[Federal Register Volume 63, Number 32 (Wednesday, February 18, 1998)]
[Rules and Regulations]
[Pages 8103-8121]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4074]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 96P-0338]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its 
decision to authorize the use, on food labels and in food labeling, of 
health claims on the association between soluble fiber from psyllium 
seed husk and reduced risk of coronary heart disease (CHD). Based on 
its review of evidence submitted with comments to the proposal, as well 
as evidence described in the proposal, the agency has concluded that 
soluble fiber from psyllium seed husk, similar to beta ()-
glucan soluble fiber from whole oats, when included as part of a diet 
low in saturated fat and cholesterol, may reduce the risk of CHD by 
lowering blood cholesterol levels. The agency has concluded, based on 
the totality of publicly available scientific evidence, that there is 
significant scientific agreement among qualified experts to support the 
relationship between soluble fiber in psyllium seed husk and CHD. 
Therefore, the agency has decided to amend the regulation that 
authorized a health claim on soluble fiber from whole oats and the risk 
of CHD to include soluble fiber from psyllium seed husk. FDA has 
determined that label statements alerting consumers to the need to 
consume adequate amounts of liquids with products containing dry or 
incompletely hydrated psyllium will be required on products bearing the 
health claim. FDA is announcing this action in response to a petition 
filed by the Kellogg Co. (the petitioner).

DATES: This regulation is effective February 18, 1998. The Director of 
the Office of the Federal Register approves of the incorporation by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of 
certain publications in 21 CFR 101.81(c)(2)(ii)(B), effective February 
18, 1998.

FOR FURTHER INFORMATION CONTACT: Virginia L. Wilkening, Center for Food 
Safety and Applied Nutrition (HFS-165), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-5483.

SUPPLEMENTARY INFORMATION:

I. Background

    On November 8, 1990, the Nutrition Labeling and Education Act of 
1990 (the 1990 amendments) (Pub. L. 101-535) was signed into law. This 
new law amended the Federal Food, Drug, and Cosmetic Act (the act) in a 
number of important ways. One of the most notable aspects of the 1990 
amendments was that they confirmed FDA's authority to regulate health 
claims on food labels and in food labeling. FDA published final rules 
implementing the 1990 amendments on January 6, 1993 (58 FR 2478). In 
those final rules, FDA adopted Sec. 101.14 (21 CFR 101.14), which sets 
out the rules for the authorization and use of health claims. The 
agency also adopted Sec. 101.70 (21 CFR 101.70), which establishes a 
process for petitioning the agency to authorize health claims about a 
substance-disease relationship and sets out the types of information 
that any such petition must include.
    In addition, FDA conducted an extensive review of the evidence on 
the 10 substance disease relationships listed in the 1990 amendments. 
As a result of its review, FDA authorized a health claim in Sec. 101.77 
(21 CFR 101.77) on the association between diets low in saturated fat 
and cholesterol and high in vegetables, fruits, and grain products that 
contain soluble fiber and a reduced risk of heart disease (58 FR 2552, 
January 6, 1993). In that rulemaking, FDA reviewed the evidence 
relating dietary fiber to heart disease and concluded that it was 
difficult to determine the relationship because dietary fiber comprises 
a diverse group of chemical substances that may be associated with 
different physiological functions (58 FR 2552 at 2572). Chemically and 
physiologically, cellulose, lignin, hemicellulose, pectin, and alginate 
(all relatively purified fiber types) behave differently from one 
another. Likewise, wheat bran, oat bran, and rice bran are not similar 
in composition. The agency noted that the available evidence made it 
difficult to correlate the role of specific fiber components to health 
effects.
    However, in its final rule, FDA noted that hypocholesterolemic 
properties may be documented for specific food fibers (58 FR 2552 at 
2567). Further, the agency stated that if manufacturers could document, 
through appropriate studies, that dietary consumption of the soluble 
fiber in their 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), they should petition for a health claim for their 
particular product.
    In accordance with the petition procedure in Sec. 101.70, FDA 
published a final rule on the relationship between soluble fiber from 
whole oats and reduced risk of heart disease (the soluble fiber from 
whole oats final rule), Sec. 101.81 (21 CFR 101.81) (62 FR 3584, 
January 23, 1997 and modified at 62 FR 15343, March 31, 1997). In that 
document, the agency concluded that, based on the totality of publicly 
available scientific evidence, there is significant scientific 
agreement among qualified experts to support the relationship between 
soluble fiber in whole oats and reduced risk of CHD. FDA also concluded 
that the type of soluble fiber in whole oats, -glucan soluble 
fiber, is the primary component responsible for the lowering of blood 
total- and LDL-cholesterol associated with consumption of whole oat 
products when part of a diet low in saturated fat and cholesterol. The 
rule specified the chemical nature of the specific fiber and methods 
for measuring its presence in foods.
    In the soluble fiber from whole oats final rule, the agency 
acknowledged the likelihood that consumption of -glucan 
soluble fiber from sources other than whole oats, as well as soluble 
fiber from other sources, 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

[[Page 8104]]

consumption of those foods has been demonstrated to help reduce 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). 
Instead, the agency stated that because soluble fiber is a family of 
very heterogeneous substances that vary greatly in their effect on risk 
of CHD, a case-by-case approach is necessary as documentation is 
developed through appropriate studies that a soluble fiber product has 
an effect on blood total- and LDL-cholesterol levels and can therefore 
be useful in reducing risk of CHD. To this end, FDA structured 
Sec. 101.81 in such a way that, while the regulation covered -
glucan soluble fiber from whole oats, it could easily be amended as 
evidence becomes available to support the use of the claim for other 
sources of soluble fiber.
    In the soluble fiber from whole oats final rule, FDA emphasized the 
importance of the dietary component of the health claim, i.e., the 
necessity for the whole oat product to be consumed as part of a low 
saturated fat, low cholesterol diet, for a complete understanding of 
the claim (62 FR 3684 at 3594). FDA stated that diets low in saturated 
fat and cholesterol are considered by expert groups to be the most 
effective dietary means of reducing heart disease risk, and that, while 
soluble fiber from whole oats could contribute to this effect, its role 
is generally recognized as being of smaller magnitude.
    In the Federal Register of May 22, 1997 (62 FR 28234), and in 
response to a petition filed under Sec. 101.70, the agency proposed to 
amend Sec. 101.81 by adding psyllium seed husk as an additional source 
of soluble fiber, thereby providing for health claims on the 
association between soluble fiber from psyllium seed husk and reduced 
risk of CHD (the psyllium husk proposed rule). In this proposed rule, 
FDA considered the relevant scientific studies and data presented in 
the petition as part of its review of the scientific literature on 
soluble fiber from psyllium seed husk and heart disease. The agency 
summarized this evidence in the proposed rule (62 FR 28234).
    The psyllium husk proposed rule included qualifying criteria for 
the purpose of identifying psyllium-containing foods eligible to bear 
the proposed health claim. The proposal also specified mandatory 
content and label information for health claim statements and provided 
model health claims.
    Section 101.81(c)(2)(ii) of the soluble fiber from whole oats 
health claim regulation lists the sources of -glucan soluble 
fiber for which FDA has evaluated data pertaining to effects on blood 
cholesterol levels and has concluded that significant scientific 
agreement exists regarding a relationship between soluble fiber in 
whole oats and the risk of CHD. In the psyllium husk proposed rule, FDA 
proposed to add new Sec. 101.81(c)(2)(ii)(B) to specify psyllium husk 
as a source of soluble fiber eligible to be the subject of this claim. 
Proposed Sec. 101.81(c)(2)(ii)(B)(1) identifies psyllium husk as the 
dried seed coat (epidermis) of the seed of Plantago ovata, known as 
blond or Indian psyllium, P. indica, or P. psyllium, and specifies that 
the purity of the psyllium husk shall be no less than 95 percent, such 
that it has 3 percent or less protein content, 4.5 percent or less of 
light extraneous matter, and 0.5 percent or less of heavy extraneous 
matter, but in no case may the combined extraneous matter exceed 4.9 
percent, as determined by U.S. Pharmacopeia (USP) methods.
    In its evaluation of the scientific evidence for a relationship 
between consumption of soluble fiber from psyllium seed husk and blood 
total- and LDL-cholesterol levels, the agency found no reliable data to 
establish a dose-response for this relationship. However, the agency 
did find that in placebo-controlled studies that tested an intake of 
10.2 grams (g) of psyllium seed husk per day as a part of a diet low in 
saturated fat and cholesterol, there were consistently significant 
effects of psyllium husk on blood total- and LDL-cholesterol levels. 
Therefore, the agency proposed to base the qualifying level of soluble 
fiber from psyllium seed husk on a total daily intake of 10.2 g husk 
(about 7 g of soluble fiber), as suggested by the petitioner. 
Therefore, the proposed qualifying criterion in 
Sec. 101.81(c)(2)(iii)(A)(2) was that the food provide at least 1.7 g 
of soluble fiber from psyllium seed husk per reference amount 
customarily consumed (RACC) (i.e., 7 g divided by 4 eating occasions 
per day). The psyllium husk proposed rule also stated that if a 
manufacturer can demonstrate that a diet low in saturated fat and 
cholesterol that includes a blend of the eligible sources of soluble 
fiber listed in Sec. 101.81(c)(2)(ii) has an effect on the risk of 
heart disease, the manufacturer should petition to amend Sec. 101.81 
further.
    To reflect the agency's tentative decision to broaden Sec. 101.81 
to include soluble fiber from psyllium seed husk, the agency proposed 
to modify the section 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.'' Accordingly, the 
agency also proposed to revise the statement ``soluble fiber from whole 
oats'' to either ``soluble fiber from certain foods'' or ``soluble 
fiber from the eligible food sources from paragraph (c)(2)(ii) of this 
section'' where appropriate in Sec. 101.81. The agency did not propose 
to modify the model claims.

II. Summary of Comments and the Agency's Responses

    In response to the psyllium husk proposed rule, the agency received 
19 letters, each containing one or more comments, from professional 
organizations, industry, consumer groups, health care professionals, 
and research scientists.
    Approximately one-half of the comments that the agency received 
agreed with one or more provisions of the psyllium husk proposed rule 
without providing grounds for this support other than those provided by 
FDA in the preamble to the psyllium husk proposed rule. A few of these 
comments also requested modification of one or more provisions of the 
proposed rule. Some comments provided additional data on the 
relationship between psyllium husk soluble fiber and CHD. Some of the 
comments that disagreed with the proposed rule provided specific 
support for their positions. The agency has summarized and addressed 
the relevant issues raised in all comments in the sections of this 
document that follow.

A. Food Substance Associated With Reduced Risk of CHD

    Health claims have two essential elements: A food substance and a 
disease or health-related condition (Sec. 101.14). The agency proposed 
to authorize a health claim on the relationship between consumption of 
soluble fiber from psyllium husk, as part of a diet low in saturated 
fat and cholesterol, and reduced risk of CHD. Further, the agency 
proposed to amend the authorized claim for soluble fiber from whole 
oats and CHD (Sec. 101.81) to include soluble fiber from psyllium husk 
and to broaden the subject of the claim to ``soluble fiber from certain 
foods'' and risk of CHD (62 FR 28234 at 28239).
1. Terminology
(Comment 1)
    Comments received in response to the proposed rule used the term 
``psyllium''

[[Page 8105]]

interchangeably with the terms ``psyllium seed husk'' and ``psyllium 
husk.'' The agency also noticed that a few comments used the term 
``psyllium'' when referring to the soluble fiber component of the 
psyllium husk. Therefore, the agency finds it important to clarify the 
terms that may be used in referring to the substance that is the 
subject of this claim as well as the common or usual name of the 
product that should be used in ingredient statements.
    The substance that is the subject of this claim is soluble fiber of 
the psyllium husk, i.e., the seed coat that has been removed from the 
psyllium seed. It is the seed husk, rather than the seed, that is the 
source of soluble dietary fiber. The purity specifications suggested by 
the petitioner and adopted in proposed Sec. 101.81(c)(2)(ii)(B)(1) 
refer to the extent to which psyllium husk has been separated from 
residual seed components.
    The agency notes that in the ingredient list of the petitioner's 
psyllium husk-containing cereal the substance is declared as ``psyllium 
seed husk'' (Ref. 1). The agency also notes that in the USP National 
Formulary this substance is referred to as ``psyllium husk'' (Ref. 2). 
The agency therefore considers both ``psyllium seed husk'' and 
``psyllium husk'' to be common or usual names for the soluble dietary 
fiber source that is the subject of this rule. In the psyllium husk 
proposed rule, the agency used the term ``psyllium'' synonymously with 
the term ``psyllium husk'' (62 FR 28234 at 28237). Upon further 
consideration, the agency concludes that the term ``psyllium'' is not 
sufficiently descriptive of the substance of this claim because this 
term is likely to be construed as inclusive of the psyllium seed. The 
psyllium seed includes nutrients and allergenic proteins that are not 
components of psyllium husk. The psyllium husk purity specifications of 
Sec. 101.81(c)(2)(ii)(B)(1) make the presence of psyllium seed in a 
food a disqualifying criterion for foods eligible to bear the claim.
    In this final rule, the agency is clarifying under 
Sec. 101.81(c)(2) that the proper terms for the soluble fiber source 
which is the substance of this rule are ``psyllium husk'' or ``psyllium 
seed husk.'' Therefore, Sec. 101.81 (c)(2)(ii)(B)(1) is revised to read 
``psyllium seed husk, also known as psyllium husk, shall have a purity 
of * * *.'' Section 101.81 (c)(2)(ii)(B)(1), (c)(2)(ii)(B)(2), and 
(c)(2)(iii)(A)(2) are revised to read ``psyllium husk'' where the term 
``psyllium'' had been used in the proposed rule.
2. Eligibility of Psyllium Seed Husk
(Comment 2)
    Some comments stated that psyllium husk is not a food and is not 
consumed by itself. The comments stated that psyllium husk is an 
ingredient or additive and, therefore, should not be eligible for a 
health claim. One comment expressed concern that a health claim on a 
food additive will put more reliance on food fortification or 
supplementation as a strategy to improve health. The comment asserted 
that the psyllium proposal represents a public policy shift that may 
result in diverting attention from the importance of a varied selection 
of foods.
    FDA disagrees with comments that psyllium husk, as a food 
ingredient, is not an appropriate substance for consideration of a 
health claim. As discussed in the final rule implementing the 1990 
amendments on the use of health claims (58 FR 2478 at 2480, January 6, 
1993), a broad range of substances are potentially subject to 
regulation under section 403 (r)(1)(B) of the act (21 U.S.C. 
343(r)(1)(B)). Section 101.14(a)(2) was written to reflect this broad 
coverage. Under the general requirements for health claims, the 
substance that is the subject of the health claim can be either a 
specific food or a component of food (Sec. 101.14(a)(2)). Moreover, the 
fact that a substance may be a ``food additive,'' within the meaning of 
that term in 21 CFR 170.3(g), does not preclude it from also being a 
``substance'' under Sec. 101.14(a)(2). Although psyllium seed husk is 
not consumed as a single food, it is a consumable portion of a seed 
grain that is, or could be, used as a component of foods (e.g., cereal, 
pasta, cookies, breakfast bars) and is a rich source of soluble fiber. 
As such, psyllium seed husk is a ``substance'' within the meaning of 
Sec. 101.14(a)(2) and thus eligible for consideration of a health 
claim.
    The agency also disagrees with the comment that the proposed health 
claim represents a public policy shift in diverting attention from the 
importance of a varied selection of foods by placing more reliance on 
food fortification or supplementation to achieve public health goals. 
The establishment of a health claim for soluble fiber from psyllium 
husk and CHD, when viewed in conjunction with existing health claims 
for fruits, vegetables, and grain products and CHD and for soluble 
fiber from whole oats and CHD, emphasizes an important role (i.e., 
possible reduced risk of CHD) of an even wider variety of food 
selections. It is important to note that the concept of formulating a 
food product with psyllium seed husk is no different than formulating a 
product with oat bran (another food ingredient supplying soluble fiber 
that is the subject of an authorized health claim). As with oat bran, 
the inclusion of psyllium husk in a food would be based on its basic 
functional properties in addition to its nutritional contribution or 
potential health benefit. The decision to include such an ingredient in 
a food would be considered food product development, not fortification. 
Therefore, the agency disagrees that the approval of this health claim 
represents a public policy shift on food fortification.

