[Federal Register: October 2, 2002 (Volume 67, Number 191)]
[Rules and Regulations]
[Page 61773-61783]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02oc02-7]
 
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 
Food and Drug Administration
 
21 CFR Part 101
 
[Docket No. 01Q-0313]
 
 
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 beta-
glucan soluble fiber from whole oat sources and reduced risk of
coronary heart disease (CHD). The amendment adds as an additional
eligible source of whole oat beta-glucan soluble fiber, the soluble
fraction of alpha-amylase hydrolyzed oat bran or whole oat flour with a
beta-glucan soluble fiber content of up to 10 percent on a dry weight
basis (dwb) and not less than that of the starting material (dwb). We
(FDA) are taking this action in response to a petition jointly filed by
the Quaker Oats Co. and Rhodia, Inc. (the petitioners). We concluded
previously that there was significant scientific agreement that a
relationship exists between the beta-glucan soluble fiber of certain
whole oat sources and the reduction of risk of CHD by lowering blood
cholesterol levels. We now have concluded, based on the publicly
available scientific evidence that, in addition to rolled oats, oat
bran, and whole oat flour, the soluble fraction of alpha-amylase
hydrolyzed oat bran or whole oat flour with a beta-glucan content up to
10 percent (dwb) and not less than that of the starting material (dwb)
is an appropriate source of beta-glucan soluble fiber for the health
claim. Therefore, we are amending the regulation that authorizes a
health claim on the relationship between soluble fiber from whole oats
and reduced risk of CHD to include this additional source of beta-
glucan soluble fiber.
 
DATES: This interim final rule is effective October 2, 2002. Submit
written or electronic comments by December 16, 2002.
 
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to
http://www.fda.gov/dockets/ecomments.
 
FOR FURTHER INFORMATION CONTACT: James E. Hoadley, 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, including
confirming 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) (58 FR 2478, January 6, 1993), which set out the
rules for the authorization and use of health claims, and Sec.  101.70
(21 CFR 101.70) (58 FR 2478, January 6, 1993), which established a
process for petitioning the agency to authorize health claims about a
substance-disease relationship and set out the types of information
that any such petition must include. Each of these regulations became
effective on May 8, 1993.
    In addition, we conducted extensive reviews of the evidence on the
10 substance-disease relationships listed in the 1990 amendments,
including dietary fiber and reduced risk of cardiovascular disease
(CVD). As a result of our review, we have authorized claims that relate
to 8 of these 10 relationships.
 
B. 1990 to 1993 Dietary Fiber and Cardiovascular Disease Health Claim
Evaluation
 
    During 1990 to 1993, we conducted an extensive review of the
relationship between dietary fiber and CVD. We examined the then
current state of scientific opinion regarding the role of total dietary
fiber in general, without focusing on any particular dietary fiber.
Although we denied the use of a health claim relating total dietary
fiber to reduced risk of CVD (58 FR 2552, January 6, 1993), we
authorized a health claim relating fruits, vegetables, and grain
products that contain dietary fiber, particularly soluble dietary
fiber, to reduced risk of CHD, one of the more common serious forms of
CVD (58 FR 2552, January 6, 1993).
    We concluded that, based on the totality of publicly available
scientific evidence, there was significant scientific agreement that
the evidence supported an association between diets low in saturated
fat and cholesterol and high in fruits, vegetables, and grain products
(i.e., foods that are low in saturated fat and cholesterol and that are
good sources of dietary fiber) and reduced risk of coronary heart
disease (58 FR 2552 at 2572). We therefore authorized a health claim in
part 101 (21 CFR part 101) in Sec.  101.77 on the association between
diets low in saturated fat and cholesterol and high in vegetables,
fruit, and grain products that contain soluble fiber and a reduced risk
of CHD.
    In the 1993 dietary fiber and CVD final rule, in response to a
comment regarding the apparent hypocholesterolemic properties of
specific food fibers, e.g., oat bran, we agreed that the effectiveness
of naturally occurring fibers in foods may be documented for specific
food products (e.g., oat bran meeting specified parameters) (58 FR 2552
at 2567). We further stated that if a manufacturer could document,
through appropriate studies, that dietary consumption of the soluble
fiber in its particular food has the effect of lowering 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 a health claim for its particular
product (58 FR 2552 at 2567).
 
C. 1997 Soluble Fiber From Whole Oats and Coronary Heart Disease Health
Claim
 
    We subsequently received a petition for, and authorized, a health
claim on the relationship between soluble fiber from whole oats and
reduced risk of CHD (the soluble fiber from whole oats final rule) (62
FR 3584, January 23, 1997; modified at 62 FR 15343, March 31, 1997). We
initially proposed to authorize a health claim on the association
between oat bran and oatmeal and reduced risk of CHD (the oats proposed
rule) (61 FR 296, January
 
[[Page 61774]]
 
4, 1996). However, we concluded in the final rule 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 3585). We
reached this conclusion based 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 blood total- and LDL-cholesterol, and that
intakes of beta-glucan soluble fiber at or above 3 gram (g) per day
were more effective in lowering serum lipids than lower intake levels
(62 FR 3584 at 3585). As such, we concluded that, rather than oat bran
and rolled oats, the appropriate substance for the subject of the
authorized claim is beta-glucan soluble fiber from whole oats. We
further determined that the relationship is scientifically valid in
that there is significant scientific agreement, based on the totality
of publicly available evidence, that beta-glucan soluble fiber from
whole oats, as part of a diet low in saturated fat and cholesterol, may
reduce the risk of CHD (62 FR 3584 at 3598).
    Several comments to the oats proposed rule suggested that products
containing whole oat flour made from 100 percent oat groats also should
be eligible to bear the health claim (62 FR 3584 at 3585). The reasons
given included: (1) Whole oat flour contains beta-glucan soluble fiber
as does oat bran and rolled oats; (2) whole oat flour is derived from
the same starting material as rolled oats (i.e., whole oat groats) and,
other than the smaller particle size of whole oat flour, whole oat
flour possesses a chemical and physical composition virtually identical
to that of rolled oats; (3) intestinal content viscosity data from
rodent studies demonstrate that whole oat flour beta-glucan soluble
fiber retains viscosity similar to that of the beta-glucan soluble
fiber from oat bran and rolled oats during processing and digestion;
and (4) data from one human clinical study and several experimental
animal studies demonstrate that whole oat flour has similar effects on
blood cholesterol levels as oat bran and rolled oats (62 FR 3584 at
3585).
    We were persuaded that the clinical data showing the positive
effects of consuming whole oat flour foods on blood cholesterol, and
comments showing compositional similarities between whole oat flour and
rolled oats, provided sufficient evidence for us to conclude that whole
oat flour has the same effects relative to reduced risk of CHD as do
oat bran and rolled oats (62 FR 3584 at 3586). Further, this conclusion
was corroborated by evidence from the rodent intestinal contents
studies. These studies demonstrate that the beta-glucan soluble fiber
from whole oat flour retains the same level of viscosity in the rodent
digestive tract as does that from rolled oats (62 FR 3584 at 3586). The
whole oats final rule concluded that beta-glucan soluble fiber was the
appropriate substance for the subject of the health claim, and that the
three eligible sources of this substance were oat bran, rolled oats,
and whole oat flour.
 
