[Federal Register Volume 61, Number 3 (Thursday, January 4, 1996)]
[Proposed Rules]
[Pages 295-337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29]



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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 (<) 300 mg/dL).
    In selecting human for review, the agency excluded studies that 
were published in abstract form because they lacked sufficient detail 
on study design and methodologies, and because they lacked necessary 
primary data. Studies using special population groups, such as insulin-
dependent diabetics, individuals with very high serum cholesterol (mean 
greater than 300 mg/dL), children with hypercholesterolemia, and 
persons who had already experienced a myocardial infarction, were also 
generally not weighed heavily because of questions about their 
relevance to the general healthy U.S. population.
3. Criteria for Evaluating the Relationship Between Oat Products and 
CHD
    FDA applied the same criteria in evaluating the relationship 
between oat products and CHD that it did in evaluating the relationship 
between dietary fiber and CVD in the 1991 dietary fiber and 
cardiovascular disease proposal (56 FR 60582 at 60587). The criteria 
that the agency used in evaluating these studies included: (1) 
Reliability and accuracy of the methods used in nutrient intake 
analysis, including measurements of total dietary soluble fiber and 
total dietary fiber; (2) available information on the soluble fiber or 
beta-glucan (-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 (< 200 mg/dL)). FDA also separately evaluated 
studies in which oat products' effects were evaluated as part of a 
``typical'' American diet (approximately 37 percent of calories from 
fat, 13 percent of calories from saturated fat, and more than 300 mg of 
cholesterol daily) and studies in which the test protocols incorporated 
a Step I or similar (e.g., American Heart Association (AHA)) dietary 
regimen (less than 30 percent of calories from fat, less than 10 
percent of calories from saturated fat, and less than 300 mg of 
cholesterol daily). Moreover, to ensure that results were not 
reflective of transient changes, such as failure of blood cholesterol 
levels to stabilize to the dramatic changes in dietary patterns that 
occur with the introduction of large amounts of test substances, FDA 
gave less weight to studies with treatment periods of less than 3 weeks 
than it gave to studies of longer duration.

C. Summary of Human Studies

    FDA's review of the 37 human studies on oat bran and oatmeal and 
serum cholesterol (Refs. 8 through 32, 34 through 39, and 41 through 
46) that were submitted with the petition is summarized in detail in 
Table 1. The results of a metaanalysis (Ref. 33) that included a number 
of the oat studies is discussed in section III.C.5. of this document.
1. Hypercholesterolemics: ``Typical'' or ``Usual'' Diets
    Eight of the studies (Refs. 8, 12, 20, 21, 25, 35, 44, and 45) show 
a relationship between consumption of oat products and reduced serum 