B. Updated Review of Scientific Evidence and Issues Related to the 
Evidence

    Under Sec. 101.14(c), FDA will issue a regulation authorizing a 
health claim only when it determines, based on the totality of publicly 
available scientific evidence, that there is significant scientific 
agreement that the claim is supported by such evidence. In its review 
of the psyllium petition, the agency completed a comprehensive review 
(see Ref. 7) of 21 human studies (Refs. 8 through 28) (62 FR 28234 at 
28237). Of these, it gave particular weight to 7 studies (Refs. 13, 14, 
15, 18, 22, 23, and 28) that were well designed and controlled and that 
reported intakes of dietary saturated fat and cholesterol.
1. Data Submitted With Comments
(Comment 3)
    One comment to the psyllium husk proposed rule noted that FDA 
excluded from comprehensive review three studies (Ref. 12, 17, and 25) 
because they lacked evidence that the study subjects were compliant 
with a low saturated fat and cholesterol diet (i.e., the American Heart 
Association ``Step 1'' diet). This comment submitted reports of 
subsequent diet analyses of these studies indicating that study 
subjects were compliant with the Step 1 diet (see Docket 96P-0338, C8). 
This comment also noted that two unpublished studies included in the 
psyllium petition have since been published or submitted for 
publication (Refs. 12 and 25).
    Another comment submitted five recently published studies for 
consideration (Refs. 29 through 33) and three studies for 
reconsideration (Refs. 14, 28, and 34). The latter were recently 
published revisions of material submitted in the psyllium petition. The 
comment stated that the published report by Jenkins et al. (Ref. 28) 
contains additional data not presented in the

[[Page 8106]]

unpublished report submitted with the petition.
    FDA, in reviewing the supplemental data for Refs. 12, 17, and 25, 
concluded that this information shows the subjects of these three 
studies were compliant with the dietary protocol and made no 
significant changes to their diets throughout the duration of the 
treatment period. Therefore, these studies have been added to the seven 
studies to which the agency gave particular weight in evaluating the 
relationship of soluble fiber from psyllium husk and CHD risk in the 
psyllium husk proposed rule. These studies are summarized in Table 1 of 
this document. The results of these three additional studies support 
the relationship between consumption of soluble fiber from psyllium 
seed husk and reduced risk of heart disease.
    The agency also reviewed the published version of the study by 
Jenkins et al. (Ref. 28) that was submitted in comments and has 
summarized this study accordingly in Table 1 of this document. The 
investigators evaluated the effect on serum lipid levels of two Step 2 
metabolic diets that provided either 6 or 12 percent of energy from 
monounsaturated fat (MUFA), approximately 60 g per day (/d) total 
dietary fiber, and psyllium seed husk-containing cereal (mean intake of 
11 g/d of psyllium seed husk) or wheat bran. The results showed 
significantly lower total- and LDL-cholesterol levels in the psyllium 
husk-supplemented groups compared to the control group at both MUFA 
levels. The saturated fat intake during the two study periods was very 
low (less than 6 percent of energy).
    The agency did not conduct an in-depth review of five of the 
studies submitted with comments. The study by Jensen and co-workers 
(Ref. 33) does not meet the agency's criteria for study selection (62 
FR 28234 at 28237) because the authors evaluated the usefulness of a 
soluble fiber mixture (containing psyllium, pectin, guar gum, and 
locust bean gum) in the long-term management of hypercholesterolemia. 
The results of this study do not allow an evaluation of the effects of 
soluble fiber from psyllium seed husk alone.
    The experimental design of the study by Ganji and Kies (Ref. 32) 
did not meet the agency's criteria for comprehensive review. In the 
psyllium proposal, the agency stated that in evaluating a study, it 
considered whether the intervention studies had been of long enough 
duration to reasonably ensure stabilization of blood lipid levels 
(i.e., greater than or equal to 3 weeks duration) (62 FR 28234 at 
28237). In this study, diets were varied in four 7-day treatment 
periods with no time between treatment periods. With this study design, 
it cannot be determined whether the subjects' blood lipids had 
stabilized to each diet or that there were no carryover effects from 
one treatment period to another. Neither did the study design have an 
adequate pre-intervention baseline period to ensure blood lipids had 
stabilized to the base diet.
    The other three studies submitted in comments that were not 
reviewed indepth were animal studies (Refs. 29 through 31). Animal 
studies are useful in studying mechanisms of action. However, the 
agency relied primarily on the clinical studies in this rule. Such an 
approach is consistent with that taken by the agency in its evaluation 
of the relationship between soluble fiber from whole oats and risk of 
CHD.
    A meta-analysis (Ref. 34) was conducted to determine the effect of 
psyllium seed husk-containing cereal products on serum lipid levels in 
hypercholesterolemic subjects and to estimate the magnitude of the 
effect among 404 subjects with mild to moderate hypercholesterolemia 
(total-cholesterol of about 200 to 300 milligrams per deciliter (mg/dL) 
who followed a low fat diet. In its review of the evidence submitted in 
the psyllium petition, the agency reviewed 6 of the 11 studies (Refs. 
11, 13, 22 through 24, and 28) included in the meta-analysis (see 
tables in Ref. 7). The remaining studies used in the meta-analysis did 
not meet the agency's criteria for study selection (62 FR 28234 at 
28237). The conclusion of the meta-analysis report was that 
hypercholesterolemic subjects who consumed the psyllium seed husk-
containing cereal had significantly lower total-cholesterol (about 5 
percent) and LDL-cholesterol (about 9 percent) compared with those 
subjects who consumed the control cereal (Ref. 34).
2. Totality of the Data on Soluble Fiber from Psyllium Seed Husk and 
CHD
(Comment 4)
    One comment stated that there was considerably more scientific data 
on psyllium seed husk presented in the petition than that reviewed by 
the agency. The comment noted that results of 56 studies were included 
in the psyllium petition. The comment expressed concern that the agency 
failed to consider studies published prior to 1988 and some additional 
evidence made available since 1988, noting that studies with soluble 
fiber mixtures, studies with treatment periods that were less than 3 
weeks in duration, and abstracts were not selected for comprehensive 
review. The comment stated that the agency began its review of the 
scientific evidence by first considering the conclusions of the Surgeon 
General's report and the Food and Nutrition Board/National Academy of 
Sciences (FNB/NAS) report (Refs. 3 and 4) and then considered the 
evidence that was made available since 1988. The comment explained that 
neither the Surgeon General's report nor the FNB/NAS report reviewed 
the evidence on psyllium up to 1988; therefore, the agency improperly 
ignored a significant portion of the scientific evidence provided in 
the petition (see Ref. 35, Table 3, pages 30 and 31). Another comment 
noted that among the 56 studies submitted in the psyllium petition (see 
Ref. 35), the results of only three failed to demonstrate that 
consumption of psyllium-containing foods was associated with risk of 
CHD through a reduction in serum cholesterol. The comment stated that 
the totality of evidence on psyllium husk that was submitted in the 
petition includes data on children and the elderly.
    Some comments stated that it is premature to authorize a claim on 
psyllium seed husk and risk of CHD because of a lack of significant 
scientific agreement on this nutrient/disease relationship. Some of 
these comments stated that the decision to propose this health claim is 
based on evidence from a limited number of studies that overall covered 
a small number of subjects, of which women were underrepresented, and 
on the absence of data on certain subpopulations (children and the 
elderly).
    The agency agrees with the comment that the Surgeon General's 
report (Ref. 3) and the FNB/NAS report (Ref. 4) did not review of all 
of the psyllium studies that were publicly available prior to 1988 and 
identified in the petition (Ref. 35). The petition identified 16 
clinical studies, published prior to 1989, of the effect of psyllium 
seed husk on blood cholesterol levels (see Ref. 35, Table 3). The 
agency had not reviewed these studies in the psyllium husk proposed 
rule, but in response to the comment, has subsequently considered them. 
Half of these studies did not meet the agency's stated criteria for 
selection of human studies (62 FR 28234 at 28237) in that they were 
conducted in special populations, were published as abstracts only, or 
the psyllium dose was unreported. Studies that used special population 
groups were excluded from review because, as explained in the psyllium 
husk proposed rule (62 FR 28234 at 28237), the results from such groups 
may not be relevant to the general healthy U.S. population. The

[[Page 8107]]

agency's rationale for excluding from review studies presented only in 
abstracts was also presented in the proposal. Abstracts do not provide 
sufficient detail regarding the methodology and results to allow a 
detailed assessment of the merits of the study. Likewise, information 
regarding actual amounts of psyllium administered is a key detail of 
the study design, without which an adequate assessment of the study 
cannot be made.
    In each of the pre-1989 clinical studies meeting the selection 
criteria, there were aspects of the study design (e.g., lack of dietary 
data, lack of a control group) that would have precluded the results of 
these studies from having a major influence on the agency's 
conclusions. Among the pre-1989 clinical studies was one double-blind 
placebo-controlled psyllium husk study with dietary data (Ref. 36). 
However, the report contained no evidence that the study subjects were 
compliant with a low saturated fat and cholesterol diet. Thus, a review 
by FDA of pre-1989 data would not have altered the conclusions reached 
by the agency in the psyllium husk proposed rule nor contribute to 
issuing the final rule.
    The agency disagrees with the comments that there is not 
significant scientific agreement that soluble fiber from psyllium husk 
may help reduce the risk of CHD through its action on blood total- and 
LDL-cholesterol levels. Some of the comments incorrectly suggested that 
the agency's decision on this nutrient/disease relationship was based 
solely on the results of the seven studies in Table 1 of the psyllium 
husk proposed rule (62 FR 28234 at 28244). As stated previously, the 
agency reviewed 21 human studies on psyllium (Refs. 8 through 28) that 
were submitted with the petition and met the agency's criteria for 
consideration (Ref. 7). Of these, the agency gave particular weight to 
seven studies. As stated in the psyllium husk proposed rule, the 
results of the seven studies (Refs. 13 through 15, 18, 22, 23, and 28), 
and now three additional studies (Refs. 12, 17, and 25) (see comment 3 
in section II.B.1 of this document), strongly support the relationship 
between soluble fiber from psyllium husk and risk of CHD in mild to 
moderate hypercholesterolemic adults (62 FR 28234 at 28238). Moreover, 
the results of the remaining clinical studies (Refs. 8 through 11, 16, 
19 through 21, 24, and 26) that were given less weight in the psyllium 
husk proposed rule were consistent in showing an effect of soluble 
fiber from psyllium husk on serum lipid levels. These studies included 
both men and women subjects and adults of all ages, including the 
elderly. It is on the totality of this evidence and conclusions from 
the 1989 Life Sciences Research Office (LSRO) report on health 
consequences of dietary fiber (Ref. 5) that the agency is basing its 
conclusion to authorize a health claim on psyllium seed husk.
3. Psyllium Consumed as a Bulk Laxative
    In the psyllium husk proposed rule, the agency included in its 
evaluation the results of studies of this nutrient/disease relationship 
in which psyllium was administered as a product marketed as a bulk-
forming fiber laxative.
(Comment 5)
    Some comments were opposed to the consideration of studies in which 
psyllium husk was supplied as a bulk-forming fiber laxative. One 
comment stated that the use of studies in which psyllium seed husk was 
consumed in different forms makes meaningful comparisons difficult. 
Other comments had no objection to the agency's use of this evidence. 
One comment stated that consuming psyllium husk as a bulk-forming fiber 
laxative at mealtime is functionally equivalent to consuming a psyllium 
husk-enriched food at mealtime. Another comment stated that clinical 
studies evaluating psyllium seed husk administered as a bulk-forming 
fiber laxative were conducted in a fashion similar to studies conducted 
with food products, including consuming the substance at mealtime, 
dietary counseling, and patient selection criteria. The comment stated 
that both compliance with the regimen and efficacy were comparable for 
food and laxative studies.
    In the psyllium husk proposed rule, the agency tentatively decided 
that including, in its comprehensive review, the three studies in which 
psyllium seed husk was administered in the form used as a laxative 
(Refs. 13, 15, and 18) was appropriate. In these studies, the psyllium 
seed husk was consumed in concentrations similar to those at which 
psyllium husk was incorporated into conventional foods in the other 
studies selected for comprehensive review (Refs. 14, 22, 23, and 28) 
(62 FR 28234 at 28238). The agency further noted that the magnitude of 
the effect of soluble fiber from psyllium husk on the change in serum 
lipid levels reported in the studies in which this substance was 
consumed in conventional foods (Refs. 14, 22, 23, and 28) was similar 
to that observed in the studies (Refs. 13, 15, and 18) in which it was 
consumed as a bulk laxative. Therefore, the agency stated that the 
results of the studies suggest that the form in which psyllium husk is 
consumed is not significant when evaluating the effect of psyllium husk 
on serum lipid levels (62 FR 28234 at 28238). Comments that were 
opposed to reliance on studies which used a psyllium husk bulk-forming 
laxative provided no new data to support their position. Therefore, the 
agency is not persuaded that it is inappropriate to rely on this 
evidence and concludes that studies that used a psyllium husk bulk-
forming laxative are appropriate in the evaluation of this nutrient/
disease relationship.
4. Studies in Subjects With Borderline to High Blood Cholesterol Levels
    The subject populations in the studies reviewed in the psyllium 
proposed rule (see Table 1, 62 FR 28234 at 28244) had borderline to 
high blood total-cholesterol levels (i.e., average baseline cholesterol 
values in the studies were between 225 and 275 mg/dL). The agency 
tentatively concluded in the psyllium proposed rule that the studies 
with hypercholesterolemic subjects are relevant to the general U.S. 
population (62 FR 28234 at 28238) and requested comments on this issue.
(Comment 6)
    Some comments agreed with the agency's view that studies of 
populations with elevated blood cholesterol are relevant to the general 
population. These comments cited current statistics of the incidence of 
elevated blood cholesterol in the U.S. population, and noted that the 
CHD risk factor that is the target of the proposed health claim is 
elevated blood cholesterol. Other comments disagreed with the view that 
the results of studies in hypercholesterolemics can be generalized to 
the general population. One comment stated that because 
hypercholesterolemic individuals are generally more responsive to 
dietary intervention that normocholesterolemic individuals, it is 
questionable whether normocholesterolemic persons would respond to 
psyllium at all.
    As the leading cause of death in this country, CHD is a disease for 
which the general U.S. population is at risk. The risk of dying from 
CHD is related to serum cholesterol levels in a continuous and positive 
manner, increasing slowly for levels between 150 mg/dl and 200 mg/dl 
and more rapidly when the cholesterol level exceeds 200 mg/dl (Ref. 
37). The public health policy elucidated by the National Cholesterol 
Education Program (NCEP), National Heart, Lung, and Blood Institute, is 
to extend the benefits of cholesterol lowering to the population as a 
whole by promoting adoption of eating patterns that can help lower the 
blood cholesterol levels of most Americans

