Food Labeling: Health Claims; Oats and Coronary Heart Disease

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 95P-0197]

RIN 0910-AA19

Food Labeling: Health Claims; Oats and Coronary Heart Disease

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to

authorize the use, on food labels and in food labeling, of health

claims on the association between oat products, i.e., oat bran and

oatmeal, and reduced risk of coronary heart disease (CHD). FDA is

proposing this action in response to a petition filed by the Quaker

Oats Co. (the petitioner). The agency has tentatively concluded that,

based on the totality of publicly available scientific evidence, diets

high in oatmeal and oat bran and low in saturated fat and cholesterol

may reduce the risk of CHD.

DATES: Written comments by April 3, 1996. The agency is proposing that

any final rule that may issue based upon this proposal become effective

upon its publication in the Federal Register.

ADDRESSES: Written comments to the Dockets Management Branch (HFA-305),

Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville,

MD 20857.

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

A. The Nutrition Labeling and Education Act of 1990

On November 8, 1990, the President signed into law the Nutrition

Labeling and Education Act of 1990 (the 1990 amendments) (Pub. L. 101-

535). This new law amended the Federal Food, Drug, and Cosmetic Act

(the act) in a number of important ways. One of the most notable

aspects of the 1990 amendments was that they confirmed FDA's authority

to regulate health claims on food labels and in food labeling. As

amended by the 1990 amendments, section 403(r)(1)(B) of the act (21

U.S.C. 343(r)(1)(B)) provides that a product is misbranded if it bears

a claim that characterizes the relationship of a nutrient to a disease

or health-related condition, unless the claim is made in accordance

with the procedures and standards contained in regulations adopted by

FDA.

Under section 403(r)(3)(B)(i) of the act, the Secretary of Health

and Human Services (and, by delegation, FDA) shall issue regulations

authorizing such 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.

Sections 403(r)(3)(B)(ii) and (r)(3)(B)(iii) of the act describe

the information that must be included in any claim authorized under the

act. The act provides that the claim shall be an accurate

representation of the significance of the substance in affecting the

disease or health-related condition, and that it shall enable the

public to comprehend the information and understand its significance in

the context of the total daily diet. Finally, section 403(r)(4)(A)(i)

of the act provides that any person may petition FDA to issue a

regulation authorizing a health claim.

The 1990 amendments, in addition to amending the act, directed FDA

to consider 10 substance-disease relationships as possible subjects of

health claims. One of the 10 substance- disease relationships was the

relationship between dietary fiber and cardiovascular disease (CVD) (58

FR 2552, January 6, 1993) (hereinafter referred to as the 1993 dietary

fiber and CVD final rule).

B. FDA's Response

In the Federal Register of January 6, 1993 (58 FR 2478), FDA

adopted a final rule that implemented the health claim provisions of

the act (hereinafter referred to as the 1993 health claims final rule).

In that final rule, FDA adopted Sec. 101.14 (21 CFR 101.14), which sets

out the circumstances in which a substance is eligible to be the

subject of a health claim (Sec. 101.14(b)), adopts the standard in

section 403(r)(3)(B)(i) of the act as the standard that the agency will

apply in deciding whether to authorize a claim about a substance-

disease relationship (Sec. 101.14(c)), sets forth general rules on how

authorized claims are to be made in food labeling (Sec. 101.14(d)), and

establishes limitations on the circumstances in which claims can be

made (Sec. 101.14(e)). The agency also adopted Sec. 101.70 (21 CFR

101.70), which establishes a process for petitioning the agency to

authorize health claims about a substance-disease relationship

(Sec. 101.70(a)) and sets out the types of information that any such

petition must include (Sec. 101.70(d)). These regulations became

effective on May 8, 1993.

In addition, FDA conducted an extensive review of the evidence on

the 10 substance-disease relationships listed in the 1990 amendments.

As a result of its review, FDA has authorized claims that relate to 8

of these 10 relationships. While the agency denied the use on food

labeling of health claims relating dietary fiber to reduced risk of CVD

(58 FR 2552), it authorized a health claim relating diets low in

saturated fat and cholesterol and high in fruits, vegetables, and grain

products that contain dietary fiber (particularly soluble fiber) to a

reduced risk of CHD, the most common, most frequently reported, and

most serious form of CVD.

In denying the dietary fiber and CVD health claim, the agency

stated that a problem in determining whether there is a relationship

between dietary fiber and heart disease is presented by the fact that

dietary fiber is a diverse group of chemical substances that may be

associated with different physiological functions (58 FR 2552 at 2572).

Chemically and physiologically, cellulose, lignin, hemicellulose,

pectin, and alginate (all relatively purified fiber types) behave

differently. Wheat bran, oat bran, and rice bran (all heterogeneous

mixtures of fibers) are not similar in composition. The agency also

noted that it is very difficult to chemically analyze dietary fiber

components, and that it is consequently hard to correlate the role of

specific fiber components to health effects.

Based on its review of numerous authoritative documents, including

Federal government reports and recent research on dietary fiber and

CHD, and on its consideration of comments received in response to its

``Health Claims; Dietary Fiber and Cardiovascular Disease'' proposed

rule (56 FR 60582, November 27, 1991) (hereinafter referred to as the

1991 dietary fiber and CVD proposal), FDA concluded that the publicly

available scientific evidence supports an association between diets low

in saturated fat and cholesterol and high in fruits, vegetables, and

grain products, foods that are low in saturated fat and cholesterol and

that are good sources of dietary fiber, and reduced risk of heart

disease (58 FR 2552 at 2572). The

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agency further stated that, although the specific roles of the numerous

potentially protective substances in such plant foods are not yet

understood, populations with diets rich in these foods experience many

health advantages, including lower rates of heart disease. The agency

noted, however, that there was no scientific agreement as to whether

the observed protective effects against heart disease are the result of

a combination of nutrient components of the foods, including soluble

fiber; of the other components of soluble fiber-rich diets (for

example, potassium and magnesium); of the displacement of saturated fat

and cholesterol from the diet; or of non-nutritive substances in these

foods. For all these reasons, the agency stated that the fact that

these foods contain dietary fiber, particularly soluble fiber, can

serve as a useful marker for identifying those fruits, vegetables, and

grain products that, when added to diets low in saturated fat and

cholesterol, may help in reducing blood LDL-cholesterol levels (58 FR

2552 at 2572). Thus, the agency authorized a health claim in

Sec. 101.77 (21 CFR 101.77) on the association between diets low in

saturated fat and cholesterol and high in vegetables, fruit, and grain

products that contain soluble fiber and a reduced risk of heart

disease.

In the 1993 dietary fiber and CVD final rule, in response to a

comment regarding the apparent hypocholesterolemic properties of

specific food fibers, e.g., oats, FDA agreed that the effectiveness of

naturally occurring fibers in foods may be documented for specific food

products (e.g., oat brans meeting specified parameters) (58 FR 2552 at

2567). Further, the agency stated that if manufacturers can document,

through appropriate studies, that dietary consumption of the soluble

fiber in their particular food has the effect of lowering low density

lipoprotein cholesterol (LDL)-cholesterol, and has no adverse effects

on other heart disease risk factors (e.g., high density lipoprotein

(HDL)-cholesterol), they should petition for a health claim for their

particular product.