D. 1998 Amendment to Broaden the Claim to ``Soluble Fiber From Certain
Foods and CHD''
 
    In the soluble fiber from whole oats final rule, we acknowledged
the likelihood that consumption of other sources of beta-glucan soluble
fiber, as well as other sources and types of soluble fibers, will
affect blood lipid levels, and thus, the risk of heart disease (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 evidence on other, nonwhole oat sources of
soluble fiber (62 FR 3584 at 3588). In 1998, FDA announced that, in
response to a health claim petition and on the totality of the
available scientific evidence, it had concluded that soluble fiber from
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 action, 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 To Amend Sec.  101.81 by Adding an Additional Eligible
Source of Beta-Glucan Soluble Fiber From Whole Oats
 
A. Background
 
    The Quaker Oats Co. and Rhodia, Inc. (the petitioners), jointly
submitted a health claim petition to FDA on April 21, 2001, under
section 403(r)(4) of the Federal Food, Drug, and Cosmetic Act (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 a fourth source of beta-glucan
soluble fiber eligible for the claim. The petitioners requested that
this amendment be made ``* * * with specific reference to the Quaker-
Rhodia group Oatrim, known as Oatrim (BETATRIM).'' The petition notes
that ``[n]ot all Oatrims have been tested for cholesterol-lowering
efficacy; hence we are limiting our petition to the subgroup Oatrim
(BETATRIM), Oatrims with demonstrated cholesterol-lowering efficacy''
(Ref. 1). FDA filed the petition for comprehensive review in accordance
with section 403(r)(4) of the act on July 20, 2001 (Ref. 2).
    The petitioners' description of the substance that is the subject
of the health claim is broader than what the available evidence
supports. We have determined that the evidence supports specifying the
substance that is the subject of the claim as the beta-glucan-
containing soluble fraction of alpha-amylase hydrolyzed oat bran or
whole oat flour with a beta-glucan soluble fiber content up to 10
percent (dwb) and not less than that of the starting material (dwb),
also known as oatrim (Ref. 3). This oatrim substance is produced by the
methods described by Inglett and Newman, 1994 (Ref. 3). In brief, the
manufacturing method consists of first preparing a 10 to 40 percent
slurry of a milled oat product (specifically, oat bran or whole oat
flour) in water containing 25 to 50 parts per million calcium to
stabilize the subsequently added alpha-amylase enzyme, and with a pH
adjusted between 5.5 and 7.5. Then the starch of the oat product is
liquefied by adding a thermostable alpha-amylase enzyme and processing
at a temperature (70 to 100 [deg]C) and time (10 to 60 minutes)
determined by the desired product properties. After completion of the
enzymatic hydrolysis of the starch, the enzyme is inactivated and the
water-soluble fraction consisting of soluble oat fiber and
maltooligosaccharides is separated from the water-insoluble residue by
centrifugation (Ref. 3). For brevity, we will refer to this substance
as oatrim, which is the substance that is the subject of the claim in
this interim final rule. Oatrim was developed by George Inglett,
Agriculture Research Service, U.S. Department of Agriculture (USDA)
(Ref. 3).
    The petition describes the substance that is the subject of the
health claim to
 
[[Page 61775]]
 
be ``oatrim (BETATRIM),'' a source of ``oat beta-glucan soluble fiber
and oat starch obtained by enzymatic and/or acid-base hydrolysis of
whole oat flour or oat bran.'' Thus, the substance as described by the
petition includes, in addition to solubilized beta-glucan-containing
oat products produced by the enzymatic hydrolysis method, solubilized
beta-glucan-containing oat products produced by an acid-base chemical
hydrolysis method. In addition, BETATRIM is the petitioners' brand-name
for a group of beta-glucan-containing food ingredients. The petitioners
have noted that the products they include under their brand-name are
``oatrims'' processed by either alpha-amylase enzymes or by acid/base
hydrolysis, and having a beta-glucan soluble fiber content ranging
between 4 and 25 percent. However, as discussed later in this preamble,
we are limiting the substance that is the subject of the health claim
to the soluble fraction of alpha-amylase hydrolyzed oat bran or whole
oat flour with a beta-glucan soluble fiber content of up to 10 percent
(dwb) and not less than that of the starting material (dwb).
 
B. 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 from whole oats health claim (Sec.
101.81), FDA recognizes the CHD risk reduction benefit resulting from
effects on blood total and LDL-cholesterol associated with certain
foods that are sources of soluble dietary fiber. While 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. 4). CVD accounts for more than 900,000
U.S. deaths annually and has been recognized as the dominant cause of
death in the United States for at least the last 50 years (Ref. 4).
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
    Oatrim is to be consumed at ``other than decreased dietary
levels,'' and contributes nutritive value when used at a level
providing at least 0.75 g beta-glucan soluble fiber per serving, in a
variety of food products. The term ``nutritive value'' is defined in
Sec.  101.14(a)(3) as ``value in sustaining human existence by such
processes as promoting growth, replacing loss of essential nutrients,
or providing energy.'' The petitioners provided three examples of food
categories (bars, beverages and beverage mixes) in which oatrim could
be used as an ingredient at a level providing 0.75 g beta-glucan
soluble fiber per serving, the level necessary to justify the claim
(Ref. 1, Table 3: Some Uses of Oatrim (BETATRIM)). At this level,
oatrim provides nutritive value because it provides a consequential
source of calories and soluble fiber. Therefore, the preliminary
requirement of Sec.  101.14(b)(3)(i) is satisfied.
3. The Substance Is Safe and Lawful
    The petition states that oatrim has been used as a food ingredient
in a variety of food products. The petition also notes that oatrim-
containing foods including cereals, frozen foods, dairy products,
beverages, baked products, mixes, and meat and poultry products have
been consumed by the public for a number of years. The agency therefore
is satisfied that the substance is a food, food ingredient, or a
component of a food ingredient.
    The petitioners assert that the basis for safe and lawful use of
oatrim in food as a food ingredient, at levels necessary to justify the
health claim, is that such food use of oatrim is GRAS (generally
recognized as safe) by GRAS self-determination. In addition, the
petitioners declare that BETATRIM derived from either oat bran or whole
oat flour, and subjected to hydrolysis by treatment with safe and
suitable food grade enzymes and/or GRAS listed food grade acids or
bases, is GRAS through scientific procedures for use as a fat
substitute in a variety of foods. The petitioners also declare that
over the last several years, Quaker Oats and Rhodia have sold BETATRIM
with a concentration of 4 to 6 percent beta-glucan soluble fiber, which
has been incorporated by food manufacturers into a number of foods,
including low-fat pancakes, muffins, biscuits, a low-fat, high-fiber
nutrition bar, and fat-free frankfurters (Ref. 1). The petitioners
submitted documentation of a 1992 GRAS self-determination for oatrim by
The Quaker Oats Co. (Ref. 1, Appendix 3), a 1991 GRAS self-
determination for oatrim by ConAgra (Ref. 1, Appendix 4), and an
individual opinion regarding the GRAS status of purified forms of beta-
glucan soluble fiber from oats (Ref. 1, Appendix 5) as evidence that
oatrim meets the safe and lawful requirement.
    The 1992 Quaker Oats Co. documentation of GRAS self-determination
(Ref. 1, Appendix 3) characterized oatrim as the water soluble,
partially enzymatically hydrolyzed starch fraction of whole oat flour.
Oatrim was described as representing about 60 percent of the whole oat
flour starting material, and containing 4 to 6 percent beta-glucan
soluble fiber and 6.9 percent total dietary fiber. The Quaker Oats Co.
determined that the use of oatrim as a fat replacer in fresh ground and
processed meats and poultry products, salad dressings, baked goods,
baking mixes, processed cheese, yogurt, ice cream and frozen desserts,
snack foods, vegetable oil spreads, icings and frostings, frozen
entrees, and confections was GRAS. The basis of the safety
determination was the similarity of oatrim to oat starch and
maltodextrin, two food ingredients that are generally recognized as
safe for food use.
    The 1991 ConAgra Specialty Grain Products Co. documentation of GRAS
self-determination (Ref. 1, Appendix 4) characterized the processing of
oatrim as ``oat flour or oat bran that is pre-gelatinized and enzyme
thinned, by alpha-amylase, to facilitate separation and recovery of the
soluble fraction.'' It noted that the basis of the safety determination
was the similarity of oatrim to other existing cereal adjuncts, such as
pre-cooked flours, pre-cooked bran, and starches.
    The petitioners also submitted a letter from Joseph F. Borzelleca,
Consultative Services, Medical College of Virginia & Toxicology and
Pharmacology, Inc. (Ref. 1, Appendix 5), stating his opinion that beta-
glucan soluble fiber extracted from oat bran or oat flour through
enzymatic or by acid/base hydrolysis and containing a maximum
concentration of beta-glucan of 25 percent is GRAS when used as a
water-binder, humectant, or texture modifier. However, the substance
that is the subject of this opinion letter is beta-glucan soluble
fiber; the letter mentions neither oatrim nor BETATRIM, and does not
describe a manufacturing process that would identify clearly the
subject of the letter as oatrim.
    The documentation of GRAS self-determination (Ref. 1, Appendices 3
and 4) includes oatrim produced by alpha-amylase hydrolysis and with a
beta-glucan content of up to approximately 10 percent. The petition
suggests that the Borzelleca Consultative Services' opinion on the GRAS
status of beta-glucan soluble fiber extends to the petitioners'
BETATRIM products that are manufactured by hydrolysis with
 
