Food Labeling: Health Claims; Soluble Dietary Fiber From Certain Foods and Coronary Heart Disease, 76150-76162 [05-24387]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 70, Number 246 (Friday, December 23, 2005)]
[Rules and Regulations]
[Pages 76150-76162]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-24387]



[[Page 76150]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 2004P-0512]


Food Labeling: Health Claims; Soluble Dietary Fiber From Certain 
Foods and Coronary Heart Disease

AGENCY: Food and Drug Administration, HHS.

ACTION: Interim final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the 
regulation authorizing a health claim on the relationship between oat 
beta-glucan soluble fiber and reduced risk of coronary heart disease 
(CHD). The amendment adds barley as an additional eligible source of 
beta-glucan soluble fiber. We (FDA) are taking this action in response 
to a petition that the National Barley Foods Council submitted. We have 
concluded, based on the totality of publicly available scientific 
evidence that, in addition to certain oat products, whole grain barley 
and certain dry milled barley grain products are appropriate sources of 
beta-glucan soluble fiber for the health claim.

DATES: This interim final rule is effective December 23, 2005. Submit 
written or electronic comments by March 8, 2006. The Director of the 
Office of the Federal Register approves the incorporation by reference 
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of certain 
publications in 21 CFR 101.81(c)(2)(ii)(A)(5) as of December 23, 2005.

ADDRESSES: You may submit comments, identified by the Docket Number 
2004P-0512 , by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following ways:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: https://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal or the agency Web site, as described in the 
Electronic Submissions portion of this paragraph.
    Instructions: All submissions received must include the agency name 
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN 
number has been assigned) for this rulemaking. All comments received 
may be posted without change to https://www.fda.gov/ohrms/dockets/
default.htm, including any personal information provided. For 
additional information on submitting comments, see the ``Comments'' 
heading of the SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to https://www.fda.gov/ohrms/dockets/default.htm 
and insert the docket number(s), found in brackets in the heading of 
this document, into the ``Search'' box and follow the prompts and/or go 
to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: James E. Hoadley, Center for Food 
Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 
5100 Paint Branch Parkway, College Park, MD, 20740-3835, telephone 301-
436-1450.

SUPPLEMENTARY INFORMATION:

I. Background

A. The Nutrition Labeling and Education Act of 1990

    The Nutrition Labeling and Education Act of 1990 (the 1990 
amendments) (Public Law 101-535) amended the Federal Food, Drug, and 
Cosmetic Act (the act) in a number of important ways. One aspect of the 
1990 amendments was that they clarified FDA's authority to regulate 
health claims on food labels and in food labeling. We issued several 
new regulations in 1993 that implemented the health claim provisions of 
the 1990 amendments. Among these were Sec.  101.14 (21 CFR 101.14), 
Health Claims: General Requirements (58 FR 2478, January 6, 1993), 
which sets out the rules for the authorization and use of health 
claims, and Sec.  101.70 (21 CFR 101.70), Petitions for Health Claims 
(58 FR 2478, January 6, 1993), which sets out a process for petitioning 
the agency to authorize health claims about substance-disease 
relationships, and sets out the types of information that any such 
petition must include. Each of these regulations became effective on 
May 8, 1993.
    When implementing the 1990 amendments, we also conducted a review 
of evidence for a relationship between dietary fiber and cardiovascular 
disease (CVD). Based on this review, we concluded that the available 
scientific evidence did not justify authorization of a health claim 
relating dietary fiber to reduced risk of CVD (58 FR 2552, January 6, 
1993). However, we did conclude there was significant scientific 
agreement that the totality of publicly available scientific evidence 
supported an association between types of foods that are low in 
saturated fat and cholesterol and that naturally are good sources of 
soluble dietary fiber (i.e., fruits, vegetables, and grain products) 
and reduced risk of CHD\1\. We therefore authorized a health claim 
about the relationship 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 CHD (21 CFR 101.77; 58 FR 
2552 at 2572). In the preamble to the 1993 dietary fiber and CVD final 
rule, FDA commented that if a manufacturer could document with 
appropriate evidence that consumption of the type of soluble fiber in a 
particular food has the effect of lowering blood low density 
lipoprotein (LDL) cholesterol, and has no adverse effects on other 
heart disease risk factors (e.g., high density lipoprotein (HDL) 
cholesterol), it should petition for authorization of a health claim 
specific for that particular dietary fiber-containing food (58 FR 2552 
at 2567).
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    \1\ CVD means diseases of the heart and circulatory system. 
Coronary heart disease, one form of cardiovascular disease, refers 
to diseases of the heart muscle and supporting blood vessels.
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B. Soluble Fiber From Certain Foods and Coronary Heart Disease Health 
Claim (Sec.  101.81 (21 CFR 101.81))

    In 1995, FDA received a petition for a health claim on the 
relationship between oat bran and rolled oats and reduced risk of CHD. 
FDA concluded there was significant scientific agreement that the 
totality of publicly available scientific evidence supported the 
relationship between consumption of whole oat products and reduced risk 
of CHD. FDA further concluded that the type of soluble fiber found in 
whole oats, i.e., beta-glucan soluble fiber, is the component primarily 
responsible for the hypocholesterolemic effects associated with 
consumption of whole oat foods as part of a diet that is low in 
saturated fat

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and cholesterol (62 FR 3584 at 3597-3598, January 23, 1997). As such, 
the final rule authorized a health claim relating the consumption of 
beta-glucan soluble fiber in whole oat foods, as part of a diet low in 
saturated fat and cholesterol, and reduced risk of CHD (the oat beta-
glucan health claim). The source of beta-glucan soluble fiber in foods 
bearing this health claim had to be one of three eligible whole oat 
products; i.e., oat bran, rolled oats, or whole oat flour (see Sec.  
101.81(c)(2)(ii)(A)). In 2002, FDA amended this health claim regulation 
to add oatrim as a fourth eligible source of beta-glucan soluble fiber 
(67 FR 61733, October 2, 2002). Oatrim is the soluble fraction of 
alpha-amylase hydrolyzed oat bran or whole oat flour.
    In the 1997 oat beta-glucan health claim final rule, we anticipated 
the likelihood that other sources and types of soluble fibers will also 
affect blood lipid levels, and thus, may reduce heart disease risk (62 
FR 3584 at 3587). At that time, FDA considered structuring the final 
rule as an umbrella regulation authorizing the use of a claim for 
``soluble fiber from certain foods'' and risk of CHD. Such action would 
have allowed flexibility in expanding the claim to other specific food 
sources of soluble fiber when consumption of those foods has been 
demonstrated to help reduce the risk of heart disease. However, the 
agency concluded that it was premature to do so inasmuch as FDA had not 
reviewed the totality of publicly available evidence on other, non-
whole oat sources of soluble fiber (62 FR 3584 at 3588). In 1998, in 
response to a health claim petition, FDA concluded that soluble fiber 
of psyllium seed husk, similar to beta-glucan soluble fiber from whole 
oats, may reduce the risk of CHD by lowering blood cholesterol levels 
(63 FR 8103, February 18, 1998). In that final rule, FDA broadened 
Sec.  101.81 to include soluble fiber from psyllium seed husk, and also 
modified the heading in Sec.  101.81 from, ``* * * Soluble fiber from 
whole oats and risk of coronary heart disease'' to ``* * *Soluble fiber 
from certain foods and risk of coronary heart disease (CHD).''