The present rulemaking is in response to a manufacturer's health

claim petition on the relationship between a specific fiber-containing

food, oats, and heart disease.

II. Petition for Oat Products and Reduced Risk of CHD

A. Background

On March 22, 1995, the Quaker Oats Co. submitted a health claim

petition to FDA requesting that the agency authorize a health claim on

the relationship between consumption of oat products and the risk of

CHD (Ref. 1). On June 29, 1995, the agency sent the petitioners a

letter stating that it had completed its initial review of the

petition, and that the petition would be filed in accordance with

section 403(r)(4) of the act (Ref. 2). In this document, the agency

will consider whether a health claim on this food-disease relationship

is justified under the standard in section 403(r)(3)(B)(i) of the act

and Sec. 101.14(c) of FDA's regulations. The following is a review of

the health claim petition.

B. Preliminary Requirements

1. The Substances Are Associated With a Disease for Which the U.S.

Population Is at Risk

CHD remains a major public health problem and the number one cause

of death in the United States. Despite the decline in deaths from CHD

over the past 30 years, this disease is still exacting a tremendous

toll in morbidity and mortality (Refs. 3 and 4). There are more than

500,000 deaths each year for which CHD is an underlying cause, and

another 250,000 deaths for which CHD is a contributing cause. About 20

percent of adults (male and female; black and white) ages 20 to 74

years have blood total cholesterol (or serum cholesterol) levels in the

``high risk'' category (total cholesterol greater than (>) 240

milligrams (mg) per (/) deciliter (dL) and LDL-cholesterol greater than

160 mg/dL) (Ref. 47). Another 31 percent have ``borderline high''

cholesterol levels (total cholesterol between 200 and 239 mg/dL and

LDL-cholesterol between 130 and 159 mg/dL) in combination with two or

more risk factors.

CHD has a significant effect on health-care costs. In 1985, total

direct costs related to CHD were estimated at $13 billion, and indirect

costs from loss of productivity due to illness, disability, and

premature deaths from this disease were an estimated $36 billion (Ref.

3).

Based on these facts, FDA concludes that, as required in

Sec. 101.14(b)(1), CHD is a disease for which the U.S. population is at

risk.

2. The Substances Are Food

Oatmeal and oat bran are foods and are used as ingredients in other

foods. These oat products contribute taste, aroma, or nutritive value

that are retained when consumed at levels necessary to justify the

petitioned claim.

Therefore, FDA tentatively concludes that these substances satisfy

the preliminary requirements of Sec. 101.14(b)(3)(i).

3. The Substances Are Safe

Oatmeal and oat bran are safe and lawful under the act. Both

substances have a long history of use as food and food ingredients and

are generally recognized as safe under Sec. 170.30(d) (21 CFR

170.30(d)).

Thus, FDA tentatively concludes that the petitioner has satisfied

the requirement of Sec. 101.14(b)(3)(ii).

III. Review of Scientific Evidence

A. Basis for Evaluating the Relationship Between Oats and CHD

In the 1991 dietary fiber and CVD proposal, the agency set forth

the basis of the relationship between dietary fiber and CVD (56 FR

60582 at 60583). In that document, the agency stated that there are

many risk factors that contribute to the development of CVD, and

specifically CHD, the most serious form of CVD and the leading cause of

disability. The agency also stated that there is general agreement that

elevated blood cholesterol levels are one of the major ``modifiable''

risk factors in the development of CVD and, more specifically, CHD. The

Federal government and other reviews have concluded that there is

substantial epidemiologic and clinical evidence that high blood levels

of total cholesterol and LDL-cholesterol are a cause of atherosclerosis

(inadequate circulation of blood to the heart due to narrowing of the

arteries) and represent major contributors to CHD (56 FR 60727 at

60728, November 27, 1991; Refs. 3 through 6). Factors that decrease

total cholesterol and LDL-cholesterol will also tend to decrease the

risk of CHD. High intakes of saturated fat and, to a lesser degree, of

dietary cholesterol are associated with elevated blood total and LDL-

cholesterol levels (56 FR 60727 at 60728). Thus, it is generally

accepted that total cholesterol and LDL-cholesterol levels can predict

the risk of developing CHD, and that dietary factors affecting blood

total cholesterol levels affect the risk of CHD (Refs. 3 through 6).

When considering the effect that the diet or components of the diet

have on blood (or serum) lipids, it is also important to consider the

effect that these factors may have on blood levels of HDL-cholesterol.

Evidence from epidemiologic studies show that elevated levels of HDL-

cholesterol are inversely related to the incidence of atherosclerosis

and thus CHD (Ref. 3). HDL- cholesterol is involved in the regulation

of cholesterol transport out of

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cells and to the liver from which it is ultimately excreted (Refs. 3

and 48). Therefore, HDL-cholesterol has a protective effect in the body

by helping to lower total cholesterol. Dietary factors that help to

significantly lower total cholesterol should, themselves, not have an

adverse affect on the level of HDL-cholesterol.

For these reasons, FDA limited its review of the relationship

between oatmeal and oat bran and CHD to effects of these food

components on blood lipid levels and on the risk of developing CHD. The

agency based its evaluation of this relationship on changes in total

blood and LDL-cholesterol from dietary intervention with oatmeal and

oat bran and with oat- containing products. This focus is consistent

with that used by the agency in response to the 1990 amendments in

deciding on the dietary saturated fat and cholesterol and CHD health

claim (Sec. 101.75) (56 FR 60727 and 58 FR 2739, January 6, 1993) and

the fruits, vegetables, and grain products and CHD claim (Sec. 101.77)

(56 FR 60582 and 58 FR 2552).

B. Review of Scientific Evidence

1. Evidence Considered in Reaching the Decision

The petitioner submitted scientific studies evaluating the

relationship between oat bran and oatmeal, consumed as foods and as

ingredients in foods, and serum lipid levels (Ref. 1). These studies

were conducted between 1980 and 1995. The petition included a review of

these studies and a summary of the evidence. Most of the studies that

were published before 1993 had been reviewed by the agency in the

proposed and final rules on dietary fiber and CVD (56 FR 60582 at 60596

and 58 FR 2552 at 2581). A review of the studies evaluating the effect

of oat products on blood lipids submitted by the petitioner, including

those previously reviewed by the agency, is provided in Table 1. In

addition, in its review of the petition, the agency considered the

conclusions of the Life Sciences Research Office (LSRO) of the

Federation of American Societies for Experimental Biology (FASEB) (Ref.

7) relative to studies involving oats.