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cholesterol in hypercholesterolemic subjects consuming a typical 
American diet. Anderson et al. (Ref. 8) in a metabolic ward study 
reported significantly lower total (12.8 percent) and LDL-cholesterol 
(12.1 percent) in male subjects consuming 110 grams (g) (7.6 g soluble 
fiber, 13.4 g total dietary soluble fiber) oat bran for 21 days (d). A 
wheat group, which consumed 40 g of wheat bran (1.3 g soluble fiber, 
7.8 g total dietary soluble fiber), experienced nonsignificant 
decreases in total (4.4 percent) and LDL-cholesterol (5.5 percent). 
There was no significant change in HDL-cholesterol in either group. 
Both groups experienced a significant decrease in weight (1 kilogram 
(kg)) compared to their mean baseline weight values. There was no 
difference in weight loss between the oat and wheat groups.
    Braaten et al. (Ref. 12) evaluated the effects on blood cholesterol 
levels of instant oat gum (7.2 g; 5.8 g -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<0.0001) and LDL-cholesterol by 10 percent (p<0.001) in the 
oat gum group compared to baseline.
    Hegsted et al. (Ref. 20) evaluated the hypocholesterolemic 
properties of rice bran and oat bran in hypercholesterolemic subjects. 
Using a cross-over design, subjects consumed treatment diets providing 
100 g/d of rice bran and oat bran for 3-week periods each. A control 
diet, which consisted of the treatment diet but with wheat flour and no 
bran, was consumed for 2 weeks before each bran period. The results 
showed significant reductions in total cholesterol with both the rice 
and oat bran diets compared to the control diet (p<0.001). During the 
two oat test periods, serum cholesterol was reduced about 10 percent 
(phase 1) and 4 percent (phase 2) compared to serum cholesterol values 
during the control period. Oat bran intervention also resulted in 
significant reductions (about 13 percent in phase 1 and about 7 percent 
in phase 2) in LDL-cholesterol. Rice bran was as effective in lowering 
serum cholesterol as oat bran.
    Kahn et al. (Ref. 21) evaluated the hypocholesterolemic properties 
of four oat bran muffins/d (80 g total daily oat bran) in 
hypercholesterolemic subjects randomized into immediate oat bran 
intervention and delayed oat bran intervention groups. The delayed oat 
bran intervention group served as the control group. After correcting 
for the time delay of the study, the results showed that oat bran 
dietary intervention significantly reduced total cholesterol by almost 
8 percent (p<0.02), LDL-cholesterol by about 10 percent (p<0.02), and 
HDL-cholesterol by almost 1 percent (p<0.03) from baseline.
    Kestin et al. (Ref. 25) reported decreased levels of total 
cholesterol (4.9 percent) and LDL-cholesterol (6.8 percent) in 
hypercholesterolemic subjects consuming 95 g/d (5.8 g soluble fiber) 
oat bran. These values were significantly lower than those observed in 
subjects consuming rice bran (p<0.01) and wheat bran (p<0.001). HDL-
cholesterol increased in all groups. The oat bran was incorporated into 
bread and muffins.
    Spiller et al. (Ref. 35) reported significantly lower total 
cholesterol (3.7 percent) and LDL-cholesterol (6.6 percent), and a 
nonsignificant increase in HDL-cholesterol (1 percent), in 
hypercholesterolemic subjects consuming 77 g/d (5 g soluble fiber) oat 
bran. Changes in total cholesterol were experienced within the first 14 
days with no significant changes occurring between days 14 and 21 of 
the study. The oat bran was mixed with water and consumed before meals. 
The calories provided by the oat bran replaced about an equal amount of 
carbohydrate calories in the subjects' diets.
    Whyte et al. (Ref. 45) reported decreases in total cholesterol of 
3.1 percent (p<0.01) and LDL-cholesterol of 5.7 percent (p<0.01) 
compared to baseline values after hypercholesterolemic subjects 
consumed 123 g (10.3 g soluble fiber) oat bran/day for 4 weeks. The oat 
bran was consumed as a breakfast cereal. Consumption of total fat and 
saturated fat remained the same during the test period.
    Van Horn et al. (Ref. 44) reported reductions in total cholesterol 
(about 6.2 percent) and LDL-cholesterol (9.2 percent) levels, compared 
to a control group, in subjects consuming 57 g of instant oats daily 
for 8 weeks. The control group experienced decreases in total 
cholesterol and LDL-cholesterol of 1.4 percent and 3.7 percent, 
respectively. The differences between the oat and control groups were 
significant (p<0.05). The authors reported greater reductions in total 
cholesterol in those individuals who had a baseline cholesterol level 
above the baseline median cholesterol level of 243 mg/dL. The authors 
also reported significantly different dietary intakes after 4 weeks of 
intervention for a number of nutrients in the oat group's diet compared 
to that of the control group. After 4 weeks of intervention, the oat 
group had higher intakes of soluble and total fiber and lower intakes 
of saturated fat and cholesterol. A metaanalysis conducted by Ripsin et 
al. (Ref. 33), which is discussed in section III.C.5. of this document, 
evidences that the changes in dietary fats and cholesterol intake in 
this study did not appear to be responsible for the drop in serum 
cholesterol levels, thus suggesting that oat bran and oatmeal were 
responsible for the observed effect.
    Results of four studies (Refs. 18, 26, 34, and 38) were 
inconclusive regarding the relationship between oat bran or oatmeal 
consumption and reduced serum lipids. Gormley et al. (Ref. 18) reported 
no effect of oatmeal porridge on serum cholesterol or HDL-cholesterol 
in hypercholesterolemic men and normocholesterolemic women. The authors 
stated that dietary intakes were monitored, but the subjects' dietary 
intakes were not reported. The amount of total dietary fiber and 
soluble fiber in the total diet and oatmeal porridge were not provided. 
Insufficient dietary controls make the results of this study difficult 
to interpret.
    Leadbetter et al. (Ref. 26) reported no significant effect of 
increasing intakes of -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<0.05). At week 8, LDL-cholesterol 
levels were 10.1 percent below baseline for group 2 and 14.9 percent 
below baseline for group 3 (p<0.05). HDL-cholesterol decreased 1 
percent, 3 percent, and 8 percent in groups 1, 2, and 3, respectively, 
at 8 weeks. The differences in HDL-cholesterol between the 3 groups 
were not significant. The differences in HDL-cholesterol in groups 2 
and 3 were significantly different from the control (p<.05). Groups 2 
and 3 experienced weight loss, but the differences between these groups 
were not significant.
    Davidson et al. (Ref. 15) evaluated the hypocholesterolemic effects 
of increasing amounts of -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<0.03) and LDL-cholesterol (p<0.002) compared to 
baseline despite an increase in energy and total fat intake. There were 
no significant changes in total cholesterol and LDL-cholesterol when 
subjects consumed the wheat diet. HDL-cholesterol showed a 
nonsignificant increase from baseline during the oat period and no 
change during the wheat period.
    In a large, controlled clinical trial, Van Horn et al. (Ref. 43) 
instructed moderately hypercholesterolemic subjects (mean total 
cholesterol of 208 mg/dL) on the AHA low fat diet. The subjects 
consumed the AHA diet alone for 6 weeks, during which time they 
experienced significantly reduced total cholesterol compared to 
baseline. The subjects were then randomized to one of 3 groups: two oat 
groups (2 oz of oat bran or oatmeal daily) or the control group (AHA 
diet only) for another 6 weeks. At the end of the intervention period, 
subjects consuming 56 g of oat bran and oatmeal had total cholesterol 
values 8 percent and 9.3 percent lower than baseline, respectively. The 
control group experienced a 4.5 percent reduction in serum cholesterol. 
At the end of the study, the differences in total cholesterol levels 
for all three groups compared to baseline levels were statistically 
significant (p<0.05), but there was no significant difference between 
the oat groups and the control. Both the oat bran and the oatmeal 
groups experienced a modest (3 percent) reduction in serum cholesterol 
beyond that achieved by the low fat diet alone.
    The modest effect of oat bran and oatmeal on serum cholesterol in 
this study may have been affected by the subjects' cholesterol levels 
before dietary intervention. The subjects' mean cholesterol level was 
208.4 mg/dL. After dietary intervention, the mean cholesterol levels 
were 201 mg/dL (control), 196.4 mg/dL (oat bran group), and 195.2 mg/dL 
(oatmeal group). Studies have shown that subjects with higher initial 
blood cholesterol levels usually experience the most reduction in total 
cholesterol from oat intervention (Refs. 6 and 33). Thus, because of 
the subjects' relatively low cholesterol levels at the initiation of 
the oats intervention period, the differences among the groups may have 
been minimized.
    Keenan et al. (Ref. 23) reported variable responses in serum lipids 
depending on the order of feeding of the diets supplemented with 56 g 
of oat bran or wheat cereal during an 18-week double-blind study with 
crossover. Subjects consumed a Step 1 diet during the first period (6 
weeks) and then were randomized to 1 of 3 groups. The control group 
consumed a Step 1 diet for another 12 weeks. The two test groups 
consumed wheat cereal or oat cereal for 6 weeks before crossover to the 
other test cereal for another 6 weeks. Interpretation of results was 
complicated by the fact that the control group showed an initial 
decline in blood cholesterol levels followed by a return to baseline at 
the end of the study. Only the oat groups maintained reduced serum 
cholesterol and LDL-cholesterol throughout the test periods. When 
compared to the control and wheat groups, these reductions were 
significant (p<.01).

