Final Rule on Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease (73 FR 47828) August 15, 2008
[Federal Register: February 25, 2008 (Volume 73, Number 37)]
[Rules and Regulations]
[Page 9938-9947]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25fe08-3]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. FDA-2008-P-0090] (formerly Docket No. 2006P-0393)
Food Labeling: Health Claims; Soluble Fiber From Certain Foods
and Risk of 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 health
claim regulation entitled ``Soluble fiber from certain foods and risk
of coronary heart disease (CHD)'' to add barley betafiber as an
additional eligible source of beta-glucan soluble fiber. Barley
betafiber is the ethanol precipitated soluble fraction of cellulase and
alpha-amylase hydrolyzed whole grain barley flour. FDA is taking this
action in response to a health claim petition submitted by Cargill,
Inc. FDA previously concluded that there was significant scientific
agreement that a claim characterizing the relationship between beta-
glucan soluble fiber of certain whole oat and whole grain barley
products and CHD risk is supported by the totality of publicly
available scientific evidence. Based on the totality of publicly
available scientific evidence, FDA now has concluded that in addition
to certain whole oat and whole grain barley products, barley betafiber
is also an appropriate source of beta-glucan soluble fiber. Therefore,
FDA is amending the health claim regulation entitled ``Soluble fiber
from certain foods and risk of CHD'' to include barley betafiber as
another eligible source of beta-glucan soluble fiber.
DATES: This interim final rule is effective February 25, 2008. Submit
written or electronic comments by May 12, 2008.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2008-
P-0090 (formerly Docket No. 2006P-0393), by any of the following
methods:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
<bullet> FAX: 301-827-6870.
<bullet> 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, as described previously, in the ADDRESSES portion
of this document under Electronic Submissions.
Instructions: All submissions received must include the agency name
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN
[[Page 9939]]
number has been assigned) for this rulemaking. All comments received
may be posted without change to http://www.regulations.gov, 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 http://www.regulations.gov 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: Jillonne Kevala, Center for Food
Safety and Applied Nutrition (HFS-830), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 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.
FDA (we) issued several new regulations in 1993 that implemented
the health claim provisions of the 1990 amendments. Among these were 21
CFR 101.14, Health claims: general requirements (58 FR 2478, January 6,
1993) and Sec. 101.70 (21 CFR 101.70), Petitions for health claims (58
FR 2478), which set out the general requirements for the authorization
and use of health claims and established a process for petitioning the
agency to authorize health claims about substance-disease relationships
and set out the types of information that any such petition must
include. These regulations became effective on May 8, 1993.
When implementing the 1990 amendments, FDA also conducted a review
of evidence for a relationship between dietary fiber and cardiovascular
disease (CVD). Based on this review, the agency 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) (1993 dietary fiber and CVD health claim final rule).
However, FDA 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\. Therefore, FDA 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 1993 dietary fiber and CVD health claim 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 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\ Cardiovascular disease 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 Risk of CHD Health Claim (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 and cholesterol (62 FR 3584 at 3597 and 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 1997 oat beta-glucan health claim final rule). 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 the 1997 oat beta-
glucan health claim final rule, FDA anticipated the likelihood that
other sources and types of soluble fibers could 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 because FDA had not reviewed the
totality of evidence on other, non-whole oat sources of soluble fiber
(62 FR 3584 at 3588).
The agency amended Sec. 101.81 (21 CFR 101.81), in response to a
health claim petition to add a health claim relating soluble fiber from
psyllium seed husk and CHD risk (63 FR 8103, February 18, 1998). At
this time, FDA 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)'' (63 FR 8103). FDA has also amended Sec. 101.81, in
response to health claim petitions, to include oatrim, whole grain
barley, and certain dry milled barley grain products as eligible
sources of beta-glucan soluble fiber. In 2002, FDA amended Sec. 101.81
to add oatrim, which is the soluble fraction of alpha-amylase
hydrolyzed oat bran or whole oat flour, as an eligible source of beta-
glucan soluble fiber (67 FR 61733, October 2, 2002), and finally, FDA
amended Sec. 101.81 to add whole grain barley and certain dry milled
barley grain products as eligible sources of beta-glucan soluble fiber
in 2005 (70 FR 76150, December 23, 2005).
II. Petition and Grounds
A. The Petition
Cargill, Inc. (petitioner), submitted a health claim petition to
FDA on June 20, 2006, under section 403(r)(4) of the act (21 U.S.C.
343(r)(4)). The petition requested that the agency expand the ``Soluble
fiber from certain foods and risk of coronary heart disease health
claim'' (Sec. 101.81) to include ``barley betafiber'' (described in
section II.B of this document) as an eligible food ingredient source of
beta-glucan soluble fiber in addition to the oat and whole grain and
dry milled barley ingredients now listed (Ref. 1). On September 28,
2006, the agency notified the petitioner that it had completed its
initial review of the petition and that the petition was
[[Page 9940]]
being 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)). The petitioner and FDA subsequently mutually agreed
to extend the deadline for the agency's decision on the petition to
March 6, 2008. The petitioner also requested that FDA issue an interim
final rule by which labeling of foods that contain ``barley betafiber''
in appropriate amounts could bear the health claim prior to publication
of a final rule.
B. Nature of the Substance
The substance that is the subject of the oat/barley portion of
current Sec. 101.81 is beta-glucan soluble fiber from the specific oat
and barley food products listed in Sec. 101.81(c)(2)(ii)(A). Current
Sec. 101.81(c)(2)(ii)(A) has been amended twice previously to list
additional oat or barley food products as eligible sources (67 FR 61773
and 70 FR 76150). Similar to these previous actions, FDA is now, in
response to Cargill's health claim petition, amending Sec.
101.81(c)(2)(ii)(A) to list barley betafiber as an eligible source of
barley beta-glucan soluble fiber.