[[Page 61776]]
 
suitable acids or bases and that have a beta-glucan content of up to 25
percent.
    FDA is not challenging the petitioners' determination that the
beta-glucan-containing soluble fraction of hydrolyzed oat bran or whole
oat flour produced by treatment with either alpha-amylase enzymes or
with suitable acids or bases is GRAS. However, the scientific evidence
submitted, as discussed in section III of this document, only supports
a relationship between oatrim, i.e., the soluble fraction of alpha-
amylase hydrolyzed oat bran or whole oat flour with beta-glucan soluble
fiber content up to 10 percent (dwb) and not less than that of the
starting material (dwb), and a reduced risk of CHD. The substance that
is the subject of this health claim does not include the soluble
fraction of hydrolyzed oat bran or whole oat flour solubilized by acids
or bases or containing a beta-glucan content of over 10 percent or with
less beta-glucan than that of the starting material. FDA has evaluated
the petitioner's position that the use of oatrim at a level providing
0.75 g beta-glucan soluble fiber per serving is safe and lawful. Based
on its review, 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 oatrim, as described previously, is
safe and lawful as a food ingredient at levels necessary to justify a
claim (Ref. 5).
    The agency has not made its own determination regarding the GRAS
status of either oatrim or other BETATRIM products. Moreover, an agency
determination of the GRAS status of these other BETATRIM products would
not be relevant to the substance that we are authorizing for this
health claim, i.e., oatrim, because such BETATRIM is different from the
oatrim that is the subject of this health claim and there is
insufficient evidence before the agency to support a finding on the
relationship between these other BETATRIM products and a reduced risk
of CHD. The agency notes that authorization of 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 Oatrim and CHD
 
    As previously noted, in the 1997 soluble fiber from whole oats
final rule the agency was persuaded that whole oat flour has the same
effects relative to reduced risk of CHD as do oat bran and rolled oats.
The agency based its conclusion on: (1) Data from a clinical study and
several experimental animal studies demonstrating that consumption of
whole oat flour had similar effects on blood cholesterol levels as does
consumption of oat bran or rolled oats and (2) compositional
similarities between whole oat flour and rolled oats (62 FR 3584 at
3586). This conclusion was corroborated by evidence that the beta-
glucan soluble fiber from whole oat flour retains the same level of
viscosity in the digestive tract as does that from rolled oats.
Accordingly, the soluble fiber from whole oats final rule included
whole oat flour, along with oat bran and rolled oats, as eligible
sources of beta-glucan soluble fiber for the health claim. We now are
applying those same criteria to evaluate the petitioned request to add
oatrim and other BETATRIM products to the sources of beta-glucan
soluble fiber listed in Sec.  101.81(c)(2)(ii)(A).
 
B. Review of Scientific Evidence of the Substance-Disease Relationship
 
1. Scientific Evidence of Efficacy in Cholesterol Reduction
    a. Human serum lipid studies of oatrim. The criteria that the
agency used to identify studies pertinent to the current review were
the same as those previously used when reviewing evidence supporting
the relationship between reduced risk of CHD and consumption of soluble
fiber from whole oat products (61 FR 296 at 298) and consumption of
psyllium husk soluble fiber (62 FR 28234 at 28237, May 22, 1997). These
criteria are: (1) Include an adequate presentation of data, study
design, and methods; (2) be available in English; (3) include
estimates, or enough information to estimate, soluble dietary fiber
intakes; (4) include direct measurement of blood total cholesterol and
other blood lipids related to CHD; and (5) be conducted in persons who
represent the general U.S. population. Further, factors that exclude
human studies from review are: (1) Reports published only in abstract
form, (2) studies using special population groups, and (3) secondary
prevention studies (i.e., subjects who already have had a myocardial
infarction). In addition, in this current evaluation of the
relationship between beta-glucan soluble fiber from oatrim and reduced
risk of CHD, the agency has included only those studies in which the
substance tested was identified to be oatrim or other BETATRIM
products.
    Reports of five human clinical studies with data on serum lipids
were submitted with this petition (Refs. 6 to 10). The study of Braaten
et al., 1994 (Ref. 7) and that of Beer et al., 1995 (Ref. 8) both
investigated the effects of oat gum on serum cholesterol levels in
humans. The study of Torronen et al., 1992 (Ref. 6) and that of Pick et
al., 1996 (Ref. 9) both investigated the effects of oat bran
concentrate products on serum cholesterol levels in humans. While oat
gums and oat bran concentrate are sources of oat beta-glucan soluble
fiber, the subject of the petition is oatrim and other BETATRIM
products, the beta-glucan-containing soluble fraction from hydrolyzed
oat bran or whole oat flour. Neither oat gum nor oat bran concentrates
are produced through an extraction process analogous to the process for
producing oatrim. As none of these four studies utilized the substance
that is the subject of the petition, they were not relevant to the
present consideration and were excluded from review.
    The study reported in Behall et al., 1997 (Ref. 10) investigated
the effects on blood lipids of adding an oat fiber extract, identified
as the oatrim developed by George Inglett, Agriculture Research
Service, USDA, to diets of mildly hypercholesterolemic subjects. The
oat fiber extracts had either 1.6 percent or 10.2 percent by weight
beta-glucan soluble fiber (low beta-glucan and high beta-glucan,
respectively). Both oat fiber extracts (high and low) were provided by
Quaker Oats Co. and by ConAgra, Inc. The petitioners comment in the
petition that all of the oatrim that was used in this study had been
processed by the enzymatic methods licensed from George Inglett. The
oat fiber extracts were added to test diets, replacing 5 percent of the
fat energy with a corresponding amount of carbohydrate energy,
resulting in beta-glucan soluble fiber consumption of approximately 0.8
g/day (maintenance diet, no oat fiber extract addition), 1.6 to 2.0 g/
day (low beta-glucan extract added), or 5.1 to 7.6 g/day (high beta-
glucan extract added). The oat fiber extracts were added to the diet in
several foods including fruit juice, applesauce, muffins, cookies,
cake, brownies, waffles, gelatin, yogurt, spaghetti sauce and meat
loaf. The study included 23 mildly hypercholesterolemic adult subjects
(age 38 to 61 years) (mean serum total-cholesterol 212 +/- 7 mmole/dL;
mean LDL-cholesterol 141 +/- 6 mmole/dL). The maintenance diet was fed
for 1 week followed by diets containing one of the oat fiber extracts
for two 5-week periods in a crossover pattern. In comparison to basal
serum lipid levels measured following the initial maintenance diet
week, serum total-cholesterol was statistically significantly lower (p
< 0.05) by 9.5 percent (low beta-glucan
 