[[Page 8108]]

(Ref. 37). A dietary intervention that lowers blood cholesterol levels 
only in persons with high levels would, like an intervention that 
lowers cholesterol levels across the entire population range, cause a 
shift in the population distribution of blood cholesterol levels 
resulting in a decrease in the mean value for the blood cholesterol 
level in the general population (Ref. 37). The anticipated effect of 
such a shift would be to reduce the morbidity from CHD and to produce a 
continued or accelerated decline in the CHD mortality rate in the 
United States. The agency is persuaded by the evidence it has reviewed 
in this rulemaking that the consumption of psyllium seed husk, as part 
of a low saturated fat and cholesterol diet, can be a prudent public 
health measure to assist in the national policy of promoting eating 
patterns that will help in achieving or maintaining desirable blood 
cholesterol levels in the general population. Therefore, it concludes 
that the health claim is relevant to the general population and should 
not be limited to a subpopulation of hypercholesterolemic individuals. 
In addition, consistent with the agency's conclusions in rulemaking on 
the dietary saturated fat and cholesterol/CHD claim (58 FR 2739 at 
2745, January 6, 1993), the wording of the health claim as ``may' or 
might' reduce the risk of heart disease'' adequately represents the 
fact that not all persons will realize the same magnitude of benefit 
from adopting the dietary change.

C. Issues Relative to Amending Sec. 101.81 to Include Soluble Fiber 
From Psyllium Seed Husk

    In the psyllium husk proposed rule, the agency tentatively 
concluded that the soluble fiber in psyllium husk, like -
glucan soluble fiber from whole oats, when consumed as part of a diet 
low in saturated fat and cholesterol, may help reduce the risk of heart 
disease. Therefore, the agency proposed to amend the authorized claim 
for -glucan soluble fiber from whole oats and risk of CHD 
(Sec. 101.81) to include soluble fiber from psyllium husk and to 
broaden the subject of the claim to ``soluble fiber from certain 
foods'' and risk of CHD.
(Comment 7)
    One comment stated that Sec. 101.81 should not be expanded to 
include soluble fiber from psyllium husk because the eligible sources 
of -glucan soluble fiber are whole grain foods that provide 
nutrients in addition to soluble fiber, whereas psyllium seed husk, 
which offers only soluble fiber, is neither a food nor a whole grain. 
The comment also stated that psyllium seed husk should not be added to 
Sec. 101.81 because the husk soluble fiber is separated from the whole 
seed, whereas -glucan soluble fiber extracted from the whole 
oat grain is not eligible for a claim. Two comments suggested that if 
the claim must be structured as a soluble fiber claim, then only those 
soluble fiber sources that elicit clinically significant reductions in 
serum cholesterol via the same mechanism should be eligible to be 
included in the claim.
    FDA disagrees with the comment that substances qualifying for a 
health claim under Sec. 101.81 must be whole grains similar to the 
whole oats that are listed under Sec. 101.81(c)(2)(ii)(A). The subject 
of the claim is soluble fiber and the food source of -glucan 
soluble fiber is whole oats. There is no scientific basis to require 
that only soluble fiber from whole grain foods can qualify for a claim. 
The soluble fiber in psyllium seed is concentrated in the outer husk. 
This is the opposite from whole oats where the soluble fiber is 
concentrated in the inner portion of the oat groat. Moreover, purified 
-glucan soluble fiber was not included as a substance eligible 
to bear the claim because, as discussed in the whole oat final rule, 
the hypocholesterolemic properties of -glucan fiber extracts 
are affected by processing. Therefore, before an extract of -
glucan fiber could qualify for the claim, it would have to be 
characterized so as to identify the processed form of the soluble fiber 
that maintains its hypocholesterolemic properties. The data on psyllium 
husk soluble fiber are associated with reduced risk of CHD via its 
documented hypocholesterolemic properties. As discussed previously (see 
comment 2 in section II.A.2 of this document), psyllium seed husk is a 
``substance'' eligible for consideration of a health claim within the 
meaning of that term in Sec. 101.14(a)(2). Therefore, the agency finds 
it appropriate to consider soluble fiber from psyllium seed husk as a 
source of soluble fiber that is eligible to be included in Sec. 101.81.
    The agency also disagrees with the comment that a soluble fiber 
source should not be included in Sec. 101.81 unless it elicits 
reductions in serum cholesterol via the same mechanism as the 
-glucan soluble fiber in whole oats. There is no scientific 
basis to require soluble fibers to have the same mechanism of action 
for lowering serum cholesterol in order to be eligible for a health 
claim under Sec. 101.81, nor did the comments provide such a basis. In 
the whole oat final rule, the agency stated that if a manufacturer can 
document that a soluble fiber product has an effect on blood lipid 
levels, and thereby can be useful in reducing the risk of CHD, the 
manufacturer may petition to amend Sec. 101.81 to include that type of 
soluble fiber-containing product as an eligible food source (62 FR 3584 
at 3588). In this rulemaking, the agency has concluded that consumption 
of soluble fiber from psyllium seed husk has an effect of lowering 
blood total- and LDL-cholesterol levels, and therefore an amendment to 
Sec. 101.81 to include psyllium seed husk as a soluble fiber source is 
eligible for a health claim under Sec. 101.81.

D. Specifications for Psyllium Seed Husk

    Based upon information provided by the petitioner, the agency 
proposed a minimum psyllium husk purity specification as a qualifying 
criterion for eligible sources of soluble fiber from psyllium. Proposed 
Sec. 101.81(c)(2)(ii)(B)(1) stated that psyllium husk shall have a 
purity of:

no less than 95 percent, such that it contains 3 percent or less 
protein, 4.5 percent or less of light extraneous matter, and 0.5 
percent or less of heavy extraneous matter, but in no case may the 
combined extraneous matter exceed 4.9 percent * * *.

(62 FR 28234 at 28243).
1. Issues Relative to Psyllium Seed Husk Specifications
(Comment 8)
    One comment noted that there are no assurances that food 
manufacturers other than the petitioner will be able to meet the 
petitioner's product specifications and therefore a compliance 
monitoring program needs to be developed prior to authorization of the 
health claim. A comment noted that due to natural variability in 
psyllium seed husk and analytical variation, a ``94 percent purity'' 
specification would better represent the practical limit of 
commercially-available ``95 percent purity'' psyllium. Accordingly, 
this comment urged FDA to adopt a minimum psyllium husk purity of 94 
percent with 5.0 percent or less of light extraneous matter and 1.0 
percent or less of heavy extraneous matter. One comment expressed 
concern that the purification of psyllium husk may render psyllium 
inactive as a hypocholesterolemic agent. This comment also urged FDA to 
determine whether the purification process described by the petitioner 
should serve as the approved purification technique for psyllium.
    The agency disagrees with the comment that a specific compliance 
monitoring system is needed for psyllium seed husk. The monitoring and

[[Page 8109]]

verification of compliance with current good manufacturing practice in 
the manufacture of human food is a routine FDA activity. The comment 
urging the agency to change the psyllium husk purity specification to 
``no less than 94 percent'' provided no data to substantiate that 
commercial supplies of psyllium seed husk do not routinely meet the 95 
percent purity specification and the agency sees no compelling reason 
to revise the proposed purity specifications. Accordingly, the agency 
is adopting the specifications proposed in Sec. 101.81(c)(2)(ii)(B)(1).
    The agency notes that evidence provided in the petition and in 
comments indicates that the psyllium seed husk in the food and bulk 
laxative products used in the clinical studies, which were discussed in 
the psyllium husk proposed rule, had a purity of at least 95 percent. 
The blood cholesterol lowering effect of psyllium seed husk is 
attributed to the soluble fiber content of the husk and not to the seed 
components. As such, the concern that the process of separating the 
psyllium husk from residual seed components would alter the 
effectiveness of psyllium husk in lowering blood cholesterol level is 
unfounded. The agency further notes that it has proposed to adopt a 
psyllium husk purity specification only, and not a purification 
process.

E. Nature of the Food Eligible to Bear the Claim

    In the proposal, the agency determined a qualifying level of 
psyllium husk for foods eligible to bear a soluble fiber and CHD claim 
based on a daily intake of approximately 7 g of soluble fiber from 
psyllium seed husk (62 FR 28234 at 28240). The agency stated that the 
level of daily intake of soluble fiber from psyllium seed husk (7 g/d 
was not based on the results of data from a dose-response study, but 
was the amount shown in clinical studies to be consistently associated 
with significant reductions in serum lipids in conjunction with a diet 
low in saturated fat and cholesterol. Therefore, the agency proposed 
that the qualifying level of soluble fiber for foods to bear a soluble 
fiber and CHD claim be 1.7 g of soluble fiber from psyllium seed husk 
per RACC (7 g divided by 4 eating occasions per day) (62 FR 28234 at 
28240). The agency asked for comments on whether this approach for 
establishing a qualifying soluble fiber level for psyllium husk-
containing products is appropriate or for data to support another 
qualifying level for psyllium husk.
1. Qualifying Criteria for Psyllium Seed Husks
(Comment 9)
    Some comments stated that it is premature to authorize this health 
claim because of the limited data regarding an appropriate dose-
response curve. One comment stated that the qualifying level for 
psyllium should be based on an intake level that will elicit a 
clinically significant 5 percent reduction in blood cholesterol. The 
comment stated that results from dose-response and meta-analysis 
studies would assuage concerns that the proposed qualifying level of 
soluble fiber from psyllium seed husk may not be an effective 
cholesterol-lowering dose. Other comments agreed with the proposed 
qualifying level for psyllium-containing foods. One comment stated that 
the revised report of the dose-response study by Davidson et al. (Ref. 
14), that was submitted with the comment, supports the effectiveness of 
10.2 g psyllium husk daily intake in significantly lowering cholesterol 
levels. In an analysis of data from subjects who completed the protocol 
(197 of 286 subjects), LDL-cholesterol levels of the group with 10.2 g 
psyllium husk daily intake was reported to be 5 percent lower than the 
control group after 24 weeks. The comment also stated that the data 
from the meta-analysis by Olson et al. (Ref. 34), which was submitted 
with the comment, lends additional support to the conclusion that 10.2 
g/d of psyllium is an appropriate level on which to base the qualifying 
criteria for this claim. One comment stated that the maximum level of 
daily psyllium husk consumption should be determined as part of the 
generally recognized as safe (GRAS) process.
    FDA notes that dose-response data are not a requirement to 
establish the qualifying criteria for a substance that is the subject 
of a health claim. Under Sec. 101.70, which describes the requirements 
for health claim petitions, the petition must address whether there is 
an optimum level of the particular substance to be consumed beyond 
which no benefit would be expected (Sec. 101.70(f)B.1.). This 
information may or may not be based on dose-response data. Even though 
the optimal or lowest effective cholesterol lowering doses can not be 
determined from the available data, the qualifying level (10.2 g/d of 
psyllium husk) has been demonstrated to be effective. The results of 
studies that evaluated the effect of psyllium husk intakes above 10.2 
g/d showed no additional benefit on serum lipid levels (Ref. 7). 
Therefore, the agency disagrees with the comments stating that dose-
response data are needed before the agency can authorize a health 
claim. The totality of scientific data, which establish a significant 
reduction in blood cholesterol based on an intake of 10.2 g/d of 
psyllium seed husk, provides an adequate basis for establishing a 
qualifying soluble fiber level for psyllium seed husk-containing 
products.
    Similarly, there is no basis to require that the qualifying 
criteria for a substance associated with risk of CHD be based on the 
amount of that substance to elicit a 5 percent reduction in blood 
total- and LDL-cholesterol levels. The data on psyllium seed husk 
suggests that the magnitude of the effect on blood lipids for intakes 
of about 10 g/d of psyllium seed husk ranges from 4 to 6 percent for 
blood total-cholesterol and about 4 to 8 percent for LDL-cholesterol 
levels in conjunction with diets low in saturated fat and cholesterol 
(Ref. 7). Although modest in size, these are clinically significant 
reductions in blood lipids that translate to a reduced risk of CHD for 
individuals with hypercholesterolemia and serve as a useful adjunct to 
a diet already low in saturated fat and cholesterol.
    In the absence of data to the contrary, the agency concludes that 
based on the evidence submitted in comments and on the totality of 
scientific data considered in its review of the petition, a daily 
intake of 7 g of soluble fiber from psyllium seed husk (10.2 g of 
psyllium seed husk) as part of a diet low in saturated fat and 
cholesterol may reduce the risk of CHD by lowering blood total- and 
LDL-cholesterol levels in individuals with mild to moderate 
hypercholesterolemia.
    FDA finds that the comment that a maximum level of daily 
consumption of psyllium husk should be determined as part of the 
psyllium husk GRAS status is not relevant to this rulemaking.
2. Issues Relative to Four Eating Occasions Per Day
(Comment 10)
    The proposed qualifying level of soluble fiber from psyllium husk 
was based on the assumption that individuals will consume four servings 
of psyllium husk-containing foods a day. Some comments questioned 
whether it is realistic to assume that consumers will consume four 
servings per day of psyllium husk-containing foods. One comment stated 
that the majority of Americans never consume any psyllium husk-
containing foods and that there is no evidence that a health claim 
would convince them to consume up to four servings of these foods 
daily. Other comments stated that the proposed rule would provide 
consumers