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    Kelley et al. (Ref. 24) reported significantly reduced serum 
cholesterol (p<0.04) and LDL-cholesterol (p<0.05) at the end of 4 weeks 
in subjects who were participating in a program of supervised aerobic 
exercises. The subjects consumed about 94 g of oat bran daily as part 
of their usual low fat, low saturated fat diets. This study lacked an 
appropriate placebo control.
    Six studies (Refs. 13, 16, 27, 28, 36, and 41) gave inconclusive 
results regarding the relationship between oat consumption and reduced 
serum lipids in hypercholesterolemic subjects consuming low fat diets. 
In a study by Bremer et al. (Ref. 13), subjects consumed either oat or 
wheat bread (about 8 slices/day) in place of other carbohydrate foods 
as part of their AHA phase II diet (total fat 25 to 30 percent of 
energy, saturated fat <8 percent of energy, polyunsaturated fat 5 to 10 
percent of energy, cholesterol <250 mg/day). Subjects had a mean intake 
of 44.6 g/day of oat bran (range of 34.2 to 68.4 g/day). The study 
showed no significant differences in total serum cholesterol or LDL-
cholesterol between the period in which the subjects consumed oat bread 
and the period in which they consumed wheat bread. However, the lack of 
an observed effect on serum cholesterol from oat bran could be 
attributable to the lower soluble fiber content of the New Zealand oat 
bran used in this study compared to oat bran used in other studies.
    Demark-Wahnefried et al. (Ref. 16) evaluated the 
hypocholesterolemic properties of oat bran in hypercholesterolemic 
subjects following one of four dietary protocols for 12 weeks: Step 1 
diet alone, Step 1 diet plus added soluble fiber from 50 g of oat bran, 
regular diet plus 50 g of oat bran, and regular diet plus 42 g of 
processed oat bran. The results of this study showed significant 
reductions (p<0.05) in serum cholesterol in all diet groups. The serum 
cholesterol levels of groups consuming diets containing the higher 
soluble fiber (approximately 4 g added soluble fiber daily) did not 
differ from groups on a dietary regimen modified only in fat and 
cholesterol content. Variable weight loss was reported among the 
groups, and dietary changes in all groups confound the results of this 
study.
    In a study by Lepre and Crane (Ref. 27), subjects received a 
prescribed low fat diet for 8 weeks before being randomly assigned to 
either the oat or wheat group. Subjects consumed 2 oat bran muffins (60 
g of oat bran, 3.2 g soluble fiber) or 2 wheat bran muffins (60 g wheat 
bran) daily for 8 weeks. At the end of the first 8-week test period, 
subjects crossed over to the other test group for another 8 weeks. The 
results showed small, nonsignificant reductions in serum cholesterol 
(2.2 percent) and LDL-cholesterol (3.1 percent) and a nonsignificant 
increase in HDL-cholesterol (3.0 percent) during the oat bran period 
compared to diet only period. During the wheat bran period, there was a 
nonsignificant increase in total cholesterol, LDL-cholesterol, and the 
ratio of LDL- to HDL-cholesterol (LDL:HDL) and a nonsignificant 
decrease in HDL-cholesterol. The results of this study were confounded 
because subjects made significant dietary changes during the diet only 
and the oat bran periods. The subjects were aware of their 
hyperlipidemias and were already on a low fat diet before the start of 
this study. They also knew in advance which days they were required to 
record their dietary intake. The intakes of dietary cholesterol and 
saturated fat were significantly less, and dietary fiber intake was 
significantly more, during the oat bran period compared to the diet 
only period. The results of this study, therefore, are inconclusive for 
an effect of oat bran on serum cholesterol.
    Mackay and Ball (Ref. 28) evaluated the hypocholesterolemic 
properties of 55 g each of low-fiber and high-fiber oat bran (New 
Zealand cultivars) and of beans in hypercholesterolemic subjects 
consuming a moderately low fat diet. The oat bran used in this study 
was specially formulated to provide specific amounts of -
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<0.05). The energy intake on 
the high-fiber oat bran diet was significantly higher than that of the 
low-fat diet alone; however, there was no reported change in body 
weights. This study lacked a placebo control which makes the study 
difficult to interpret. Also, the source of this oat bran, a New 
Zealand cultivar, may have contributed to the lack of a 
hypocholesterolemic response to oat bran in this study (see Refs. 13 
and 26).
    Stewart et al. (Ref. 36) reported no significant differences in 
serum cholesterol, LDL-, or HDL-cholesterol in subjects consuming an 
oat-free, low fat diet or a low fat diet with 50 g/d of oat bran for 6 
weeks each. However, the subjects' compliance with the required dietary 
protocol in this study was poor. The authors reported a wide 
variability among the subjects' diets at baseline as well as a 
variability in the intake of oat bran. Moreover, both processed and 
unprocessed New Zealand oat brans were used in this study. As stated in 
the previous paragraph, the type of oat bran cultivar used, and the 
method of processing the oat bran, may have affected the results of 
this study.
    Uusitupa et al. (Ref. 41) evaluated the hypocholesterolemic effects 
of a -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<0.01) and LDL-
cholesterol (p<0.05) during the oat cereal period. However, the results 
are difficult to interpret because the fruits consumed with the muesli 
cereal may have contributed to the observed reduction in serum 
cholesterol.
    Zhang et al. (Ref. 46) compared the hypocholesterolemic properties 
of oat 