The petition states that barley betafiber is a concentrated barley
beta-glucan soluble fiber product derived from whole barley flour. The
petitioner's description of the barley betafiber manufacturing process
reflects information contained in the petitioner's patent entitled
``Improved Dietary Fiber Containing Materials Comprising Low Molecular
Weight Glucan'' (World Intellectual Property Organization,
International Publication Number WO 2004/086878 A2) (Ref. 2) and a
report of an expert panel on the generally recognized as safe (GRAS)
status of barley betafiber commissioned by the petitioner (Ref. 3). The
patent and the GRAS status report provide information on multiple
variations of procedures for manufacturing concentrated barley beta-
glucan soluble fiber products; these procedures differ from the
manufacturing procedures for producing the unique barley betafiber
substance that is the subject of the petition. Further, the clinical
trial reported in the petition tested two different barley beta-glucan
soluble fiber concentrates--a high molecular weight concentrate and a
low molecular weight concentrate. The petitioner specified that the
barley betafiber product, which is the subject of the petition, is only
the low molecular weight concentrate studied in the clinical trial
(Ref. 4). FDA was not satisfied that the information in the petition
was sufficiently specific in describing the manufacturing process for
the unique barley betafiber product for which there is scientific
evidence to permit a showing that the product is comparable in
cholesterol-lowering ability to the other oat and barley food products
listed in current Sec. 101.81(c)(2)(ii)(A). Discussion between the
agency and the petitioner resulted in the description of the barley
betafiber manufacturing process presented in the following paragraph
and in final Sec. 101.81(c)(2)(ii)(A)(6) (Refs. 2 through 5).
Barley betafiber is produced from an aqueous slurry of whole grain
barley flour, starting with addition of an exogenous grain liquefying
enzyme preparation with cellulase and alpha-amylase activity, derived
from Bacillus amyloliquefaciens. The cellulase activity of the enzyme
preparation acts on the beta-glucan soluble fiber in barley flour,
since beta-glucan is a type of cellulose, and the alpha-amylase
activity of the enzyme preparation acts on the starch in the barley
flour. The temperature of the slurry is kept at or above the
gelatinization temperature of the barley starch but below cellulase
enzyme inactivation temperature; i.e., about 65[deg] C, for about 30 to
60 minutes, to facilitate a partial hydrolysis of both the beta-glucan
soluble fiber and starch. The pH of the slurry is kept in the range of
about 5 to 7. When the cellulase enzymatic hydrolysis of barley flour
has modified the beta-glucan soluble fiber to the desired extent, the
cellulase activity of the enzyme preparation is heat inactivated. After
the cellulase activity of the enzyme preparation has been deactivated,
an exogenous thermo-stable amylolytic enzyme is added to the barley
flour slurry for continued hydrolysis of starch molecules at the higher
temperature. The slurry is held at the higher temperature until
substantially all the starch has been hydrolyzed. A clear aqueous
extract, which contains barley betafiber and the sugars and dextrins
resulting from substantial hydrolysis of starch is then separated from
insoluble material by centrifugation. Barley betafiber is precipitated
from the aqueous extract supernatant with ethanol to separate it from
other soluble components (i.e., substantially hydrolyzed starch,
protein, lipids and other minor components) that remain suspended in
the aqueous extract supernatant. The resultant barley betafiber
precipitate is then dried and milled. The molecular weight range of
barley betafiber produced by this procedure is 120 to 400 kilodaltons
(Refs. 2, 3, and 5). The molecular weight range of barley betafiber is
substantially reduced from that of native barley beta-glucan soluble
fiber. The molecular weight range of native barley beta-glucan soluble
fiber has been reported to range from about 500 to 3,330 kilodaltons
depending upon the cultivars and applied extraction procedures,
although lower molecular weight values of 80 to 300 kilodaltons have
also been reported (Ref. 1). In final Sec. 101.81(c)(2)(ii)(A)(6), FDA
defines barley betafiber by its manufacturing process, as follows
``Barley betafiber. Barley betafiber is the ethanol precipitated
soluble fraction of cellulase and alpha-amylase hydrolyzed whole grain
barley. Barley betafiber is produced by hydrolysis of whole grain
barley flour, as defined in paragraph (c)(2)(ii)(A)(5) of this section,
with a cellulase and alpha-amylase enzyme preparation, to produce a
clear aqueous extract that contains mainly partially hydrolyzed beta-
glucan and substantially hydrolyzed starch. The soluble, partially
hydrolyzed beta-glucan is separated from the insoluble material by
centrifugation, and after removal of the insoluble material, the
partially hydrolyzed beta-glucan soluble fiber is separated from the
other soluble compounds by precipitation with ethanol. The product is
then dried, milled and sifted. Barley betafiber shall have a beta-
glucan soluble fiber content of at least 70 percent on a dry weight
basis.''
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 beta-glucan soluble fiber 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. 6). Heart disease has been recognized as
the leading cause of death in the United States for at least the last
50 years (Ref. 6). Based on these facts,
[[Page 9941]]
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 of the health claim is beta-glucan soluble fiber from
listed oat and barley sources. The petitioner requests an amendment to
add barley betafiber to the list of eligible sources of beta-glucan
soluble fiber. Barley betafiber is derived from whole barley flour.
Barley flour 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 barley betafiber, a processed whole barley flour
product, is a ``substance'' as defined in 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)). The level necessary to justify the claim is 0.75 g
beta-glucan soluble fiber per serving. The term ``nutritive value'' is
defined in Sec. 101.14(a)(3) as ``a value in sustaining human
existence by such processes as promoting growth, replacing lost
essential nutrients, or providing energy.'' The petitioner provided
several examples of food categories (bars, beverages, bread, breakfast
cereals, cookies, crackers, instant rice, pasta, muffins, salad
dressings, snack chips, soups, tortillas and taco shells, vegetarian
patties/crumbles, and reduced fat yogurt) in which barley betafiber
could be used as an ingredient at a maximum level of 3 grams (g) beta-
glucan soluble fiber per serving. Beta-glucan soluble fiber at 0.75 to
3 g per serving contributes nutritive value because it provides a
source of calories and soluble fiber. In addition to its role as a
source of beta-glucan soluble fiber, barley betafiber also has
technical effects, including food applications as a thickener (e.g.,
soups), texturizer (e.g., snack foods), humectant (e.g., retain
moisture of tortillas), or fat replacer (e.g., dressings for salads).
Therefore, FDA concludes that the preliminary 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 petitioner
asserts that the use of barley betafiber as a food ingredient is GRAS.
The petitioner included in its health claim petition documentation of
its 2003 GRAS self-determination for barley betafiber, which contains
70 percent or more pure barley beta-glucan soluble fiber as evidence
that barley betafiber meets the safe and lawful requirement (Ref. 3).