[[Page 8110]]

with an increased selection of foods containing soluble fiber in 
sufficient quantities to have a potentially beneficial influence on CHD 
risk and thus have a positive public health impact.
    FDA acknowledges that foods containing psyllium seed husk are not 
widely available; e.g., the petitioner currently produces only one 
product, a breakfast cereal, containing psyllium. However, the agency 
disagrees with the comments that it is unrealistic to consider that 
consumers could consume psyllium-containing foods four times a day. Two 
studies (Refs. 8 and 14) that were reviewed by the agency tested 
psyllium seed husk incorporated into a variety of foods that were 
consumed during the day. These products included cereal, fruit drinks, 
peanut butter, cookies, muffins, bread, pasta, and snack bars. In 
addition to these products, the petitioner identified other food 
products in which psyllium could be used, such as toaster pastries, 
rolls, biscuits, tortillas, waffles, pancakes, pizza crust, stuffing, 
breakfast bars, and a variety of ready-to-eat cereals (Ref. 35, pp. 90 
and 91). Authorization of a claim on soluble fiber from psyllium seed 
husk will be an incentive for manufacturers to expand product lines to 
provide consumers with additional soluble fiber-containing products 
that can be part of a heart healthy diet. Based on these facts, the 
agency finds that a factual predicate exists to support the contention 
that psyllium husk-containing foods could be consumed at four eating 
occasions a day and, therefore, finds that the comments that questioned 
whether such consumption was realistic are without support.
    The agency notes that the approach used to determine the qualifying 
level of soluble fiber from psyllium husk (i.e., dividing the amount 
shown to provide a significant reduction in blood lipid levels by 4 
eating occasions per day) is consistent with that used to determine the 
qualifying level of -glucan soluble fiber from whole oats in 
the soluble fiber from whole oats final rule. In that document, the 
agency pointed out that the approach used to derive the qualifying 
level of soluble fiber from whole oats is somewhat different from that 
used in authorizing other health claims. It stated:
    Specifically, the guiding principle for other health claims is 
to use the established definition for ``good source'' or ``high'' 
which characterizes the amount of a nutrient, based on a percentage 
of the Daily Value (DV) for the nutrient, in a serving of food. In 
this way, products that qualify to bear the claim contain a 
meaningful level of the substance per serving compared to the 
recommended intake of the substance from all food sources. In the 
case of this final rule, there is no DV for -glucan soluble 
fiber or soluble fiber.
(62 FR 3584 at 3592).
The agency had also indicated in the soluble fiber from whole oat final 
rule that it intends to propose to establish a Daily Reference Value 
(DRV) for soluble fiber (62 FR 3584 at 3588). The establishment of a 
DRV for soluble fiber would not only permit claims for ``good source'' 
and ``high'' in soluble fiber, but would allow the agency to consider 
amendments to Sec. 101.81 to establish a single qualifying level for 
soluble fiber from all eligible soluble fiber sources that would be 
effective in lowering cholesterol. Available scientific evidence 
suggests that there are a variety of soluble fibers in foods that may 
demonstrate the benefit. Thus, smaller dietary contributions from any 
one source could be appropriate given the potential for multiple 
sources of such fibers.
    A DRV for soluble fiber would establish a qualifying level for 
soluble fiber blends in a food that would be effective in lowering 
cholesterol in hypercholesterolemic individuals. However, in the 
absence of a DRV for soluble fiber, the qualifying criteria for the 
eligible sources of soluble fiber in this health claim must be based on 
the scientific evidence specific for each soluble fiber source. The 
agency intends to amend Sec. 101.81 to revise the qualifying levels of 
soluble fibers when a DRV for soluble dietary fiber has been 
established.
    The agency notes that existing Sec. 101.81(d)(6) provides for an 
optional statement informing consumers of the level of daily intake of 
-glucan from whole oats that may help reduce the risk of CHD 
and the contribution that one serving of the product makes to this 
specified intake level. However, when issuing the soluble fiber from 
whole oats and reduced risk of CHD health claim, FDA inadvertently 
overlooked the requirement in Sec. 101.14(d)(2)(vii) of the general 
requirements for health claims. That section states that if the claim 
is about the effects of consuming the substance at other than decreased 
levels, and if no definition for ``high'' has been established (e.g., 
where the claim pertains to a food either as a whole food or as an 
ingredient in another food), the claim must specify the daily dietary 
intake necessary to achieve the claimed effect, as established in the 
regulation authorizing the claim.
    As stated, FDA has not established a DRV for soluble fiber. As a 
result, the term ``high'' is not defined for soluble fiber. Therefore, 
consistent with Sec. 101.14(d)(2)(vii), a claim for soluble fiber from 
whole oats requires specification of the daily dietary intake from 
whole oats (3 g or more per day of -glucan soluble fiber from 
whole oats) necessary to achieve a reduction in the risk of CHD. This 
requirement is independent of the optional statement provided in 
Sec. 101.81(d)(6).
    When discussing the optional statement under Sec. 101.81(d)(6) in 
the soluble fiber from whole oats final rule, FDA stated that when the 
amount of soluble fiber to be consumed per day is stated, the amount 
per serving is also needed so that consumers would not be misled to 
believe that a serving of the food contributes the full daily amount 
(62 FR 3584 at 3596). Therefore, to be consistent with the current 
regulation in Sec. 101.14(d)(2)(vii) and with the need to specify the 
amount of soluble fiber that a serving of food contributes when the 
daily dietary intake is specified in the claim, the agency is 
requiring, under Sec. 101.81(c)(2)(i)(G), that this information be 
included in a health claim for both whole oats and psyllium husk 
soluble fiber claims. However, because FDA did not note this 
requirement in the soluble fiber from whole oats final rule, firms 
currently marketing foods that bear the health claim for whole oats may 
wait until the next printing of their food labels and labeling for such 
foods to incorporate this added information.
    Therefore, the agency is adding Sec. 101.81(c)(2)(i)(G) in this 
final rule to clarify current regulatory requirements. Existing 
Sec. 101.81(d)(6), which provides for the same information for whole 
oats as an optional statement, is being removed. Accordingly, 
Sec. 101.81(c)(2)(i)(G) states that the claim shall specify that an 
intake of 7 g or more per day of soluble fiber from psyllium seed husk, 
or an intake of 3 g or more per day of -glucan soluble fiber 
from whole oats may help reduce the risk of CHD. Such a claim must be 
accompanied by information on the contribution that one serving of the 
product makes to the specified daily dietary intake level. Any foods 
containing psyllium seed husk, or whole oats, and bearing the health 
claim are required to include this information as part of the claim.
3. Blends of Eligible Soluble Fibers
    In the psyllium husk proposed rule, the agency noted that foods 
might be produced with a blend of the eligible soluble fibers listed in 
Sec. 101.81(c)(2)(ii) and stated that it would be willing to consider 
whether such foods should be eligible to bear the health claim (62 FR 
28234 at 28240). However, the agency stated that it does not have the 
data from which to evaluate the relationship between consumption of 
foods

[[Page 8111]]

containing both psyllium and whole oats and risk of heart disease, and 
cannot assume that foods containing a blend of these grains would have 
the same ability to affect blood total- and LDL-cholesterol levels when 
compared to a product containing either whole oats or psyllium. In the 
proposal, the agency encouraged manufacturers to petition to amend 
Sec. 101.81 further if it can be demonstrated that a diet that is low 
in saturated fat and cholesterol that includes a blend of the eligible 
soluble fibers listed in Sec. 101.81(c)(2)(ii) has an effect on the 
risk of heart disease.
(Comment 11)
    One comment agreed with the agency's tentative conclusion not to 
include blends of the eligible soluble fibers at this time. The comment 
stated that data should be submitted to verify the effectiveness of any 
soluble fiber blend.
    The agency agrees that data are needed to verify the effectiveness 
of blends of soluble fiber. In the absence of a review of such data, 
FDA is not including the option of a blend of the eligible soluble 
fibers listed in Sec. 101.81(c)(2)(ii) in this final rule. While some 
studies submitted to the agency did evaluate the usefulness of soluble 
fiber mixtures in lowering blood cholesterol levels, they were outside 
the scope of this rulemaking, which pertains to the effects of soluble 
fiber from psyllium alone. As a result, time and resource constraints 
did not allow for an indepth review of how blends of eligible soluble 
fibers might work in synergy with one another. Such a task would better 
be addressed as a part of rulemaking to establish a DRV for soluble 
fiber and a review of qualifying levels.

F. Soluble Fiber From Certain Foods and From Eligible Food Sources

    In the psyllium husk proposed rule, the agency proposed to modify 
the section heading of 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'' (62 FR 28234 at 28241). The 
agency stated that:
    ``soluble fiber from certain foods'' reflects the fact that the 
subject of the claim is no longer a specific source of soluble 
fiber, i.e., beta-glucan from whole oats, but rather a broader class 
of substances that includes those sources of soluble fiber for which 
there is significant scientific agreement that they may help to 
reduce the risk of heart disease.
(62 FR 28234 at 28241).
The agency also proposed to revise the statement ``soluble fiber from 
whole oats'' in Sec. 101.81(a), (a)(3), (b), (b)(2), (c)(2)(i), 
(c)(2)(i)(A), (d)(3), and (e) to state ``soluble fiber from certain 
foods,'' and in Sec. 101.81(c)(2)(i)(E), (c)(2)(i)(F), and (d)(2) to 
read ``soluble fiber from the eligible food sources from paragraph 
(c)(2)(ii) of this section'' (62 FR 28234 at 28241).
(Comment 12)
    The agency received one comment that raised issues relative to the 
agency's decision to modify the soluble fiber from whole oats and CHD 
rule to a claim on soluble fiber from certain foods. This comment 
argued that the final rule for Sec. 101.81 inappropriately refocused 
this claim from ``whole oats'' to ``soluble fiber from whole oats'' and 
heart disease. The comment asserted that -glucan was included 
in the whole oats proposed rule only as a quantitative measure of whole 
oats for compliance purposes. This comment further argued that because 
the eligible source of -glucan soluble fiber is whole oat 
products whereas the eligible source of psyllium soluble fiber is an 
isolated fiber-rich fraction (e.g., husk) separated from the whole 
psyllium seed, these substances should not be combined in one 
regulation.
    The agency disagrees that the focus of Sec. 101.81 should be whole 
oats. The rationale for positioning this claim as a soluble fiber claim 
was explained in the soluble fiber from whole oats final rule (62 FR 
3584 at 3585).