II. Petition and Grounds

A. The Petition

    The National Barley Foods Council (petitioner), submitted a health 
claim petition to FDA on August 3, 2004, under section 403(r)(4) of the 
act (21 U.S.C. 343(r)(4)). The petition requested that the agency amend 
the ``Soluble fiber from certain foods and coronary heart disease 
health claim'' at Sec.  101.81 to include barley and barley products as 
an additional source of beta-glucan soluble fiber eligible for the 
health claim (Ref. 1). On November 10, 2004, we notified the petitioner 
that we had completed our initial review of the petition and that the 
petition had been filed for further action in accordance with section 
403(r)(4) of the act. If the agency does not act, by either denying the 
petition or issuing a proposed regulation to authorize the health 
claim, within 90 days of the date of filing for further action, the 
petition is deemed to be denied unless an extension is mutually agreed 
upon by the agency and the petitioner (section 403(r)(4)(A)(i) of the 
act and Sec.  101.70(j)(3)(iii)). On February 4, 2005, FDA and the 
petitioner mutually agreed to extend the deadline to publish the 
agency's decision on the petition until August 9, 2005. On August 3, 
2005, FDA and the petitioner agreed to further extend the deadline to 
December 31, 2005. The petitioner requested that FDA issue an interim 
final rule by which labeling of barley-containing foods could bear the 
health claim prior to publication of a final rule.

B. Nature of the Substance

    The petitioner requests that Sec.  101.81 be amended to include 
barley in addition to oats as a source of beta-glucan soluble fiber 
associated with reducing the risk of CHD. The petitioner further 
requests that whole grain barley (dehulled or hulless), and certain dry 
milled barley products, i.e., pearl, flakes, grits, meal, flour, beta-
glucan enriched meal fractions, and bran, be determined as eligible 
barley sources of beta-glucan soluble fiber.
    The substance which is the subject of the existing oat beta-glucan 
health claim is beta-glucan soluble fiber from oat sources listed in 
Sec.  101.81(c)(2)(ii)(A). The requested amendment will expand the 
substance of the claim to include both oat and barley sources of beta-
glucan soluble fiber. From an analytical perspective, beta-glucan 
soluble fiber from barley is the same substance as beta-glucan soluble 
fiber from oat sources. The method now specified in Sec.  
101.81(c)(2)(ii)(A) for the measurement of beta-glucan soluble fiber 
from oat sources, AOAC Official Method 992.28, is a method designated 
by AOAC INTERNATIONAL to be used for both oat and barley fractions and 
it is the same analytical method identified by the petition for 
measurement of beta-glucan soluble fiber from barley sources.
    The petition characterizes the barley sources of beta-glucan 
soluble fiber as dehulled or hulless whole grain barley and barley 
products produced from dehulled or hulless clean, sound barley grain by 
standard dry milling processes, which may include steaming or 
tempering, and that provide at least 4 percent (dry weight basis (dwb)) 
of beta-glucan soluble fiber and total dietary fiber content of at 
least 8 percent (dwb) (flour, grits, flakes, and meal), or at least 5.5 
percent (dwb) of beta-glucan soluble fiber and at least 15 percent 
(dwb) total dietary fiber (bran and beta-glucan enriched barley 
fractions). For whole grain (dehulled and hulless) barley, the petition 
specified the minimum beta-glucan soluble fiber content as 4 percent 
(dwb) and the minimum total dietary fiber content as 10 percent (dwb).
    Most barley varieties have a tough fibrous adherent hull covering 
the grain which must be removed for the grain to be edible. There are 
also hulless barley varieties in which, similar to wheat, the hull 
falls away during harvesting and the grain can be processed directly 
into food products without dehulling. The petition thus has specified 
the eligible sources of the barley beta-glucan soluble fiber to include 
both dehulled and hulless whole barley grain.
    In addition to dehulled or hulless whole barley grain, the petition 
has specified that dry milled barley products that are eligible sources 
of the beta-glucan soluble fiber be produced from dehulled or hulless 
barley grain by standard dry milling processes. The petition includes 
dry milled barley products only and does not include beta-glucan 
extracts produced through ``wet milling'' processes. Wet milling 
processes used to extract or concentrate the beta-glucan soluble fiber 
component of barley are likely to alter physiochemical properties of 
fiber and other components of the grain. All but two of the dry milled 
barley products specified in the petition have been formally defined by 
the American Association of Cereal Chemists (AACC) in a ``Barley 
Glossary'' which is published in AACC Approved Methods (Ref. 2). Two 
additional dry milled barley products, which are not defined in the 
AACC Barley Glossary, i.e., barley meal and beta-glucan enriched barley 
fractions, are included in the petition as beta-glucan soluble fiber 
sources. The petition characterizes barley meal as differing from 
barley flour only in that it is unsifted and thus has a higher portion 
of bran and germ present than sifted barley flour. The petition has 
defined ``beta-glucan enriched barley fractions'' as fractions of dry 
milled barley that are enriched in endosperm cell walls by either 
mechanical sifting or air classification and that provide at least 5.5 
percent (dwb) of beta-glucan soluble fiber and a total dietary fiber 
content of at least 15 percent (dwb). The

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beta-glucan content of barley endosperm cell walls is greater than that 
of barley endosperm cell contents. During milling, endosperm cell walls 
break up into larger particles than do endosperm cell contents. Sieving 
or air classification milling steps can be used to separate milled 
barley flour or meal by particle size to produce endosperm cell wall-
enriched fractions. Since barley endosperm cells walls have a greater 
beta-glucan content than do barley endosperm cell contents, these 
endosperm cell wall-enriched barley fractions have a greater beta-
glucan content than of the starting flour or meal. For simplicity, in 
this document we will be referring to endosperm cell wall-enriched 
barley fractions as ``sieved barley meal.''
    The petition specifies that the dry milled barley products which 
are the subject of this petition, with the exception of barley bran and 
sieved barley meal, have a minimum beta-glucan soluble fiber content of 
at least 4 percent (dwb), and a minimum total dietary fiber content of 
at least 8 percent (dwb). The petition specifies that eligible barley 
bran and sieved barley meal have a minimum beta glucan soluble fiber 
and total dietary fiber content of 5.5 percent (dwb) and 15 percent 
(dwb) respectively. The petition specifies that eligible whole grain 
barley (dehulled and hulless) have a minimum beta glucan soluble fiber 
and total dietary fiber content of 4 percent dwb and 10 percent dwb 
respectively. The petitioner selected the minimum beta-glucan soluble 
fiber and total dietary fiber content specifications for the whole 
grain barley and dry milled barley products that are eligible sources 
of beta-glucan soluble fiber to be inclusive of most all commercially 
available dry milled barley products, while excluding barley products 
such as barley brewers grain in which the soluble fiber has been 
depleted.