2. Criteria for Selection of Human Studies

The criteria that the agency used to select pertinent studies were

that the studies: (1) Present data and adequate descriptions of the

study design and methods; (2) be available in English; (3) include

estimates, or enough information to estimate, soluble dietary fiber

intakes; (4) include direct measurement of blood total cholesterol and

other blood lipids related to CHD; and (5) be conducted in persons who

represent the general U.S. population (adults with blood total

cholesterol levels less than (-glucan, the predominant soluble fiber in oats)

content of the oat products and control food; (3) measurement of study

endpoints (i.e., total cholesterol, LDL-cholesterol, and HDL-

cholesterol); and (4) general study design characteristics. The

characteristics of general study design included randomization of

subjects, appropriateness of controls, selection criteria for subjects,

attrition rates (including reasons for attrition), potential for

misclassification of individuals with regard to dietary intakes,

presence of recall bias and interviewer bias, recognition and control

of confounding factors (for example, intake of saturated fat and other

nutrients, monitoring body weight, and control of weight loss),

appropriateness of statistical tests and comparisons, and statistical

power of the studies. The agency considered whether the intervention

studies that it evaluated had been of long enough duration to

reasonably ensure stabilization of blood lipids (greater than or equal

to 3 weeks duration). Finally, the agency considered it highly

desirable if the available information on a study included information

on the total dietary fiber and total dietary soluble fiber content of

baseline, treatment, and control diets and on the nutrient intakes of

the subjects during the course of the study.

As stated above, dietary saturated fat and cholesterol affect blood

lipid levels (Refs. 4 through 6). Previous reviewers have generally

concluded that, in persons with relatively higher baseline levels of

blood cholesterol, responses to treatment tend to be of a larger

magnitude than is seen in persons with more normal blood cholesterol

levels (56 FR 60582 at 60587 and Refs. 4 through 6). To take into

account these factors, FDA separately evaluated studies on mildly to

moderately hypercholesterolemic individuals (persons with elevated

blood total cholesterol levels of 200 to 300 mg/dL) and studies on

normocholesterolemic individuals (persons with normal blood total

cholesterol levels (-glucan), an extract

of oat bran comprised of almost entirely -glucan soluble fiber

plus some trace elements, or a placebo (maltodextrin) when mixed with a

noncarbonated diet fruit drink (250 milliliters (mL)) and consumed

twice a day at each main meal for 4 weeks by hypercholesterolemic

subjects. Results showed significantly lower total cholesterol by 9.2

percent (p-glucan from oat bran on serum

cholesterol in 40 hypercholesterolemic men and women. Subjects consumed

0, 30, 60, or 90 g oat bran/day for 1-month intervals. The authors

stated that the New Zealand oats used in this study were lower in

soluble fiber (3.7 to 4.2 percent -glucan) than oat bran used

in studies that showed a significant lowering of serum cholesterol with

oat bran supplementation.

Saudia et al. (Ref. 34) reported no significant difference in serum

cholesterol levels in hypercholesterolemic subjects consuming oat bran

daily for 93 days. The subjects consumed 3 ounces (oz) (about 84 g) of

oat bran daily with their usual diet for 3 months. The subjects' total

dietary intake, including their intake of total and saturated fat and

cholesterol, before and during the trial were not reported. The authors

stated that the subjects may have changed their diets during the test

period because the study took place over summer months and because of

an increased awareness by the subjects of risk-reducing behavior and

lifestyles. The study also lacked a control group, thus making the

results of this study difficult to interpret.

Torronen et al. (Ref. 38) showed small reductions in serum

cholesterol, LDL-, and HDL-cholesterol in an oat bran

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group compared to baseline, but these reductions were not statistically

significant. An oat bran concentrate was prepared and incorporated into

a loaf of bread (11.2 g -glucan per loaf). A control bread was

made with wheat flour. The use of oat bran concentrate in this study

does not provide evidence for an effect of oat bran per se on serum

cholesterol because the authors state that the method of concentrating

and processing the oat bran and -glucan may have affected the

effectiveness of the -glucan in lowering serum cholesterol.

Animal studies by these authors confirmed that the method of producing

the oat bran concentrate produced significantly weaker

hypocholesterolemic responses than untreated oat bran or concentrates

with higher viscosities.

One study (Ref. 32) showed equivocal results in reducing total

cholesterol. Poulter and coworkers reported small but significant

reductions in serum cholesterol and LDL-cholesterol in

hypercholesterolemic subjects consuming 50 g of oat cereal compared to

subjects consuming the same amount of cereal without oats. Subjects

with baseline cholesterol values greater than 231 mg/dL experienced the

most significant reduction in serum cholesterol. However, the results

of this study are difficult to interpret because some subjects made

changes in their diets after starting the trial. There was a

significant reduction in total energy from fat compared to baseline

intakes. Similarly, the ratio of polyunsaturated fat to saturated fat

in the subjects' diet also fell significantly during the oat period.

2. Hypercholesterolemics: Low Fat Diets

Results of six studies (Refs. 11, 15, 23, 24, 39, and 43) showed a

cholesterol reducing effect of oatmeal or oat bran in

hypercholesterolemic subjects who consumed the oat products as part of

a low fat diet. Beling et al. (Ref. 11) divided the subjects into 3

groups. Group 1 consumed their regular (not fat modified) diet. Groups

2 and 3 consumed an AHA fat modified diet. There were significantly

lower total and LDL-cholesterol levels after 4 weeks in groups 2 and 3.

In groups 2 and 3, total cholesterol decreased by 10 percent and 11.8

percent, and LDL-cholesterol decreased by 11.5 percent and 11.8

percent, respectively. From weeks 5 to 8, group 2 continued on the AHA

diet, while group 3 consumed the AHA diet plus 56 g oat bran cereal/

day. At the end of week 8, total cholesterol had decreased by 2.3

percent, 8.4 percent, and 12.2 percent from baseline levels for groups

1, 2, and 3, respectively. The mean total cholesterol level of the oat

group was significantly different from the control group and the group

that consumed only the AHA diet (p-glucan from oat bran and oatmeal in

hypercholesterolemic subjects consuming a Step 1 diet. The results

showed that groups consuming diets containing 3 g/d or more of

-glucan experienced significant declines in blood total

cholesterol (7 to 10 percent) and LDL-cholesterol (10 to 16 percent)

compared to baseline. Blood total cholesterol levels of groups

consuming diets containing 1 to 2.4 g daily of -glucan did not

differ significantly from baseline.