G. Issues Relative to the Safety of Psyllium Seed Husk

    Prior to submitting the health claim petition, the petitioner had 
petitioned FDA to affirm that the use of psyllium seed husk in grain-
based foods is GRAS (55 FR 4481, February 8, 1990). In the psyllium 
husk proposed rule, the agency noted that although FDA has reached no 
decision on the GRAS affirmation for the use of this substance, the 
petition appears to contain evidence that the use of psyllium seed husk 
at levels necessary to justify a claim is safe and lawful, as required 
by Sec. 101.14(b)(3)(ii) (62 FR 28234 at 28236). However, the agency 
indicated that there are some public safety concerns with the 
consumption of psyllium seed husk (e.g., colonic epithelial cell 
proliferation, allergenicity, and gastrointestinal obstruction). The 
agency asked for comments on whether these concerns would be a basis 
for not authorizing the proposed health claim. The agency also 
recognized that an increase in psyllium consumption is likely if the 
proposed health claim is authorized (62 FR 28234 at 28236). Therefore, 
the agency asked for comments on what type of actions may be necessary 
to ensure that long-term consumption of psyllium seed husk will be at 
safe levels, e.g., limiting psyllium husk content of foods or the kinds 
of foods that can bear a claim.
1. Restrictions on Psyllium Husk Content of Foods or on Types of Foods 
That Can Bear a Claim.
(Comment 13)
    FDA received several comments regarding the safety of psyllium 
husk-containing foods. Some comments stated that psyllium husk has a 
long history of safe human consumption as a laxative product at the 
intake level upon which the qualifying food level of psyllium husk is 
based. Furthermore, the comments noted that prior authoritative reviews 
of the safety of psyllium husk in food, such as the 1993 LSRO 
evaluation of the safety of psyllium seed husk as a food ingredient 
(Ref. 39), concluded that there were no grounds to suggest that 
consumption of as much as 25 g/d of psyllium husk would be a hazard to 
the public. These comments argued that therefore it is unnecessary for 
FDA to restrict the types of psyllium husk-containing food products, 
the amount of psyllium husk that may be in a food product, or the 
amount of psyllium husk that should be consumed per day as conditions 
for use of the soluble fiber from psyllium husk health claim. Other 
comments asserted that there is inadequate information about limits of 
how much psyllium husk can be incorporated into foods, or about safe 
levels of intake for long-term consumption. These comments argued that 
there should be limits placed on permissible levels of psyllium husk in 
foods and types of foods to which psyllium husk may be added. One 
comment suggested that psyllium husk-containing foods be required to 
bear a label statement warning consumers of the maximum amount of 
psyllium husk that should be consumed per day.
    FDA agrees that there is a history of human oral consumption of 
psyllium husk, both in food and over-the-counter (OTC) products, at the 
daily intake level contemplated for this health claim. The daily intake 
of psyllium husk that FDA has concluded is effective in reducing CHD 
risk (10.2 g psyllium husk, which is the amount of psyllium husk that 
is necessary to provide 7 g of soluble fiber) is well below the daily 
intake level that the 1993 LSRO psyllium husk report (Ref. 39) 
concluded was safe (i.e., 25 g psyllium husk). FDA does not expect 
authorization of the health claim to result in potential psyllium husk 
consumption exceeding this safe level.
    The 1993 LSRO report based its calculation of the potential daily 
intake of psyllium husk, for a consumer preferentially selecting 
products containing psyllium husk, on the

[[Page 8112]]

selection of four servings of psyllium husk-containing foods per day. 
FDA considers four servings per day to be a reasonable estimate of 
consumption for several reasons.
    First, consumers who are looking for foods that are identified as 
useful in reducing risk of CHD need not seek only psyllium-husk 
containing foods. They will also be able to select from foods that use 
the health claims approved for foods low in saturated fat and 
cholesterol (Sec. 101.75 (21 CFR 101.75)); for fruits, vegetables, and 
grain products that contain fiber, particularly soluble fiber 
(Sec. 101.77); and for foods containing soluble fiber from whole oats 
(Sec. 101.81).
    Second, many types of frequently-consumed foods will not offer 
psyllium husk-containing alternatives. For example, foods such as raw 
meat, fish, and poultry; eggs; fats and oils; nuts and seeds; and raw 
fruits and vegetables are not suitable candidates for the addition of 
psyllium husk. In addition, technological or organoleptic effects of 
the use of psyllium husk at levels needed to make a health claim will 
limit its use in other categories of foods.
    Third, because the subject health claim is only allowed on foods 
that are low in fat, saturated fat, and cholesterol, not all foods to 
which psyllium husk could be feasibly be added would be eligible to 
bear a health claim. Thus, there would be no incentive for a 
manufacturer to add psyllium husk to such foods, other than at the 
small amounts that may be used for technological purposes (e.g., 
emulsifiers or binders).
    Lastly, most of the new psyllium husk-containing foods that are 
expected to be developed are grain-based and as such are often used as 
alternates for one another in usual dietary patterns (e.g., cereals, 
breakfast bars, toaster pastries, rolls, biscuits, pancakes, or waffles 
served at breakfast).
    For the mentioned reasons, FDA, in evaluating this health claim, 
considers the selection of four servings of psyllium husk-containing 
foods per day to be a reasonable expectation of consumption when 
considering the possible use of psyllium husk in all food categories.
    Estimation of the potential daily intake of psyllium husk is also 
dependent upon the amount of the ingredient in each food. In the 1993 
LSRO report, maximum levels of use were reported as designated by the 
Kellogg Co. at 7.5 percent by weight for bread-based products (e.g., 
bread, rolls, muffins, doughnuts, biscuits, tortillas, waffles, 
pancakes, pizza crust and stuffing), pasta, and toaster pastries. In 
addition, the maximum levels of use were reported to be 10 percent by 
weight for breakfast bars, and 15 percent by weight for ready-to-eat 
cereals (Ref. 39). Assuming the highest maximum level of use, 15 
percent in ready-to-eat cereals, the consumption of four 30 g servings 
(i.e., the reference amount customarily consumed for high fiber cereals 
(Sec. 101.12(b) Table 2)) would result in a daily intake of 18 g (30 g 
multiplied by 15 percent = 4.5 g/serving, multiply by 4 servings = 18 
g/d). Moreover, any technological uses of psyllium husk in foods are at 
such low levels (e.g., 0.5 percent in frozen desserts) that they are 
not likely to have a notable impact on total daily intake.
    A total daily intake of 18 g is within the range of intakes 
considered safe in the 1993 LSRO report (i.e., up to 25 g/d) (Ref. 39). 
However, FDA expects that actual consumption will be less than this 
amount because the maximum use levels were designated prior to the 
agency's establishment of the health claim qualifying level. FDA 
expects that manufacturers who develop new psyllium husk-containing 
foods would do so to make use of the health claim. As such, the health 
claim qualifying level (i.e., 2.6 g per reference amount) would be a 
major factor in determining the amount of psyllium husk to include in 
new psyllium husk-containing foods.
    Based on these considerations, the agency disagrees with the 
comments that argued that limits should be placed on permissible levels 
of psyllium husk in foods or on the types of foods to which psyllium 
husk may be added. Therefore, no changes are being made to 
Sec. 101.81(c)(iii)(A)(2) that describes the nature of the food.
    As noted in the psyllium husk proposed rule (62 FR 28234 at 28235), 
a preliminary review of the petitioner's GRAS affirmation petition 
revealed that it contains significant evidence supporting the safety of 
the consumption of up to 25 g/d of psyllium husk in a variety of food 
categories (i.e., types of foods). This amount is well in excess of the 
levels necessary to justify a health claim (i.e., 10.2 g/d) and the 
amounts that would reasonably be expected to be consumed in a day. 
Accordingly, based on the totality of the evidence, FDA is not at this 
time taking issue with the petitioner's view that the use of psyllium 
husk is safe and lawful. Therefore, the agency concludes that the 
petitioner has provided evidence that satisfies the requirements in 
Sec. 101.14(b)(3)(ii) that psyllium seed husk at the levels necessary 
to justify a claim is safe and lawful.
(Comment 14)
    Several comments discussed evidence from animal studies suggesting 
that the relationship between effects of dietary fiber on rodent 
colonic mucosal proliferation and the development of neoplasia is 
unclear. These comments stated that colonic epithelial cell 
proliferation is not a significant issue relative to the safety of 
psyllium seed husk as there is no consensus as to whether epithelial 
cell proliferation in rodent colonic mucosa is relevant to risk of 
colon cancer. Some comments noted that colonic epithelial cell 
proliferation is an issue of concern that needs additional research.
    The agency agrees that colonic epithelial proliferation is not 
sufficiently validated as a reliable endpoint for prediction of colon 
tumorigenesis. While the rate of epithelial cell proliferation in the 
rodent gastrointestinal tract has been reported to be increased by some 
soluble dietary fibers and decreased by some insoluble dietary fibers, 
there is no evidence upon which to conclude that the influence of 
dietary fiber on the rate of epithelial proliferation is either adverse 
or beneficial. Whether psyllium husk influences colonic epithelial cell 
proliferation in humans as it does in rodents is unknown. Although 
enhanced cellular proliferation is associated with the neoplastic 
process, proliferation rates have been reported to be variably 
influenced by a number of dietary constituents and other exogenous and 
endogenous factors, and a significant overlap in proliferation rates 
between subjects at high and low risk of colon cancer has been observed 
(Ref. 40). Therefore, the agency concludes that the issue of epithelial 
cell proliferation is not a basis on which to deny this health claim.
2. Allergic Potential of Psyllium Husk
    In the psyllium husk proposed rule, the agency acknowledged reports 
of allergic reactions from consumption of psyllium husk-containing 
food. The majority of these reports involved ingestion of a cereal made 
with psyllium husk of less than 95 percent

[[Page 8113]]

purity. Because information provided by the petitioner suggested that 
the purity of the psyllium husk is inversely related to its 
allergenicity, FDA proposed a purity criterion for psyllium husk to be 
eligible for the claim. Under comment 8 in section II.D.1 of this 
document, the agency stated that psyllium husk purity specifications of 
proposed Sec. 101.81(c)(2)(ii)(B)(1) are being adopted in the final 
rule.
(Comment 15)
    Two comments stated that the declaration of an ingredient in the 
ingredient list of the food label is sufficient labeling to alert 
consumers to the presence of allergenic components in foods and that 
additional labeling is unnecessary. Other comments stated that in 
consideration of the allergic potential of psyllium, the presence of 
psyllium husk in a food should be declared on the principal display 
panel in addition to the ingredient declaration.
    Some comments agreed with the proposed husk purity specifications 
as an adequate means of reducing the potential for allergic responses. 
One comment explained that the major source of allergenic proteins in 
psyllium seed husk is from residual portions of the whole seed. The 
comment stated that the removal of the inner seed portions leaves a 
very low level of residual protein in 95 percent purity psyllium husk 
and thus, the potential for serious allergic reactions would be rare. 
However, the comment also suggested that a label statement with an 
appropriate caution as to the risk for allergic reactions would provide 
added assurances for consumers. Still other comments argued that the 
proposed purity standards for psyllium seed husk will not eliminate the 
risk for allergic reactions to psyllium husk-containing foods and as 
such, a cautionary statement alerting consumers to the risk of allergic 
reactions should be required labeling. None of the comments provided 
data.
    The agency is not convinced by these comments that labeling, other 
than declaration in the ingredient statement when psyllium husk is 
added as a food ingredient, is necessary because of psyllium's allergic 
potential. The agency recognizes the possibility of isolated cases of 
allergic reactions to ingested allergenic substances in foods or food 
components, including psyllium seed husk. However, the agency believes 
that the declaration of the allergenic substance in the ingredient list 
on the food label provides adequate information for consumers regarding 
the presence of allergenic ingredients in food products. Psyllium seed 
husk is required to be declared in the ingredient statement of a food 
to which it is added. The agency has no basis for concluding that 
additional labeling requirements for the use of this health claim would 
have an impact on reducing the potential for allergic reactions from 
consumption of psyllium husk-containing foods. The agency would not 
object to any additional truthful, nonmisleading information regarding 
allergenicity that a manufacturer may wish to include on the food 
label.
3. Gastrointestinal Obstruction
    In the psyllium proposed rule, the agency discussed the potential 
for esophageal and gastrointestinal obstructions to occur following 
consumption of psyllium seed husk when not consumed with sufficient 
liquid (62 FR 28234 at 28236). The agency noted that the LSRO expert 
panel (Ref. 39) reported that esophageal and gastrointestinal 
obstruction due to psyllium seed husk was associated almost exclusively 
with consumption without proper hydration of bulk-forming fiber 
laxatives and not with consumption of psyllium-containing cereal 
consumed with milk (62 FR 28234 at 28236). Comments were requested on 
whether psyllium husk-containing foods should carry a statement 
advising that the product be consumed with liquids, or whether the 
potential for blockage is not an issue of concern for psyllium husk-
containing food (62 FR 28234 at 28236).
(Comment 16)
    Several comments discussed the potential for esophageal and 
gastrointestinal obstructions from consumption of psyllium husk without 
sufficient liquid. These comments recommended that the agency adopt 
labeling requirements for psyllium husk-containing foods advising 
consumers to drink adequate fluids when consuming such foods. Some of 
these comments suggested that such statements be similar to those 
required under Sec. 201.319 (21 CFR 201.319) (Warning Statements 
Required for Over-the-Counter Drugs Containing Water-Soluble Gums as 
Active Ingredients (58 FR 45194, August 26, 1993)) for OTC products to 
ensure consumers are aware of the consequences of inadequate hydration. 
In general, these comments justified their recommendations on the basis 
that authorization of the proposed health claim would encourage 
incorporation of psyllium seed husk into additional types of foods, and 
that these new food products containing significant amounts of psyllium 
seed husk will not necessarily be intended to be consumed with liquids. 
One comment asserted that a label statement advising the consumption of 
the psyllium husk-containing food with liquids is unnecessary because 
psyllium husk-containing foods would be consumed at meals when it is 
likely that sufficient liquid would also be consumed. The comment 
argued that the soluble fiber in psyllium husk-containing foods is 
already hydrated, which would reduce its ability to swell in the 
gastrointestinal tract. This comment further noted that the 1993 LSRO 
report on the safety of using psyllium seed husk as a food ingredient 
(Ref. 39) found no safety issues in this regard. None of the comments 
provided data.
    The agency agrees with comments suggesting that authorization of a 
claim for soluble fiber from psyllium husk and risk of CHD may lead to 
an increase in the number and type of foods containing psyllium husk. 
Moreover, the agency agrees that there are no assurances that new 
psyllium husk-containing foods are likely to be consumed at meals or 
with liquids. Foods such as cookies, breakfast bars, and toaster 
pastries may be consumed as snacks at times when a liquid is not 
consumed. Psyllium husk could also be incorporated into dietary 
supplement products that may be consumed apart from meals. The comment 
that stated that the psyllium seed husk in foods is already hydrated, 
which would affect its ability to swell in the gastrointestinal tract, 
provided no data to document or with which to evaluate differences in 
the swell volume and rate of swelling of different psyllium husk-
containing foods.
    The LSRO expert panel that considered the safety of psyllium seed 
husk used as a food ingredient (Ref. 39) concluded that the moderate 
amounts of psyllium seed husk that are likely to be used in toaster 
pastries, bread-based products, breakfast bars, pasta, and cereals 
would not be expected to cause gastrointestinal obstruction. However, 
this panel further concluded that the possibility of obstruction would 
be reduced by suitable suggestions that these products be consumed with 
fluids.
    The agency addressed the risk of esophageal obstruction by water 
soluble gums (including psyllium husk) in an advance notice of proposed 
rulemaking to establish a monograph for OTC laxative, antidiarrheal, 
emetic, and antiemetic drug products (40 FR 12902, March 21, 1975). The 
agency discussed in the final rule the evidence of at least 191 cases 
of esophageal obstruction and 8 cases of asphyxia, resulting in 18 
deaths, associated with orally-administered OTC laxative and weight 
control products containing a variety of