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bran (118 g) with wheat flour using a crossover design. The subjects 
consumed one of the test substances as part of a low fiber base diet 
for 3 weeks before crossover to the other test substance. During the 
oat period, serum cholesterol was significantly lower than during the 
wheat flour period. The results of this study are difficult to 
interpret because all subjects had ileostomies (i.e., an opening from 
the ileum through the abdominal wall, permitting drainage of the 
contents of the small intestine) and the mechanism by which oat bran 
lowers serum lipids in this group may not apply to the general 
population.
3. Normocholesterolemics: ``Typical'' or ``Usual'' Diets
    The results of two studies (Refs. 17 and 29) support a cholesterol 
lowering effect of oat bran or oatmeal in subjects with normal serum 
cholesterol values. A third study (Ref. 14) showed evidence of the 
cholesterol-lowering effects of oat bran postprandially.
    Gold and Davidson (Ref. 17) reported a significant (p<0.05) 
reduction in total cholesterol (5.3 percent) and LDL-cholesterol (8.7 
percent) compared to baseline measures in normocholesterolemic subjects 
consuming 2 oat bran muffins/d for 4 weeks. The oat bran muffins 
provided a total of 34 g oat bran. There were no data given on the 
subjects' dietary intake before or during the test period.
    Marlett et al. (Ref. 29) studied the mechanism of serum cholesterol 
reduction by oat bran using a single isotope to determine bile acid 
kinetics. During the first month, normo- cholesterolemic subjects 
consumed a low fiber control diet provided in a metabolic unit. During 
the second month, this same diet was supplemented with 100 g of oat 
bran. The results showed significantly lowered serum cholesterol 
compared to baseline values during both periods. Serum cholesterol on 
the low fiber diet was reduced 14 percent (p<0.01) and on the oat bran 
diet 22 percent (p<0.01) compared to baseline values. Serum cholesterol 
during the high fiber period was also significantly lower than that of 
the low fiber period (an additional decrease of 9 percent).
    Cara et al. (Ref. 14) evaluated the effects of oat bran and other 
high fiber-containing foods on postprandial lipemia in 6 
normocholesterolemic men. The subjects consumed, on separate days, a 
low fiber (control) meal or a high fiber test meal enriched with 10 g 
of oat bran, rice bran, wheat fiber, or wheat germ. The results of this 
study showed that the oat bran test meal produced the greatest 
reduction in serum cholesterol compared to the other fibers tested. The 
differences between serum cholesterol levels in the oat bran test and 
those in the control test remained significant (p<0.05) 7 hours 
postprandial. The results of this study support a significant short 
term effect on serum cholesterol, but they do not address long term 
effectiveness of oat bran in maintaining reduced serum cholesterol 
levels.
    The results of one study (Ref. 31) was inconclusive for an effect 
of oatmeal on serum cholesterol in normo-cholesterolemic subjects. 
O'Kell and Duston (Ref. 31) reported no significant differences in 
serum cholesterol and HDL-cholesterol in subjects consuming 1/2 to 3/4-
cup of oatmeal daily for a series of 3-month test periods over the 
course of a year. After each 3-month oatmeal period, the subjects 
consumed their usual diets without oatmeal for 3 months. The results of 
this study were difficult to interpret because the subjects' dietary 
intakes before and during the study were not reported, and subject 
compliance was not adequately addressed.
    One study (Ref. 37) showed equivocal results in reducing total 
cholesterol. Swain et al. evaluated the hypocholesterolemic effects of 
oat bran and wheat bran in a group of young females with normal serum 
cholesterol (mean total cholesterol of 185 mg/dL) using a double-blind, 
cross-over study design. The subjects consumed an average of 87 g oat 
bran and 93 g wheat bran/day during each 6-week test period. The 
authors reported statistically significant reductions from baseline 
levels in total cholesterol (p<0.05) and LDL-cholesterol (p<0.05) in 
both bran test periods. The differences between the oat bran and wheat 
bran groups were not significant. The results of this study are 
difficult to interpret because of dietary changes during the oat bran 
period. The subjects significantly increased their intake of total 
calories from fat and saturated fat compared to the wheat period. Mean 
body weight was unchanged over the short test period suggesting that 
there was a substitution effect with the diet. Young premenopausal 
women with low serum cholesterol levels do not represent a population 
at risk for CHD. Therefore, the benefits of oat bran may not be 
reflected in this group.
4. Normocholesterolemics: Low Fat Diets
    One study (Ref. 42) reported significantly lower total cholesterol, 
compared to a control group, after 4-weeks of oat intervention in 
subjects with normal to mildly elevated total cholesterol. The oat 
group consumed a Phase II AHA diet (low fat, low saturated fat, low 
cholesterol) plus 56 g of oatmeal daily compared to a control group 
that consumed only the Phase II diet. Over the next 4 weeks, however, 
serum cholesterol levels increased slightly in the oat group and 
decreased slightly in the control group. After 8 weeks, serum 
cholesterol was reduced 3.1 percent in the oat group and 1.4 percent in 
the control group. There were no significant differences in total serum 
cholesterol levels between the groups. Subgroup analysis of the data 
showed greater reductions in serum cholesterol among those subjects in 
the oat group who had the highest baseline cholesterol levels. The 
results of this study suggest a modest benefit of oatmeal in lowering 
serum cholesterol in subjects with normal cholesterol levels.
    One survey (Ref. 19) showed equivocal results for an effect of oat 
bran or oatmeal on serum cholesterol. He et al. (Ref. 19) evaluated the 
relationship between the intakes of oats and buckwheat and serum 
cholesterol in a population of Chinese by conducting a survey of their 
dietary habits. This particular population group consumed a high 
energy, low fat, and high fiber diet, and had active working 
lifestyles. The results of this study showed that the groups consuming 
greater than 25 g of oats a day had significantly lower serum 
cholesterol than those who ate less than 25 g of oats a day or no oats. 
All baseline serum cholesterol values, however, were under 160 mg/dL. 
The results of this study were difficult to interpret because this 
population group is one whose diets and lifestyles do not reflect that 
of the general American population. The results of this study are also 
confounded because of the questionable assessment of dietary intake of 
oat bran and oatmeal and the absence of any controls.
5. Other Studies
    Evidence for the cholesterol-lowering effect of soluble fiber from 
oatmeal and oat bran was evaluated using a metaanalysis (Ref. 33). In 
this study, after pooling the raw data from 13 studies (Refs. 11, 15 
through 17, 23, 25, 30, 37, 39, 40, and 42 through 44) that reported on 
the effect of consumption of oatmeal and oat bran on total cholesterol, 
a modest reduction (average decrease of 5 to 6 mg/dL) on blood total 
cholesterol levels was found.
    To assess whether other dietary factors, i.e., substitution of oats 
for dietary fats and cholesterol, might have been responsible for the 
drop in blood 