[[Page 61777]]
 
extract) and by 14.8 percent (high beta-glucan extract) following the
oat fiber extract supplemented diet periods. The mean serum total-
cholesterol levels were also statistically different (p < 0.05) between
the two beta-glucan extract-supplemented diet periods. Likewise, for
oat fiber extract-supplemented diets, statistically significant
decreases (p < 0.05) of serum LDL-cholesterol levels of 14.8 percent
(low beta-glucan extract) and by 20.8 percent (high beta-glucan
extract) were observed, compared to the maintenance diet period. Serum
LDL-cholesterol levels were not significantly different between the two
oat fiber extract-supplemented diets. Serum HDL-cholesterol levels were
not significantly different among the maintenance, low beta-glucan, or
high beta-glucan diet periods.
    The results of Behall et al., 1997 (Ref. 10), the only available
study that evaluated the effects of oatrim on human serum lipid levels,
demonstrate that consumption of a variety of foods containing oatrim
produced by the enzymatic method, in amounts providing sufficient beta-
glucan soluble fiber to qualify for the health claim, may contribute to
statistically significant reductions in serum total- and LDL-
cholesterol levels. Further, there appears to be a positive dose-
response of the amount of beta-glucan soluble fiber from oatrim and the
beneficial effect on serum total cholesterol.
    b. Animal serum lipid studies of oatrim. The petition included
reports from nine studies that investigated the effects of processed
oat bran products on cholesterol metabolism in experimental animal
models (Refs. 3, and 11 to 18). Among these were studies in which the
oat products tested were oat gums (Refs. 11, 12, 14, and 15) or
processed oat bran concentrate (Refs. 13 and 17). Results from these
six studies were not directly relevant to the consideration of oatrim
or other BETATRIM products as a source of beta-glucan soluble fiber
eligible for the health claim, and were thus excluded from review.
Three of the nine studies investigated effects of oatrim products on
blood cholesterol level in experimental animals (Refs. 3, 16, and 18).
Preliminary data from Inglett and Newman 1994 (Ref. 3) suggested
reductions of plasma total- and LDL-cholesterol associated with the
addition of oatrim containing 10-percent beta-glucan to the diet in a
hypercholesterolemic chick model. These results were confirmed by
Inglett et al., 1994 (Ref. 16) in a followup study with a larger sample
of chicks and with an oatrim containing 8.6-percent beta-glucan. Oatrim
did not affect plasma HDL-cholesterol levels in either of the above two
studies (Refs. 3 and 16).
    Yokoyama et al., 1998 (Ref. 18) reported on the effects of oatrim
on cholesterol levels in a hypercholesterolemic hamster model. The
hamster diets were supplemented with one of four oat flour products, or
with cellulose. The oat flour products included a beta-glucan-enriched
oat flour, a 5-percent beta-glucan oatrim, a 10-percent beta-glucan
oatrim, and a beta-glucan-free hydrolyzed oatrim. All diets, except for
the cellulose control and the beta-glucan-free hydrolyzed oatrim,
contained equivalent amounts of beta-glucan. The two oatrim-containing
diets and the beta-glucan-free oatrim hydrolyzate diet, were effective
in showing statistically significant decreases (p < 0.05) in plasma
total- and LDL-cholesterol levels relative to that of the cellulose-
containing diet. The beta-glucan enriched oat flour-containing diet
reduced neither plasma total- nor LDL-cholesterol levels. Statistically
significant reductions (p < 0.05) in the plasma HDL-cholesterol level,
relative to that of the cellulose-containing control diet, occurred
with the two oatrim-containing diets and with the enriched oat flour-
containing diet, but not with the oatrim hydrolyzate-containing diet.
    Consistent with the clinical study, data from three animal models
corroborate the finding that oatrim products containing beta-glucan
soluble fiber lower blood total- and LDL-cholesterol levels.
Furthermore, with the exception of the study employing a hamster model
(Ref. 18), HDL-cholesterol levels were not significantly altered.
2. Composition of Oatrim Relative to Whole Oat Products
    As discussed previously, a key factor in our decision to add whole
oat flour to the food sources of beta-glucan soluble fiber eligible for
the health claim was evidence that, other than being milled to a
smaller particle size, the composition of whole oat flour and rolled
oats is the same (62 FR 3584 at 3586). Oat bran differs from whole oat
flour in that a portion of the starch-rich endosperm of whole oat flour
has been removed whereas the outer soluble fiber-rich layers of the oat
groat are retained. Although oatrim is derived from two of the same
eligible food sources of beta-glucan soluble fiber currently authorized
for the health claim, i.e., whole oat flour and oat bran, the
composition of oatrim differs from each. Oatrim differs from oat bran
and whole oat flour in that, in the manufacturing of oatrim, much of
the starch present in the whole oat flour or remaining in the oat bran
has been converted to soluble amylodextrins, and nonwater soluble
components of the starting milled oat products are removed by
centrifugation. However, like oat bran, the oatrim fraction produced
from the manufacturing methods of Inglett and Newman, 1994 (Ref. 3)
retains most of the beta-glucan soluble fiber and fiber-associated
substances found in whole oat products.
3. Rat Intestinal Viscosity Studies
    As explained in the soluble fiber from whole oats final rule, the
viscosity of intestinal contents is known to be a critical factor in
the ability of soluble dietary fiber to reduce the risk of CHD, and
soluble dietary fiber viscosity is affected in unpredictable ways by
food processing, or following ingestion, by the digestive system (62 FR
3584 at 3586). Therefore, evidence demonstrating that the level of
viscosity in the digestive tract of the beta-glucan-containing oatrim
is similar to the level of viscosity of rolled oats, oat bran, and
whole oat flour is an important factor in our decision to add oatrim as
an additional source of oat beta-glucan soluble fiber eligible for the
health claim. As noted in the soluble fiber from whole oats final rule
(62 FR 3584 at 3587), there are no generally accepted or validated
criteria for predicting which sources or processed forms of beta-glucan
soluble fiber beyond oat bran, rolled oats, and whole oat flour are
capable of reducing blood total- and LDL-cholesterol levels. Therefore,
FDA must evaluate data that are relevant to each source of beta-glucan
soluble fiber and compare these data to other authorized sources. FDA
considered evidence demonstrating that the processed sources of beta-
glucan soluble fiber retain the same level of viscosity in the
digestive tract as soluble fiber from rolled oats to determine whether
the processed forms can provide the same benefits as rolled oats (62 FR
3584 at 3586).
    The petitioners submitted results of animal tests to show that
beta-glucan soluble fiber from oatrim or other BETATRIM products
retains the viscosity characteristics of soluble fiber in whole oat
products (rolled oats, oat bran, and whole oat flour) in the rodent
digestive tract (Refs. 19 to 22). Gallaher et al., 1999 (Ref. 21)
reported data on rat intestinal contents supernatant viscosity (ICSV)
resulting from rats consuming an oat product meal. Rats that had been
fasted overnight were meal-fed a whole oat-based cereal (Cheerios,
cooked and uncooked oatmeal, or cooked oat bran).
 
[[Page 61778]]
 
 Two hours later, the intestinal contents were collected, then
centrifuged, and the viscosities of the resultant supernatants were
determined. Differences in resultant mean ICSV values among the whole
oat-based cereals tested were not statistically significant (p
 0.05). Gallaher et al., 1999 (Ref. 21) did not report data
regarding the beta-glucan content of the whole oat-based cereals
tested; however, based on information provided in the study report we
have estimated that the whole oat-based cereal test meals contained
approximately 0.12 g (Cheerios) to 0.22 g (oat bran) of beta-glucan per
meal.
    The ICSV data from Gallaher et al., 1999 (Ref. 21) were
subsequently compared to ICSV data for the petitioners' enzymatically
processed BETATRIM, also tested by Gallaher under the same test
protocol (Ref. 22). The BETATRIM tested included a 4-percent beta-
glucan BETATRIM, a 20-percent beta-glucan BETATRIM, and a blend of the
two containing 12-percent beta-glucan. The petition identified the
BETATRIM products used in this study as all having been produced with
the alpha-amylase process. These test meals provided between 0.02 g and
0.10 g beta-glucan per meal. The blended 12-percent beta-glucan test
meal (0.06 g beta-glucan/meal) yielded a mean ICSV value comparable to
that of 0.12 to 0.22 g beta-glucan/meal from whole oat-based cereals.
The mean ICSV value resulting from the high beta-glucan BETATRIM (0.10
g beta-glucan/meal) was approximately four times greater than that of
0.12 to 0.22 g beta-glucan/meal from whole oat-based cereals. These
data indicate that the enzymatic processing of whole oat products into
BETATRIM, and the subsequent digestion in the rat gastrointestinal
tract, do not degrade the viscosity of oat beta-glucan soluble fiber
relative to that of whole oat products.
    The petitioners provided a report of a third viscosity study that
was conducted to compare the viscosity of BETATRIM processed by the
acid/base chemical method to that of BETATRIM enzymatically processed
(Ref. 22). This viscosity study was conducted with the same test
protocol as before, and using two sources of 20-percent beta-glucan
content BETATRIM, one enzymatically processed and the other acid/base
processed. The mean ICSV values for the two sources of 20-percent beta-
glucan content BETATRIM were not statistically significantly different
and were comparable to that of the previous study. No data were
provided with respect to comparative ICSV values of enzymatic and acid/
base processed BETATRIM products with beta-glucan content less than 20
percent.
    The ICSV data demonstrate that the viscosity characteristics of
beta-glucan soluble fiber in intact whole oat products is not degraded
in the beta-glucan-containing soluble fraction of alpha-amylase
hydrolyzed whole oat products. Further, the type of hydrolysis
treatment, alpha-amylase enzymatic or acid/base, does not appear to
have an effect on viscosity characteristics in products with beta-
glucan content of 20 percent.
 