Turnbull and Leeds (Ref. 39) evaluated the effects of oats and

wheat on total cholesterol in hypercholesterolemic subjects consuming a

low fat diet. During a 1-month run-in period (baseline), the subjects

consumed the low fat diet alone and experienced a 7.6 percent (not

significant) reduction in total cholesterol. The subjects were then

randomized to receive 150 g/d of oats or wheat while consuming the low

fat diet for another month. At the end of the month, subjects crossed

over to the other grain supplement. The results of this study showed

that during the oat period, subjects experienced significant reductions

in total cholesterol (p-

glucan. The low-fiber oat bran provided 1.9 g -glucan, and the

high-fiber oat bran provided about 3 g -glucan. The results of

this study showed no significant changes in serum cholesterol or LDL-

cholesterol from any of the test substances. HDL-cholesterol, however,

increased in all groups compared to baseline values, and these

increases were statistically significant (p-glucan-enriched oat bran and regular wheat bran in

hypercholesterolemic subjects consuming an AHA Step 1 diet. Baseline

serum cholesterol values were determined during a 4-week run-in period

when the subjects consumed the AHA Step 1 diet with no bran. The

subjects were then randomized into two groups to receive the -

glucan-enriched oat bran or regular wheat bran for an 8-week test

period. The brans were provided in sachets (62 g/sachet), and the

subjects instructed to increase their daily consumption of bran in a

step-wise approach until they consumed the entire contents of the

sachet or until they reached the highest tolerable amount. The mean

intake of oat bran during the test period was 50 g. At the end of 4

weeks of bran intervention, there was a significant reduction in serum

cholesterol in the oat bran group compared to baseline. By the end of 8

weeks, however, the differences were no longer significant. There was

no change in LDL-cholesterol in the oat bran group after 4 weeks, but a

small, nonsignificant reduction (about 3 percent) after 8 weeks. There

was a small, nonsignificant increase in serum cholesterol in the wheat

bran group. The results of this study were difficult to interpret

because subjects did not adhere to the reduced fat diet and failed to

consume the required amount of bran.

Two studies (Refs. 10 and 46) showed equivocal results in reducing

total cholesterol. Bartram et al. (Ref. 10) evaluated the effect of oat

bran muesli cereal on serum cholesterol in 13 men and women who had

been on a low cholesterol diet for 6 months. The subjects consumed 60 g

of oat muesli (made with lowfat milk and 120 g of bananas, grapes, and

apples) for 3 weeks. The results of this study showed a significant

reduction in serum cholesterol (8-10 percent) (p-glucan.

The results of the study by Demark-Wahnefried et al. (Ref. 16)

suffered from a lack of statistical power to detect changes between

groups, variable weight loss among the groups, and significant dietary

changes during the course of the study.

IV. Decision To Propose a Health Claim Relating Oat Products to

Reduction in Risk of CHD

The petition set out the conclusions reached by the Federal

government and other recognized scientific bodies, as well as those

reached in review articles and in pertinent human studies published

since 1987. FDA reviewed this information as well as those studies that

evaluated the effects on serum cholesterol and LDL-cholesterol levels

from dietary intervention with oat bran or oatmeal in subjects with

normal to elevated serum cholesterol levels.

FDA tentatively concludes that, based on the totality of publicly

available scientific evidence, there is significant scientific

agreement to support the relationship between consumption of oat bran

or oatmeal as foods, or as ingredients in foods, and the risk of CHD.

The strongest evidence for the effect of oat bran or oatmeal on the

risk of CHD is provided by studies that

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measured the effect of dietary oat consumption on the two major risk

factors for CHD, total and LDL-cholesterol. FDA is aware of five

studies of that effect in which problems associated with subject

compliance and weight loss were avoided and in which appropriate

controls were used (Refs. 12, 25, 29, 39, and 45). All of these studies

showed a significant relationship between oat consumption and lowered

serum total and LDL-cholesterol levels and no adverse effect on other

CHD risk factors, such as significantly lowering HDL-cholesterol. The

daily oat intake ranged from an estimated 70 g oat bran (Ref. 12) to

150 g oat bran (Ref. 39). Four of these studies (Refs. 12, 25, 39, and

45) were conducted in subjects with mild to moderately elevated levels

of serum cholesterol. One study (Ref. 29) used subjects with normal

serum cholesterol levels.

Braaten et al. (Ref. 12) showed that when subjects consumed an

amount of purified oat gum (containing 80 percent -glucan)

equivalent to consuming 70 g oat bran daily, total and LDL-cholesterol

were significantly reduced, and HDL-cholesterol remained unchanged. The

oat gum was consumed with a typical American diet.

Kestin et al. (Ref. 25) showed significant reductions in total and

LDL-cholesterol, compared to blood lipid levels during wheat and rice

bran periods, in subjects who consumed 95 g oat bran/day for 4 weeks

(Ref. 25). HDL-cholesterol showed slight, nonsignificant increases

compared to baseline in all diet periods. The subjects consumed the

test foods as part of their usual diet.

Subjects with moderate hypercholesterolemia showed significant

reductions in total and LDL-cholesterol after they consumed 150 g oats/

day for 4 weeks compared to baseline lipid levels (Ref. 39). These same

subjects experienced small increases in total and LDL-cholesterol (not

significant) after consuming wheat products. Blood levels of HDL-

cholesterol increased slightly (not significant) during the oat period

but remained the same during the wheat period. All subjects consumed a

low fat diet in this study.

Whyte et al. (Ref. 45) reported significant reductions in total and

LDL-cholesterol in subjects who consumed 123 g oat bran/day for 4 weeks

as part of their usual diets. The subjects experienced a slight

increase in total cholesterol and no change in LDL-cholesterol after

consuming wheat bran. HDL-cholesterol increased slightly (not

significant) during both bran periods.

In a study designed to assess the mechanism by which oat bran

lowers total cholesterol, Marlett et al. (Ref. 29) reported significant

reductions in total cholesterol in the period in which subjects

consumed oat bran compared to a wheat control period. The subjects

consumed 100 g oat bran/day for 4 weeks during the high fiber period

and wheat gluten during the low fiber, control period, with their usual

diets.

The results of 12 other studies (Refs. 8, 11, 15, 17, 20, 21, 23,

24, 35, and 42 through 44) also support the relationship between oat

consumption and reduction in total and LDL-cholesterol. Six studies

(Refs. 8, 17, 20, 21, 35, and 44) showed the benefits of oat

intervention in reducing serum total and LDL-cholesterol in subjects

consuming a typical American diet. HDL-cholesterol showed no

significant change in four of these studies (Refs. 8, 20, 21, and 35)

and a significant reduction in one study (Ref. 21). The amount of oat

bran or oatmeal consumed in these studies ranged from 34 g/day (Ref.

17) to 110 g/d (Ref. 8).

Three studies (Refs. 15, 23, and 24) showed a significant effect of

oat bran or oatmeal on total and LDL-cholesterol that was beyond that

of a Step 1 diet alone. The results of the three other studies (Refs.

11, 42, and 43) showed lower, nonsignificant, total and LDL-cholesterol

in subjects who consumed oat bran or oatmeal compared to the group who

consumed the Step 1 or Step 2 diets alone. In two of these studies

(Refs. 42 and 43), the subjects' lipid values after a run-in period on

the low fat diet ranged from a mean of 193 to 197 mg/dL. The lack of

significant difference between the diet only and the oat groups in

these studies may be overshadowed by the effect of the diet alone on

subjects who had initially low total and LDL-cholesterol levels. There

were no significant changes in HDL- cholesterol from the consumption of

a low fat diet plus oats. The range of oat intake in these studies

ranged from 35 g (Ref. 43) to 100 g/day (Ref. 24).