[[Page 303]]
total cholesterol levels, Ripsin and coworkers used the experimentally 
derived, predictive equation of Keys to see whether dietary changes in 
fat components of the test diets could account for the observed 
decreases in serum cholesterol (Ref. 33). The results of their analysis 
showed that reduction in fat and cholesterol intake attributable to 
substituting oat bran or oatmeal for these food components did not 
account for all of the blood cholesterol reduction observed. Oat bran 
and oatmeal apparently had some effect beyond that of simply replacing 
fat and cholesterol in the diet. The authors concluded, therefore, that 
incorporation of oat products into diets causes a modest decrease in 
average blood cholesterol.
    The authors also suggested that there was a dose-response 
relationship between the amount of soluble fiber from oat bran or 
oatmeal and the reduction in blood cholesterol levels, with intakes of 
soluble fiber from oats above 3 g/day showing more effect than lower 
intakes. They stated that there is significant evidence of an 
interaction between dose and initial cholesterol levels. The trials 
that used subjects with initial serum cholesterol levels of 229 mg/dL 
or higher demonstrated fivefold greater reductions in total cholesterol 
with 3 g/d or more of soluble fiber from oat bran or oatmeal than 
trials whose subjects had lower initial cholesterol levels. 
Additionally, the authors noted that other components in oats may play 
a role in the observed cholesterol reduction and suggested the need for 
long-term clinical trials (6 months or more) with multiple doses to 
verify their conclusions from the metaanalysis.
    LSRO, in its 1987 report entitled ``Physiological Effects and 
Health Consequences of Dietary Fiber,'' stated that oat bran has been 
shown to exert a substantial cholesterol-lowering effect in patients 
with hypercholesterolemia (Ref. 7). It noted that the effects of oat 
bran are not as pronounced in subjects with normal serum cholesterol as 
they are in subjects with elevated serum lipid levels.
6. Summary
    Of the 37 studies that FDA reviewed, 4 studies (Refs. 9, 14, 22, 
and 30) had short test periods, ranging from 7 hours to 18 days and, 
thus, did not meet the agency's criteria for selecting pertinent 
studies with respect to study duration (i.e., intervention test period 
of no less than 3 weeks).
    Seventeen studies (Refs. 8, 11, 12, 15, 17, 20, 21, 23, 24, 25, 29, 
35, 39, 42 through 45) demonstrated a positive effect of oat bran or 
oatmeal on total and LDL-cholesterol. The majority of these studies 
showed statistically significant reductions in total and LDL-
cholesterol in hypercholesterolemic subjects consuming either a typical 
American diet (Refs. 8, 12, 20, 21, 25, 35, 44, and 45) or a low fat 
diet (Refs. 11, 15, 23, 24, 39, 42, and 43). The results of three 
studies showed a statistically significant effect of oat bran or 
oatmeal in subjects with normal serum cholesterol consuming either a 
typical American diet (Refs. 17 and 29) or a low fat diet (Ref. 42). 
The amount of oat bran or oatmeal consumed daily to lower total and 
LDL-cholesterol in the above studies ranged from 34 g (2.5 g soluble 
fiber) (Ref. 17) to 123 g (10.3 g soluble fiber) (Ref. 45). In those 
studies that evaluated HDL-cholesterol responses to oat intervention, 
three reported a slight, nonsignificant decrease in HDL-cholesterol 
(Refs. 8, 11, and 21); four reported no change (Refs. 12, 20, 23, and 
35); and five reported a slight increase in HDL- cholesterol as a 
result of oat intervention (Refs. 24, 25, 39, 42, and 45).
    Five studies (Refs. 10, 19, 32, 37, and 46) showed equivocal 
results in reducing serum cholesterol. The results by Bartram et al. 
(Ref. 10) were difficult to interpret because fruits were included in 
the oat bran cereal. The soluble fiber of the fruit may have had an 
independent effect on serum lipid levels. The questionable assessment 
of dietary intake and the lack of temporal sequence in an uncontrolled, 
cross-sectional survey conducted by He et al. (Ref. 19) make the 
beneficial results of this study difficult to interpret. In addition, 
the population group used in this study (i.e., Chinese farmers and 
migrants) do not reflect the general population in the United States. 
The agency also questioned the appropriateness of the population groups 
used in two other studies (Refs. 37 and 46). Zhang et al. (Ref. 46) 
showed significant reductions in total cholesterol in subjects who had 
ileostomies. The mechanism by which oat bran or oatmeal help lower 
serum lipids in this population may not reflect the general population 
in the United States. Swain and coworkers (Ref. 37) evaluated the 
cholesterol-lowering properties of oat bran and wheat in a group of 
young pre-menopausal women with low serum cholesterol levels, a group 
who does not represent a population at risk for CHD. Dietary changes 
were reported during the oat period which also make interpretation of 
the results difficult.
    Significant dietary changes during the oat intervention period made 
it difficult to interpret the results of another study (Ref. 32). 
Poulter et al. (Ref. 32) reported significant reductions in total and 
LDL-cholesterol in subjects consuming 56 g of oat cereal. There were no 
significant changes in total and LDL-cholesterol when the subjects 
consumed their usual (control) cereal. However, an analysis of the 
nutrient data revealed a significant reduction in total energy from fat 
and in the ratio of polyunsaturated to saturated fat (P:S) during the 
oat period.
    In the 11 studies in which no effect on serum lipid levels were 
found (Refs. 13, 16, 18, 26 through 28, 31, 34, 36, 38, and 41), a 
number of reasons were advanced for the lack of a positive finding. A 
lack of compliance and changes in dietary intakes by the subjects 
plagued a number of these studies (Refs. 18, 27, 31, 34, and 41). The 
source of the oat cultivars allegedly contributed to the lack of an 
effect of oat bran or oatmeal on serum lipids in four others (Refs. 13, 
26, 28, and 36). The authors of these studies noted that New Zealand 
oat cultivars tend to have lower levels of soluble fiber than oat 
cultivars used in studies showing cholesterol-lowering properties.
    The processing of oats allegedly caused a loss of effectiveness in 
another study (Ref. 38). Torronen and coworkers found that wet milling 
Finnish oats to produce an oat bran concentrate negatively affected the 
hypocholesterolemic properties of oat -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 

[[Page 304]]
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<0.03) in the study by Kahn et al. (Ref. 21), the HDL:LDL and 
HDL:total cholesterol ratios were improved, compared to baseline, 
because of significant reductions in total cholesterol (8 percent) and 
LDL-cholesterol (10 percent).
    Oat bran and oatmeal were tested in a variety of food forms but 
produced fairly consistent results, showing that the way in which these 
foods are consumed does not alter their effect on serum lipids. They 
were consumed as hot and cold cereals or used in a variety of other 
foods, such as muffins, breads, shakes, and entrees.
    The eleven studies that did not show reduced total and LDL-
cholesterol from the consumption of oat bran or oatmeal (Refs. 13, 16, 
18, 26 through 28, 31, 34, 36, 38, and 41) do not detract from the 
agency's tentative conclusion about this relationship or that the claim 
is valid. 

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The lack of result in five of these studies (Refs. 13, 26, 28, 36, and 
38) was apparently attributed to the oat source, i.e., New Zealand 
cultivars, or to the method of processing oat bran. The results of the 
remaining six studies were associated with a lack of subject compliance 
and significant changes in dietary intake during the test periods, or 
to problems in study design, i.e., a lack of statistical power to 
detect changes between groups.
    Given all of this evidence, the agency is proposing a health claim 
on the relationship between oat bran and oatmeal and reduced risk of 
CHD.