C. Review of Preliminary Requirements for a Health Claim

1. The Substance Is Associated With a Disease for Which the U.S. 
Population Is at Risk
    CHD continues to be a disease that has a large impact on mortality 
and morbidity in the general adult U.S. population. As explained in the 
existing oat beta-glucan health claim (Sec.  101.81(b)), FDA recognizes 
the CHD risk reduction benefit of certain foods that are sources of 
soluble dietary fiber resulting from effects on lowering blood total 
and LDL-cholesterol. Although age-adjusted CHD mortality rates in the 
United States had been steadily decreasing since approximately 1960, 
recent evidence has suggested that the decline in CHD mortality has 
slowed (Ref. 3). Heart disease has been recognized as the leading cause 
of death in the United States for at least the last 50 years (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 Substance Is a Food
    The substance which is the subject of the existing oat beta-glucan 
health claim is beta-glucan soluble fiber from specified oat sources, 
i.e., oat bran, rolled oats, whole oat flour, and oatrim (Sec.  
101.81(c)(2)(ii)(A)). The petitioner requests an amendment to extend 
the eligible sources of beta-glucan soluble fiber to include those from 
whole grain barley and certain dry milled barley products. Barley grain 
is a commonly consumed human food and beta-glucan soluble fiber is a 
nutrient component of this food, thus the beta-glucan soluble fiber 
from whole grain barley and dry milled barley products that include 
bran, flakes, grits, pearl, flour, meal, and sieved barley meal is a 
``substance'' as defined by Sec.  101.14(a)(2). Health claim general 
requirements provide that where a substance is to be consumed at 
``other than decreased dietary levels'' the substance must contribute 
taste, aroma, nutritive value, or any other technical effect as listed 
in 21 CFR 170.3(o), and must retain that attribute when consumed at 
levels necessary to justify the claim (Sec.  101.14(b)(3)(i)). Whole 
grain barley and dry milled barley products are consumed by humans for 
their nutritive value, and retain that attribute when consumed at 
levels necessary to justify the claim. Thus the agency concludes that 
the requirement of Sec.  101.14(b)(3)(i) is satisfied.
3. The Substance Is Safe and Lawful
    Section 101.14(b)(3)(ii) requires that the substance be a food or a 
food ingredient or a component of a food ingredient whose use at the 
levels necessary to justify a claim has been demonstrated by the 
proponent of the claim, to FDA's satisfaction, to be safe and lawful 
under the applicable food safety provisions of the act. The petition 
states that dry milled barley grain is a human food of natural 
biological origin that has been widely consumed in the United States 
for its nutrient properties prior to January 1, 1958, without known 
detrimental effects, which is subject only to conventional processing 
as practiced prior to January 1, 1958, and for which no known safety 
hazard exists. The petitioner's description of the use of dry milled 
barley grain as a food ingredient and the use of whole grain barley, as 
sources of barley beta-glucan soluble fiber, are consistent with FDA's 
definition of food ingredients ordinarily regarded as ``generally 
recognized as safe'' (GRAS) (21 CFR 170.30(d)). FDA is satisfied that 
the petitioner has demonstrated the use of barley beta-glucan soluble 
fiber, from whole grain barley and dry milled barley grain product 
sources that are included in this rule, is safe and lawful under the 
applicable food safety provision of the act.

III. Review of Scientific Evidence of the Substance-Disease 
Relationship

A. Basis for Evaluating the Relationship Between Barley and CHD

    FDA has identified the following endpoints to use in identifying 
CHD risk reduction for purposes of a health claim evaluation: Coronary 
events (myocardial infarction, ischemia), cardiovascular death, 
atherosclerosis, high blood pressure, elevated serum total cholesterol, 
and elevated serum LDL-cholesterol. FDA considers high blood pressure, 
elevated serum total cholesterol, and elevated serum LDL-cholesterol 
levels as surrogate endpoints for CHD (Ref. 4). FDA considers low HDL-
cholesterol levels a risk factor for CHD (National Institutes of Health 
Consensus Conference, 1993). Elevated levels of serum total and LDL 
cholesterol, a prerequisite for atherosclerotic disease, is a major 
cause of CHD (Ref. 4). To evaluate the potential effects of beta-glucan 
soluble fiber from whole grain barley and dry milled barley products on 
CHD risk, FDA focused on serum total and LDL cholesterol levels to 
evaluate the relationship between barley beta-glucan and CHD risk. This 
focus is consistent with existing Sec.  101.81, in which FDA concluded 
that there was significant scientific agreement that the relationship 
between consumption of whole grain oats and CHD risk is mediated 
primarily by the effect of dietary beta-glucan soluble fiber on serum 
lipids.
    FDA previously concluded that there is significant scientific 
agreement regarding the relationship between consumption of soluble 
fiber-containing whole oat foods and reduced risk of CHD (62 FR 3584 at 
3598). FDA concluded that the type of soluble fiber found in whole oat 
foods, i.e., beta-glucan soluble fiber, is primarily responsible for 
the observed association between consumption of whole oat foods and the 
lowering of blood cholesterol. As such, to evaluate the evidence 
supporting the petitioned

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request to extend the beta-glucan soluble fiber from whole oat health 
claim to include beta-glucan soluble fiber from whole grain barley and 
dry milled barley products, FDA focused on evidence from human clinical 
studies of the effects of consuming beta-glucan soluble fiber from 
whole grain barley and dry milled barley products on blood lipids.

