Food Labeling: Health Claims; Oats and Coronary Heart Disease

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

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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

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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).

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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.

1. The Quaker Oats Company, ``Petition for Health Claim--Oat

Products and Coronary Heart Disease,'' March 22, 1995 [CP1].

2. Scarbrough, F. Edward, CFSAN, FDA, Letter to Ted Moeller,

Quaker Oats Company, June 29, 1995.

3. DHHS, Public Health Service (PHS), ``The Surgeon General's

Report on Nutrition and Health,'' U.S. Government Printing Office,

Washington, DC, 1988.

4. National Research Council, National Academy of Sciences,

``Diet and Health,'' National Academy Press, Washington, DC, 1989.

5. DHHS, PHS and the National Institutes of Health (NIH),

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on Detection, Evaluation, and Treatment of High Blood Cholesterol in

Adults,'' NIH, Bethesda, MD, 1989.

6. DHHS, PHS and the National Institutes of Health, ``National

Cholesterol Education Program: Population Panel Report,'' Bethesda,

MD, 1989.

7. LSRO, FASEB, ``Physiological Effects and Health Consequences

of Dietary Fiber,'' Bethesda, MD, 1987.

8. Anderson, J. W., N. H. Gilinsky, D. A. Deakins, S. F. Smith,

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Hypercholesterolemic Men to Oat-bran and Wheat Bran Intake,''

American Journal of Clinical Nutrition, 54:678-83, 1991.

9. Anderson, J. W., D. B. Spencer, C. C. Hamilton, S. F. Smith,

J. Tietyen, C. A. Bryant, and P. Oeltgen,``Oat-bran Cereal Lowers

Serum Total and LDL Cholesterol in Hypercholesterolemic Men,''

American Journal of Clinical Nutrition, 52:495-499, 1990.

10. Bartram, P., S. Gerlach, W. Scheppach, F. Keller, and H.

Kasper, ``Effect of a Single Oat Bran Cereal Breakfast on Serum

Cholesterol, Lipoproteins, and Apolipoproteins in Patients with

Hyperlipoproteinemia Type IIa,'' Journal of Parenteral and Enteral

Nutrition, 16:533-537, 1992.

11. Beling, S., L. Detrick, and W. Castelli, ``Serum Cholesterol

Response to a Processed Oat Bran Cereal Among Hypercholesterolemics

on a Fat-modified Diet,'' unpublished clinical trial submitted by

the Quaker Oats Co., 1991.

12. Braaten, J. T., P. J. Wood, F. W. Scott, M. S. Wolyneta, M.

K. Lowe, P. Bradley-White, M. W. Collins, ``Oat Beta-glucan Reduces

Blood Cholesterol Concentration in Hypercholesterolemic Subjects,''

European Journal of Clinical Investigation, 48:465-474, 1994.

13. Bremer, J. M., R. S. Scott, and C. J. Lintott, ``Oat Bran

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Australia and New Zealand Journal of Medicine, 21:422-426, 1991.

14. Cara, L., C. Cubois, P. Borel, M. Armand, M. Senft, H.

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Lipemia in Healthy Adults,'' American Journal of Clinical Nutrition,

55:81-88, 1992.

15. Davidson, M. H., L. D. Dugan, J. H. Burns, J. Bova, K.

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of the American Medical Association, 265(14):1833-39, 1991.

16. Demark-Wahnefried, W., J. Bowering, and P. S. Cohen,

``Reduced Serum Cholesterol with Dietary Change Using Fat-modified

and Oat Bran Supplemented Diets,'' Journal of the American Dietetic

Association, 90:223-9, 1990.

17. Gold, K. V. and D. M. Davidson, ``Oat Bran as a Cholesterol-

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Journal of Medicine, 148:299-302, 1988.

18. Gormley, T. R., J. Kevany, J. P. Egan, and R. McFarland,

``Investigation of the Potential of Porridge as a

Hypocholesterolemic Agent,'' Israel Journal of Food Science and

Technology, 2:85-91, 1978.