[[Page 8114]]

water soluble gums (58 FR 45194 at 45195). The agency concluded that 
there is a risk that these types of products will swell to form a 
viscous adhesive mass (i.e., viscous gel) that can block the throat or 
esophagus. Because of this risk, the agency requires warning and 
direction statements for OTC drug products containing water soluble 
gums, including psyllium husk, as active ingredients when these 
products are marketed in a dry or partially hydrated form 
(Sec. 201.319). Fully hydrated water soluble gums were acknowledged to 
not pose any significant risk of causing esophageal obstruction (58 FR 
45194 at 45196).
    In the final rule on ``Warning Statements Required for OTC Products 
Containing Water-Soluble Gums as Active Ingredients,'' the agency 
stated that it will continue to evaluate the use of water-soluble gums 
in any product marketed for human consumption, food or drug, and 
appropriate warnings will be proposed if a need to do so is found (58 
FR 45194 at 45196).
    The agency anticipates that authorization of a health claim for 
soluble fiber from psyllium husk may result in an increase of both the 
type and number of foods containing psyllium husk, and that foods 
eligible to bear the psyllium husk health claim will contain amounts of 
psyllium husk comparable to that commonly found in OTC laxative drugs. 
However, the agency recognizes that there are inherent differences 
between foods in conventional food form, which contain other food 
ingredients such as salt, sugar, and flour in addition to psyllium 
husk, and OTC drug products that would influence the likelihood of 
esophageal obstruction occurring from the ingestion of psyllium husk-
containing foods. For example, drug products are formulated in tablets, 
capsules, and powders that are usually intended to be ingested and 
swallowed as a single bolus, whereas a serving of food is not swallowed 
as a single bolus, but eaten in several bites, chewed, and swallowed 
over a period of time. Psyllium husk-containing conventional foods also 
differ from drug products in that the psyllium husk in a food in 
conventional food form is dispersed within a larger volume of other 
food components (e.g., sugars, salt, wheat flour, egg). Dispersion in 
other ingredients prevents the soluble fiber of psyllium husk from 
physically associating to form a gel network (i.e., a viscous adhesive 
mass) (Refs. 41 and 42). Because a strong gel network is not formed due 
to the presence of these other ingredients, the food product will swell 
and thicken in a similar fashion to other high fiber foods (e.g., 
ready-to-eat cereals), without forming a viscous mass capable of 
causing obstruction (Ref. 42). The agency believes that, because the 
composition and manner of consumption of psyllium husk-containing 
conventional foods, unlike OTC products, inhibit the formation of a 
viscous gel in the esophagus, the label requirements for OTC drug 
products may not be applicable to certain foods containing psyllium 
husk that bear a health claim.
    Section 201(n) of the act (21 U.S.C. 321(n)) states that, in 
determining whether labeling is misleading, the agency shall take into 
account not only representations made about the product, but also the 
extent to which the labeling fails to reveal facts material in light of 
such representations made or suggested in the labeling or material with 
respect to consequences which may result from use of the article to 
which the labeling relates under the conditions of use as are customary 
or usual (see 21 CFR 1.21). Thus, the omission of certain material 
facts from the label or labeling on a food causes the product to be 
misbranded within the meaning of sections 403(a)(1) and 201(m) of the 
act (21 U.S.C. 343(a)(1)).
    As discussed out in the final rule on warning statements for OTC 
products (58 FR 45194), esophageal obstruction and asphyxiation are 
potential health risks associated with the oral consumption of dry or 
incompletely hydrated psyllium husk when these products are ingested 
without adequate fluid or when they are used by individuals with 
esophageal narrowing or dysfunction, or with difficulty swallowing. 
There is the possibility that esophageal obstruction and choking from 
ingestion of psyllium husk-containing food would be a consequence of 
extending the food use of psyllium husk to certain types of food 
products, such as those that are predominately composed of psyllium 
husk. Therefore, FDA has determined that the potential for esophageal 
blockage from not consuming adequate amounts of fluids when consuming 
certain types of dry or incompletely hydrated psyllium husk-containing 
food is a material fact.
    The agency concludes that it would be misleading under section 
201(n) of the act for certain foods to contain dry or incompletely 
hydrated psyllium husk without a label statement relative to potential 
risks and concerns for adequate fluid intake. Therefore, in this final 
rule FDA is amending its regulations to require a statement 
[hereinafter ``label statement''] to inform consumers of the potential 
consequence if the psyllium husk-containing food is not consumed 
appropriately, to inform consumers of the action necessary to avoid the 
consequence, and to advise persons with swallowing difficulties to 
avoid consumption of the product.
    Because the concern for esophageal obstruction exists whether or 
not the food bears a health claim, FDA is codifying the need for the 
required label statement in Sec. 101.17 Food labeling warning and 
notice statements (21 CFR 101.17) rather than in the health claim 
regulation. The required label statement is also reflected in 
Sec. 101.81(c)(1). Accordingly, FDA is adding paragraph (f)(1) to 
Sec. 101.17 to specify that when dry or incompletely hydrated psyllium 
husk is present in a food and the food bears a health claim, the label 
must include a statement such as:
    The food should be eaten with at least a full glass of liquid. 
Eating this product without enough liquid may cause choking. Do not 
eat this product if you have difficulty swallowing.
    In the psyllium proposed rule, the agency had specifically 
requested comments on whether psyllium husk-containing foods should 
carry a statement advising that the product be consumed with liquids. 
However, the agency had not suggested that it was considering requiring 
labeling for all psyllium husk-containing foods regardless of whether 
the food label bears a health claim statement. Therefore, FDA is not 
attempting, in this final rule, to extend the required statement to 
psyllium husk-containing foods not subject to this rulemaking, i.e., 
foods not bearing a health claim. Instead, the agency plans to propose, 
in a separate rulemaking, that the required label statement be extended 
to other psyllium husk-containing foods that do not bear a health 
claim.
    However, as discussed previously, the agency recognizes that there 
are factors that suggest that the formation of a viscous adhesive mass, 
which is associated with a risk of choking, does not result from 
consumption of certain psyllium husk-containing foods that are in a 
conventional food form. Therefore, the agency believes that certain dry 
or incompletely hydrated conventional food products, i.e., those that 
do not form a viscous adhesive mass under usual conditions of use, 
would not require the label statement. The agency believes that an 
exemption from the label statement should be available to firms when a 
viscous adhesive mass is not formed when the product is exposed to 
fluids so that the product poses no greater risk to the consumer than a 
comparable product without psyllium husk. The agency does not currently

[[Page 8115]]

have data or information on which it could base such an exemption for 
specific conventional food products. Moreover, because FDA, under 
Sec. 101.70(j)(4)(i), is obligated to publish this final rule within 
the time limitation established for issuing final rules for health 
claim proceedings, the agency is unable, in this final rule, to specify 
the conditions under which exemptions to the label statement for 
certain conventional food products are warranted. Consequently, the 
agency will provide firms that seek such an exemption with guidance as 
to what would be necessary to demonstrate that such an exemption to the 
label statement is warranted. The agency will further evaluate the need 
for the label statement on specific types of psyllium husk-containing 
foods that bear a health claim in the separate rulemaking that will 
address the extension of the label statement to psyllium husk-
containing foods that do not bear a health claim. If the agency 
challenges a firm's determination that its conventional food product is 
entitled to the exemption in Sec. 101.17(f)(1), and as a result is not 
misbranded within the meaning of section 201(n) of the act without such 
label statement, the agency will evaluate the basis for the firm's 
exemption on a case-by-case basis.
    Section 403(f) of the act requires that mandatory label information 
be prominently placed on the label with such conspicuousness (compared 
with other words, statements, designs, or devices in the labeling) as 
to render it likely to be read and understood by the ordinary 
individual under customary conditions of use. FDA has generally 
considered the label information panel to be the appropriate location 
for notice and warning statements. As discussed in the agency's 
rulemaking requiring warning statements on iron-containing dietary 
supplements (62 FR 2218, January 15, 1997), consumer focus group 
studies establish that a warning statement need not be placed on the 
principal display panel (PDP) to be effective in informing consumers of 
the hazard. Participants in the focus groups reasoned that the front of 
the product package was used for marketing purposes and stated that 
they were accustomed to looking at the ``back of products'' for 
nutrition and factual information, including warning statements (Ref. 
43). Consequently, in the case of iron-containing dietary supplements, 
the agency required that the warning statement appear on the 
information panel.
    The agency believes that for the required label statements on 
psyllium husk-containing products, the requirement for prominence and 
conspicuousness would similarly be met if the statements appeared on 
the information panel. However, the agency would not object to firms 
placing the required statement on the PDP, because the PDP would 
provide even greater prominence. Accordingly, FDA is requiring in 
Sec. 101.17(f)(2) that the required statement for psyllium husk-
containing foods appear either on the product information panel or on 
the PDP.
    The requirement in the act for prominent display means that the 
required label statement must appear in a manner that makes it readily 
observable and likely to be read. The agency notes that 21 CFR 101.2(c) 
requires that mandatory information appearing on the PDP and 
information panel, including information required by Sec. 101.17, 
appear prominently and conspicuously in a type size no less than one-
sixteenth inch.
    In addition, current agency regulations that require a ``warning'' 
statement on the product label or in labeling (e.g., the statement 
required by Sec. 101.17(e) on iron-containing dietary supplements in 
solid oral dosage form) or a label ``notice'' statement (e.g., the 
statement required by Sec. 101.17(d)(3) on protein products that are 
not covered by the requirements of Sec. 101.17(d)(1) and (d)(2)) 
require that the identifying term ``WARNING'' or ``NOTICE'' be 
capitalized and immediately precede the language of the applicable 
labeling statement. Based on FDA's experience in rulemaking pertaining 
to warning statements on protein products (47 FR 25379, June 11, 1982), 
as the severity of the consequences lessens, the severity of the 
warning may also lessen. Therefore, the agency considers the term 
``NOTICE'' to be appropriate to alert consumers to the label statement. 
Accordingly, the agency is requiring in Sec. 101.17(f)(2) that the 
capitalized word ``NOTICE'' immediately precede the required elements 
of the label statement.
4. Laxative effects
(Comment 17)
    One comment noted that psyllium husk is primarily consumed for its 
laxative effect. This comment asserted that the label and labeling of 
psyllium husk-containing foods should inform consumers about the 
adverse effects of consuming excess amounts of psyllium by including a 
disclosure statement such as ``Consumption of psyllium in excess of --
-- mg may cause diarrhea.'' Other comments noted that intake of 
psyllium-containing foods is self-limiting due to satiety and laxative 
effects.
    FDA disagrees that the possible effects on bowel function of 
consuming 10 g/d of psyllium seed husk in foods would be considered as 
causing diarrhea or an adverse health consequence. Diarrhea is 
characterized by loose, watery bowel movements. The water-holding 
capacity and bulking effect of undigested soluble fiber from psyllium 
husk softens colonic contents and stimulates peristalsis, both of which 
facilitate movement of the colonic contents. Ingestion of psyllium husk 
does not lead to diarrhea. The expected effect of the use of bulk-
forming fiber laxatives is an increase in stool volume and frequency of 
bowel movements. There is no reason to consider that a daily intake of 
10 g of psyllium seed husk as a component of food would have any effect 
on the bowel other than to promote normal functioning by softening 
fecal contents and increasing fecal volume. Because the daily intake of 
psyllium seed husk that is approved for this health claim is the same 
customary daily intake when used as a laxative, amounts in excess of 
that required for laxation are not needed to obtain potential benefits, 
in reduced risk of CHD, from consumption of psyllium seed husk. 
Moreover, consumption in excess of 10.2 g/d of psyllium seed husk would 
not be expected to result in diarrhea because intake of psyllium husk 
increases stool volume and frequency of bowel movements. Softening of 
fecal contents is not diarrhea and does not represent an adverse health 
effect as suggested by the comment. Therefore, the agency finds that 
there is no basis on which to require, as suggested by the comment, a 
warning statement to alert consumers about possible adverse effects 
from consuming psyllium husk-containing foods.

