[Federal Register Volume 67, Number 191 (Wednesday, October 2, 2002)]
[Rules and Regulations]
[Pages 61773-61783]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-25067]


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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