Two studies (Ref. 20 and 23) used wheat as a placebo control. The

results of these studies showed significantly lower total and LDL-

cholesterol in subjects who consumed oat bran compared to those who

consumed wheat.

A metaanalysis (Ref. 33) using pooled, raw data from a number of

oat studies (Refs. 11, 15 through 17, 23, 25, 30, 37, 39, 40, and 42

through 44) found that an intake of 3 g soluble fiber (used as a marker

for oat bran and oatmeal) or more produced modest reductions (average

decrease of 5 to 6 mg/dL) of serum total cholesterol levels. The

decrease in total cholesterol was largest in those trials with subjects

that initially had high total cholesterol levels.

As stated in section III.A. of this document, Federal government

and other reviews have concluded that there is substantial

epidemiologic and clinical evidence that high blood levels of total

cholesterol and LDL-cholesterol represent major contributors to CHD (56

FR 60727 at 60728, and Refs. 3 through 5). Dietary factors that

decrease total cholesterol and LDL-cholesterol will affect the risk of

CHD (Refs. 3 through 6). Based on the scientific evidence presented in

the petition, the agency tentatively concludes that there is

significant scientific evidence to show that oat bran and oatmeal will

help reduce serum lipids, and that such reductions may reduce the risk

of CHD. In the majority of clinical studies evaluating oat products,

total and LDL-cholesterol fractions were shown to be the most affected

by oat intervention. Regular consumption of oat bran or oatmeal, in an

amount to provide 3 g or more of oat -glucan soluble fiber,

resulted in reduced total and LDL-cholesterol levels in subjects with

normal and elevated serum cholesterol levels.

Changes in HDL-cholesterol levels as a result of oat intervention

were generally absent or not significant (Refs. 8, 11 through 13, 18,

20, 23 through 28, 32, 35 through 39, 41, 42, and 45). A tendency

toward an increase in HDL-cholesterol was shown in nine studies (Refs.

13, 24, 25, 27, 28, 32, 39, 42, and 45); no change was shown in nine

studies (Refs. 8, 12, 18, 20, 23, 24, 35, 36, and 41); and a

nonsignificant decrease in HDL-cholesterol was shown in three studies

(Ref. 11, 26, and 38). Although HDL-cholesterol was reduced 0.9 percent

(p-glucan soluble fiber. The

paragraph states that oat -glucan be determined by the

Association of Official Analytical Chemists (AOAC) official method

(i.e., method 992.28), per reference amount customarily consumed

(RACC).

The requirement that the food contain oat bran or oatmeal is

consistent with the scientific evidence that shows that oat bran or

oatmeal, when consumed as a food or as an ingredient in food, helps to

lower total and LDL-cholesterol.

The agency is not proposing to permit a claim for oat gums or oat

fibers, substances that may be manufactured by different methods and

are not well defined chemically or physically. These substances, like

all food fibers, are a complex matrix and factors, such as the

fermentability; particle size; molecular weight; chemical structure;

water holding capacity; nonfiber components; net charge; viscosity; and

cation-exchange capacity, binding, and chelation, may affect their

physiological properties (Ref. 7).

The effects of processing on the physiological properties of oat

bran were evidenced in three studies. In a study by Torronen et al.

(Ref. 38), a specially processed oat bran concentrate incorporated into

bread to provide 11.2 g/d -glucan showed no effect on lowering

serum lipids in a controlled study with hypercholesterolemic subjects.

Two other studies testing a specially processed oat fiber source

providing 3.3 g/d -glucan soluble fiber (Ref. 35) and oat gum

providing 5.8 g/d -glucan soluble fiber (Ref. 12) showed

significant reductions in blood total and LDL-cholesterol levels. The

latter two studies showing a cholesterol-lowering response did not

adequately characterize the material being tested to permit their (oat

fiber source and oat gum) inclusion in the regulations, however. If

manufacturers can document, through appropriate studies, that dietary

consumption of a well-characterized oat product, e.g., purified

extracts of oat gum or modified oat fiber isolates, has the effect of

lowering total and LDL-cholesterol levels, and has no adverse effects

on other heart disease risk factors (e.g., HDL-cholesterol), they

should submit that information in comments or petition FDA to amend

Sec. 101.81 to cover the substance.

Because the subject of this health claim petition is the effect of

oatmeal or oat bran on the risk of CHD, it is appropriate to consider

the levels of oat bran and of oatmeal intake that have been shown to

have significant effects on the levels of serum total and LDL-

cholesterol in establishing qualifying levels for foods to bear an

oatmeal or oat bran and CHD health claim. In the clinical studies that

showed that consumption of oatmeal or oat bran lowered total and LDL-

cholesterol, daily consumption ranged from 35 g (Ref. 43) to 84 g (Ref.

15) of oat bran and 34 g (Ref. 17) to 150 g (Ref. 39) of oatmeal. Based

on values provided in the petition, 35 g of oatmeal would provide about

1.75 g of -glucan soluble fiber, and 34 g of oat bran would

provide about 2.5 g of -glucan soluble fiber (Ref. 1, p. 66).

The higher the daily intake of oatmeal and oat bran, the higher the

intake of -glucan soluble fiber and the better the response in

lowering serum lipids. This observation is supported by the

metaanalysis of oat products by Ripsin et al. (Ref. 33) and is

consistent with the agency's comments on the Davidson et al. study

(Ref. 15) in the preamble to the 1993 dietary fiber and CVD final rule

(58 FR 2552 at 2568):

* * * [B]ased on the results of this study, an intake of soluble

fiber (in this case, -glucan from oats) of about 3 g per

day or more was beneficial in that it resulted in a significant

lowering of serum cholesterol in persons consuming a low-fat diet.

An intake of 3 g of -glucan soluble fiber is equivalent to

approximately 60 g of oatmeal or 40 g of oat bran (dry weight) (Ref. 1,

p. 67), the approximate midpoints of the consumption ranges of oat bran

and oatmeal that had an effect on blood lipids. The petitioner

suggested that 40 g of oat bran, 60 g of oatmeal, and 3 g -

glucan soluble fiber be considered as the standard for determining the

qualifying levels of oat bran and oatmeal for this health claim.

Applying a regression analysis to the results of Davidson et al. (Ref.

15), and using -glucan soluble fiber as a marker for oat bran

and oatmeal, the petitioner determined that 3 g -glucan would

be required to achieve a 5 percent reduction in serum cholesterol (Ref.

1, p. 22-27). The petition stated that a 5 percent reduction in serum

cholesterol is a desirable goal because that is the level that was

achieved as a result of a dietary fat and cholesterol focused

intervention in the Multiple Risk Factor Intervention Trial (MRFIT) and

Lipid Research Council (LRC) clinical trials (Refs. 1 and 40).