B. Review of Scientific Evidence of the Substance-Disease Relationship

    A health claim characterizes the relationship between a substance 
and a disease or health-related condition (21 CFR 101.14(a)(1)). The 
substance must be associated with a disease or health-related condition 
for which the general U.S. population, or an identified U.S. population 
subgroup, is at risk (Sec.  101.14(b)(1)). Health claims characterize 
the relationship between the substance and a reduction in risk of 
contracting a particular disease.\2\
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    \2\ See Whitaker v. Thompson, 353 F.3d 947, 950-51 (D.C. Cir.) 
(upholding FDA's interpretation of what constitutes a health claim), 
cert. denied, 125 S.Ct. 310 (2004).
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    FDA's review of the evidence to support the petitioned amendment of 
the oat beta-glucan health claim was conducted consistent with FDA 
published guidance on significant scientific agreement in the review of 
health claims (Ref. 5) and focused on evidence from intervention 
studies.
1. Assessment of Intervention Studies
    This petition identified reports of 11 human clinical studies with 
data on barley consumption and serum lipids (Refs. 6 to 16). We 
excluded six of these reports from our review because no scientific 
conclusions relative to effects of barley beta-glucan soluble fiber on 
CHD risk could be drawn from them. One of these excluded reports (Ref. 
6) was available only as an abstract and therefore did not provide 
sufficient information about the study for FDA to determine critical 
elements, such as the study population characteristics and the 
composition of the products used. In addition, the lack of a detailed 
study description prevents FDA from determining whether the study is 
flawed in critical elements such as design, conduct, and data analysis. 
FDA must be able to review the critical elements of a study to 
determine whether any scientific conclusions relevant to the health 
claim can be drawn from it. These problems are not limited to 
abstracts, but include other similar publications, such as meta-
analyses\3\ and review articles,\4\ book chapters, letters to the 
editor, and committee reports.
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    \3\ A meta-analysis is the process of systematically combining 
and evaluating the results of clinical trials that have been 
completed or terminated.
    \4\ Review articles summarize the findings of individual 
studies.
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    A second excluded report, Lupton et al., 1994 (Ref. 7), tested 
potential cholesterol-lowering effects of spent brewer's grain barley 
and of barley oil, neither of which contains beta-glucan soluble fiber. 
Because this report did not provide information about the substance 
that is the subject of the health claim, it was excluded from further 
review. Another excluded report, Keogh et al., 2003 (Ref. 8), tested 
potential cholesterol-lowering effects of a beta-glucan concentrate 
product extracted from barley bran. The whole grain barley and dry 
milled barley products which are the sources of beta-glucan soluble 
fiber in the petition do not include wet milled barley products such as 
the beta-glucan concentrate used in Keogh et al., 2003. Beta-glucan 
extraction processes (e.g., hot water or alcohol washes, and extreme pH 
conditions), unlike dry milling processes, are likely to alter 
physiochemical properties of soluble fiber and other components of 
grain and will alter the relative proportions of beta-glucan soluble 
fiber and other components of the grain. The composition of wet milled 
barley beta-glucan products may be substantially different from that of 
dry milled barley products and thus the results of Keogh et al., 2003 
do not assist our evaluation of evidence supporting a health claim for 
dry milled barley products. The three other excluded reports (Refs. 9, 
10, and 11) did not contain enough information to estimate the barley 
beta-glucan soluble fiber in the test diets. Without knowing the amount 
of barley beta-glucan soluble fiber added to these studies' diets, FDA 
was unable to draw any conclusions as to the effect of barley beta-
glucan soluble fiber on CHD risk from this evidence. The remaining 5 of 
the 11 reports of human clinical studies (Refs. 12 to 16) were of a 
sufficient quality for us to consider in our review of the evidence 
supporting the relationship between reduced risk of CHD and consumption 
of beta-glucan soluble fiber from whole grain barley and dry milled 
barley products included as sources of beta-glucan soluble fiber in 
this petition.
    The study reported in Behall et al., 2004a (Ref. 12) investigated 
the effects of dry milled barley products (barley flour, barley flakes, 
and pearled barley) incorporated into a controlled whole-grain diet on 
blood lipids of mildly hypercholesterolemic men. The study included 18 
mildly hypercholesterolemic adult males (mean age 46 years; mean 
baseline total cholesterol 238 milligrams/deciliter (mg/dL); mean 
baseline LDL-cholesterol 155 mg/dL). The test diet was a Step I diet 
(total fat 31 percent of energy, saturated fat 7.6 percent of energy, 
total dietary fiber 27 grams (g)/day) that included whole grain test 
foods (pancakes, spice cake, no-bake cookies, hot cereal, toasted 
flakes, steamed pilaf, and muffins). The test personnel prepared three 
versions of the whole grain test diet differing in levels of dry milled 
barley products. One version of the test diet, made with whole wheat 
flour, wheat flakes, and brown rice, but no barley, contained only 
trace amounts of beta-glucan soluble fiber. Another version of the test 
diet made with barley flour, barley flakes, and pearled barley 
replacing the wheat and rice in test foods, provided 6 g barley soluble 
fiber per day. The third version of the test diet was made with half 
whole wheat/brown rice and half barley to provide 3 g barley soluble 
fiber per day. The three whole grain test diets were designed to 
provide approximately the same amount of total dietary fiber per day, 
and vary only in the amount of barley beta-glucan soluble fiber. 
Following a 2-week run-in period consuming the test diet without barley 
to allow subjects to adjust to the dietary fiber level, the study 
administered each the three test diets (0, 3, or 6 g per day barley 
soluble fiber) to each participant in random order over three 
consecutive 5-week periods. In comparison to the 0 g per day barley 
soluble fiber diet period, there was a statistically significant (p < 
0.05) 7.5 percent reduction of serum total cholesterol following the 6 
g per day barley soluble fiber diet. Similarly, there was a 
statistically significant 8.5 percent reduction in serum LDL-
cholesterol level following the 6 g per day barley soluble fiber period 
compared to the 0 g per day period. Reductions in serum total and LDL-
cholesterol following the 3 g per day soluble barley fiber period were 
not statistically significant. Serum HDL cholesterol levels were not 
significantly different among the three diet periods.
    Another study by Behall et al., (Ref. 13) investigated the effects 
of dry milled barley products (barley flour, barley flakes, and pearled 
barley) in a controlled whole-grain diet on blood lipids of mildly 
hypercholesterolemic adults. The study included 25 mildly 
hypercholesterolemic adult men and women (average baseline total 
cholesterol 223 mg/dL; average baseline LDL-cholesterol 145 mg/dL). The 
test

[[Page 76154]]