C. Physiochemical Properties
 
    As noted previously, there are no generally accepted or validated
criteria for predicting which sources or processed forms of beta-glucan
soluble fiber are capable of reducing blood LDL-cholesterol, and
therefore have an effect on CHD risk. Comments to the original soluble
fiber from the whole oats proposed rule (62 FR 3584 at 3591) suggested
that the effect on blood lipids from consumption of beta-glucan soluble
fiber is related to both the molecular weight and the solution
viscosity of the beta-glucan. The comments stated that processing
methods can alter the molecular structure of the beta-glucan molecule
and may cause it to lose its effect on blood cholesterol levels. The
comments suggested that to ensure that the processed oat-containing
food product will provide the effects associated with beta-glucan
soluble fiber in the starting material, i.e., oat bran, rolled oats,
and whole oat flour, the finished oat product should be tested to
determine whether its beta-glucan soluble fiber has retained the
physical properties, such as molecular weight, that it had in the
starting material. FDA was not convinced, at the time of our initial
soluble fiber from whole oats and CHD risk health claim rulemaking,
that there was a need to require molecular weight or viscosity testing
of foods containing oat bran, rolled oats, or whole oat flour. Although
processing of whole oat substances could result in extensive
depolymerization of the beta-glucan, there was clinical evidence
demonstrating that most oat bran or rolled oats products processed as
ready-to-eat cereals, muffins, breads, or other foods, whether they
were consumed hot or cold, were effective in significantly lowering
blood lipids when consumed as part of an appropriate diet.
    Some studies failed to find blood lipid lowering effectiveness
associated with consumption of highly processed oat gum extracts, but
such studies were not relevant to FDA's analysis because FDA was
authorizing the health claim for whole oat products only. As we are now
proposing to extend eligible beta-glucan sources to include a processed
extract of oat bran and whole oat flour, we also need to reconsider the
utility of physiochemical measures of the beta-glucan soluble fiber
sources that would be predictive of effectiveness in lowering blood
lipids. However, we are unaware of clinical data that establish a
direct correlation of any physiochemical measures (e.g., molecular
weight, or viscosity) and of beta-glucan soluble fiber sources and
effects on blood lipids.
    Viscosity data from the ex vivo rat intestinal model of Gallaher et
al. (Ref. 21) have been considered as corroborating evidence that the
processing of whole oat flour or of oatrim does not significantly
affect viscosity properties of the whole oat starting material from
which it is made. However, we have no direct clinical evidence
demonstrating the applicability of this model to predicting blood
lipid-lowering effect in humans. Further, there are many methods of
measuring the complex viscosity properties and the result is dependent
upon the conditions of measurement. Although we do not recognize a
standard method for measuring soluble viscosity applicable to a range
of conditions, we do accept that soluble fiber viscosity is a major
physiochemical property responsible for physiological effects of
consuming soluble fiber, e.g., lowering blood lipids, and that
viscosity is related to polymer size of the soluble fiber. For example,
a study of viscosity as a variable in effectiveness of beta-glucan in
altering blood glucose and insulin responses to an oral glucose load
(Ref. 23) found a significant correlation between peak blood glucose
and a combination of beta-glucan concentration and molecular weight.
The agency is requesting comment and scientific data on the potential
of using a molecular weight or other physiochemical properties as a
predictive parameter of the ability of beta-glucan soluble fiber from
highly processed sources to be effective in lowering blood lipids.
    Lacking direct evidence correlating physicochemical properties of a
substance with cholesterol-lowering efficacy in humans, we continue to
rely on clinical intervention studies demonstrating effectiveness of a
beta-glucan source in LDL-cholesterol reduction when we authorize
additional eligible sources of beta-glucan soluble fiber. For this
health claim, we were able to determine that a beta-glucan source from
oat bran or whole oat flour (the starting materials), combined with
limitations on the manufacturing
 
[[Page 61779]]
 
process (the alpha-amylase process used to manufacture the oatrim
substance tested by Behall et al. (Ref. 10)) and on the beta-glucan
content of the finished product, are sufficient to ensure an adequate
description of the substance that is the subject of this claim. The
substance that is the subject of the claim, i.e. oatrim, is that which
was used in the Behall et al. study (Ref. 10) that demonstrated a
reduction in risk of CHD. Parties considering variations of the
processing method used to produce the oatrim used in the Behall et al.
clinical trial (Ref. 10) would need to demonstrate the bioequivalence
in cholesterol reduction of their products to those oat beta-glucan
sources listed in Sec.  101.81(c)(2)(ii)(A), and submit these data to
FDA in a petition to amend the health claim regulation to include such
processing variations in the definition of oatrim.
 
IV. Decision To Amend the Health Claim: Soluble Fiber From Whole Oats
and Reduced Risk of CHD to Include Oatrim as an Eligible Source of Oat
Beta-Glucan Soluble Fiber
 