FDA also received a notice informing FDA that the petitioner
determined, through scientific procedures, that the use of barley
betafiber is GRAS. FDA issued a letter (Ref. 7) in response to this
notice stating that the agency had no questions at the time regarding
petitioner's conclusions that barley betafiber is GRAS under the
intended conditions of use.
The 2003 Cargill GRAS self-determination stipulates that barley
betafiber is obtained from food-grade whole grain barley flour by water
extraction at elevated temperature, while starch is removed during the
extraction process by treatment with enzymes that are GRAS for use in
food manufacturing processes, specifically alpha-amylases from Bacillus
licheniformis and B. amyloliquefaciens. The extracted barley betafiber
is recovered by precipitation with denatured ethanol suitable for food
production, and contains 70 percent or more beta-glucan, 2 to 12
percent protein, and less than 3 percent of each sugars, lipids, and
inorganic salts. The basis of the safety determination relies on the
fact that barley betafiber contains only native components of barley
and is formed by the action of applied food-grade enzymes, residues, or
processing aids.
In addition, barley is a traditional food with a long history of
safe use, since at least 8,000 B.C. based on archeological discoveries
(Ref. 3). In the Maghreb countries of Morocco, Algeria, Libya, and
Tunisia, barley is used in a variety of traditional foods (bread, soup,
porridge), resulting in an average intake of up to 172 g per person per
day (Morocco). With this intake of barley, about 6 g per person per day
of pure beta-glucan soluble fiber is consumed. The preparation of these
traditional foods involves baking or boiling for longer periods of
time, which ensures extraction of beta-glucan from its natural context
(cell walls, complexes with proteoglycans). The physiological
properties of beta-glucan as a dietary fiber may, therefore, be found
in these traditional foods as is intended to be achieved with the
addition to processed foods of barley beta-glucan concentrate.
The intended uses of barley betafiber listed as a food ingredient
stated in the 2003 Cargill GRAS self-determination include the
following food categories: Bars, beverages, bread (whole grain and
specialty), breakfast cereals (ready to eat and cooked), cookies
(lite), crackers (reduced fat), instant rice, macaroni products,
muffins (reduced fat), salad dressings (lite), snack chips (reduced
fat), soups, tortillas and taco shells, vegetarian patties/crumbles,
and reduced fat yogurt. The maximum incorporation rate for each of
these food applications is 3 g beta-glucan soluble fiber from barley
betafiber per serving.
FDA concludes that the petitioners have satisfied the preliminary
requirement of Sec. 101.14(b)(3)(ii) to demonstrate, to FDA's
satisfaction, that the use of beta-glucan soluble fiber from barley
betafiber at levels necessary to justify the health claim is safe and
lawful under the applicable food safety provisions of the act. The
agency has not made its own determination regarding the GRAS status of
barley betafiber or beta-glucan soluble fiber from barley betafiber.
Furthermore, the agency notes that a regulation to authorize a health
claim for a substance should not be interpreted as affirmation that the
substance is GRAS.
III. Review of Scientific Evidence of the Substance-Disease
Relationship
A. Basis for Evaluating the Relationship Between Beta-Glucan Soluble
Fiber from Barley Betafiber and CHD
The types of data that FDA has recognized in previous CHD health
claim evaluations as useful for assessing CHD risk reduction are:
Coronary events (myocardial infarction, ischemia), cardiovascular
death, atherosclerosis, high blood pressure, serum total cholesterol,
and serum LDL cholesterol. FDA considers high blood pressure, serum
total cholesterol, and serum LDL cholesterol levels to be the only
currently validated surrogate measures for CHD risk (Ref. 8). Elevated
levels of serum total and LDL cholesterol, a prerequisite for
atherosclerotic disease, is a major modifiable risk factor in the
development of CHD (Ref. 8). For these reasons, the agency based its
original evaluation of the relationship between oat beta-glucan soluble
fiber and CHD risk (62 FR 3584) and subsequent evaluations to add
oatrim (67 FR 61773) and barley as eligible sources of beta-glucan
soluble fiber (70 FR 76150) in the health claim, primarily on evidence
for serum total and LDL cholesterol-lowering effects of beta-glucan
soluble fiber containing food ingredients. As such, our evaluation of
the evidence
[[Page 9942]]
supporting the petitioned request to extend the eligible barley sources
to include barley betafiber (as described in section II.B of this
preamble), focused on evidence from human randomized controlled trials
of the effects of consuming beta-glucan soluble fiber from barley
betafiber on blood lipids. This focus is consistent with existing Sec.
101.81 in which FDA concluded that there is significant scientific
agreement that the relationship between CHD risk and consumption of
beta-glucan soluble fiber from certain oat and barley food ingredients
is mediated primarily by the effect of the beta-glucan soluble fiber on
serum lipids.
FDA's determination of significant scientific agreement that the
totality of publicly available scientific evidence supports the
relationship between beta-glucan soluble fiber from certain oat and
barley foods and CHD risk is documented in rulemaking for Sec. 101.81.
When issuing the 1997 oat beta-glucan health claim final rule, 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). In
the 2002 and 2005 amendments to the health claim to add oatrim and
whole grain and dry milled barley products, respectively, as eligible
sources of beta-glucan soluble fiber, the agency considered evidence
that beta-glucan soluble fiber from those sources had comparable
cholesterol-lowering effects to that from the sources previously listed
in Sec. 101.81(c)(2)(ii)(A) as further support for FDA's previous
determination that there is significant scientific agreement that a
relationship exists between consumption of certain beta-glucan soluble
fiber sources and reduced risk of CHD (67 FR 61773 at 61779 and 70 FR
76150 at 76155). Similarly, FDA considers that scientific evidence to
establish that the cholesterol-lowering effects of beta-glucan soluble
fiber from barley betafiber are comparable to the effects of beta-
glucan soluble fiber from the oat/barley products in current Sec.
101.81(c)(2)(ii)(A) builds on the substantial base of scientific
evidence that already establishes significant scientific agreement for
the association between consumption of the oat/barley products now
listed and reduced risk of CHD. FDA's review of the evidence to support
the petitioned amendment of the health claim regulation entitled
``Soluble fiber from certain foods and risk of CHD'' was conducted
consistent with FDA published guidance on significant scientific
agreement in the review of health claims (Ref. 9) and focused on
evidence from intervention studies.