V. Description and Rationale for Components of Health Claim

A. Relationship Between Oatmeal and Oat Bran and CHD and the 
Significance of the Relationship

    Proposed Sec. 101.81(a) describes the relationship between diets 
high in oat bran or oatmeal and the risk of CHD. In proposed 
Sec. 101.81(a)(1), the agency recounts that CHD is the most common and 
serious form of CVD, and that CHD refers to diseases of the heart 
muscle and supporting blood vessels. The regulation also notes that 
high blood total and LDL-cholesterol levels are associated with 
increased risk of developing CHD. The regulation identifies the levels 
of total cholesterol and LDL-cholesterol that would put an individual 
at high risk of developing CHD and those serum lipid levels that are 
associated with borderline high risk. The intent is to provide 
consumers with information to help them understand the seriousness of 
CHD.
    In proposed Sec. 101.81(a)(2), the agency recounts that populations 
with a low incidence of CHD tend to have low blood total and LDL-
cholesterol levels. It states that these populations also tend to have 
dietary patterns that are low in total fat, saturated fat, and 
cholesterol and high in fruits, vegetables, and grain products, such as 
oatmeal and oat bran. This information is consistent with that provided 
in the authorized health claim for fruits, vegetables, and grain 
products and CHD (Sec. 101.77). The agency tentatively finds that this 
information provides a basis for a better understanding of the numerous 
factors that contribute to the risk of CHD and the relationship between 
oat bran and oatmeal and a low fat diet.
    Proposed Sec. 101.81(a)(3) describes the relationship between oat 
bran and oatmeal, foods low in saturated fat and cholesterol, and 
reduction in the CHD risk factors. The paragraph states that several 
studies have shown that diets high in oatmeal or oat bran are 
associated with reduced blood lipid levels. This information 
encapsulates the scientific evidence about how oatmeal and oat bran can 
contribute to reduction in heart disease risk factors.
    Proposed Sec. 101.81(b) describes the significance of the diet-
disease relationship. In proposed Sec. 101.81(b)(1), the agency 
recounts that CHD remains a major public health concern in the United 
States because the disease accounts for more deaths than any other 
disease or group of diseases. The claim states that early management of 
modifiable risk factors for CHD is a major public health goal that can 
assist in reducing the risk of CHD. This information is consistent with 
the evidence that lowering blood total and LDL-cholesterol levels 
reduces the risk of CHD (56 FR 60727, 58 FR 2739, and Refs. 3 through 6 
and 47).
    In proposed Sec. 101.81(b)(2), the significance of the relationship 
between oatmeal and oat bran and CHD risk factors in context of the 
total diet is discussed. The agency recounts that many Americans' 
intakes of saturated fat and cholesterol exceed recommended levels, and 
it summarizes public health recommendations for the diet (56 FR 60727 
at 60738 and Sec. 101.75(b)(3)). This paragraph also states that 
scientific evidence demonstrates that diets high in oatmeal and oat 
bran and low in saturated fat and cholesterol are associated with 
reduced blood lipids. FDA tentatively concludes that the latter 
statement is scientifically valid based on the evidence that it has 
reviewed on this nutrient-disease relationship.

B. Nature of the Claim

    In Sec. 101.81(c)(1) (21 CFR 101.81(c)(1)), FDA is proposing to 
require that all of the general requirements for health claims set out 
in Sec. 101.14 be met. This provision is consistent with the provisions 
of the other specific health claim regulations in part 101, subpart E, 
of the Code of Federal Regulations (CFR) (21 CFR part 101, subpart E).
    In Sec. 101.81(c)(2)(i), FDA is proposing to authorize a health 
claim on the relationship between diets high in oat bran or oatmeal and 
the risk of CHD. The agency is proposing to do so based on its review 
of the scientific evidence on this nutrient-disease relationship which 
shows that diets that are high in oat bran or oatmeal help to reduce 
total and LDL-cholesterol levels in individuals with normal to elevated 
blood total cholesterol (Refs. 8, 11, 12, 15, 17, 20, 21, 23 through 
25, 29, 35, 39, 44, and 45). This result is significant for the risk of 
heart disease because elevated levels of total and LDL-cholesterol are 
associated with increased risk of CHD (Refs. 3 through 6).
    In Sec. 101.81(c)(2)(i)(A), the agency is proposing to require, 
consistent with other health claims, that the relationship be qualified 
with the terms ``may'' or ``might.'' These terms are used to make clear 
that not all persons can necessarily expect to benefit from these 
dietary changes (56 FR 60727 at 60740 and 58 FR 2552 at 2573).
    In Sec. 101.81(c)(2)(i)(B), the agency is proposing to require, 
consistent with other authorized health claims, that the terms 
``coronary heart disease'' or ``heart disease'' be used in specifying 
the disease. These terms are commonly used in dietary guidance 
materials, and therefore they should be readily understandable to the 
consumer (56 FR 60727 at 60740 and 58 FR 2552 at 2573).
    In Sec. 101.81(c)(2)(i)(C)(1), the agency is proposing that the 
claim describe the relationship between diets high in oatmeal or oat 
bran and risk for CHD. Based on its review of the scientific evidence 
submitted with the petition, the agency tentatively concludes that 
there is significant scientific agreement that diets high in oat bran 
or oatmeal may help to reduce blood total and LDL-cholesterol levels, 
the major modifiable risk factors for CHD (Refs. 12, 17, 20, 21, 25, 
29, 35, 44, and 45).
    The petitioner stated in its petition that there is significant 
scientific evidence to show that the effect of oats on lowering serum 
lipids is independent of a diet low in saturated fat and cholesterol. 
In light of this evidence, the petitioner argued that any health claim 
that is authorized need not refer to such a diet. The petitioner 
explained that important public health policy objectives, as well as 
FDA's statutory mandate to authorize health claims supported by 
significant scientific agreement, mandate that FDA issue a regulation 
that requires only that claims describe the relationship between oat 
products and reduced risk of CHD (Ref. 1, p. 68).
    The agency acknowledges that there were a number of studies that 
showed that high intakes of oat bran and oatmeal lowered blood total 
and LDL-cholesterol in subjects that otherwise consumed a typical 
American diet (Refs. 12, 17, 20, 21, 25, 29, 35, 44, and 45). However, 
as stated in section V.A. of this document, CHD is a major public 
health concern in the United States, and that the totality of the 
scientific evidence provides strong and consistent support that diets 
high in saturated fat and cholesterol are associated with elevated 
levels of blood total and LDL-cholesterol, and thus CHD (56 FR 60727 