diet was the same as in the previous Behall et al. study (Ref. 12), 
i.e., a STEP I diet including whole grain test foods and with barley 
ingredients substituted for whole wheat/brown rice ingredients to 
produce three versions of test diet providing 0 g, 3 g, or 6 g per day 
of barley beta-glucan, but each with approximately the same amount of 
total dietary fiber. As in the previous study, the 17-week experimental 
period consisted of a 2-week run-in period followed by three 
consecutive 5-week periods during which each participant was 
administered each of the three versions of test diet in random order. 
In comparison to the 0 g per day barley beta-glucan diet period, there 
were statistically significant (p < 0.05) reductions of serum total 
cholesterol following both the 3 g and 6 g per day barley beta-glucan 
diets (5 percent and 6 percent reductions, respectively). Similarly, 
there were statistically significant reductions of serum LDL-
cholesterol following both the 3 g and 6 g per day barley beta-glucan 
diets compared to the 0 g per day diet (10 percent and 13 percent 
reductions, respectively). Serum HDL cholesterol levels were not 
different among the three diet periods.
    The study reported in McIntosh et al., 1991 (Ref. 14) investigated 
the effects of dry milled barley products (barley bran and barley 
flakes), as compared to wheat, on blood lipids of mildly 
hypercholesterolemic men. The study included 21 mildly 
hypercholesterolemic adult males (mean age 43 years; mean baseline 
total cholesterol 240 mg/dL; mean baseline LDL-cholesterol 177 mg/dL). 
Throughout the study, participants consumed their customary diets but 
replaced their customary grain-based foods with similar test foods 
(bread, muesli, pasta, and biscuits) provided by study personnel. The 
test foods were made with either whole wheat flour, or with barley bran 
and barley flakes replacing portions of the whole wheat flour. The 
grain-based test foods provided about 50 percent of total caloric 
intake and about 65 percent of total dietary fiber intake. The whole 
wheat test foods and the barley test foods were equivalent in content 
of energy, total fat, saturated fat, total dietary fiber, and soluble 
dietary fiber content. The diet with whole wheat test foods provided 
1.5 g beta-glucan per day, whereas the diet with barley test foods 
provided 8 g beta-glucan per day. Following a 3-week run-in period with 
the usual diets, the participants consumed the diets supplemented with 
either whole wheat test foods or barley test foods in random order 
during two consecutive 4-week periods. In comparison to the whole wheat 
test food period, there were statistically significant (p < 0.05) 
reductions of serum total cholesterol (6 percent reduction) and of 
serum LDL-cholesterol (7 percent reduction) following the barley test 
food period. Serum HDL cholesterol levels were not different between 
the two diet periods.
    The study reported in Newman et al., 1989 (Ref. 15) investigated 
the effects of dry milled barley (barley flour), in comparison to 
wheat, on blood lipids of adult men. The study included 14 adult males 
(age greater than 35 years; total cholesterol range 140-247 mg/dL; LDL-
cholesterol range 71-187 mg/dL). During the study, the participants 
consumed their customary diets but with three servings per day of test 
foods (muffins, applesauce bars, breads, muffins, cookies, and cereal) 
made with either whole wheat flour and wheat bran or with barley flour 
replacing similar foods of the customary diet. Both the wheat and 
barley grain-based test foods provided about 42 g total dietary fiber 
per day. The barley test foods provided approximately 3 g soluble beta-
glucan per day. The 4-week study was a randomized, blinded study with 
one half of the participants consuming the wheat flour/bran test foods 
for 4 weeks, and the other half receiving the barley test foods for 4 
weeks. At the end of the test period, mean serum total and LDL-
cholesterol levels were significantly (p < 0.05) lower in the barley 
group than in the wheat group.
    The study reported in Li et al., 2003 (Ref. 16) investigated the 
effects of whole grain barley on blood lipids of young healthy female 
Japanese. The study included 10 healthy Japanese medical students 
(average age 20 years; average baseline total cholesterol 140 mg/dL; 
average baseline LDL-cholesterol 53 mg/dL). During the study, 
participants consumed a typical Japanese diet (approximately 2,000 
kcal/day, 35 percent fat) that the investigators provided. During the 
barley diet period, barley replaced 30 percent of the daily rice 
intake. The barley provided approximately 5 g per day of soluble 
dietary fiber. Each participant consumed the control diet (rice only) 
and barley diet (70 percent rice, 30 percent barley) in random order 
during two 4-week periods separated by a 4-week interval. In comparison 
to the control diet period, there were statistically significant (p < 
0.05) reductions of blood total cholesterol (14.5 percent reduction) 
and of blood LDL-cholesterol (21 percent reduction) following the 
barley diet period. Blood HDL cholesterol levels were not different 
between the two diet periods.
    In summary, the five clinical trials included in our review which 
tested the impact of consuming whole grain barley and dry milled barley 
products (bran, flakes, flour and pearled barley) on serum lipids 
(Refs. 12 through 16), consistently reported statistically significant 
lower serum total and LDL-cholesterol levels following 4 to 5 weeks of 
consuming diets in which whole grain barley or dry milled barley 
product ingredients replaced wheat and rice ingredients. Serum HDL 
cholesterol levels were not affected by consuming the barley foods. The 
lowest daily dietary intake of barley beta-glucan fiber effective in 
significantly lowering serum total and LDL-cholesterol reported in 
these studies was 3 g per day.
2. Eligible Barley Sources of Beta-Glucan Soluble Fiber
    The oat beta-glucan health claim, at Sec.  101.81(c)(2)(ii)(A), 
lists four eligible oat sources of beta-glucan soluble fiber; i.e., oat 
bran, rolled oats, whole oat flour, and oatrim. FDA is amending Sec.  
101.81(c)(2)(ii)(A) to add dehulled and hulless whole grain barley and 
certain dry milled barley products to this list of eligible sources of 
beta-glucan soluble fiber.
    Below, the agency describes the eligible sources of barley beta-
glucan soluble fiber from dry milled barley products and the 
specifications for all eligible sources.
    The five clinical trials with barley cited previously used the 
following barley sources in their test foods: Whole grain barley, 
barley bran, barley flour, barley flakes, and pearled barley. Each dry 
milled product used in the clinical studies is processed only to the 
extent that milling has altered the particle size of the intact grain, 
and in some cases the product is also subjected to a particle size 
separation process (e.g., sifting). The barley sources of beta-glucan 
soluble fiber in this rule, i.e., dehulled or hulless whole grain 
barley, barley bran, flakes, grits, pearl, flour, meal, and sieved 
barley meal, are produced from dry milling processes only. Wet milling, 
as opposed to dry milling, involves slurrying the grain under pH, 
temperature, chemical, or enzyme conditions that cause changes other 
than just particle size. The one barley clinical trial that was 
excluded from our review because the product tested was a wet milled 
barley beta-glucan extract (Ref. 8) reported finding no effect of the 
barley beta-glucan extract on serum lipids.
    There are many variations in dry milling processes for barley, most 
of the

[[Page 76155]]

resulting dry milled barley products are defined in the AACC ``Barley 
Glossary'' (Ref. 2), including barley bran, flakes, grits, pearl, and 
flour. The petition describes two additional dry milled barley 
products: Barley meal and sieved barley meal. Barley meal is unsifted, 
ground, whole grain barley. The petition described sieved barley meal 
as endosperm cell wall-enriched fractions of barley meal or barley 
flour resulting from including a particle size separation step (either 
sieving or air classification) in the dry milling process. Although the 
petitioner's term for this barley product was ``beta-glucan enriched 
barley fractions,'' we are using the term ``sieved barley meal'' in 
this rulemaking as that is descriptive of the how this dry milled 
barley product is produced and to clarify that a barley ``beta-glucan 
enriched'' product produced by any other process is not included as an 
eligible source of barley beta-glucan soluble fiber.
    The petition requests that the eligible barley sources of beta-
glucan soluble fiber added to Sec.  101.81 include, in addition to the 
whole grain barley and dry milled barley products used in the clinical 
studies FDA included in its review (i.e., barley bran, flakes, flour, 
and pearl barley), three dry milled barley products that were not used 
in the reviewed clinical studies (i.e., barley grits, meal, and sieved 
barley meal). FDA agrees with the petitioner that the additional barley 
products represent variations of the extent of dry milling and as such 
involve more textural difference and not compositional differences that 
would result in an outcome that is different from that in clinical 
trials. FDA is amending Sec.  101.81(c)(2)(ii)(A) to add as eligible 
barley sources of beta-glucan soluble fiber, whole grain barley, barley 
bran, barley flakes, barley grits, barley flour, barley meal, sieved 
barley meal, and pearl barley. The petition has specified the minimum 
beta-glucan soluble fiber content of eligible dry milled barley 
products, with the exception of sieved barley meal and barley bran, to 
be at least 4 percent (dwb), and the minimum total dietary fiber 
content to be at least 8 percent (dwb). The minimum beta-glucan soluble 
fiber and total fiber content specified in the petition for eligible 
barley bran and sieved barley meal is at least 5.5 percent (dwb) and 15 
percent (dwb), respectively. The minimum beta-glucan soluble fiber and 
total fiber content specified in the petition for eligible whole grain 
barley is at least 4 percent (dwb) and 10 percent (dwb), respectively. 
The petition states that these dietary fiber content specifications 
were selected based on typical analyses of commercially available dry 
milled barley products in the United States. FDA is adopting the 
dietary fiber content specifications recommended by the petitioner that 
must be met in order for the listed sources of beta-glucan soluble 
fiber to be considered eligible sources.