B. Assessment of Intervention Studies
This petition identified one relevant human randomized controlled
trial of how consumption of beta-glucan soluble fiber from barley
betafiber affects heart disease risk and serum lipid levels. A summary
of this trial was included in the petition and subsequently published
in a peer reviewed scientific journal (Ref. 4). FDA also evaluated
reported results from randomized controlled trials of other types of
beta-glucan concentrates, extracts, and gums (Refs. 10 through 19).
The study reported in Keenan et al. 2007 (Ref. 4) investigated the
effects of consuming concentrated barley beta-glucan soluble fiber-
enriched foods (fruit drink and corn flakes) on blood lipids in
hypercholesterolemic men and women. The study was conducted as a
randomized, double-blind, placebo-controlled, parallel arm study of
five groups with 30 to 32 subjects per group. The study included a
total of 155 hypercholesterolemic adult subjects, between 25 and 73
years of age, with baseline serum LDL cholesterol levels between 140
and 190 milligrams per deciliter (mg/dL). The subjects were instructed
to follow a diet low in saturated and trans fatty acids (less than 10
percent kilocalories (kcals) per day) and to consume three servings of
the concentrated barley beta-glucan soluble fiber-enriched test foods
per day, one serving with each of three major meals. The concentrated
barley beta-glucan soluble fiber-enriched test foods were formulated to
provide either 3 or 5 g of beta-glucan soluble fiber per day; a placebo
version of the test foods without added barley beta-glucan extracts was
also used. Two concentrated barley beta-glucan soluble fiber products
were used; one is the barley betafiber produced from the manufacturing
process described in section II.B of this preamble, and was described
in the study report as a low molecular weight (LMW) extract; the other
concentrated barley beta-glucan soluble fiber product of the study was
described as a high molecular weight (HMW) beta-glucan extract. The HMW
barley beta-glucan extract was processed in a fashion similar to that
for barley betafiber but omitted the cellulase enzymatic hydrolysis
step, thus producing a concentrated source of barley beta-glucan
soluble fiber with a molecular weight similar to that of the endogenous
beta-glucan soluble fiber in barley grain from which it was derived.
Following a 4-week run-in period to adjust to the low saturated/
trans fat diet, the subjects were randomly assigned to one of five
treatment groups: placebo control, 3 g per day barley betafiber, 5 g
per day barley betafiber, 3 g per day HMW beta-glucan extract, and 5 g
per day HMW beta-glucan extract. Subjects consumed the test foods daily
for 6 weeks. Consumption of 3 or 5 g beta-glucan per day from barley
betafiber significantly lowered serum total cholesterol levels (6.0
percent and 9.9 percent, respectively) relative to the placebo control
group. Consumption of 3 or 5 g beta-glucan per day from the HMW barley
beta-glucan extract also significantly lowered serum total cholesterol
(7.0 percent and 11.2 percent, respectively) relative to the placebo
control group. Serum LDL cholesterol levels were significantly
decreased in all active treatment groups. At the end of the 5-week
intervention period, the mean serum LDL cholesterol level of the 3 g
per day beta-glucan from barley betafiber group was 10 mg/dL lower than
the mean serum LDL cholesterol level of the placebo control group,
representing a 7.5 percent reduction in LDL cholesterol relative to the
placebo control group. The reduction in mean serum LDL cholesterol for
the 5 g per day beta-glucan from barley betafiber group relative to the
placebo control group was 16 mg/dL or 12 percent. The reduction in mean
serum LDL cholesterol for the 3 g per day HMW beta-glucan group was 12
mg/dL or 8 percent relative to the placebo control group. For the 5 g
per day HMW beta-glucan group, the reduction in mean LDL cholesterol
was 19 mg/dL or 13 percent relative to the placebo control group. There
were no statistically significant differences between barley betafiber
and the HMW barley beta-glucan extract groups, or between 3 g per day
or 5 g per day beta-glucan groups, in the magnitude of the cholesterol
lowering effects.
The magnitude of cholesterol-lowering reported by Keenan et al.
(Ref. 4) for 3 and 5 g per day beta-glucan from barley betafiber is
consistent with the magnitude of cholesterol-lowering observed with
similar barley beta-glucan soluble fiber intake levels consumed as dry
milled barley foods (70 FR 76150 at 76153). The randomized controlled
trials with dry milled barley foods that FDA considered when previously
[[Page 9943]]
amending the health claim to add dry milled barley had reported mean
serum LDL cholesterol reductions of between 10 and 19 mg/dL from barley
beta-glucan intake levels of 3 to 8 g per day. Based on evidence from
the randomized controlled trials of dry milled barley ingredients which
FDA relied upon when adding barley products to the health claim, the
data for barley betafiber from Keenan et al. are consistent with the
expected magnitude of cholesterol-lowering from consumption of the
barley products listed in current Sec. 101.81(c)(2)(ii)(A)(5).
Clinical trial evidence of oat/barley beta-glucan extracts other
than barley betafiber indicate that not all oat/barley beta-glucan
extracts affect serum total and LDL cholesterol levels as consistently
as does consumption of the intact oat and barley grain from which they
have been extracted (Refs. 10 through 19). This indicates that some
extraction processes negatively affect whatever characteristics of
beta-glucan soluble fiber in whole grain oats and barley that are
responsible for the cholesterol-lowering effect. Accordingly, data from
trials of beta-glucan extracts and concentrates other than barley
betafiber support FDA's previous position (62 FR 3584 at 3587) that oat
and barley products will be added to the health claim as eligible
sources of beta-glucan soluble fiber only on a case-by-case basis when
FDA is presented with adequate supporting evidence.
Evidence from the randomized controlled trial reported by Keenan et
al. (Ref. 4) indicates that beta-glucan soluble fiber from barley
betafiber, prepared as described in section II of this preamble, is
comparable to beta-glucan soluble fiber from the oat and barley sources
now included in current Sec. 101.81 in regard to cholesterol-lowering
properties. Evidence from randomized controlled trials of other oat or
barley beta-glucan extracts indicate that some forms of processing of
oat and barley grain to extract or concentrate beta-glucan can
negatively affect whatever properties of oat and barley beta-glucan are
responsible for the cholesterol-lowering effect. Therefore, results
from Keenan et al. can not be extrapolated to beta-glucan extracts
other than the specific products tested in the trial. Results from the
Keenan et al. trial also demonstrate that the serum cholesterol-
lowering effects were comparable for beta-glucan soluble fiber from
barley betafiber (i.e., the LMW product in the Keenan et al. trial) and
for the barley beta-glucan extract that was not subjected to beta-
glucan hydrolysis (the HMW product in the Keenan et al. trial) (Ref.