[[Page 3599]]

19. He, J., M. J. Klag, P. K. Whelton, J-P. Mo, J-Y. Chen, P-S.

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20. Hegsted, M., M. M. Windhauser, K. Morris, and S. B. Lester,

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21. Kahn, R. F., K. W. Davidson, J. Garner, and R. S. McCord,

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22. Kastan, H. H., S. Stern, D. J. A. Jenkins, K. Hay, N.

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Journal of Clinical Nutrition, 55:976-980, 1992.

23. Keenan, J. M., J. B. Wenz, S. Myers, C. Ripsin, and Z.

Huang, ``Randomized Controlled Cross-over Trial of Oat Bran in

Hypercholesterolemic Subjects,'' Journal of Family Practice, 33:600-

608, 1991.

24. Kelley, M. J., J. Hoover-Plow, J. F. Nichols-Bernhard, L. S.

Verity, and H. B. Brewer, ``Oat Bran Lowers Total and Low-Density

Lipoprotein Cholesterol but not Lipoprotein in Exercising Adults

with Borderline Hypercholesterolemia,'' Journal of the American

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25. Kestin, M., R. Moss, P. M. Clifton, and P. J. Nestel,

``Comparative Effects of Three Cereal Brans on Plasma Lipids, Blood

Pressure, and Glucose Metabolism in Mildly Hypercholesterolemic

Men,'' American Journal of Clinical Nutrition, 52:661-6, 1990.

26. Leadbetter, J., M. J. Ball, and J. I. Mann, ``Effects of

Increasing Quantities of Oat Bran in Hypercholesterolemic People,''

American Journal of Clinical Nutrition, 54:841-845, 1991.

27. Lepre, F. and S. Crane, ``Effect of Oat Bran on Mild

Hyperlipidaemia,'' The Medical Journal of Australia, 157:305-306,

1992.

28. Mackay, S. and M. J. Ball, ``Do Beans and Oat Bran Add to

the Effectiveness of a Low-fat Diet?'', European Journal of Clinical

Nutrition, 46:641-648, 1992.

29. Marlett, J. A., K. B. Hosig, N. W. Vollendorf, F. L.

Shinnick, V. S. Haack, and J. A. Story, ``Mechanism of Serum

Cholesterol Reduction by Oat Bran,'' Hepatology, 20:1450-1457, 1994.

30. O'Brien, L. T., R. J. Barnard, and J. A. Hall, ``Effects of

a High-Complex-Carbohydrate Low-Cholesterol Diet Plus Bran

Supplement on Serum Lipids,'' Journal of Applied Nutrition, 37:26-

34, 1985.

31. O'Kell, R. T. and A. A. Duston, ``Lack of Effect of Dietary

Oats on Serum Cholesterol,'' Missouri Medicine, 85:726-728, 1988.

32. Poulter, N., C. L. Chang, A. Cuff, C. Poulter, P. Sever, and

S. Thom, ``Lipid Profiles After the Daily Consumption of an Oat-

based Cereal: A Controlled Crossover Trial,'' American Journal of

Clinical Nutrition, 58:66-69, 1993.

33. Ripsin, C. M., J. M. Keenan, D. R. Jacobs, P. J. Elmer, R.

R. Welch, L. Van Horn, K. Liu, W. H. Turnbull, F. W. Thye, M.

Kestin, M. Hegsted, D. M. Davidson, M. H. Davidson, L. D. Dugan, W.

Demark-Wahnefried, and S. Beling, ``Oat Products and Lipid

lowering--A Meta-analysis,'' Journal of the American Medical

Association, 267:3317-3325, 1992.

34. Saudia, T. L., B. R. Barfield, and J. Barger, ``Effect of

Oat Bran Consumption on Total Serum Cholesterol Levels in Healthy

Adults,'' Military Medicine, 157:567-568, 1992.

35. Spiller, G. A., J. W. Farquhar, J. E. Gates, and S. F.

Nichols, ``Guar Gum and Plasma Cholesterol, Effect of Guar Gum and

an Oat Fiber Source on Plasma Lipoproteins and Cholesterol in

Hypercholesterolemic Adults,'' Arteriosclerosis and Thrombosis,

11:1204-1208, 1991.