IV. Decision to Amend the Health Claim

    Evidence from five clinical trials (Refs. 12 through 16) 
consistently demonstrate that consuming whole grain barley and dry 
milled barley products, such as barley bran, flakes, flour and pearled 
barley that provide at least 3 g beta-glucan fiber per day, is 
effective in lowering serum total and LDL-cholesterol levels, which in 
turn may reduce the risk of CHD. The cholesterol-lowering effects of 
beta-glucan soluble fiber in dry milled barley products is comparable 
to that of the oat sources of beta-glucan now listed in Sec.  
101.81(c)(2)(ii)(A). When issuing the oat beta-glucan health claim the 
agency concluded that the beta-glucan soluble fiber component of oat 
products plays a significant role in the relationship between whole 
grain oats and the risk of CHD based, in part, on evidence that there 
is a dose response between the level of beta-glucan soluble fiber from 
whole oats and the level of reduction in serum LDL cholesterol, and 
evidence that intakes at or above 3 g per day were more effective in 
lowering serum lipids than lower intake levels (62 FR 3584 at 3585). 
The petition notes that a comparison of the serum cholesterol lowering 
evidence for barley beta-glucan soluble fiber, which has been submitted 
with the petition, and the oat beta-glucan soluble fiber/cholesterol-
lowering dose-response evidence, which was cited in the oat beta-glucan 
health claim rulemaking, shows that the cholesterol lowering efficacy 
of the oat and the barley sources of beta-glucan soluble fiber are very 
similar. FDA agrees that the effect, on serum cholesterol, of consuming 
whole grain oat and dry milled barley sources of beta-glucan soluble 
fiber appears equivalent. FDA also agrees that the scientific evidence 
supports a minimum daily effective intake of beta-glucan soluble fiber 
from dry milled barley products the same as that which was previously 
found for beta-glucan soluble fiber from whole oat sources, i.e., 3 g 
per day. Therefore, FDA is amending Sec.  101.81(c)(2)(i)(G)(1) to 
include 3 g or more per day of barley sources of beta-glucan soluble 
fiber, alone or in combination with whole oat sources of such fiber.
    Barley beta-glucan can be measured by the same quantitative 
analytical method as is currently specified in Sec.  101.81 for the 
determination of oat beta-glucan. Based on the totality of the publicly 
available scientific evidence, FDA concludes there is significant 
scientific agreement, among experts qualified by scientific training 
and experience, for a claim about the relationship between certain 
beta-glucan soluble fiber sources and reduced risk of CHD. Thus, we are 
amending Sec.  101.81(c)(2)(ii)(A) to include dehulled or hulless whole 
grain barley and certain dry milled barley products as additional 
sources of beta-glucan soluble fiber. We also find that the serum 
cholesterol-lowering efficacy of barley beta-glucan soluble fiber and 
of oat beta-glucan are comparable and, like oat beta-glucan, 3 g per 
day of barley beta-glucan is a sufficient daily dietary intake to 
achieve a reduction in serum total and LDL cholesterol.
    The barley products that are to be included in this amendment as 
eligible sources of beta-glucan soluble fiber include dehulled and 
hulless whole grain barley, and certain dry milled barley products 
including barley bran, barley flakes, barley flour, barley grits, and 
pearl barley as they are defined in the AACC Barley Glossary (Ref. 2), 
barley meal which is an unsifted ground barley grain, and sieved barley 
meal which is an endosperm cell-wall enriched fraction resulting from 
sieving or air classification of barley flour or barley meal to 
separate fractions based on particle size. The sieved barley meal 
fraction retains the coarser particles that originate from endosperm 
cell wall. Minimum dietary fiber content specifications for these 
barley products, recommended in the petition as representative of 
commercially available barley products in the United States are a 
minimum of 4 percent beta-glucan soluble fiber and 10 percent total 
dietary fiber for dehulled and hulless whole grain barley; a minimum of 
5.5 percent beta-glucan soluble fiber and 15 percent total dietary 
fiber for barley bran and sieved barley meal; and a minimum of 4 
percent beta-glucan soluble fiber and 8 percent total dietary fiber for 
all other dry milled barley products. All dietary fiber values are on a 
dwb.
    The oat beta-glucan health claim requires that a food bearing the 
claim on its label include one of the whole grain ingredients listed 
within Sec.  101.81(c)(2)(ii)(A), and that the whole oat ingredient 
provide at least 0.75 gram of beta-glucan soluble fiber per reference 
amount customarily consumed of the food product (Sec.  
101.81(c)(2)(iii)(A)). FDA arrived at

[[Page 76156]]