4). This evidence demonstrates that the cholesterol-lowering ability of
beta-glucan soluble fiber in barley betafiber is not affected by the
process used in the manufacture of barley betafiber to reduce the
molecular weight of the barley betafiber product.
IV. Decision to Amend the Health Claim
Available evidence demonstrates that foods enriched with beta-
glucan soluble fiber from barley betafiber at levels sufficient to
provide at least 3 g beta-glucan soluble fiber per day are effective in
lowering serum LDL-cholesterol levels, which may reduce the risk of
CHD. As noted previously, when issuing the 1997 oat beta-glucan health
claim final rule 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 clinical trial results reported by
Keenan et al. (Ref. 4) demonstrating the cholesterol-lowering effect of
consuming beta-glucan soluble fiber from barley betafiber are
consistent in magnitude with what would be expected based on the oat
beta-glucan soluble fiber/cholesterol-lowering dose-response evidence,
which was cited in the 1997 oat beta-glucan health claim final rule,
and cholesterol-lowering effect of consuming beta-glucan soluble fiber
from dry milled barley grain ingredients (70 FR 76150 at 76155). Thus,
FDA concludes that the cholesterol-lowering effect of beta-glucan
soluble fiber from barley betafiber is comparable to that of beta-
glucan soluble fiber from whole grain oat and dry milled barley sources
currently listed in Sec. 101.81(c)(2)(ii)(A). FDA also concludes that
the scientific evidence supports a minimum daily effective intake of
beta-glucan soluble fiber from barley betafiber the same as that which
was previously found for whole oat and dry milled barley sources of
beta-glucan soluble fiber, i.e., 3 g per day. Therefore, FDA is
amending Sec. 101.81, by adding Sec. 101.81(c)(2)(ii)(A)(6) to list
barley betafiber as an eligible source of beta-glucan soluble fiber.
Consistent with current Sec. 101.81(c)(2)(i)(G)(1), the source of the
3 g or more per day of beta-glucan soluble fiber may be from whole oats
or barley, including the barley betafiber source, or a combination of
oats and barley eligible sources. In addition, consistent with the
description of other oat and barley products listed in current Sec.
101.81, amended Sec. 101.81 will specify barley betafiber by the
method of production as described in section II.B of this preamble. The
agency is satisfied that the description of the method for producing
barley betafiber appropriately characterizes the barley product being
added to the regulation. Further, barley beta-glucan can be measured by
the same quantitative analytical method as is currently specified in
Sec. 101.81(c)(2)(ii)(A) for the determination of oat beta-glucan and
barley beta-glucan from whole grain barley and dry milled barley
products. 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, FDA is amending Sec.
101.81(c)(2)(ii)(A) to include barley betafiber derived from whole
barley flour, prepared as described in section II.B of this document,
as an additional source of beta-glucan soluble fiber.
The requirement in Sec. 101.81(c)(2)(iii)(A) states that a food
bearing the claim on its label include one of the ingredients listed
within Sec. 101.81(c)(2)(ii)(A) and that the ingredient provide at
least 0.75 gram of beta-glucan soluble fiber per reference amount
customarily consumed (RACC) of the food product. This level is based on
the minimum daily effective intake of beta-glucan soluble fiber from
barley betafiber and is the same as that which was previously found for
whole oat and dry milled barley sources of beta-glucan soluble fiber,
i.e., 3 g per day. FDA arrived at a value of 0.75 gram beta-glucan
soluble fiber per RACC based on a standard assumption that the daily
dietary intake is divided over four eating occasions per day (three
meals and a snack) (62 FR 3584 at 3592). Thus, adding barley betafiber
as an additional eligible source of beta-glucan soluble fiber will
further increase the type and number of qualifying food products and
make it easier for consumers to select barley and oat products at four
eating occasions per day. Thus, FDA is retaining under the ``Nature of
the food eligible to bear the claim'' section of the codified text of
this interim final rule, 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)(2)).
There is strong consistent scientific evidence that diets high in
saturated fat
[[Page 9944]]
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. 8). 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 issuing the 1997 oat
beta-glucan health claim final rule, 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 in the 1997 oat beta-glucan health claim final rule that
the 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)). FDA reiterated this position and
extended it to soluble fiber from listed barley products when the
agency amended Sec. 101.81 to add whole grain barley and certain dry
milled barley products as eligible sources of beta-glucan soluble fiber
in 2005 (70 FR 76150 at 76156).
Beta-glucan soluble fiber from barley betafiber functions
comparably to beta-glucan soluble fiber from the listed oat and barley
sources in current Sec. 101.81(c)(2)(ii)(A) in its effect on reducing
LDL and total cholesterol. Barley betafiber, as a source of beta-glucan
soluble fiber, is a useful adjunct to selection of diets low in
saturated fat and cholesterol to reduce CHD risk. Thus, the agency is
requiring that the beta-glucan soluble fiber from barley betafiber
health claim be subject to the requirements in 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 Amendments to the Soluble Fiber from Certain Foods
and Risk of Coronary Heart Disease Health Claim Regulation
A. Nature of the Substance; Eligible Sources of Soluble Fiber
Section 101.81(c)(2)(ii) (nature of the substance) lists the types
and sources of soluble fiber that have been demonstrated to FDA's
satisfaction to have a relationship to a reduced risk of CHD. Section
101.81(c)(2)(ii)(A) lists beta-glucan soluble fiber from whole oat and
barley sources, along with specifying an AOAC INTERNATIONAL method of
analysis for beta-glucan soluble fibe, which will be used by FDA for
verifying compliance. Section 101.81(c)(2)(ii)(A)(1) through
(c)(2)(ii)(A)(5) identifies the whole oat and barley products that are
eligible sources of beta-glucan, i.e., oat bran, rolled oats, whole oat
flour, oatrim, whole grain barley, and dry milled barley.
FDA is amending Sec. 101.81(c)(2)(ii)(A) by adding Sec.