    Results from Behall et al., 1997 (Ref. 10) indicate that, like the
effects of consuming rolled oats, oat bran, and whole oat flour, the
beta-glucan-containing soluble fraction from alpha-amylase hydrolyzed
oat bran and whole oat flour with a beta-glucan soluble fiber content
up to 10 percent is effective in reducing blood total- and LDL-
cholesterol levels, which in turn may reduce the risk of heart disease.
Three studies employing various animal models also demonstrate a
relationship between consumption of oatrim and a reduction in
cholesterol levels. Furthermore, results from an experimental animal
model of intestinal viscosity indicate that oatrim yields intestinal
contents supernatant viscosity similar to that of beta-glucan soluble
fiber in whole oat products. These data provide evidence of a
physiological equivalence of beta-glucan soluble fiber from oatrim and
beta-glucan soluble fiber from whole oat sources such as oat bran and
rolled oats. Thus, these data support FDA's previous determination
that, based on the totality of publicly available evidence, there is
significant scientific agreement that a relationship exists between
consumption of certain beta-glucan soluble fiber sources and reduced
risk of CHD.
    The petition requested that the amendment specifically reference
Quaker-Rhodia BETATRIM brand-name products because they are the only
sources with demonstrated blood cholesterol-lowering efficacy and
retention of the whole oat product viscosity characteristics. We note,
however, that the substance tested in the clinical cholesterol-lowering
efficacy study, i.e., alpha-amylase hydrolyzed oat bran or whole oat
flour, with not more than 10 percent beta-glucan content, was
manufactured both by the Quaker Oats Co. and by ConAgra, Inc. Because
the data upon which this health claim is based is not limited to
petitioners' brand name products, FDA will not limit the health claim
to these products. Instead, the health claim will be available to any
substances that meet FDA's definition of oatrim, as specified
previously.
    Moreover, the substance tested in the clinical cholesterol-lowering
efficacy study did not include acid-base hydrolyzed products or
products with beta-glucan content exceeding 10 percent. Therefore, as
previously discussed, the agency is not including substances other than
oatrim, defined as the beta-glucan containing soluble fraction from
alpha-amylase hydrolyzed oat bran or whole oat flour with a beta-glucan
soluble fiber content up to 10 percent (dwb) and not less than that of
the starting material (dwb), as an eligible source of beta-glucan for
this health claim. Based on the information before us, we are persuaded
that the clinical evidence of positive effects on blood cholesterol of
consuming this oatrim substance, provides sufficient evidence for the
agency to conclude that oatrim has the same effects relative to reduced
risk of CHD as do rolled oats, oat bran and whole oat flour. Further,
this conclusion is corroborated by evidence from rat intestinal
contents studies that demonstrate that processing of such oatrim does
not degrade the viscosity characteristics of beta-glucan soluble fiber
relative to the viscosity characteristics of the whole oat sources from
which it is produced. The available clinical study demonstrated
efficacy of oatrim on reducing serum cholesterol with oatrim added to
the diet by incorporating it into a variety of foods including fruit
juice, applesauce, muffins, cookies, cake, brownies, waffles, gelatin,
yogurt, spaghetti sauce, and meat loaf. These foods cover a range of
viscosities, densities, and textures (Ref. 10). The foods were
functional, and the petitioners did not note any matrix effects on
beta-glucan availability. Therefore, we conclude that the health claim
for oatrim need not be restricted to any particular food category or
type (Ref. 5).
    In conclusion, we find that there is sufficient evidence to amend
Sec.  101.81(c)(2)(ii)(A) by adding the beta-glucan-containing soluble
fraction from alpha-amylase hydrolyzed oat bran or whole oat flour with
a beta-glucan content up to 10 percent (dwb) and not less than that of
the starting material (dwb) as the fourth source of beta-glucan soluble
fiber. We are not restricting the eligible substance to the Quaker-
Rhodia BETATRIM brand-name, so that all foods that meet the eligibility
requirements for oatrim under Sec.  101.81 may use the claim. To this
end, we are amending Sec.  101.81, as discussed in section V of this
document, to include beta-glucan soluble fiber from oatrim.
    We have also concluded that there is insufficient evidence at this
time to include beta-glucan-containing acid/base hydrolyzed oat
products as a substance eligible for the health claim. Although there
are direct clinical data and corroborating animal plasma lipids and
viscosity data to support addition of oatrim with a beta-glucan content
up to 10 percent, the only available data regarding hydrolyzed oat bran
or whole oat flour with a beta-glucan content over 10 percent and that
is manufactured using acid/base hydrolysis, are from a single
experiment comparing viscosity of two oat products containing 20-
percent beta-glucan. In one oat product, the hydrolysis treatment was
alpha-amylase; in the other oat product, the hydrolysis treatment was
acid/base (Ref. 22). In section II.B.3 of this document, we discussed
whether oatrim used at levels necessary to justify a claim has been
demonstrated to be a safe and lawful substance. FDA is not challenging
the petitioners' contention that BETATRIM products produced from oat
bran and whole oat flour treated with either alpha-amylase, or suitable
acids or bases, and containing up to 25-percent beta-glucan, are GRAS.
Hence, our decision not to include hydrolyzed oat products with a beta-
glucan content of more than 10 percent and beta-glucan-containing acid/
base hydrolyzed oat products, as substances which may be used in a food
to make the food eligible to bear a claim about such sources of soluble
fiber and reduced risk of CHD, rests on the lack of sufficient data to
demonstrate such a relationship. We will evaluate any clinical data
submitted in response to this interim final rule to demonstrate, by
validated measures, that a relationship exists between consumption of
hydrolyzed oat products with beta-glucan content over 10 percent and of
acid/base hydrolyzed oat products and a reduced risk of CHD, to
determine whether such data warrant a modification to this rule.
 
[[Page 61780]]
 
V. Description of Modifications to Sec.  101.81
 
A. Nature of the Substance; Eligible Sources of Soluble Fiber
 
    Section 101.81(c)(2)(ii) (nature of the substance; eligible sources
of soluble fiber) lists the types and sources of soluble fiber that
have been demonstrated to FDA's satisfaction to have a relationship to
the reduced risk of CHD. Section 101.81(c)(2)(ii)(A) lists beta-glucan
soluble fiber from whole oat sources, along with a method of analysis
for beta-glucan soluble fiber by the Association of Official Analytical
Chemists. Section 101.81(c)(2)(ii)(A)(1) through (c)(2)(ii)(A)(3)
identifies the whole oat products that are eligible sources of beta-
glucan, i.e., oat bran, rolled oats, and whole oat flour.
    The nature of the substance for which we have concluded there is
sufficient evidence to justify its addition to the list of eligible oat
sources of beta-glucan is more narrowly circumscribed than that of the
BETATRIM products requested by the petitioners. Oatrim, the substance
to be added as an eligible oat source of beta-glucan soluble fiber is
defined by the specific manufacturing process described by Newman and
Inglett, 1994 (Ref. 3), by the limitations on the starting material
from which the oatrim is extracted (i.e., oat bran or whole oat flour
as defined in Sec.  101.81(c)(2)(ii)(A)), and by the limitations on the
beta-glucan content of the finished product (i.e., not less than that
of the starting material and not more than 10 percent (dwb)).
    In this interim final rule, we are amending Sec.
101.81(c)(2)(ii)(A) by adding Sec.  101.81(c)(2)(ii)(A)(4) which will
specify the beta-glucan-containing soluble fraction of alpha-amylase
hydrolyzed oat bran and whole oat flour, with a beta-glucan content up
to 10 percent (dwb) and not less than that of the starting material
(dwb), as a source of beta-glucan soluble fiber eligible to be the
subject of this claim. Since the processing of oat bran and whole oat
flour into oatrim involves only a liquefaction of starch and separation
of insoluble components without alteration of the beta-glucan soluble
fiber present in the starting material, we are specifying that the
beta-glucan content of the oatrim product is not less than that of the
starting material (dwb). New Sec.  101.81(c)(2)(ii)(A)(4) specifies:
    Oatrim. The soluble fraction of alpha-amylase hydrolyzed oat
bran or whole oat flour, also known as oatrim. Oatrim is produced
from either oat bran as defined in paragraph (c)(2)(ii)(A)(1) of
this section, or whole oat flour as defined in paragraph
(c)(2)(ii)(A)(3) of this section by solubilization of the starch in
the starting material with an alpha-amylase hydrolysis process, and
then removal by centrifugation of the insoluble components
consisting of a high portion of protein, lipid, insoluble dietary
fiber, and the majority of the flavor and color components of the
starting material. Oatrim shall have a beta-glucan soluble fiber
content up to 10 percent (dwb) and not less than that of the
starting material (dwb).
 