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at 60737). Dietary estimates for American adults show that the average 
saturated fat intakes of American adults are about 13 percent of 
calories, total fat intakes are about 37 percent of calories, and 
average cholesterol intakes range from 300 to over 400 mg daily for 
adult men and women (56 FR 60727 at 60738). The current intakes of 
saturated fat and total fat are thus well in excess of recommended 
goals of less than 10 percent and 30 percent of calories. Dietary 
guidelines from both government and private-recognized scientific 
bodies conclude that the majority of the American population would 
benefit from decreased consumption of dietary saturated fat and 
cholesterol (Refs. 3 through 6).
    The results of several studies showed that while daily consumption 
of oat bran or oatmeal lowered total cholesterol and LDL-cholesterol, 
the effects of dietary intake of oat bran or oatmeal were particularly 
evident when the diets were low in saturated fat and cholesterol (Refs. 
11, 15, 24, 39, and 43). Thus, the agency tentatively finds that it 
will be more helpful to Americans' efforts to maintain healthy dietary 
practices if the effect of oats on serum lipids is described in context 
of a healthy diet. This information is extremely important to a full 
understanding of the significance of the claim.
    The agency tentatively finds that for the public to understand 
fully, in the context of the total daily diet, the significance of 
consumption of oat bran and oatmeal on the risk of CHD (see section 
403(r)(3)(B)(iii) of the act), information about the total diet needs 
to be included as part of the claim. Therefore, in 
Sec. 101.81(c)(2)(i)(C)(2), the agency is proposing to require that the 
claim include the fact that the effect of dietary consumption of 
oatmeal or oat bran on the risk of CHD is particularly evident when 
these foods are consumed as part of a diet that is low in saturated fat 
and cholesterol. Based on its review of the scientific evidence 
submitted with the petition, the agency tentatively concludes that 
there is significant scientific agreement that diets high in oat bran 
or oatmeal and low in saturated fat and cholesterol are associated with 
reduced blood total and LDL-cholesterol levels (Refs. 11, 15, 23, 24, 
39, 42, and 43).
    FDA is proposing to require that this dietary information be 
included as part of the full health claim to ensure that people 
understand the significance of the information in the claim. A diet low 
in saturated fat and cholesterol is important because if intake of 
these dietary components are not controlled, then there is a 
significant question as to whether high fiber diets will have their 
full effect on blood total and LDL-cholesterol levels, and thus on the 
risk of heart disease. However, based on information supplied by the 
petitioner, FDA tentatively concludes that a claim that diets high in 
oat bran or oatmeal may reduce the risk of heart disease is truthful, 
not misleading, and scientifically valid without this additional 
information. Therefore, FDA tentatively finds that it is appropriate to 
require that a label that bears an oat bran or oatmeal health claim 
disclose the fact that a diet should be high in oat bran and oatmeal 
and low in saturated fat and cholesterol, but that it is not necessary 
to require that the latter dietary information be disclosed in 
immediate proximity of the oat bran or oatmeal claim each time the 
claim appears on the label or in labeling (see the discussion of 
Sec. 101.81(c)(2)(ii) below). FDA is proposing to require only that the 
full statement of the claim disclose the fact that the effect of the 
dietary intake of oat bran or oatmeal is particularly evident when the 
diet is low in saturated fat and cholesterol.
    Proposed Sec. 101.81(c)(2)(i)(D), consistent with other authorized 
health claims, requires that the claim not attribute any degree of risk 
reduction of CHD to consumption of oat products. None of the studies 
that the agency reviewed provide a basis for determining the percent 
reduction in risk of CHD likely from consuming diets high in oat 
products.
    The agency considered proposing to require that the claim state 
that the development of CHD depends on many factors. This statement has 
been required in the two authorized heart disease health claims 
(Secs. 101.75 and 101.77) (although the agency has recently proposed to 
delete this requirement in a document that published in the Federal 
Register of December 21, 1995 (60 FR 66206) (hereinafter referred to as 
the 1995 proposal). The petitioner requested that the statement 
regarding the multifactorial nature of CHD be listed under optional 
requirements for the health claim (Ref. 1, p. 68). The petitioner 
stated 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 petitioner did not provide any data to support this 
observation. The petition stated that the ``depends on many factors'' 
language makes the health claim cumbersome, unnecessarily long, and 
detracts from its central and critical consumer message. The petition 
stated that using the required statement ``may help'' (i.e., ``may help 
reduce the risk of heart disease'') more simply, directly, and 
succinctly indicates to consumers that oatmeal and oat bran are not 
magic bullets, and that other factors are associated with CHD risk.
    The agency agrees 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. In response to 
comments on the scientific standard proposed for health claims, the 
agency stated in the 1993 health claims final rule (58 FR 2478 at 
2505):

* * * Further, absolute claims about diseases affected by diet are 
generally not possible because such diseases are almost always 
multifactorial. Diet is only one factor that influences whether a 
person will get such a disease. For example, in the case of calcium 
and osteoporosis, genetic predisposition (e.g., where there is a 
family history of fragile bones with aging) can play a major role in 
whether an individual will develop the disease. Because of factors 
other than diet, some individuals may develop the disease regardless 
of how they change their dietary patterns to avoid the disease. For 
those individuals, a claim that changes in dietary patterns will 
reduce the risk of disease would be false. Thus, health claims must 
be free to use the term ``may'' with respect to the potential to 
reduce the risk of disease. * * *

    The agency notes that FDA has been asked in a petition from the 
National Food Processors Association (NFPA) (Docket No. 94P-0390) to 
reevaluate the required elements of the health claim and to consider a 
number of options including the option of using an abbreviated health 
claim and eliminating the multifactorial element of the health claim 
requirements. In the 1995 proposal, the agency initiated rulemaking 
that, in part, proposed to eliminate or make optional some of the 
required elements. More specifically, the agency proposed to make 
optional the statement ``a disease caused by many factors'' (see 
section IV.E. of the 1995 proposal), and to permit the use of certain 
abbreviated health claims on the label or labeling of a product (see 
section IV.C. of the 1995 proposal) (60 FR 66206). In this proposed 
rule on oat bran and oatmeal and CHD, the agency is proposing to make 
the phrase ``depends on many factors'' optional information. In place 
of the requirement for stating the multifactorial nature of 

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the disease, the agency is proposing Sec. 101.81(c)(2)(i)(E) to require 
that the claim not imply that the consumption of oat bran and oatmeal 
is the only recognized means of achieving a reduced risk of CHD. Thus, 
the agency tentatively concludes that the concept of the multifactorial 
nature of CHD will be preserved without adding additional words to the 
claim. The agency requests comment on whether consumers will be misled 
to believe that reduction of risk will be achieved if the 
multifactorial nature of CHD is not stated on the claim. This proposed 
rule would also permit use of a shortened version of the claim in 
conjunction with the full claim (see section IV.C. of the 1995 
proposal).