101.81(c)(2)(ii)(A)(6), which would specify barley betafiber as being
the ethanol isolated, soluble fraction of cellulase and alpha-amylase
hydrolyzed whole grain barley flour, with a beta-glucan content of at
least 70 percent on a dry weight basis (dwb). Thus, Sec.
101.81(c)(2)(ii)(A)(6) will read as follows ``Barley betafiber. Barley
betafiber is the ethanol precipitated soluble fraction of cellulase and
alpha-amylase hydrolyzed whole grain barley. Barley betafiber is
produced by hydrolysis of whole grain barley flour, as defined in
paragraph (c)(2)(ii)(A)(5) of this section, with a cellulase and alpha-
amylase enzyme preparation, to produce a clear aqueous extract that
contains mainly partially hydrolyzed beta-glucan and substantially
hydrolyzed starch. The soluble, partially hydrolyzed beta-glucan is
separated from the insoluble material by centrifugation, and after
removal of the insoluble material, the partially hydrolyzed beta-glucan
soluble fiber is separated from the other soluble compounds by
precipitation with ethanol. The product is then dried, milled and
sifted. Barley betafiber shall have a beta-glucan soluble fiber content
of at least 70 percent on a dry weight basis.''
B. Nature of the Food Eligible to Bear the Claim
Section 101.81(c)(2)(iii)(A)(2) (nature of the food) currently
states ``The food containing the oatrim from paragraph (c)(2)(ii)(A)(4)
of this section shall contain at least 0.75 g of beta-glucan soluble
fiber per reference amount customarily consumed of the food product;''
Because FDA is amending Sec. 101.81 to add barley betafiber, FDA
is amending Sec. 101.81(c)(2)(iii)(A)(2) as follows ``The food
containing the oatrim from paragraph (c)(2)(ii)(A)(4) of this section
or the barley betafiber from paragraph (c)(2)(ii)(A)(6) of this section
shall contain at least 0.75 g of beta-glucan soluble fiber per
reference amount customarily consumed of the food product;''
C. Other Requirements
All other requirements in Sec. 101.81(c)(1) through (c)(2)(i) and
the optional information in Sec. 101.81(d) will apply to the use of
the health claim authorized in Sec. 101.81 for barley betafiber-
containing products.
D. Model Health Claims
This interim final rule to amend existing Sec. 101.81(c)(2) does
not affect the model health claims specified in paragraph (e) of Sec.
101.81. Thus, the model health claims in Sec. 101.81(e) apply to a
claim about beta-glucan soluble fiber from barley betafiber and a
reduced risk of CHD.
VI. Analysis of Impacts
FDA has examined the impacts of this 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).
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 agency believes that
this interim final rule is not a significant regulatory action as
defined by the Executive order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this interim final rule concerns voluntary
claims, the agency certifies that the interim final rule will not have
a significant economic impact on a substantial number of small
entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
[[Page 9945]]
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $127 million, using the most current (2006) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
interim final rule to result in any 1-year expenditure that would meet
or exceed this amount.
FDA has identified the following three options regarding this
petition: (1) Deny the petition; (2) authorize the petition (add only
barley betafiber to the ``Soluble fiber from certain foods and risk of
coronary heart disease health claim`` in Sec. 101.81 (the soluble
fiber and CHD health claim)); or (3) add barley betafiber to the
soluble fiber-CHD health claim and also expand the scope of the claim
to include all sources of soluble fiber. FDA concludes that authorizing
the petition by adding barley betafiber to the soluble fiber and CHD
health claim is the best option of those identified.
Option One: Deny the Petition
FDA can only define costs and benefits relative to a baseline. FDA
usually selects the option of taking no action as the baseline because
it helps readers identify the costs and benefits of actions that change
the status quo. In this case, denying the petition would correspond to
taking no action because it would imply no change in the soluble fiber
and CHD health claim and thus the continuation of the status quo. By
definition, the baseline itself has no costs or benefits. This does not
mean that we ignore the costs and benefits of the baseline. Instead, it
means that FDA expresses the costs and benefits of the baseline in how
it calculates the costs and benefits of the other regulatory options.
Option Two: Authorize the Petition (Add Only Barley Betafiber to the
Soluble Fiber and CHD Health Claim)
This option would allow producers who use barley betafiber to use
the soluble fiber and CHD health claim on their product labels under
certain conditions. Producers would only choose to change product
labels or reformulate products if they believe that the benefits that
they will derive from doing so are at least as great as the costs of
making those changes. FDA has reviewed the data supplied in the
petition and concludes that the claim is truthful and not misleading.
If this interim final rule is finalized without change, FDA can be sure
that to whatever extent producers use the claim, consumers will be in a
better position, assuming that more information that is truthful and
not misleading is always better for consumers. Based on this, FDA can
conclude that adding barley betafiber to the soluble fiber and CHD
health claim is better for social welfare than denying the petition.
Option Three: Add Barley Betafiber to the Soluble Fiber and CHD Health
Claim and Also Expand the Scope of the Claim to Include All Sources of
Soluble Fiber
This option would allow producers who use barley betafiber and all
other sources of soluble fiber to use the soluble fiber and CHD health
claim on their product labels under certain conditions rather than just
listing specific sources of soluble fiber. Similar to option two,
producers would only choose to change product labels or reformulate
products if they believed that the benefits that they will derive from
doing so are at least as great as the costs of making those changes. In
addition, this option would reduce the future burden on manufacturers
of petitioning FDA to use the soluble fiber and CHD health claim for
additional sources of soluble fiber, and it would also reduce the
agency's burden of evaluating each petition for each individual source
of soluble fiber. However, by expanding the use of the claim to all
sources of soluble fiber without reviewing the scientific data on each
source, FDA would not be able to verify that the claim was being used
under circumstances where it is truthful and not misleading to
consumers. If the expanded claim was used on a product that did not
reduce the risk of CHD, then the expanded claim could actually result
in an increase in CHD. This would happen if consumers were misled into
thinking that they were reducing their risk of CHD by consuming a
product that actually did not reduce the risk of CHD. As a result, they
might not take other beneficial steps that would decrease their risk of
CHD.