B. Nature of the Food Eligible to Bear the Claim
 
    Section 101.81(c)(2)(iii)(A)(1) currently specifies that a food
eligible to bear the health claim shall include one or more of the
whole oat foods from paragraph (c)(2)(ii)(A) of this section (i.e., oat
bran, rolled oats, whole oat flour), and that the whole oat food shall
contain at least 0.75 g of soluble fiber per reference amount
customarily consumed of the food product. We are concerned that
expanding the eligible sources of beta-glucan soluble fiber from the
current three whole oat sources to include oatrim, which is an extract
of whole oat sources and has a character more as a food ingredient than
as a whole oat food, may render current paragraph (c)(2)(iii)(A)(1)
open to different interpretations as to the contribution of soluble
fiber from oatrim-containing foods to meet the 0.75 g requirement.
Oatrim-containing foods could contain sources of soluble dietary fiber
other than oatrim. Although such foods may meet the criteria in Sec.
101.81(c)(2)(iii)(A)(1) to bear the health claim (e.g., include a whole
oat product listed in paragraph (c)(2)(ii)(A) and contain at least 0.75
g of soluble fiber), they would not necessarily contain sufficient
beta-glucan soluble fiber from the oatrim ingredient to contribute in a
meaningful way to the 3 g or more per day of beta-glucan fiber from
whole oats necessary to reduce the risk of CHD.
    The ``Nature of the Food'' section of the whole oats health claim
originally was worded: ``The food shall contain at least 0.75 gram (g)
per reference amount customarily consumed of whole oat soluble fiber
from the eligible sources listed in paragraph (c)(2)(ii) of this
section * * *''
    However, when proposing to amend this regulation to broaden the
health claim to the proposed rule on ``Soluble Fiber from Certain Foods
and CHD'' and to add psyllium seed husk as an additional source of
soluble dietary fiber eligible for the claim (62 FR 28234, May 22,
1997) the wording of Sec.  101.81(c)(2)(iii)(A) was unintentionally
changed to the present form that requires ``* * * 0.75 gram (g) of
soluble fiber per reference amount customarily consumed of the food
product * * *'' The phrase used initially, ``whole oat soluble fiber,''
was intended to mean beta-glucan soluble fiber from whole oats (62 FR
3584 at 3588). This was based on information that the soluble fiber
content of whole oats is predominantly (approximately 87 percent or
more) beta-glucan. Thus, the total soluble fiber content of whole oats
significantly reflects the beta-glucan present. Moreover, the agency
thought the term ``soluble fiber'' would be more familiar to consumers
than ``beta-glucan,'' because soluble fiber can be declared on the
nutrition label; whereas, beta-glucan is a technical term that may not
be widely understood. However, because of the possibility that oatrim-
containing foods bearing the health claim could have insufficient
amounts of beta-glucan, the specific type of soluble fiber that is the
subject of this interim final rule, FDA is redesignating current Sec.
101.81(c)(2)(iii)(A)(2), and adding new paragraph (c)(2)(iii)(A)(2)
specifying that the oatrim-containing food bearing the health claim
contain at least 0.75 g of beta-glucan per reference amount customarily
consumed. FDA also is specifying that current paragraph
(c)(2)(iii)(A)(1) refer to the three oat products previously authorized
(i.e., oat bran, rolled oats, and whole oat flour).
    In addition, FDA intends to consider in a future separate
rulemaking the advisability of amending paragraph Sec.
101.81(c)(2)(iii)(A)(1) to clarify that any food eligible for the
health claim on the basis of containing a whole oat food must contain
at least 0.75 g of beta-glucan soluble fiber from the whole oat source
rather than 0.75 g of soluble fiber of unspecified type.
 
C. Other Requirements
 
    All other requirements in Sec.  101.81(c)(1) through (c)(2)(i) must
be met before any health claim involving an oatrim-containing product
can be utilized. FDA is providing that any or all of the optional
information in Sec.  101.81(d) may apply to oatrim.
 
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.
 
VI. 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
 
[[Page 61781]]
 
upon publication pending consideration of public comment and
publication of a final regulation, if the agency determines that such
action is necessary. This authority enables us to act promptly on
petitions that provide 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. Interim final 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)).
    The petitioners have submitted requests for the agency to consider
making any proposed regulation on the petitioned health claim effective
upon publication of an interim final rule (Ref. 1). We acknowledge that
all three of the eligible criteria in section 403(r)(7)(A) of the act
have been met in the petition submitted by Quaker Oats and Rhodia, Inc.
The health claim will provide consumers with important health
information on the package label regarding the role of oatrim products
in lowering cholesterol and reducing the risk of heart disease. The
health claim also will provide consumers with scientifically sound
information on the nutritional and health benefits of foods containing
oatrim and will enable consumers to develop and maintain healthy
dietary practices that include the incorporation of foods containing
hydrolyzed oat products into their diets. Therefore, we are granting
petitioners' requests for issuance of an interim final rule for this
health claim.
 
VII. Analysis of Impacts
 
A. Regulatory Impact Analysis
 
    We have examined the economic implications of this interim final
rule as required by Executive Order 12866 and the Regulatory
Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform
Act of 1995. 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 of $100 million or more, or adversely affecting
in a material way a sector of the economy, competition, or jobs. A
regulation also is considered a significant regulatory action if it
raises novel legal or policy issues. We have determined that this
interim final rule is not a significant regulatory action as defined by
Executive Order 12866.
    This interim final rule will not generate any compliance costs
relative to the status quo, because it does not require anyone to
undertake any new activity. No firm will choose to use the claim
allowed by this rule unless the firm believes that doing so will
increase its profits. Because it specifies the manner in which a health
claim can be made in product labeling, this rule imposes restrictions
that may lead to social costs compared with alternative requirements
for making the claim. The costs of making the claim under the specified
requirements, however, would not differ significantly from the costs
under plausible alternative requirements.
    This interim final rule will generate social benefits because it
provides for new information in the market regarding the relationship
between soluble fiber and the risk of CHD. We have already authorized a
health claim on beta-glucan soluble fiber from certain other whole oat
sources and psyllium seed husk as sources of soluble fiber and the risk
of CHD. Amending the existing health claim to include oatrim as an
eligible source of beta-glucan soluble fiber will allow firms to inform
consumers of the benefits of soluble fiber from oatrim. The provisions
of this information in this format will signal to consumers that we
have found the claim to be truthful, not misleading, and scientifically
valid. Because it specifies the conditions under which a health claim
can be made, this rule may lead to benefits that are greater or smaller
than under alternative requirements for making the claim. The benefits
of allowing the relevant claim, however, would not differ significantly
from the benefits under plausible alternative requirements.
 
B. Regulatory Flexibility Analysis
 
    We have examined the economic implications of this interim final
rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612).
If a rule has a significant economic impact on a substantial number of
small entities, the Regulatory Flexibility Act requires the agency to
analyze regulatory options that would minimize the economic impact of
the rule on small entities.
    As previously explained, this interim final rule will not generate
any compliance costs for any small entities, because it does not
require small entities to undertake any new activity. No small business
will choose to use the soluble fiber from oatrim and CHD claim allowed
by this rule unless it believes that doing so will increase its
profits. Accordingly, we certify that this interim final rule will not
have a significant economic impact on a substantial number of small
entities. Under the Regulatory Flexibility Act, no further analysis is
required.
 
C. Unfunded Mandates
 
    Title II of the Unfunded Mandates Reform Act of 1995 (Public Law
104-4) requires cost-benefit and other analyses before any rulemaking
if the rule would include a ``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 1 year.'' We have determined that this interim
final rule does not constitute a significant regulatory action under
the Unfunded Mandates Reform Act.
 
VIII. 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.
 
IX. Paperwork Reduction Act
 
    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 oatrim and
reduced risk of CHD is a ``public disclosure of information originally
supplied by the Federal government to the recipient for the purpose of
disclosure to the public'' (5 CFR 1320.3(c)(2)).
 
X. Federalism
 
    We have analyzed this interim final rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
the rule does not contain policies that have substantial direct effects
on the States, on the relationship between the National
 
[[Page 61782]]
 
Government and the States, or on the distribution of power and
responsibility among the various levels of government. Accordingly, we
have concluded that the interim final rule does not contain policies
that have federalism implications as defined in the Executive order and
consequently, a federalism summary impact statement is not required.
 
XI. Comments
 
    Interested persons may submit to the Dockets Management Branch (see
ADDRESSES) written or electronic comments regarding this interim final
rule by [see DATES]. Two copies of any written comments are to be
submitted, except that individuals may submit one copy. Submit one
electronic 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 Dockets Management Branch office between 9 a.m. and
4 p.m., Monday through Friday.
 