H. General Health Claim Issues

1. Health claims for substances with OTC drug uses.
(Comment 18)
     One comment stated that approving a claim on a product that 
incorporates an OTC drug into a food would set a precedent for allowing 
claims on ``functional foods,'' foods consumed primarily for their 
purported ability to prevent or treat disease. The comment stated that 
this was not the intent of Congress when it passed the 1990 amendments.
    FDA notes that bran, as well as psyllium husk, are listed as 
effective bulk-forming laxative active ingredients in the tentative 
final monograph on laxative drug products for OTC human use (50 FR 
2124, January 15, 1985) and that oat bran is also an eligible source of 
soluble fiber from whole oats for this

[[Page 8116]]

health claim. The fact that a substance also has uses as an OTC drug 
does not bear on its recognized status as a food. FDA notes that 
psyllium seed husk is a recognized source of dietary fiber and an 
established food ingredient. Therefore, the comment is not relevant to 
this rulemaking.
2. Food-Specific Health Claims
(Comment 19)
    Some comments stated that the proposed claim for a specific soluble 
fiber should not be authorized because claims for specific foods create 
the false impression that consumption of those foods is a more 
important factor than is the overall diet in reduction of risk of CHD. 
Other comments asserted that allowing health claims for individual 
substances portrays specific foods as panaceas or functional foods and 
undermines the purpose of the 1990 amendments. One comment expressed 
concern that claims about individual sources of dietary fiber are 
inconsistent with the important dietary guidance of choosing diets high 
in fruits, vegetables, whole grain foods, and other good sources of 
fiber. One comment stated that the proposed claim does not inform the 
consumer that frequent, long-term consumption of soluble fiber from 
psyllium husk is necessary to lower cholesterol levels.
    FDA addressed the issue of the appropriate subject of health claims 
in rulemaking leading to, and including, the January 6, 1993, final 
rule on general requirements for health claims (see 56 FR 60537 at 
60542, November 27, 1991; 58 FR 2478 at 2479, January 6, 1993). While 
some comments to proposed rulemaking maintained that health claims 
should only be permitted for nutrients listed in nutrition labeling, 
others argued that Congress intended claims to be authorized for foods 
as well as nutrients. Comments quoted private and public health 
organizations' testimony before Congress that health claims should 
reflect dietary recommendations about foods and ``should assist the 
public to integrate specific food products into a well balanced diet'' 
(58 FR 2478 at 2479). After extensive discussion, final rules 
implementing the 1990 amendments defined health claims as claims 
characterizing the relationship of any substance to a disease or 
health-related condition, and defined ``substance'' as a specific food 
or component of food (Sec. 101.14(a)(1) and (a)(2)). This permitted 
health claims to be established for both nutrients and foods.
    In the soluble fiber from whole oats final rule, the agency 
addressed comments that expressed concern that a claim on whole oat 
foods would portray the specific food as a ``magic bullet'' in reducing 
heart disease risk. This concern was ameliorated when the scientific 
evidence supported changing the subject of the claim to soluble fiber 
from whole oats. In addition, the importance of a total diet low in 
saturated fat and cholesterol to the nutrient/disease relationship was 
emphasized (62 FR 3584 at 3585 and 3590). FDA noted that diets low in 
saturated fat and cholesterol are considered by expert groups to be the 
most effective dietary means of reducing heart disease risk. The agency 
stated that while soluble fiber from whole oats contributes to this 
effect, its role is generally recognized as being of smaller magnitude 
(62 FR 3584 at 3590 and 3594).
    Likewise, the agency concludes that the concerns described 
previously that were raised in comments to the psyllium husk proposed 
rule are adequately addressed by the fact that a health claim on 
psyllium-containing foods will be required to state the subject of the 
claim as ``soluble fiber from psyllium husk'' and to describe the 
nutrient/disease relationship in the context of a diet low in saturated 
fat and cholesterol. The comment provided no evidence to suggest that 
health claims about specific foods or food ingredients will not 
encourage consumers to follow dietary recommendations to eat a varied 
diet containing other foods that are also good sources of fiber.
     FDA notes that the subject health claim, as is the case for all 
authorized health claims, requires that the claim be stated in the 
context of a daily diet. This is accomplished through specific 
requirements describing the nature of the claim, i.e., the relationship 
of the substance to the disease or health-related condition in 
paragraph (c)(2)(i) of each health claim regulation. These requirements 
are intended to show the nature of the relationship between the subject 
of the claim and the disease or health condition and to prevent any 
misunderstanding that health benefits will accrue from single or 
infrequent consumption of the subject nutrient or adherence to the 
suggested dietary regimen. Examples of such wording include 
``throughout life'' in the calcium/osteoporosis claim (21 CFR 101.72), 
``daily'' in the folate/neural tube defect claim (21 CFR 101.79), 
``diets low in fat * * *'' in health claims pertaining to cancer (21 
CFR 101.73, 101.76, and 101.78) and ``diets low in saturated fat and 
cholesterol * * *'' in health claims pertaining to heart disease 
(Secs. 101.75, 101.77, and 101.81). Therefore, the agency is making no 
changes in response to this comment.
    The preamble of the soluble fiber from whole oats health claim 
final rule considered the impact of the health claim on consumer 
perception of food label references to oats (62 FR 3584 at 3596). A 
comment had suggested that as consumers become aware of the 
relationship between soluble fiber from whole oats and reduced risk of 
CHD, statements such as ``made with oat bran'' would be an implied 
nutrient content or health claim. In response to this comment, FDA 
stated that it did not have information from which to conclude that 
terms such as ``oat bran,'' ``rolled oats,'' or ``whole oat flour'' are 
always in a context that constitutes an implied nutrient content or 
health claim, and as such FDA would continue its policy to evaluate the 
context of label statements on a case-by-case basis (62 FR 3584 at 
3597). The agency further noted that if experience with label 
statements about oat ingredients or other information persuades FDA 
that additional regulatory controls are needed, the agency can take 
action to establish appropriate regulations. The agency does not have 
reason at this time to change this policy.

III. Environmental Impact

    The agency has previously considered the environmental effects of 
this rule as announced in the psyllium husk proposed rule (62 FR 
28234). The proposed rule incorrectly cited a claim of categorical 
exclusion under previous 21 CFR 25.24(a)(11). The agency has 
determined, based on information contained in an environmental 
assessment prepared under previous 21 CFR 25.31a(b)(5), that this 
action has no significant impact on the environment and that an 
environmental impact statement is not required. No new information or 
comments have been received that would affect this determination. The 
agency's finding of no significant impact and the evidence supporting 
that finding, contained in an environmental assessment, may be seen in 
the Dockets Management Branch (address above) between 9 a.m. and 4 
p.m., Monday through Friday.

IV. Analysis of Economic Impacts

A. Benefit-Cost Analysis

    FDA has examined the impacts of the final rule under Executive 
Order 12866. Executive Order 12866 directs agencies to assess all costs 
and benefits of available regulatory alternatives and, when regulation 
is necessary, to select the regulatory approach that maximizes net 
benefits (including potential

[[Page 8117]]

economic, environmental, public health and safety effects; distributive 
impacts; and equity). According to Executive Order 12866, a rule is 
significant if it meets any one of a number of specified conditions, 
including having an annual effect on the economy of $100 million, 
adversely affecting in a material way a sector of the economy, 
competition, or jobs, or if it raises novel legal or policy issues. FDA 
finds that this rule is not a significant rule as defined by Executive 
Order 12866.
    In addition, FDA has determined that this rule does not constitute 
a significant rule under the Unfunded Mandates Reform Act of 1995 
requiring cost-benefit and other analyses. A significant rule is 
defined in section 1531(a) as ``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 (adjusted annually 
for inflation) in any 1 year * * *.''
    Finally, in accordance with the Small Business Regulatory 
Enforcement Fairness Act, the administrator of the Office of 
Information and Regulatory Affairs of the Office of Management and 
Budget has determined that this final rule is not a major rule for the 
purpose of Congressional review.
    The authorization of health claims about the relationship between 
soluble fiber from psyllium seed husk and CHD results in either costs 
or benefits only to the extent that food manufacturers elect to take 
advantage of the opportunity to use the claim. The authorization of the 
health claim will not require that any labels be redesigned, or that 
any product be reformulated. However, the labels of foods containing 
whole oats and bearing the health claim will require revision to 
specify the daily dietary intake of -glucan soluble fiber from 
whole oats necessary to achieve the claim effect. Because FDA is 
allowing firms to wait to incorporate this change with other regularly 
scheduled changes, this provision will not result in additional costs.
    This final health claim will allow manufacturers to highlight the 
benefits of soluble fiber from psyllium seed husk in addition to other 
eligible food sources of soluble fiber for which FDA has already 
approved a health claim. The benefit of establishing this health claim 
is to provide for new information in the market regarding the 
relationship between soluble fiber from psyllium seed husk and risk of 
heart disease and to provide consumers with the assurance that this 
information is truthful, not misleading, and scientifically valid.

B. Small Entity Analysis

    FDA has examined the impacts of the final rule under 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 agencies to analyze regulatory 
options that would minimize the economic impact of that rule on small 
entities.
    Small entities will incur costs only if they opt to take advantage 
of the marketing opportunity presented by this regulation. FDA cannot 
predict the number of small entities that will choose to use the claim. 
However, no firm, including small entities, will choose to bear the 
cost of redesigning labels unless they believe that the claim will 
result in increased sales of their product. Therefore, this rule will 
not result in either a decrease in revenues or a significant increase 
in costs to any small entity. Accordingly, under the Regulatory 
Flexibility Act, 5 U.S.C. 605(b), the agency certifies that this final 
rule will not have a significant economic impact on a substantial 
number of small entities.

V. Paperwork Reduction Act

    In the psyllium proposal, FDA stated its tentative conclusion that 
the proposed rule contained no information collection provisions 
necessitating clearance by the Office of Management and Budget (OMB) 
and asked for comments on whether the proposed rule imposed any 
paperwork burden. No comments addressing the question of paperwork 
burden were received. FDA has evaluated the final rule and concludes 
that it contains no information collection provisions. Although the 
final rule would amend Sec. 101.17 to require a label statement on 
foods containing psyllium husk and bearing a health claim, FDA is 
supplying the information that must be disclosed in the label 
statement. Therefore, the label statement is a ``public disclosure of 
information originally supplied by the Federal government to the 
recipient for purpose of disclosure to the public'' (5 CFR 1320(c)(2)); 
as such, it is not a ``collection of information'' subject to OMB 
review under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et 
seq.).

VI. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Kellogg Co., Kellogg's Bran Buds Cereal with natural wheat 
bran and psyllium (product packaging) Kellogg Co., Battle Creek, MI, 
1997.
    2. The U.S. Pharmacopeia (USP 23), The National Formulary (NF 
18), United States Pharmacopeial Convention, Inc., Rockville, MD, p. 
1341-1342, 1995.
    3. DHHS, Public Health Service (PHS), ``The Surgeon General's 
Report on Nutrition and Health,'' U.S. Government Printing Office, 
Washington, DC, pp. 83-137, 1988.
    4. Food and Nutrition Board, National Academy of Sciences, 
``Diet and Health: Implications for Reducing Chronic Disease Risk,'' 
National Academy Press, Washington, DC, pp. 291-309 and 529-547, 
1989.
    5. LSRO, FASEB, ``Physiological Effects and Health Consequences 
of Dietary Fiber,'' Bethesda, MD, 1987.
    6. LSRO, FASEB, ``Evaluation of Publicly Available Scientific 
Evidence Regarding Certain Nutrient-Disease Relationships: 6. 
Dietary Fiber and Cardiovascular Disease,'' Bethesda, MD, 1991.
    7. Saltsman, J., Memo to file with Table 1: ``Summary of 
Clinical Trials: Psyllium and CHD,'' and Table 2: ``Psyllium and 
CHD,'' Docket No. 96P-0338, Dockets Management Branch, January 28, 
1997.
    8. Abraham, Z. D. and T. Mehta, ``Three-Week Psyllium-Husk 
Supplementation: Effect on Plasma Cholesterol Concentrations, Fecal 
Steroid Excretion, and Carbohydrate Absorption in Men,'' American 
Journal of Clinical Nutrition, 47:67-74, 1988.
    9. Anderson, J. W., N. Zettwoch, T. Feldman, J. Tietyen-Clark, 
P. Oeltgen, and C. W. Bishop, ``Cholesterol-Lowering Effects of 
Psyllium Hydrophilic Mucilloid for Hypercholesterolemic Men,'' 
Archives of Internal Medicine, 148:292-296, 1988.
    10. Anderson, J. W, T. L. Floore, P. B. Geil, D. S. O'Neal, and 
T.K. Balm, ``Hypocholesterolemic Effects of Different Bulk-Forming 
Hydrophilic Fibers as Adjuncts to Dietary Therapy in Mild to 
Moderate Hypercholesterolemia,'' Archives of Internal Medicine, 
151:1597-1602, 1991.
    11. Anderson, J. W., S. Riddell-Mason, N. J. Gustafson, S. F. 
Smith, and M. Mackey, ``Cholesterol Lowering Effects of Psyllium-
Enriched Cereal as an Adjunct to a Prudent Diet in the Treatment of 
Mild to Moderate Hypercholesterolemia,'' American Journal of 
Clinical Nutrition, 56:93-98, 1992.
    12. Anderson, J. W., M. H. Davidson, L. Blonde, W. V. Brown, W. 
J. Howard, H. Ginsberg, L. D. Allgood, and K. W. Weingand, ``Long-
Term Cholesterol-Lowering Effects of Psyllium as an Adjunct to Diet 
Therapy in the Treatment of Hypercholesterolemia,'' Submitted to 
Family Medicine.
    13. Bell, L. P., K. Hectorne, H. Reynolds, T. K. Balm, and D. B. 
Hunninghake, ``Cholesterol-lowering Effects of Psyllium Hydrophilic 
Mucilloid--adjunct Therapy to a Prudent Diet for Patients With Mild 
to Moderate Hypocholesterolemia,'' Journal of the American Medical 
Association (JAMA), 261:3419-23, 1989.
    14. Davidson, M. H., K. C. Maki, J. C. Kong, L. D. Dugan, S. A. 
Torri, H. H. Hall, K. B.