FDA cannot conclude that the cost savings of option three outweigh
the increased risk of a false or misleading claim being made under the
expanded claim. Therefore FDA cannot conclude that option three is
better for social welfare than option two. Moreover, the agency
believes that expanding the soluble fiber and CHD health claim to all
sources of soluble fiber without reviewing the scientific data
supporting such a claim of CHD risk reduction for each individual
source of fiber would be a failure to carry out our statutory
responsibility under section 403(r)(3)(B) of the act to issue health
claim regulations only when the agency determines that there is
significant scientific agreement that the claim is supported by the
totality of publicly available scientific evidence.
VII. Environmental Impact
The agency has determined under 21 CFR 25.32(p) 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.
VIII. Paperwork Reduction Act of 1995
FDA concludes that the labeling provisions of this interim final
rule are not subject to review by the Office of Management and Budget
because they do not constitute a ``collection of information'' under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Rather, the
food labeling health claim on the association between consumption of
barley betafiber beta-glucan soluble fiber and CHD risk is a ``public
disclosure of information originally supplied by the Federal Government
to the recipient for the purpose of disclosure to the public'' (see 5
CFR 1320.3(c)(2)).
IX. Federalism
FDA has analyzed this interim final rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the rule has a preemptive effect on State law. Section 4(a) of the
Executive order requires agencies to ``construe * * * a Federal statute
to preempt State law only where the statute contains an express
preemption provision or there is some other clear evidence that the
Congress intended preemption of State law, or where the exercise of
State authority conflicts with the exercise of Federal authority under
the Federal statute.'' Section 403A of the act (21 U.S.C. 343-1) is an
express preemption provision. Section 403A(a)(5) of the act provides
that ``* * * no State or political subdivision of a State may directly
or indirectly establish under any authority or continue in effect as to
any food in interstate commerce--* * * any requirement respecting any
claim of the type described in section 403(r)(1) of the act made in the
label or labeling of food that is not identical to the requirement of
section 403(r). * * *''
Currently, this provision operates to preempt States from imposing
health claim labeling requirements concerning beta-glucan soluble fiber
from barley betafiber and reduced risk of CHD because no such
requirement had been
[[Page 9946]]
imposed by FDA under section 403(r) of the act. This interim final
rule, if finalized without change, would amend existing food labeling
regulations to add barley betafiber as an eligible source of beta-
glucan soluble fiber to the authorized health claim for soluble fiber
from certain foods and risk of CHD. Although this rule would have a
preemptive effect in that it would preclude States from issuing any
health claim labeling requirements for beta-glucan soluble fiber from
barley betafiber and a reduced risk of CHD that are not identical to
those that would be required by this interim final rule, this
preemptive effect is consistent with what Congress set forth in section
403A of the act. Section 403A(a)(5) of the act displaces both State
legislative requirements and State common law duties. (Medtronic v.
Lohr, 518 U.S. 470, 503 (1996) (Breyer, J., concurring in part and
concurring in judgment); id. at 510 (O'Connor, J., joined by Rehnquist,
C.J., Scalia, J., and Thomas, J., concurring in part and dissenting in
part); Cipollone v. Liggett Group, Inc., 505 U.S. 504, 521 (1992)
(plurality opinion); id. at 548-49 (Scalia, J., joined by Thomas, J.,
concurring in judgment in part and dissenting in part).
FDA believes that the preemptive effect of this interim final rule,
if finalized without change, is consistent with Executive Order 13132.
Section 4(e) of the Executive order provides that ``when an agency
proposes to act through adjudication or rulemaking to preempt State
law, the agency shall provide all affected State and local officials
notice and an opportunity for appropriate participation in the
proceedings.'' FDA provided the States with an opportunity for
appropriate participation in this rulemaking on December 12, 2007, when
FDA's Division of Federal and State Relations provided notice via fax
and email transmission to State health commissioners, State agriculture
commissioners, food program directors, and drug program directors as
well as FDA field personnel of FDA's intent to amend the health claim
regulation authorizing health claims for soluble fiber from certain
foods and risk of CHD (Sec. 101.81). It advised the States of FDA's
possible action and encouraged the States and local governments to
review the petition and to provide any comments to the docket (Docket
No. 2006P-0393), until January 12, 2008. FDA received no comments in
response to the notice. FDA is also providing an opportunity for State
and local officials to comment on this interim final rule.
In conclusion, the agency has determined that the preemptive
effects of this interim final rule are consistent with Executive Order
13132.
X. Issuance of an Interim Final Rule and Immediate Effective Date
FDA is 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 is necessary to: (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 all three of the criteria in section
403(r)(7)(A) of the act have been met for the amendment to the soluble
fiber from certain foods and risk of CHD health claim to list barley
betafiber as eligible source of beta-glucan soluble fiber. This health
claim amendment will help enable consumers to develop and maintain
healthy dietary practices. The health claim will also provide consumers
with important knowledge regarding the effects of beta-glucan soluble
fiber in reducing the risk of, and will provide consumers with
scientifically sound information on the benefits of foods containing
beta-glucan soluble fiber from barley betafiber. 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 for soluble
fiber from barley betafiber and CHD, effective 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 the Division of Dockets Management, in any of the ways noted in the
ADDRESSES section at the beginning of this document, comments regarding
this interim final rule by (see DATES). 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 Dockets Management
Branch between 9 a.m. and 4 p.m., Monday through Friday.
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.
XI. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper 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
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through FDMS only.
XII. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site address, but FDA is not responsible for
any subsequent changes to the Web site after this document publishes in
the Federal Register.)
1. Cargill, Inc., ``Petition for Health Claim--Barley Betafiber
and Coronary Heart Disease,'' (Docket 2006P-0393 CP1), June 20,
2006.
2. Cargill, Inc., ''Petition for Health Claim--Barley Betafiber
and Coronary Heart Disease,'' Appendix 4, (Docket 2006P-0393), June
20, 2006.
3. Cargill, Inc., ``Petition for Health Claim--Barley Betafiber
and Coronary Heart Disease,'' Appendix 1, (Docket 2006P-0393), June
20, 2006.
4. Keenan, J.M., Goulson, M., Shamliyan, T., et al., ''The
Effects of Concentrated Barley Beta-Glucan on Blood Lipids in a
Population of Hypercholesterolaemic Men and Women,'' British Journal
of Nutrition, 97:1162-1168, 2007.
5. E-mail from Lore Kolberg, Cargill, Inc., to Jillonne Kevala,
FDA, August 28, 2006.