XII. References
 
    The following references have been placed on display in the Dockets
Management Branch (see ADDRESSES) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
    1. The Quaker Oats Co. and Rhodia, Inc., ``Oatrim (BetaTrim\TM\)
Health Petition,'' HCN1, vol. 1, Docket No. 01Q-0313, April 12,
2001.
    2. Letter from Lynn Larsen, Center for Food Safety and Applied
Nutrition, FDA, to Priscilla Samuel and Robert Murray, The Quakers
Oats Co., Let 1, Docket No. 01Q-0313 and James T. Elfstrum, Rhodia,
Inc., Let 2, Docket No. 01Q-0313, July 20, 2001.
    3. Inglett, G.E., and R. K. Newman, ``Oat Beta-Glucan-
Amylodextrins: Preliminary Preparations and Biological Properties,''
Plant Foods for Human Nutrition, 45:53-61, 1994.
    4. Cooper, R., J. Cutler, P. Desvigne-Nickens, S. P. Fortmann,
L. Friedman, R. Havlik, G. Hogelin, J. Marler, P. McGovern, G.
Morosco, L. Mosca, T. Pearson, Jeremiah Stamler, D. Stryer, and T.
Thom, ``Trends and Disparities in Coronary Heart Disease, Stroke,
and Other Cardiovascular Diseases in the United States. Findings of
the National Conference on Cardiovascular Disease Prevention,''
Circulation, 102:3137-3147, 2000.
    5. Memorandum to the record concerning oatrim beta-glucan health
claim petition, prepared by Michael A. Adams, FDA, June 28, 2002.
    6. Torronen, R., L. Kansanen, M. Uusitupa, O. Hanninen, O.
Myllymaki, H. Harkonen, and Y. Malkki, ``Effects of an Oat Bran
Concentrate on Serum Lipids in Free-Living Men with Mild to Moderate
Hypercholesterolemia,'' European Journal of Clinical Nutrition,
46:621-627, 1992.
    7. Braaten, J. T., P. J. Wood, F. W. Scott, M. S. Wolynetz, M.
K. Lowe, P. Bradley-White, and M. W. Collins, ``Oat Beta-Glucan
Reduces Blood Cholesterol Concentration in Hypercholesterolemic
Subjects,'' European Journal of Clinical Nutrition, 48:465-474,
1994.
    8. Beer, M. U., E. Arrigoni, and R. Amado, ``Effects of Oat Gum
on Blood Cholesterol Levels in Healthy Young Men,'' European Journal
of Clinical Nutrition, 49:517-522, 1995.
    9. Pick, M. E., Z. J. Hawrysh, M. I. Gee, E. Toth, M. L. Garg,
and R. T. Hardin, ``Oat Bran Concentrate Bread Products Improve
Long-Term Control of Diabetes: A Pilot Study,'' Journal of the
American Dietetic Association, 96:1254-1261, 1996.
    10. Behall, K. M., D. J. Scholfield, and J. Hallfrisch, ``Effect
of Beta-Glucan Level in Oat Fiber Extracts on Blood Lipids in Men
and Women,'' Journal of the American College of Nutrition, 16:46-51,
1997.
    11. Chen, W.-J. L, J. A. Anderson, and M. R. Gould, ``Effects of
Oat Bran, Oat Gum and Pectin on Lipid Metabolism of Cholesterol-Fed
Rats,'' Nutrition Reports International, 24:1093-1098, 1981.
    12. Welch, R. W., D. M. Peterson, and B. Schrmaka,
``Hypocholesterolemic and Gastrointestinal Effects of Oat Bran
Fractions in Chick,'' Nutrition Reports International, 38:551-561,
1988.
    13. Ranhotta, G. S., J. A. Gelroth, K. Astroth, and C. S. Rao,
``Relative Lipidemic, Responses in Rats Fed Oat Bran or Oat Bran
Concentrate,'' Cereal Chemistry, 67:509-511, 1990.
    14. Oda, T., S. Aoe, S. H. Sanda, and Y. Ayano, ``Effects of
Soluble Fiber Preparations Isolated from Oat, Barley, and Wheat on
Liver Cholesterol Accumulation in Cholesterol-Fed Rats,'' Journal of
Nutritional Science and Vitaminology,'' 39:73-79, 1993.
    15. Oda, T., S. Aoe, S. Imanishi, Y. Kanazawa, H. Sandra, and Y.
Ayano, ``Effects of Dietary Oat, Barley, and Guar Gums on Serum and
Lipid Concentrations in Diet-Induced Hyper-triglyceridemic Rats,''
Journal of Nutritional Science and Vitaminology,'' 40:213-217, 1994.
    16. Inglett, G. E., K. Warner, and R. K. Newman, ``Sensory and
Nutritional Evaluations of Oatrim,'' Cereal Foods World, 39:775-759,
1994.
    17. Malkki, Y., K. Pelkon, O. Myllymaki, R. Torronen, O.
Hanninen, and K. Syrjanen, ``Effects of Oat Bran Concentrate on Rat
Serum Lipids and Liver Fat Infiltration,'' European Journal of
Clinical Nutrition, 49:S321-S324, 1995.
    18. Yokoyama W. H., B. E. Knuckles, A. Stafford, and G. Inglett,
``Raw and Processed Oat Ingredients Lower Plasma Cholesterol in the
Hamster,'' Journal of Food Science, 63:713-715, 1998.
    19. Freiburger, L. M., and D. D. Gallaher, ``Association Between
Intestinal Contents Viscosity and Cholesterol Lowering in Rats Fed
Fermentable and non-Fermentable Dietary Fibers,''Federation of
American Societies for Experimental Biology Journal, 14: A291, 2000.
    20. Freiburger, L. M., and D. D. Gallaher, ``Mechanism of
Cholesterol Lowering in Rats Fermentable and non-Fermentable Dietary
Fibers,'' Federation of American Societies for Experimental Biology
Journal, 15: A290, 2001.
    21. Gallaher, D. D., K. J. Wood, C. M. Gallaher, L. F. Marquart,
and A. M. Engstrom, ``Intestinal Contents Supernatant Viscosity of
Rats Fed Oat-Based Muffins and Cereal Products,'' Cereal Chemistry,
76:21-24, 1999.
    22. Gallaher, D. D., ``Intestinal Contents Supernatant Viscosity
of Rats Meal-Fed Oatrim and Its Cholesterol Lowering Effect in
Rats,'' (Sup 1, Docket No. 01Q-0313) 1999.
    23. Wood, P. J., M. V. Beer, and G. Butler, ``Evaluation of the
Role of Concentration and Molecular Weight of Oat Beta-Glucan in
Determining Effect of Viscosity on Plasma Glucose and Insulin
Following an Oral Glucose Load,'' British Journal of Nutrition,
84:19-23, 2000.
 
List of Subjects in 21 CFR Part 101
 
    Food labeling, Nutrition, Reporting and recordkeeping requirements.
 
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
101 is amended as follows:
 
PART 101--FOOD LABELING
 
    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.
 
    2. Section 101.81 is amended by adding paragraph (c)(2)(ii)(A)(4),
by revising paragraph (c)(2)(iii)(A)(1), by redesignating paragraph
(c)(2)(iii)(A)(2) as paragraph (c)(2)(iii)(A)(3), and by adding new
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) * * *
    (4) Oatrim. The soluble fraction of alpha-amylase hydrolyzed oat
bran or whole oat flour, also known as oatrim. Oatrim is produced from
either oat bran as defined in paragraph (c)(2)(ii)(A)(1) of this
section or whole oat flour as defined in paragraph (c)(2)(ii)(A)(3) of
this section by solubilization of the starch in the starting material
with an alpha-amylase hydrolysis process, and then removal by
centrifugation of the insoluble components consisting of a high portion
of protein, lipid, insoluble dietary fiber, and the majority of the
flavor and color components of the starting material. Oatrim shall have
a beta-glucan soluble fiber content up to 10 percent (dwb) and not less
than that of the starting material (dwb).
* * * * *
 
[[Page 61783]]
 
    (iii) * * *
    (A) * * *
    (1) One or more of the whole oat foods from paragraphs
(c)(2)(ii)(A)(1), (c)(2)(ii)(A)(2), and (c)(2)(ii)(A)(3) of this
section, and the whole oat foods shall contain at least 0.75 gram (g)
of soluble fiber per reference amount customarily consumed of the food
product; or
    (2) 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; or
* * * * *
 
    Dated: September 27, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-25067 Filed 9-27-02; 4:39 pm]
BILLING CODE 4160-01-S