this value based on a standard assumption that the daily dietary intake 
is divided over four eating occasions (three meals and a snack). FDA 
concluded that in adding whole oat flour to the eligible whole oat 
sources of beta-glucan soluble fiber that were included in the final 
rule there would be sufficient numbers and types of whole oat-
containing food products available to increase the likelihood that 
whole oat food products will be consumed at four eating occasions per 
day (62 FR 3584 at 3592). Adding whole grain barley and dry milled 
barley products as additional eligible sources of beta-glucan soluble 
fiber will further increase the type and number of qualifying food 
products and make it easier for consumers to select whole grain barley, 
dry milled barley or whole oat containing food products at four eating 
occasions per day. Thus, FDA is retaining under the ``Nature of the 
food eligible to bear the claim'' section of this regulation the 
criterion that foods eligible to bear the claim contain at least 0.75 
gram of soluble fiber (Sec.  101.81(c)(2)(iii)(A)(1)).
    FDA authorized use of the oat beta-glucan health claim in 1997, in 
part, on the basis of clinical evidence demonstrating that consumption 
of whole oat foods such as oat bran, oatmeal, and whole oat flour 
lowers serum cholesterol. FDA also considered scientific evidence for a 
dose-response between the amount of beta-glucan consumed and the 
cholesterol-lowering effect (Ref. 17), and evidence that at least 3 
grams of soluble fiber consumed per day in whole oat foods is 
sufficient for effective cholesterol lowering (Ref. 18). Information 
provided in the oat beta-glucan health claim petition indicated that 
the soluble fiber content of whole oats is predominantly beta-glucan. 
Therefore, FDA concluded that the total soluble fiber content of whole 
oats significantly reflects the beta-glucan present in whole oats (62 
FR 3584 at 3588).
    Although FDA had concluded that oat beta-glucan soluble fiber plays 
a significant role in the relationship between whole grain oats and 
reduced risk of CHD (62 FR 3584 at 3585), FDA had considered the term 
``beta-glucan'' a technical term that presumably would not be widely 
understood, and that the term ``soluble fiber'' is more familiar to 
consumers because soluble fiber can be used on the nutrition label 
under 21 CFR 101.9(c)(6)(i)(A). As such, this health claim statement 
must identify the substance using the term ``soluble fiber'' (62 FR 
3584 at 3588).
    The standard method for measurement of beta-glucan in oat and 
barley (AOAC Official Method 992.28) measures total beta-glucan content 
of the grain product without differentiating soluble and insoluble 
fractions. There is no standard method, nor a single definition for, 
soluble beta-glucan. Typically a grain product is analyzed for either 
soluble fiber or for total beta-glucan. Information in the original oat 
beta-glucan health claim petition convinced FDA that the total soluble 
fiber content of whole oats significantly reflects the beta-glucan 
content (62 FR 3584 at 3588). Information and data provided in the 
current petition demonstrate that the solubility of beta-glucan in oats 
and barley are similar and that the test for total beta-glucan is an 
adequate marker for the cholesterol-lowering functionality of whole 
oat, whole grain barley, and dry milled barley in foods. Therefore, FDA 
is requiring that the barley beta-glucan health claim identify the 
substance with the term ``soluble fiber,'' although the substance is to 
be measured as total beta-glucan.
    There is strong and consistent scientific evidence that diets high 
in saturated fat and cholesterol are associated with elevated serum 
total and LDL cholesterol, and that elevated serum cholesterol levels 
are a major modifiable risk factor for CHD. Expert groups recommend 
lowering dietary saturated fat and cholesterol as a primary lifestyle 
change for reducing heart disease risk (Ref. 4). Comments to the 1997 
oat beta-glucan health claim final rule expressed concern that a CHD 
risk claim that does not include a reference to a low saturated fat, 
low cholesterol diet may mislead consumers into thinking that the 
single food, e.g., oat products, would appear to be a ``magic bullet'' 
(62 FR 3584 at 3594). Further, based on the scientific evidence, the 
role of soluble fiber from whole oats in the diet is generally 
recognized as being of smaller magnitude in reducing CHD risk compared 
to consumption of a low saturated fat, low cholesterol diet. When 
authorizing the oat beta-glucan health claim FDA concluded that 
although selection of foods with soluble fiber from whole oats is a 
useful adjunct to selection of diets low in saturated fat and 
cholesterol in reducing CHD risk, it would not be in the best interest 
of public health nor consistent with the scientific evidence to imply 
that selecting diets with soluble fiber from whole oats is a substitute 
for consuming diets low in saturated fat and cholesterol (id.). 
Therefore, FDA required that the oat beta-glucan health claim statement 
include the phrase ``diets that are low in saturated fat and 
cholesterol and that include soluble fiber from * * *'' (Sec.  
101.81(c)(2)(i)(A)).
    Barley beta-glucan soluble fiber functions comparably to oat beta-
glucan soluble fiber in its effect on reducing LDL and total 
cholesterol. Barley beta-glucan soluble fiber sources are a useful 
adjunct to selection of diets low in saturated fat and cholesterol to 
reduce CHD risk. Thus, the agency is requiring the barley beta-glucan 
health claim to include the information that selection of barley foods 
containing beta-glucan soluble fiber should ``be part of a diet low in 
saturated fat and cholesterol,'' consistent with Sec.  
101.81(c)(2)(i)(A). Including a reference to a low saturated fat, low 
cholesterol diet in the health claim will enable the public to 
understand the relative significance of the information in the context 
of a total daily diet (21 U.S.C. 343(r)(3)(A)(iii)).

V. Description of Modifications to Sec.  101.81

A. Requirements of the Health Claim

    Specific requirements of the ``nature of the claim'' paragraph in 
Sec.  101.81(c)(2)(i) of the soluble fiber from certain foods and risk 
of CHD health claim include, in part, that the claim specify the daily 
dietary intake of the soluble fiber source associated with coronary 
heart disease risk reduction. FDA is amending Sec.  
101.81(c)(2)(i)(G)(1) to indicate that the source of the 3 g or more 
per day of beta-glucan soluble fiber may be from whole oats or barley 
or a combination of oats and barley. FDA is amending Sec.  
101.81(c)(2)(ii)(A) to add barley sources of beta-glucan soluble fiber 
in addition to whole oat sources. In addition, FDA is amending Sec.  
101.81(c)(2)(ii)(A) by adding Sec.  101.81(c)(2)(ii)(A)(5) to list 
dehulled and hulless whole grain barley and specific dry milled barley 
products as eligible sources of beta-glucan soluble fiber. The specific 
dry milled barley products include, barley bran, barley flakes, barley 
grits, pearl barley, barley flour, barley meal, and sieved barley meal 
produced from clean, sound dehulled or hulless barley grain using 
standard dry milling techniques, which may include steaming or 
tempering. Eligible dehulled and hulless whole grain barley has a beta-
glucan soluble fiber content of at least 4 percent (dwb) and a total 
dietary fiber content of at least 10 percent (dwb). Eligible barley 
flakes, barley grits, pearl barley, barley flour, and barley meal have 
a beta-glucan soluble fiber content of at least 4 percent (dwb) and 
total dietary fiber content of at least 8 percent (dwb). Eligible 
barley bran and sieved barley

[[Page 76157]]

meal have a beta-glucan soluble fiber content of at least 5.5 percent 
(dwb) and total dietary fiber content of at least 15 percent (dwb). FDA 
is incorporating by reference in new Sec.  101.81(c)(2)(ii)(A)(5) the 
Barley Glossary (AACC Method 55-99), published in Approved Methods of 
the American Association of Cereal Chemists, that contains definitions 
for barley bran, barley flakes, barley flour, barley grits, pearl 
barley, dehulled barley, and hulless barley. FDA is amending the 
``nature of the food eligible to bear the claim'' paragraph at Sec.  
101.81(c)(2)(iii)(A)(1) to indicate that the eligible sources of beta-
glucan fiber will include both whole oat and barley foods.

B. Optional Information

    FDA is amending the ``optional information'' paragraph of this 
section (at Sec.  101.81(d)(5)) to indicate that the eligible sources 
of beta-glucan fiber will include both whole oat and barley foods.