36. Stewart, F. M., J. M. Neutze, and R. Newsome-White, ``The

Addition of Oat Bran to a Low Fat Diet has no Effect on Lipid Values

in Hypercholesterolaemic Subjects,'' New Zealand Medical Journal,

106:398-340, 1992.

37. Swain, J. F., I. L. Rouse, C. B. Curley, and F. M. Sacks,

``Comparison of the Effects of Oat Bran and Low Fiber Wheat on Serum

Lipoprotein Levels and Blood Pressure'' New England Journal of

Medicine, 322:147-52, 1990.

38. Torronen, R., L. Kansanen, M. Uusitupa, O. Hanninen, O.

Myllymaki, H. Harkonen, and Y. Malkki, ``Effects of an Oat Bran

Concentrate on Serum Lipids in Free-living Men with Mild to Moderate

Hypercholesterolaemia,'' European Journal of Clinical Nutrition,

46:621-627, 1992.

39. Turnbull, W. H. and A. R. Leeds, ``Reduction of Total and

LDL-cholesterol in Plasma by Rolled Oats,'' Journal of Clinical

Nutrition and Gastroenterology,, 2:1-4, 1987.

40. Grover, S. A., M. Abrahamowicz, L. Joseph, C. Brewer, L.

Coupal, S. Suissa, ``The Benefits of Treating Hyperlipidemia to

Prevent Coronary Heart Disease,'' Journal of the American Medical

Association, 267: 816-822, 1992.

41. Uusitupa, M. I. J., E. Ruuskanen, E. Makinen, J. Laitinen,

E. Toskala, K. Kervinen, and A. Kesaniemi, ``A Controlled Study on

the Effect of Beta-glucan-rich Oat Bran on Serum Lipids in

Hypercholesterolemic Subjects: Relation to Apolipoprotein E

Phenotype,'' Journal of the American College of Nutrition, 11:651-

659, 1992.

42. Van Horn, L., L. A. Emidy, K. Liu, Y. Liao, C. Ballew, J.

King, and J. Stamler, ``Serum Lipid Response to a Fat-modified,

Oatmeal-enhanced Diet,'' Preventive Medicine, 17:377-386, 1988.

43. Van Horn, L., K. Liu, D. Parker, L. Emidy, Y. Liao, W. H.

Pan, D. Giumetti, J. Hewitt, and J. Stamler, ``Serum Lipid Response

to Oat Product Intake with a Fat-modified Diet,'' Journal of the

American Dietetic Association, 86:759-764, 1986.

44. Van Horn, L., A. Moag-Stahlberg, K. Liu, C. Ballew, K. Ruth,

R. Hughes, J. Stamler, ``Effects on Serum Lipids of Adding Instant

Oats to Usual American Diets,'' American Journal of Public Health,

81:183-88, 1991.

45. Whyte, J., R. McArthur, D. Topping, and P. Nestel, ``Oat

Bran Lowers Plasma Cholesterol in Mildly Hypercholesterolemic men,''

Journal of the American Dietetic Association, 92:446-449, 1992.

46. Zhang, J. G. Hallmans, H. Andersson, I. Bosaeur, P. Aman, P.

Tidehag, R. Stenling, E. Lundin, and S. Dahlgren, ``Effect of Oat

Bran on Plasma Cholesterol and Bile Acid Excretion in Nine Subjects

with Ileostomies,'' American Journal of Clinical Nutrition, 56:99-

105, 1992.

47. Sempos, C. T., J. I. Cleeman, M. D. Carroll, C. L. Johnson,

P. S. Bachorik, D. J. Gordon, V. L. Burt, R. R. Briefel, C. D.

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the Second Report of the National Cholesterol Education Program

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1992.

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51. Schultz, William B., FDA, Letter to John R. Cady, National

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1034, 1989.

53. Levy, A., CFSAN, FDA, ``Summary Report on Health Claims

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54. Derby, B., CFSAN, FDA, Memorandum to Victor Frattali,

October 25, 1995.

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59. Wood, P. J., J. T. Braaten, F. W. Scott, D. Riedel, and L.

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Viscous Properties of Oat Gum on Plasma Glucose and Insulin

Following an Oral Glucose Load,'' British Journal of Nutrition,

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Serum Lipids,'' Unpublished study, 1996. (See comments C-1197 and

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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