 C St. SW., 
rm. 3321, Washington, DC, or at the Office of the Federal Register, 800 
North Capitol St. NW., suite 700, Washington, DC;
    (1) Oat bran. Oat bran is produced by grinding clean oat groats or 
rolled oats and separating the resulting oat flour by suitable means 
into fractions such that the oat bran fraction is not more than 50 
percent of the original starting material and provides at least 5.5 
percent (dry weight basis (dwb)) -glucan soluble fiber and a 
total dietary fiber content of 16 percent (dwb), and such that at least 
one-third of the total dietary fiber is soluble fiber;
    (2) Rolled oats. Rolled oats, also known as oatmeal, produced from 
100 percent dehulled, clean oat groats by steaming, cutting, rolling, 
and flaking, and provides at least 4 percent (dwb) of -glucan 
soluble fiber and a total dietary fiber content of at least 10 percent.
    (3) Whole oat flour. Whole oat flour is produced from 100 percent 
dehulled, clean oat groats by steaming and grinding, such that there is 
no significant loss of oat bran in the final product, and provides at 
least 4 percent (dwb) of -glucan soluble fiber and a total 
dietary fiber content of at least 10 percent (dwb).
    (B) [Reserved]
    (iii) Nature of the Food Eligible to Bear the Claim.
    (A) 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;
    (B) The amount of soluble fiber shall be declared in the nutrition 
label, consistent with Sec. 101.9(c)(6)(i)(A).
    (C) The food shall meet the nutrient content requirements in 
Sec. 101.62 for a ``low saturated fat,'' ``low cholesterol,'' and ``low 
fat'' food.
    (d) Optional information--(1) The claim may state that the 
development of heart disease depends on many factors and may identify 
one or more of the following risk factors for heart disease about which 
there is general scientific agreement: A family history of CHD; 
elevated blood total and LDL-cholesterol; excess body weight; high 
blood pressure; cigarette smoking; diabetes; and physical inactivity. 
The claim may also provide additional information about the benefits of 
exercise and management of body weight to help lower the risk of heart 
disease;
    (2) The claim may state that the relationship between intake of 
diets low in saturated fat and cholesterol that include soluble fiber 
from whole oats and reduced risk of heart disease is through the 
intermediate link of ``blood cholesterol'' or ``blood total- and LDL-
cholesterol;''
    (3) The claim may include information from paragraphs (a) and (b) 
of this section, which summarize the relationship between diets low in 
saturated fat and cholesterol that include soluble fiber from whole 
oats and coronary heart disease and the significance of the 
relationship;
    (4) The claim may specify the name of the eligible soluble fiber;
    (5) The claim may state that a diet low in saturated fat and 
cholesterol that includes soluble fiber from whole oats is consistent 
with ``Nutrition and Your Health: Dietary Guidelines for Americans,'' 
U.S. Department of Agriculture (USDA) and Department of Health and 
Human Services (DHHS), Government Printing Office (GPO);
    (6) A claim based on -glucan soluble fiber from whole oats 
may state that an intake of 3 g or more per day of -glucan 
soluble fiber from whole oats may help reduce the risk of CHD, provided 
that the claim also states the contribution one serving of the product 
makes to this specified intake level for -glucan soluble 
fiber;
    (7) The claim may state that individuals with elevated blood total- 
and LDL-cholesterol should consult their physicians for medical advice 
and treatment. If the claim defines high or normal blood total- and 
LDL-cholesterol levels, then the claim shall state that individuals 
with high blood cholesterol should consult their physicians for medical 
advice and treatment;
    (8) The claim may include information on the number of people in 
the United States who have heart disease. The sources of this 
information shall be identified, and it shall be current information 
from the National Center for Health Statistics, the National Institutes 
of Health, or ``Nutrition and Your Health: Dietary Guidelines for 
Americans,'' USDA and DHHS, GPO;
    (e) Model health claim. The following model health claims may be 
used in food labeling to describe the relationship between diets low in 
saturated fat and cholesterol that include soluble fiber from whole 
oats and reduced risk of heart disease:
    (1) Soluble fiber from foods such as [name of soluble fiber source 
from paragraph (c)(2)(ii) of this section or 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 or name of food product] may reduce the risk of heart 
disease.

    Dated: January 9, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-1598 Filed 1-22-97; 8:45 am]
BILLING CODE 4160-01-F