6. Cooper, R., Cutler, J., Desvigne-Nickens, P., et al.,
``Trends and Disparities in Coronary Heart Disease, Stroke, and
Other Cardiovascular Diseases in the United States: Findings of the
National Conference on
[[Page 9947]]
Cardiovascular Disease Prevention,'' Circulation, 102:3137-3147,
2000.
7. Agency Response Letter to Generally Recognized as Safe Notice
No. GRN 000207, FDA, Center for Food Safety and Applied Nutrition,
Office of Food Additive Safety, December 19, 2006.
8. National Heart, Lung, and Blood Institute; National
Cholesterol Education Program Expert Panel on Detection, Evaluation,
and Treatment of High Blood Pressure in Adults (Adult Treatment
Panel III), Third Report of the NCEP Adult Treatment Panel III,
Executive Summary, Bethesda (MD): National Institutes of Health,
National Heart, Lung and Blood Institute,
(www.nhlbi.nih.gov/guidelines/cholesterol/atp_iii.htm),
May 2001.
9. Guidance for Industry: Significant Scientific Agreement in
the Review of Health Claims for Conventional Foods and Dietary
Supplements, Rockville, MD: U.S. Food and Drug Administration;
December 1999, Available from: http://www.cfsan.fda.gov/~dms/ssaguide.html.
10. Bi[ouml]rklund, M., vanRees, A., Mensink, R.P., et al.,
``Changes in Serum Lipids and Postprandial Glucose and Insulin
Concentrations After Consumption of Beverages with [beta]-Glucans
from Oats or Barley: A Randomized Dose-Controlled Trial,'' European
Journal of Clinical Nutrition, 59:1272-1281, 2005.
11. Keogh, G.F., Cooper, G.J.S., Mulvey, T.B., et al.,
``Randomized Controlled Crossover Study of the Effect of a Highly
[beta]-Glucan-Enriched Barley on Cardiovascular Disease Risk Factors
in Mildly Hypercholesterolemic Men,'' American Journal of Clinical
Nutrition, 78:711-718, 2003.
12. Kerckhoffs, D.A.J.M., Hornstra, G., and R.P. Mensink,
``Cholesterol-Lowering Effect of [beta]-Glucan from Oat Bran in
Mildly Hypercholesterolemic Subjects May Decrease When [beta]-Glucan
is Incorporated Into Bread and Cookies,'' American Journal of
Clinical Nutrition, 78:221-227, 2003.
13. Lovegrove, J.A., Clohessy, A., Milon, H., et al, ``Modest
Doses of [beta]-Glucan Do Not Reduce Concentrations of Potentially
Atherogenic Lipoproteins,'' American Journal of Clinical Nutrition,
72:49-55, 2000.
14. Naumann, E., vanRees, A.B., [Ouml]nning, G., et al.,
``[beta]-Glucan Incorporated Into a Fruit Drink Effectively Lowers
Serum LDL-Cholesterol Concentrations,'' American Journal of Clinical
Nutrition, 83:601-605, 2006.
15. Pick, M.E., Hawrysh, Z.J., Gee, M.I., et al., ``Oat Bran
Concentrate Bread Products Improve Long-Term Control of Diabetes: A
Pilot Study,'' Journal of the American Dietetic Association,
96:1254-1261, 1996.
16. Beer, M.U., Arrigoni, E., and R. Amado, ``Effects of Oat Gum
on Blood Cholesterol Levels in Healthy Young Men,'' European Journal
of Clinical Nutrition, 49:517-522, 1995.
17. Braaten, J.T., Wood, P.J., Scott, F.W., et al., ``Oat
[beta]-Glucan Reduces Blood Cholesterol Concentration in
Hypercholesterolemic Subjects,'' European Journal of Clinical
Nutrition, 48:465-474, 1994.
18. Pomeroy, S., Tupper, R., Cehun-Anders, and P. Nestel, ``Oat
[beta]-Glucan Lowers Total and LDL-Cholesterol,'' Australian Journal
of Nutrition and Dietetics, 58:51-55, 2001.
19. T[ouml]rr[ouml]nen, R., Kansanen, L., Uusitupa, M., et al.,
``Effects of an Oat Bran Concentrate on Serum Lipids in Free-Living
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of Clinical Nutrition, 46:621-627, 1992.
List of Subjects in 21 CFR Part 101
Food labeling, Nutrition, Reporting and recordkeeping requirements.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
101 is amended as follows:
PART 101--FOOD LABELING
0
1. The authority citation for 21 CFR part 101 continues to read as
follows:
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371; 42 U.S.C. 243, 264, 271.
0
2. Section 101.81 is amended by adding paragraph (c)(2)(ii)(A)(6) and
by revising paragraph (c)(2)(iii)(A)(2) to read as follows:
Sec. 101.81 Health claims: Soluble fiber from certain foods and risk
of coronary heart disease (CHD).
* * * * *
(c) * * *
(2) * * *
(ii) * * *
(A) * * *
(6) Barley betafiber. Barley betafiber is the ethanol precipitated
soluble fraction of cellulase and alpha-amylase hydrolyzed whole grain
barley. Barley betafiber is produced by hydrolysis of whole grain
barley flour, as defined in paragraph (c)(2)(ii)(A)(5) of this section,
with a cellulase and alpha-amylase enzyme preparation, to produce a
clear aqueous extract that contains mainly partially hydrolyzed beta-
glucan and substantially hydrolyzed starch. The soluble, partially
hydrolyzed beta-glucan is separated from the insoluble material by
centrifugation, and after removal of the insoluble material, the
partially hydrolyzed beta-glucan soluble fiber is separated from the
other soluble compounds by precipitation with ethanol. The product is
then dried, milled and sifted. Barley betafiber shall have a beta-
glucan soluble fiber content of at least 70 percent on a dry weight
basis.
* * * * *
(iii) * * *
(A) * * *
(2) The food containing the oatrim from paragraph (c)(2)(ii)(A)(4)
of this section or the barley betafiber from paragraph (c)(2)(ii)(A)(6)
of this section shall contain at least 0.75 g of beta-glucan soluble
fiber per reference amount customarily consumed of the food product; or
* * * * *
Dated: February 15, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-3418 Filed 2-22-08; 8:45 am]
BILLING CODE 4160-01-S