VII. Issuance of an Interim Final Rule and Immediate Effective Date

    We are issuing this rule as an interim final rule, effective 
immediately, with an opportunity for public comment. Section 403(r)(7) 
of the act authorizes us to make proposed regulations issued under 
section 403(r) of the act effective upon publication pending 
consideration of public comment and publication of a final regulation, 
if the agency determines that such action is necessary for public 
health reasons. This authority enables us to act promptly on petitions 
that provide for information that will help: (1) Enable consumers to 
develop and maintain healthy dietary practices, (2) enable consumers to 
be informed promptly and effectively of important new knowledge 
regarding nutritional and health benefits of food, or (3) ensure that 
scientifically sound nutritional and health information is provided to 
consumers as soon as possible. Proposed regulations made effective upon 
publication under this authority are deemed to be final agency action 
for purposes of judicial review. The legislative history indicates that 
such regulations should be issued as interim final rules (H. Conf. 
Rept. No. 105-399, at 98 (1997)).
    We are satisfied that each of the three criteria in section 
403(r)(7)(A) of the act have been met in the petition submitted by the 
National Barley Foods Council. This health claim will enable consumers 
to develop and maintain healthy dietary practices, such as increasing 
consumption of foods containing types of soluble dietary fiber shown to 
help reduce CHD risk. The health claim also will provide consumers with 
important new knowledge regarding the effects of consuming whole grain 
barley and dry milled barley products on blood cholesterol, and will 
provide consumers with scientifically sound information about an 
additional dietary choice which may help reduce the risk of CHD. 
Therefore, we are using the authority given to us in section 
403(r)(7)(A) of the act to issue an interim final rule authorizing a 
health claim relating consumption of barley beta-glucan soluble fiber 
and CHD risk, effectively immediately.
    FDA invites public comment on this interim final rule. The agency 
will consider modifications to this interim final rule based on 
comments made during the comment period. Interested persons may submit 
to Division of Dockets Management (see ADDRESSES) written or electronic 
comments regarding this interim final rule. This regulation is 
effective upon publication in the Federal Register. The agency will 
address comments and confirm or amend the interim final rule in a final 
rule.

VIII. Analysis of Impacts

    FDA has examined the impacts of the interim final rule under 
Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-
612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).

A. Regulatory Impact Analysis

    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). Executive 
Order 12866 classifies a rule as significant if it meets any one of a 
number of specified conditions, including having an annual effect on 
the economy in a material way, adversely affecting competition, or 
adversely affecting jobs. A regulation is also considered a significant 
regulatory action if it raises novel legal or policy issues. FDA has 
determined that this interim final rule is not a significant regulatory 
action as defined by Executive Order 12866.
1. Need for Regulation
    Current labeling regulations do not permit foods containing 
threshold amounts of beta-glucan soluble fiber from the whole grain 
barley or dry milled barley to claim health benefits that link their 
intake with a reduction in the risk of CHD. Such claims are authorized 
for foods containing threshold amounts of beta-glucan soluble fiber-
containing whole oat foods, and scientific evidence links consumption 
of foods with the same amount of beta-glucan soluble fiber from barley 
with the same health benefits. Allowing foods containing beta-glucan 
soluble fiber from barley to claim the same health benefits as those 
containing beta-glucan soluble fiber from whole oats will improve diet-
related information available on food labels. Making this information 
available to consumers may facilitate disease risk-reducing dietary 
choices.
2. Regulatory Options
    The regulatory options include: (1) No regulatory action and (2) 
the interim final rule.
3. Benefits and Costs From No Regulatory Action
    The absence of any regulatory action is considered the baseline 
option for comparison with the regulatory option. There would be no 
compliance costs and no benefits in the absence of regulatory action.
4. Benefits and Costs From the Interim Final Rule
    a. Benefits from the interim final rule--The benefit from the 
interim final rule is the reduced CHD risk that may result from 
consumers' substituting barley foods containing beta-glucan soluble 
fiber for currently consumed, less healthful alternatives. Heart 
disease is the leading cause of death and permanent disability in the 
United States (Ref. 19). The National Center for Health Statistics in 
the Centers for Disease Control and Prevention (CDC) reports that in 
2002 there were approximately 23 million non-institutionalized adults 
diagnosed with heart disease, resulting in approximately 700,000 
deaths. According to the same source, heart disease patients made 
approximately 20.8 million office-based physician visits and 
approximately 1.1 million hospital outpatient visits in that year. In 
addition, there were approximately 4.4 million hospital discharges of 
heart disease patients, with average lengths of stay of approximately 
4.4 days. As an indication of the extent to which this disease is 
disabling, the CDC reports that approximately 66 percent of heart 
patients fail to fully recover (Ref. 20).
Overview of Benefits Analysis
    This interim final rule may result in a reduction in the risk of 
heart disease by enabling at-risk consumers to make healthier food 
choices. We first describe

[[Page 76158]]

the theoretical framework for estimating the increase in the market 
shares and healthful consumption as a result of this interim final 
rule. We use results from FDA's 2001 Food Label and Packaging Survey 
(FLAPS) to compute the total sales of products with health claims from 
soluble fiber from whole oats to estimate a potential market share of 
foods containing beta-glucan soluble fiber from barley (Ref. 21). We 
describe the FLAPS data set, and use the estimated market share of 
foods claiming health benefits from beta-glucan soluble fiber from 
barley as the upper bound for the increase in healthful consumption 
from this interim final rule. We account for existing consumption of 
foods that are equally as healthful as the new foods containing beta-
glucan soluble fiber from barley to adjust the upper bound in order to 
estimate the increase in healthful food consumption. We then suggest a 
link between any estimated increase in healthful food consumption and a 
reduction in the incidence of CHD. Finally, we suggest further 
adjustments to any estimated reductions in health risks from more 
healthful food consumption based on an assumed uneven distribution of 
diet-related health risks across the population.
Theoretical Framework
    We assume that prices, taste, and health attributes determine 
consumer demand for food products within a food group, and that an 
increase in the consumer demand for an item within a food group results 
in an offsetting decrease in demand for other items within that group. 
In addition, we assume that an increase in the consumption of healthful 
products in the aggregate may result if there is a decrease in the 
relative price of healthful products compared with products in general. 
However, a decrease in the relative price of one healthful product may 
also result in a decrease in the demand for other healthful products.
    We assume that the total sales of products within a general product 
group remain constant, so any increase in consumption of healthful 
products as a result of this interim final rule would be offset by a 
decrease in consumption of other products within the same product 
group; these other products may be more, less, or equally healthful. To 
the extent that aggregate consumption of products from an entire 
product group increases, aggregate consumption of products from other 
groups will decrease. In this analysis, however, we do not consider the 
effects of changes in aggregate consumption of product groups that do 
not contain products with health claims.
Using FLAPS to Estimate the Market Share of Foods Claiming Health 
Benefits From Soluble Fiber From Whole Oats
    We use results from FDA's 2001 FLAPS to estimate the increase in 
market shares of foods containing beta-glucan soluble fiber from barley 
(Ref. 21). The 2001 FLAPS survey contains label information on 1,281 
products selected from 238 food types from 57 food groups. The 
information includes detailed descriptions of the labels including any 
health claims, structure-and-function claims, and nutrient content 
claims. We combine the label information with total sales information 
obtained from the Information Resources Incorporated (IRI) data used to 
des