The petitioner stated that while current research may not

demonstrate that -glucan is the only component of oats that

affects blood lipids, it does suggest that it is an excellent marker

for cholesterol reduction potential (Ref. 1, p. 64). The petitioner

stated that the amount of -glucan also serves as a marker for

the content of oat bran and oatmeal in foods. Using 40 g of oat bran,

60 g of oatmeal, and 3 g -glucan as the qualifying amounts for

a CHD claim, the petitioner suggested that a single serving of an oat-

containing product (i.e., 1 RACC) should provide \1/3\ of this amount

(based on 3 servings a day). Thus, an oat bran-containing product would

have to contain at least 13 g oat bran (\1/3\ x 40 g) that provides 1

g -glucan (\1/3\ x 3 g) soluble fiber per RACC. An oatmeal-

containing product would have to contain no less than 20 g oatmeal (\1/

3\ x 60) that provides 1 g -glucan soluble fiber. The

petitioner stated that this approach is reasonable because it would

permit a wide variety of low fat, oat-containing products, e.g.,

muffins, cereals, and breads, to qualify for this health claim. The

petitioner provided several examples of meals, developed on the basis

of U.S. Dietary Guidelines, that demonstrated how 40 g of oat bran and

60 g of oatmeal, providing 3 g of -glucan soluble fiber, could

be incorporated into a diet that is consistent with dietary guidelines

(Ref. 1, pp. 43-54).

The agency agrees that, based on Davidson et al. (Ref. 15), the

metaanalysis (Ref. 33), and other studies that reported the amount of

-glucan soluble fiber in oat products, 3 or more grams of oat

-glucan soluble fiber were associated with significant

reductions in serum cholesterol. The agency also agrees that not all

oat bran or oatmeal-containing products that might otherwise qualify

for this claim contain that amount per RACC of oat product. Based on

nutrient composition data presented in the petition (Ref. 1, pp. 38-

39), only oat bran hot and cold cereals contain 3 g -glucan

soluble fiber would qualify for this proposed health claim. Thus,

limiting eligibility for the claim to products with 3 g -

glucan soluble fiber would have the unintended effect of eliminating a

number of low fat, oat-containing products, e.g., oatmeal cereals,

oatmeal waffles, oat bran muffins, and oatmeal breads, from bearing an

oatmeal or oat bran and CHD health claim.

The petition states that the most common oat food forms are oat

bran and oatmeal consumed as hot cereals (Ref. 1, p.33). The mean daily

dietary intake by oat consumers of oatmeal and oat bran hot cereals is

43.3 g (dry weight basis) and the median intake is 40.1 g (Ref. 1, p.

33). The petition states that the 90th and 95th percentiles of intake

are 71.3 and 84.2 g (dry weight basis) per day, respectively.

Therefore, it is reasonable to assume that a person could consume a

total of, or more than, 40 g oat bran, 60 g oatmeal, or a combination

of the

[[Page 309]]

two that provides 3 g -glucan soluble fiber if the oat

products are consumed over the course of a day.

The agency has generally made the assumption that a daily food

consumption pattern includes three meals and a snack (see 58 FR 2302 at

2379, January 6, 1993). Therefore, one approach to determining the

qualifying levels of oat bran, oatmeal, and oat -glucan

soluble fiber for a CHD health claim is to divide the effective levels

of these substances by four eating occasions per day. Using this

approach, an oat bran product would have to provide at least 10 g of

oat bran and 0.75 g -glucan soluble fiber, and an oatmeal

product would have to provide at least 15 g of oatmeal and 0.75 g

-glucan soluble fiber per RACC in order to qualify to bear an

oat and CHD health claim. However, considering that the mean daily

dietary intake of oatmeal and oat bran is 43 g, and that that amount is

consumed mostly in the form of hot cereal, and considering the nature

of this food, it is not expected that people will consume oat-

containing products 4 times a day. The agency is persuaded by the

petitioner's argument that oat products can reasonably be expected to

be consumed 3 times a day, being incorporated into a variety of

products. Thus, an oat bran-containing product would have to provide no

less than 13 g oat bran and 1 g -glucan soluble fiber per

RACC, and an oatmeal- containing product would have to provide no less

than 20 g oatmeal and 1 g -glucan soluble fiber. Therefore,

the agency tentatively finds that use of 13 g oat bran and 20 g oatmeal

that provide 1 g -glucan soluble fiber as the qualifying

criteria for this proposed rule is appropriate and is proposing these

levels in this document.

The proposed qualifying requirement of 1 g -glucan soluble

fiber per RACC of oat bran or oatmeal-containing product is higher than

the amount of soluble fiber that is required for a food to qualify to

bear the fruits, vegetables, and grain products and CHD health claim

(Sec. 101.77). Under Sec. 101.77(c)(ii)(C), a food need only contain,

without fortification, 0.6 g soluble fiber per RACC. In the preamble to

the 1993 dietary fiber and CVD final rule, the agency explained that

the 0.6 g of soluble fiber was based in part on the recommendation by

the LSRO expert panel that 25 percent of the recommended daily intake

of fiber be soluble fiber (58 FR 2552 at 2573 and 2574). The agency

also stated that the 0.6 g soluble fiber is consistent with the

definition of a ``good source'' of a nutrient (i.e., 10 percent of the

daily reference value (DRV)). The agency explained that the 10 percent

level is deemed useful and appropriate because very few foods could

naturally meet the requirement for a ``high'' source of soluble fiber.

The current dietary guidance recommendations of five or more servings

of fruits and vegetables and six or more servings of grain products

daily, if followed, would likely result in intakes of soluble fiber

close to or exceeding the recommended daily intake of 6 g (58 FR 2552

at 2574). Thus, the 0.6 g of soluble fiber was intended to allow a

number of fruits, vegetables, and grain products to qualify. The agency

stated that without this alternate level very few fruits, vegetables,

and grain products would qualify for the health claim (58 FR 2552 at

2574).

Based on the scientific evidence reviewed in this document, higher

daily intakes of oat bran and oatmeal (about 40 g and 60 g,

respectively) that provided 3 g/d or more of -glucan soluble

fiber were associated with significant cholesterol-lowering benefits

(Refs. 15 and 33). As discussed above, it is reasonable to assume that

oat bran and oatmeal would likely not be consumed in more than three

eating occasions per day. Therefore, the agency tentatively finds that

the proposed criterion that the oat bran or oatmeal provide 1 g

-glucan soluble fiber per RACC is appropriate for this health

claim. The agency is asking for comments on this tentative

determination.

In Sec. 101.81(c)(2)(iii)(B), the agency is proposing, consistent

with other authorized heart disease health claims, that foods bearing

the health claim meet requirements for ``low saturated fat,'' ``low

cholesterol,'' and ``low fat.'' In the preamble to the final rule on

fruits, vegetables, and grain products and heart disease (Sec. 101.77,

58 FR 2552 at 2572), the agency stated that populations with diets rich

in these low saturated fat and low cholesterol foods experience many

health advantages, including lower rates of heart disease. In the

preamble to the proposed rule on dietary lipids and heart disease (56

FR 60727 at 60739), the agency stated that while total fat is not

directly linked to increased risk of CHD, it may have significant

indirect effects. Foods that are low in total fat facilitate reductions

in intakes of saturated fat and cholesterol to recommended levels.