C. Presentation of the Claim

    In proposed Sec. 101.81(c)(2)(ii), the agency is providing for how 
the health claim is to be presented on the label or labeling. This 
paragraph states that all of the elements listed in 
Sec. 101.81(c)(2)(i) must be included in one presentation of the claim 
on the label or labeling. As discussed in sections V.A. and B. of this 
document, the scientific evidence provides strong and consistent 
support that diets high in saturated fat and cholesterol are associated 
with elevated levels of blood total and LDL-cholesterol, the major 
modifiable risk factors for CHD. Because the typical American diet 
tends to be high in saturated fat and cholesterol, dietary guidelines 
recommend that Americans modify their intakes of food that contain 
significant levels of saturated fat and cholesterol. From a public 
health standpoint, it is important for the public to comprehend the 
significance of the relationship between diets high in oat bran or 
oatmeal and CHD risk in context of a diet low in saturated fat and 
cholesterol. This relationship is supported by significant scientific 
evidence as discussed above.
    However, the 1995 proposal permits a short, simple statement of 
certain health claims that is truthful, not misleading, and 
scientifically valid, which may be used on the principal display panel, 
as long as the full claim appears on the particular label or in the 
particular labeling in which the short statement appears, and there is 
a referral statement from the shortened to the full claim (60 FR 
66206). In recognition of this fact, FDA is providing in proposed 
Sec. 101.81(c)(2)(ii) that if a full statement of the claim appears on 
a label or in a piece of 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) so long as there is a 
referral statement to the full statement of the claim in immediate 
proximity with the shortened statement. FDA has explained above the 
basis for its tentative conclusion that the shortened claim need not 
include the information in paragraph (c)(2)(i)(C)(2) regarding the 
importance of low saturated fat and cholesterol diet.
    The referral statement that FDA is proposing accompany the 
shortened claim is consistent with that provided for in the general 
requirements for nutrient content claims (Sec. 101.13) and health 
claims (Sec. 101.14(d)(2)(iv)). This referral statement is short and 
thus consistent with the use of an abbreviated claim. It is important, 
however, because the agency tentatively finds that it is essential that 
the consumer be directed to the full claim. Specifically drawing the 
consumer's attention to the full claim will help to ensure that he or 
she is able to comprehend the information that is being presented in 
the context of the total daily diet.
    In its 1993 health claims final rule, the agency stated that it did 
not believe that it is appropriate to use abbreviated health claims as 
referral statements (58 FR 2478 at 2512). The agency was concerned that 
an abbreviated claim would not include facts that are material in light 
of the representation that is made and that are necessary to understand 
the claim in the context of the daily diet. The agency was concerned 
that confusion is possible whenever the full health claim information 
appears in a location different from that of the reference statement 
and is especially likely to occur when a multiplicity of labeling is 
associated with a product.
    The agency has tentatively concluded that this proposed rule 
addresses these concerns. It is providing for an abbreviated statement 
that reflects the facts that are material under section 201(n) of the 
act (21 U.S.C. 321(n)) and that are necessary to ensure that the claim 
is scientifically valid. It is also providing for an accompanying 
referral statement to additional information that is necessary for a 
full understanding of the claim. The agency is concerned, however, 
about the possibility that consumers may not read the complete claim, 
and thus that they will not have all of the facts necessary to fully 
understand the significance of the claim being made and to comprehend 
the claim in the context of the daily diet. For this reason, the agency 
is asking for data to demonstrate that permitting a shortened claim in 
this manner will not significantly decrease the likelihood that 
consumers will read the full claim so long as it appears prominently on 
the label or in the piece of labeling.
    In new Sec. 101.81 (c)(2)(ii)(A) and (c)(2)(ii)(B), the agency is 
proposing, consistent with requirements for nutrient content claims in 
Sec. 101.13 (g)(1) and (g)(2), requirements for the typesize and 
location of the referral statement.
    FDA has long held that accompanying information should be in a size 
reasonably related to that of the information that it modifies. Section 
403(f) of the act requires that information required under the act be 
placed on the label with such conspicuousness as to render it likely to 
be read. Section 403(r)(2)(B) of the act requires that a referral 
statement for nutrient content claims appear prominently, although it 
does not specify specific requirements such as to typesize or style. 
For nutrient content claims, FDA established type size requirements for 
referral and disclosure statements related to the area of the surface 
bearing the principal display panel rather than to the type size used 
for the nutrient content claim. The proportionality between the size of 
the referral statement and the size of the label ensures that the 
referral statement is presented with appropriate prominence. However, 
when the claim is less than twice what the minimum size of the referral 
statement would be given the size of the label and Sec. 101.105(i) (21 
CFR 101.105(i)) the type size of the referral statement may be less 
than that required under Sec. 101.105 for net quantity of contents. In 
such circumstances, the referral statement is of appropriate prominence 
if it is at least one-half the size of the claim and not less than one-
sixteenth of an inch. This approach to the type size requirement for 
the referral statement provides flexibility to firms in utilizing label 
space but still ensures adequate prominence for this statement. Because 
health claim referral statements are used similarly to those that 
accompany nutrient content claims and are likely to appear on the 
principal display panel, the agency tentatively concludes that a health 
claim referral statement should have the same type size requirements as 
those for nutrient content claims. Therefore, the agency tentatively 
concludes that the requirements for the referral statement set forth in 
Sec. 101.105 (c)(2)(ii)(A) and (c)(2)(ii)(B) are appropriate when a 
shortened health claim is used and is including them in this proposed 
rule.

D. Nature of the Food

    Proposed Sec. 101.81(c)(2)(iii)(A) requires that the food bearing 
the health claim contain 13 g of oat bran or 20 g 

[[Page 308]]
oatmeal, and that the oat bran or oatmeal contain, without 
fortification, at least 1.0 g of -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), 
``National Cholesterol Education Program: Report of the Expert Panel 
on Detection, Evaluation, and Treatment of High Blood Cholesterol in 
Adults,'' NIH, Bethesda, MD, pp. 1-79, 1989.
6. DHHS, PHS, and NIH, ``National Cholesterol Education Program: 
Population Panel Report,'' Bethesda, MD, pp. 1-27, 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, D. 
S. O'Neal, D. W. Dillon, and P. R. Oeltgen, ``Lipid Responses of 
Hypercholesterolemic Men to Oat-bran and Wheat Bran Intake,'' 
American Journal of Clinical Nutrition, 54:678-683, 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. 

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13. Bremer, J. M., R. S. Scott, and C. J. Lintott, ``Oat Bran and 
Cholesterol Reduction: Evidence Against Specific Effect,'' Australia 
and New Zealand Journal of Medicine, 21:422-426, 1991.
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, 
and K. B. Drennan, ``The Hypocholesterolemic Effects of Beta-glucan 
in Oatmeal and Oat Bran--a Dose-Controlled Study,'' Journal of the 
American Medical Association, 265(14):1833-1839, 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, 90:223-229, 1990.
17. Gold, K. V., and D. M. Davidson, ``Oat Bran as a Cholesterol-
reducing Dietary Adjunct in a Young, Healthy Population,'' Western 
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.
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 
Risk Factors in an Ethnic Minority of China,'' American Journal of 
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' 
Effects on Blood Lipids and Lipoproteins,'' American 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 
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.
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49. Saltsman, Joyce J., CFSAN, FDA, Memorandum to file, May 19, 
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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 

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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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[FR Doc. 96-29 Filed 1-3-96; 8:45 am]
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