Therefore, the agency tentatively concludes that proposed

Sec. 101.81(c)(2)(iii)(B) sets forth an appropriate requirement for

food to be eligible to bear the oatmeal and oat bran/CHD claim.

E. Optional Information

FDA is proposing in Sec. 101.81(d)(1) that the claim may state that

the development of heart disease depends on many factors and,

consistent with authorized CHD health claims, may list the risk factors

for heart disease that are listed in Secs. 101.75(d)(1) and

101.77(d)(1). The agency is also proposing, in response to the

petition, that the claim may provide additional information about the

benefits of exercise and body weight management. This additional

information can provide a context that is useful for an understanding

of the relationship between oat bran and oatmeal and heart disease, but

manufacturers should be cautioned that it should not be presented in a

way that is misleading to the consumer.

In proposed Sec. 101.81(d)(2), consistent with Secs. 101.75(d)(2)

and 101.77(d)(2), FDA is providing that the claim may state that the

relationship between a diet high in oat bran or oatmeal and reduced

risk of heart disease is through the intermediate link of ``blood

cholesterol'' or ``blood total cholesterol'' and ``LDL- cholesterol.''

The relationship between oat bran or oatmeal and reduced blood total

cholesterol and LDL-cholesterol is supported by the scientific evidence

presented in this proposal.

In Sec. 101.81(d)(3), the agency is proposing that, consistent with

Secs. 101.75(d)(3) and 101.77(d)(3), the claim may include information

from Sec. 101.81(a) and (b). These paragraphs summarize information

regarding the relationship between diets high in oat bran or oatmeal

and the risk of CHD and about the significance of that relationship.

This information helps to convey the seriousness of CHD and the role

that a diet high in oat bran and oatmeal can play to help reduce the

risk of CHD.

In Sec. 101.81(d)(4), the agency is proposing that the claim may

state that oat bran or oatmeal are good sources of dietary fiber,

particularly soluble fiber. In referring to the fiber components the

claim may use the terms ``fiber,'' ``dietary fiber,'' and ``soluble

fiber.'' If the term ``soluble fiber'' is used in the claim, the

declaration of soluble fiber content is required. This proposed

provision is consistent with Sec. 101.9(c)(6)(i)(A), which states that

the declaration of soluble fiber on the nutrition label is voluntary,

except that when a claim is made on the label or in labeling about

soluble fiber, label declaration is required.

The agency is proposing that the claim may include any of the

optional information authorized to be included

[[Page 310]]

in Secs. 101.75(d)(5), (d)(6), and (d)(7) and 101.77(d)(5), (d)(6), and

(d)(7). The health claim may state that diets high in oat bran or

oatmeal and low in saturated fat and cholesterol are part of a dietary

pattern that is consistent with dietary guidelines for Americans. The

claim may state that individuals with elevated serum lipids should

consult their physicians for medical advice and treatment and may

include information on the prevalence of CHD in the United States. The

intent of this information is to provide consumers with information

that will help them understand the seriousness of CHD in the United

States and to help them understand that diets high in oat bran or

oatmeal are consistent with dietary guidelines.

In proposed Sec. 101.81(d)(8), in response to the petition, the

claim may provide information about the amount of food, such as bowls,

servings or slices, to be consumed daily. This information may give the

consumer a better perspective on how much oat bran and oatmeal is

needed to help lower serum cholesterol levels.

F. Model Health Claims

In proposed Sec. 101.81(e), FDA is providing model health claims to

illustrate the requirements of new Sec. 101.81. FDA emphasizes that

these model health claims are illustrative only. These model claims

illustrate the required, and some of the optional, elements of the

proposed rule. If the agency authorizes a claim about the relationship

between oat products and CHD, manufacturers will be free to design

their own claim so long as it is consistent with Sec. 101.81(c).

In Sec. 101.81(e)(1), the model claim illustrates all of the

required elements of the proposed health claim. The claim states

``Diets high in [oat bran or oatmeal] and low in saturated fat and

cholesterol may reduce the risk of heart disease.''

In Sec. 101.81(e)(2), the model claims provide examples of a

shortened claim with the required referral statement.

VI. Environmental Impact

The agency has 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. Therefore, neither an

environmental assessment nor an environmental impact statement is

required.

VII. Analysis of Impacts

FDA has examined the impacts of the proposed rule under Executive

Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).

Executive Order 12866 directs agencies to assess all costs and benefits

of available regulatory alternatives and, when regulation is necessary,

to select regulatory approaches that maximize net benefits (including

potential economic, environmental, public health and safety, and other

advantages; distributive impacts; and equity).

The Regulatory Flexibility Act requires analyzing options for

regulatory relief for small businesses. FDA finds that this proposed

rule is not a significant rule as defined by Executive Order 12866. In

accordance with the Regulatory Flexibility Act, the agency certifies

that the proposed rule will not have a significant impact on a

substantial number of small businesses.

This proposed rule will not result in significant costs to

industry. Some oat manufacturers are currently using FDA's approved

health claim regarding the benefits of fruits, vegetables, and grain

products. This proposed health claim will allow them to specifically

highlight the benefits of oat bran and oatmeal. Consumers will benefit

from the additional information regarding the relationship of oat

products and CHD.

VIII. Paperwork Reduction Act

FDA tentatively concludes that this proposed rule contains no

reporting, recordkeeping, labeling, or other third party disclosure

requirements; thus there is no ``information collection'' necessitating

clearance by the Office of Management and Budget. However, to ensure

the accuracy of this tentative conclusion, FDA is seeking comment on

whether this proposed rule to permit health claims on the association

between oat products (i.e., oat bran and oatmeal) and reduced risk of

CHD imposes any paperwork burden.

IX. Effective Date

FDA is proposing to make these regulations effective upon

publication in the Federal Register of a final rule based upon this

proposal.

X. Comments

Interested persons may, on or before April 3, 1996, submit to the

Dockets Management Branch (address above) written comments regarding

this proposal. Two copies of any comments are to be submitted, except

that individuals may submit one copy. Comments are to be identified

with the docket number found in brackets in the heading of this

document. Received comments may be seen in the office above between 9

a.m. and 4 p.m., Monday through Friday.

XI. 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 Co., ``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 Co., 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, pp. 83-137, 1988.

4. National Research Council, National Academy of Sciences, ``Diet

and Health,'' National Academy Press, Washington, DC, pp. 291-309

and 529-547, 1989.

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

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Adults,'' NIH, Bethesda, MD, pp. 1-79, 1989.

6. DHHS, PHS, and NIH, ``National Cholesterol Education Program:

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Dietary Fiber,'' Bethesda, MD, 1987.

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

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

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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,

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Nutrition, 16:533-537, 1992.

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

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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

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

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

A. M. Pauli, P. M. Bernard, and D. Lairon, ``Effects of Oat Bran,

Rice Bran, Wheat Fiber, and Wheat Germ on Postprandial 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. Story,

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

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

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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.

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

and G-Q. He, ``Oats and Buckwheat Intakes and Cardiovascular Disease

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Clinical Nutrition, 61:366-372, 1995.

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

``Stabilized Rice Bran and Oat Bran Lower Cholesterol in Humans,''

Nutrition Research, 13:387-398, 1993.

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

Bran Supplementation for Elevated Serum Cholesterol,'' Family

Practice Research Journal, 10:37-46, 1990.

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

Minkin, and W. R. Bruce, ``Wheat Bran and Oat-bran Supplements'

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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

Dietetic Association, 94:1419-1421, 1994.

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, 52:661-666, 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

Metaanalysis,'' 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, 322:147-152, 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,

81:183-188, 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. Brown,

K. Lippel, and B. M. Rifkind, ``Prevalence of High Blood Cholesterol

Among U.S. Adults. An Update Based on Guidelines from the Second

Report of the National Cholesterol Education Program Adult Treatment

Panel,'' Journal of the American Medical Association, 269:3009-3014,

1993.

48. Ross, R., ``Atherosclerosis,'' in Cecil--Textbook of Medicine,

edited by Wyngaarden, J. B., L. H. Smith, and J. C. Bennett,

Harcourt Brace Jovanevich, Inc., Philadelphia, p. 293-295, 1992.

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49. Saltsman, Joyce J., CFSAN, FDA, Memorandum to file, May 19,

1995.

50. DHHS and USDA, ``Nutrition and Your Health: Dietary Guidelines

for Americans,'' U.S. Gov. Printing Office, 273-930, 1990.

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

Processors Association, May 11, 1995.

List of Subjects in 21 CFR Part 101

Food labeling, Incorporation by reference, Nutrition, Reporting and

recordkeeping requirements.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under

authority delegated to the Commissioner of Food and Drugs, it is

proposed that 21 CFR part 101 be 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, 331, 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: Oat products and risk of coronary heart

disease.

(a) Relationship between diets high in oatmeal and oat bran and the

risk of coronary heart disease. (1) Cardiovascular disease means

diseases of the heart and circulatory system. Coronary heart disease

(CHD) is the most common and serious form 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

CHD. High CHD rates occur among people with high total cholesterol

levels of 240 milligrams per deciliter (mg/dL) (6.21 millimoles per

liter (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 coronary heart disease.

(2) Populations with a low incidence of coronary heart disease 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 oatmeal and oat bran.

(3) Oat bran and oatmeal are low in saturated fat and cholesterol

and a good source of soluble fiber. Scientific evidence demonstrates

that diets high in these oat products are associated with reduced blood

total and LDL-cholesterol levels.

(b) Significance of the relationship between diets high in oatmeal

and oat bran and the risk of coronary heart disease. (1) Coronary heart

disease 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 coronary heart disease is a major

public health goal that can assist in reducing the risk of coronary

heart disease. 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. Intakes of cholesterol are, on

average, at or above recommended levels. One of the major public health

recommendations relative to coronary heart disease 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 mg or less per day. 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.

(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 high in oatmeal or oat bran with reduced risk of

coronary 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 oatmeal or oat bran ``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) The claim states that:

(1) Diets high in oatmeal or oat bran may reduce the risk of

coronary heart disease; and

(2) The effect of dietary intake of oatmeal or oat bran on the risk

of coronary heart disease is particularly evident when these foods are

consumed as part of a diet that is low in saturated fat and

cholesterol.

(D) The claim does not attribute any degree of risk reduction for

coronary heart disease to diets high in oat bran or oatmeal and low in

saturated fat and cholesterol.

(E) The claim does not imply that consumption of oat bran or

oatmeal is the only recognized means of achieving a reduced risk of

coronary heart disease.

(ii) Presentation of the claim. All of the elements listed in

paragraph (c)(2)(i) of this section must be included in one

presentation of the claim displayed prominently on the label or in the

labeling on which the claim appears. Other presentations of the claim

on that label or labeling, including on the principal display panel,

need not include the information in paragraph (c)(2)(i)(C)(2) of this

section provided that, displayed prominently and in immediate proximity

to a shortened statement of the claim, the following referral statement

is used: ``See __________ for more information'' with the blank filled

in with the identity of the panel on which is presented the statement

of the claim that includes all of the elements in paragraph (c)(2)(i)

of this section.

(A) The referral statement ``See [appropriate panel] for more

information'' shall be in easily legible boldface print or type, in

distinct contrast to other printed or graphic matter, that is no less

than that required by Sec. 101.105(i) for net quantity of contents,

except where the size of the claim is less than 2 times the required

size of the net quantity of contents statement, in which case the

referral statement shall be no less than one-half the size of the claim

but no smaller than one-sixteenth of an inch.

(B) The referral statement shall be immediately adjacent to any

presentation of the health claim that does not include all of the

elements in paragraph (c)(2)(i) of this section, and there may be no

intervening material between the claim and the referral statement. If

the abbreviated health claim appears on more than one panel of the

label, the referral statement shall be adjacent to the claim on each

panel except for the panel that bears the full health claim, where it

may be omitted.

(iii) Nature of the food. (A) The food shall contain no less than

20 g oatmeal or 13 g oat bran that provides, without fortification, at

least 1 g of -glucan soluble fiber per reference amount

customarily consumed. Beta-glucan will be determined by method No.

992.28 from the ``Official Methods of Analysis of the Association of

Official Analytical Chemists,'' 15th ed. (1993), which is

[[Page 313]]

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, 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;

(B) 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 coronary

heart disease; 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 oat

bran and oatmeal 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 oat bran or

oatmeal and coronary heart disease and the significance of the

relationship.

(4) The claim may state that oat bran and oatmeal are good sources

of dietary fiber, particularly soluble fiber. In referring to the oat

fiber component, the claim may use the terms ``fiber,'' ``dietary

fiber,'' or ``soluble fiber.'' If the claim uses the term soluble

fiber, the total soluble fiber content shall be declared in the

nutrition information panel, consistent with Sec. 101.9(c)(6)(i)(A).

(5) The claim may state that a diet low in saturated fat and

cholesterol and high oatmeal or oat bran 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) 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;

(7) 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;

(8) The claim may provide information about the amounts of oat-

containing food, e.g., bowls, servings, slices, to be consumed in a

day.

(e) Model health claim. The following model health claims may be

used in food labeling to describe the relationship between oat bran and

oatmeal and reduced risk of heart disease:

(1) The following is an example of a full claim: Diets high in [oat

bran/oatmeal] and low in saturated fat and cholesterol may reduce the

risk of heart disease.

(2) The following are examples of a shortened claim:

(A) [Front panel] Diets high in [oat bran or oatmeal] may reduce

the risk of heart disease

See [side/back] panel for more information

(B) [Front panel] Eating [oat bran or oatmeal] daily may reduce

heart disease risk

See [side/back] panel for more information

Dated: December 22, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

Note: The following tables will not appear in the Code of

Federal Regulations.

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