[[Page 8118]]

Drennan, S. Anderson, V. Fulgoni, L. Saldanha, and B. Olson, ``Long-
Term Effects of Consuming Psyllium-Enriched Foods on Serum Lipids,'' 
accepted for publication in the American Journal of Clinical 
Nutrition, 1997.
    15. Everson, G. T., B. P. Daggy, C. McKinley, and J. A. Story, 
``Effects of Psyllium Hydrophilic Mucilloid on LDL-Synthesis and 
Bile Acid Synthesis in Hypercholesterolemic Men,'' Journal of Lipid 
Research, 33:1183-1192, 1992.
    16. Gelissen, I. C., B. Brodie, and M. A. Eastwood, ``Effect of 
Plantago Ovata (Psyllium) Husk and Seeds on Sterol Metabolism: 
Studies in Normal and Ileostomy Subjects,'' American Journal of 
Clinical Nutrition, 59:395-400, 1994.
    17. Keane, W. F., V. T. Miller, L. P. Bell, C. E. Halstenson, L. 
D. Allgood, H. Tully, and J. C. LaRosa, ``Effect of Psyllium in 
Conjunction With a Low-Fat Diet on Plasma Lipids in Elderly Patients 
With Mild-to-Moderate Hypercholesterolemia,'' Unpublished, 1996.
    18. Levin, E. G., V. T. Miller, R. A. Muesing, D. B. Stoy, T. K. 
Balm, and J. C. LaRosa, ``Comparison of Psyllium Hydrophilic 
Mucilloid and Cellulose as Adjuncts to a Prudent Diet in the 
Treatment of Mild to Moderate Hypercholesterolemia,'' Archives of 
Internal Medicine, 150:1822-1827, 1990.
    19. Neal, G. W., and T. K. Balm, ``Synergistic Effects of 
Psyllium in the Dietary Treatment of Hypercholesterolemia,'' 
Southern Medical Journal, 83:1131-1137, 1990.
    20. Schectman, G., J. Hiatt, and A. Hartz, ``Evaluation of the 
Effectiveness of Lipid-lowering Therapy (Bile Acid Sequestrants, 
Niacin, Psyllium, and Lovastatin) for Treating Hypercholesterolemia 
in Veterans,'' American Journal of Cardiology, 71:759-765, 1993.
    21. Sprecher, D. L., B.V. Harris, A. C. Goldberg, E. C. 
Anderson, L. M. Bayuk, B. S. Russell, D. S. Crone, C. Quinn, J. 
Bateman, B. R. Kuzmak, and L. D. Allgood, ``Efficacy of Psyllium in 
Reducing Serum Cholesterol Levels in Hypercholesterolemic Patients 
on High- or Low-Fat Diets,'' Annals of Internal Medicine, 119:545-
554, 1993.
    22. Stoy, D. B., J. C. LaRosa, B. K. Brewer, M. Mackey, and R. 
A. Muesing, ``Cholesterol-lowering Effects of Ready-to-Eat Cereal 
Containing Psyllium,'' Journal of the American Dietetic Association, 
93:910-912, 1993.
    23. Stoy, D. B., J. C. LaRosa, B. K. Brewer, L. G. Saldhanda, 
and R. A. Muesing, ``Lipid Lowering Effects of Ready-to-Eat Cereal 
Containing Psyllium: a Randomized Crossover Trial,'' Unpublished, 
1993.
    24. Summerbell, C. D., P. Manley, D. Barnes, and A. Leeds, ``The 
effects of Psyllium on Blood Lipids in Hypercholesterolaemic 
Subjects,'' Journal of Human Nutrition and Dietetics, 7:147-151, 
1994.
    25. Weingand, K. W., N-A. Le, B. R. Kuzmak, W. V. Brown, B. P. 
Daggy, T. A. Miettinen, B. V. Howard, and W. J. Howard, ``Effects of 
Psyllium on Cholesterol and Low-Density Lipoprotein Metabolism in 
Subjects With Hypercholesterolemia,'' Endocrinology and Metabolism, 
4:141-150, 1997.
    26. Gupta, R. R., C. G. Agrawal, G. P. Singh, and A. Ghatak, 
``Lipid-lowering Efficacy of Psyllium Hydrophilic Mucilloid in Non-
insulin Dependent Diabetes Mellitus With Hyperlipidaemia,'' Indian 
Journal of Medical Research, 100:237-241, 1994.
    27. Stewart, R. B., W. E. Hale, M. T. Moore, F. E. May, and R. 
G. Marks, ``Effect of Psyllium Hydrophilic Mucilloid on Serum 
Cholesterol in the Elderly,'' Digestive Diseases and Sciences, 36: 
329-334, 1991.
    28. Jenkins, D., T. M. S. Wolever, E. Vidgon, C. W. C. Kendall, 
T. P. P. Ransom, et al., ``Effect of Psyllium in 
Hypercholesterolemia at Two Monounsaturated Fatty Acid Intakes,'' 
American Journal of Clinical Nutrition, 65:1524-1533, 1997.
    29. Arjmandi, B. H., E. Sohn, S. Juma, S. R. Murphy, and B. P. 
Daggy, ``Native and Partially Hydrolyzed Psyllium Have Comparable 
Effects on Cholesterol Metabolism in Rats,'' Journal of Nutrition, 
127:463-469, 1997.
    30. Daggy, B. P., N. C. O'Connell, G. R. Jerdack, B. A. Stinson, 
and K. D. R. Setchell, ``Additive Hypocholesterolemic Effect of 
Psyllium and Cholestyramine in the Hamster: Influence of Fecal 
Sterol and Bile Acid Profiles,'' Journal of Lipid Research, 38:491-
502, 1997.
    31. Fernandez, M. L., M. Vergara-Jiminez, K. Conde, T. Behr, and 
G. Abdel-Fattah, ``Regulation of Apolipoprotein B-Containing 
Lipoproteins by Dietary Soluble Fiber in Guinea Pigs,'' American 
Journal of Clinical Nutrition, 65:814-822, 1997.
    32. Ganji, V., and C. V. Kies, ``Psyllium Husk Fiber 
Supplementation to the Diets Rich in Soybean or Coconut Oil: 
Hypocholesterolemic Effect in Healthy Humans,'' International 
Journal of Food Science and Nutrition, 47:103-110, 1996.
    33. Jensen, C. D., W. Haskell, and J. Whittman, ``Long-Term 
Effects of Water-Soluble Dietary Fiber in the Management of 
Hypercholesterolemia in Healthy Men and Women,'' American Journal of 
Cardiology, 79:34-37, 1997.
    34. Olson, B. H., S. M. Anderson, M. P. Becker, J. W. Anderson, 
D. B. Hunninghake, D. J. A. Jenkins, J. C. LaRosa, J. M. Rippe, D. 
C. K. Roberts, D. B. Stoy, C. D. Summerbell, A. S. Truswell. T. M. 
S. Wolever, D. H. Morris, and V. L. Fulgoni III, ``Psyllium-Enriched 
Cereals Lower Blood Total Cholesterol and LDL Cholesterol, but not 
HDL Cholesterol, in Hypercholesterolemic Adults: Results of a Meta-
Analysis,'' Journal of Nutrition, 127:1973-1980, 1997.
    35. Kellogg Co., ``Petition for Health Claim--Soluble Fiber from 
Psyllium and Coronary Heart Disease,'' Item CP1, Docket 96P-0338, 
Dockets Management Branch, June 12, 1996.
    36. Anderson, J. W., N. Zettwoch, T. Feldman, J. Tietyen-Clark, 
P. Oeltgen, and C. W. Bishop, ``Cholesterol-lowering Effects of 
Psyllium Hydrophilic Mucilloid for Hypercholesterolemic Men,'' 
Archives of Internal Medicine, 148:292-296, 1988.
    37. DHHS, National Heart, Lung, and Blood Institute, National 
Cholesterol Education Program, ``Report of the Expert Panel on 
Population Strategies for Blood Cholesterol Reduction (Population 
Panel Report),'' Chapter II. Background and Introduction, NIH 
Publication No. 93-3046, Bethesda, MD, 1993.
    38. DHHS and USDA, ``Nutrition and Your Health: Dietary 
Guidelines for Americans,'' 4th Ed., Home and Garden Bulletin No. 
232, U.S. Government Printing Office, 1995.
    39. LSRO, ``The Evaluation of the Safety of Using Psyllium Seed 
Husk as a Food Ingredient,'' Bethesda, MD, December 1993.
    40. Einspar, J. G., D. S. Alberts, S. M. Gapstur, R. M. Bostick, 
S. S. Emmerson, and E. W. Gerner, ``Surrogate End-Point Biomarkers 
as Measures of Colon Cancer Risk and Their Use in Cancer 
Chemoprevention Trials,'' Cancer Epidemiology, Biomarkers and 
Prevention, 6:37-48, 1997.
    41. Whistler & Daniel, in Food Chemistry, 2nd Ed., Fennema, O. 
R., ed. Marcel Dekker, Inc., New York, pp. 108-112, 1985.
    42. Letter from V. L. Fulgoni, Kellogg's to C. J. Lewis, FDA, 
December, 18, 1997.
    43. Memorandum from A. S. Levy, FDA, to K. Falci, FDA, June 26, 
1997.

List of Subjects in 21 CFR Part 101

    Food labeling, Incorporation by reference, Nutrition, Reporting and 
recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 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.

    2. Section 101.17 is amended by adding paragraph (f) to read as 
follows:

Sec. 101.17  Food labeling warning and notice statements.

* * * * *
    (f) Foods containing psyllium husk. (1) Foods containing dry or 
incompletely hydrated psyllium husk, also known as psyllium seed husk, 
and bearing a health claim on the association between soluble fiber 
from psyllium husk and reduced risk of coronary heart disease, shall 
bear a label statement informing consumers that the appropriate use of 
such foods requires consumption with adequate amounts of fluids, 
alerting them of potential consequences of failing to follow usage 
recommendations, and informing persons with swallowing difficulties to 
avoid consumption of the product (e.g., ``NOTICE: This food should be 
eaten with at least a full glass of liquid. Eating this product without 
enough liquid may cause choking. Do not eat this product if you have 
difficulty in swallowing.''). However, a product in conventional food 
form may be exempt from this requirement if a viscous adhesive mass

[[Page 8119]]

is not formed when the food is exposed to fluids.
    (2) The statement shall appear prominently and conspicuously on the 
information panel or principal display panel of the package label and 
any other labeling to render it likely to be read and understood by the 
ordinary individual under customary conditions of purchase and use. The 
statement shall be preceded by the word ``NOTICE'' in capital letters.
    3. Section 101.81 is amended by revising the section heading, the 
heading for paragraphs (a) and (b), and paragraphs (a)(3), (b)(2), 
(c)(1), (c)(2)(i) introductory text, (c)(2)(i)(A), (c)(2)(i)(E), 
(c)(2)(i)(F), (c)(2)(iii)(A), (d)(2), (d)(3), and (e); by adding 
paragraphs (c)(2)(i)(G) and (c)(2)(ii)(B); and by removing paragraph 
(d)(6) and redsignating paragraph (d)(7) as (d)(6) and paragraph (d)(8) 
as (d)(7) to read as follows:


Sec. 101.81  Health claims: Soluble fiber from certain foods and risk 
of coronary heart disease (CHD).

    (a) Relationship between diets that are low in saturated fat and 
cholesterol and that include soluble fiber from certain foods and the 
risk of CHD. * * * 
* * * * *
    (3) Scientific evidence demonstrates that diets low in saturated 
fat and cholesterol may reduce the risk of CHD. Other evidence 
demonstrates that the addition of soluble fiber from certain foods to a 
diet that is low in saturated fat and cholesterol may also help to 
reduce the risk of CHD.
    (b) Significance of the relationship between diets that are low in 
saturated fat and cholesterol and that include soluble fiber from 
certain foods and the risk of CHD. * * * 
* * * * *
    (2) Intakes of saturated fat exceed recommended levels in the diets 
of many people in the United States. One of the major public health 
recommendations relative to CHD risk is to consume less than 10 percent 
of calories from saturated fat and an average of 30 percent or less of 
total calories from all fat. Recommended daily cholesterol intakes are 
300 milligrams (mg) or less per day. Scientific evidence demonstrates 
that diets low in saturated fat and cholesterol are associated with 
lower blood total- and LDL-cholesterol levels. Soluble fiber from 
certain foods, when included in a low saturated fat and cholesterol 
diet, also helps to lower blood total- and LDL-cholesterol levels.
    (c) Requirements. (1) All requirements set forth in Sec. 101.14 
shall be met. The label and labeling of foods containing psyllium husk 
shall be consistent with the provisions of Sec. 101.17(f).
    (2) Specific requirements. (i) Nature of the claim. A health claim 
associating diets that are low in saturated fat and cholesterol and 
that include soluble fiber from certain foods with reduced risk of 
heart disease may be made on the label or labeling of a food described 
in paragraph (c)(2)(iii) of this section, provided that:
    (A) The claim states that diets that are low in saturated fat and 
cholesterol and that include soluble fiber from certain foods ``may'' 
or ``might'' reduce the risk of heart disease.
* * * * *
    (E) The claim does not attribute any degree of risk reduction for 
CHD to diets that are low in saturated fat and cholesterol and that 
include soluble fiber from the eligible food sources from paragraph 
(c)(2)(ii) of this section; and
    (F) The claim does not imply that consumption of diets that are low 
in saturated fat and cholesterol and that include soluble fiber from 
the eligible food sources from paragraph (c)(2)(ii) of this section is 
the only recognized means of achieving a reduced risk of CHD.
    (G) The claim specifies the daily dietary intake of the soluble 
fiber source that is necessary to reduce the risk of coronary heart 
disease and the contribution one serving of the product makes to the 
specified daily dietary intake level. Daily dietary intake levels of 
soluble fiber sources listed in paragraph (c)(2)(ii) of this section 
that have been associated with reduced risk coronary heart disease are 
:
    (1) 3 g or more per day of B-glucan soluble fiber from whole oats.
    (2) 7 g or more per day of soluble fiber from psyllium seed husk.
    (ii) * * *
    (B)(1) Psyllium husk from the dried seed coat (epidermis) of the 
seed of Plantago (P.) ovata, known as blond psyllium or Indian 
psyllium, P. indica, or P. psyllium. To qualify for this claim, 
psyllium seed husk, also known as psyllium husk, shall have a purity of 
no less than 95 percent, such that it contains 3 percent or less 
protein, 4.5 percent or less of light extraneous matter, and 0.5 
percent or less of heavy extraneous matter, but in no case may the 
combined extraneous matter exceed 4.9 percent, as determined by U.S. 
Pharmacopeia (USP) methods described in USP's ``The National 
Formulary,'' USP 23, NF 18, p. 1341, (1995), which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies 
may be obtained from the U.S. Pharmacopeial Convention, Inc., 12601 
Twinbrook Pkwy., Rockville, MD 20852, or may be examined at the Center 
for Food Safety and Applied Nutrition's Library, 200 C St. SW., rm. 
3321, Washington, DC, or at the Office of the Federal Register, 800 
North Capitol St. NW., suite 700, Washington, DC;
    (2) FDA will determine the amount of soluble fiber that is provided 
by psyllium husk by using a modification of the Association of Official 
Analytical Chemists' (AOAC's) method for soluble dietary fiber (991.43) 
described by Lee et al., ``Determination of Soluble and Insoluble 
Dietary Fiber in Psyllium-containing Cereal Products,'' Journal of the 
AOAC International, 78 (No. 3):724-729, 1995, which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies 
may be obtained from the Association of Official Analytical Chemists 
International, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877-2504, or may be examined at the Center for Food Safety and 
Applied Nutrition's Library, 200 C St. SW., rm. 3321, Washington, DC, 
or at the Office of the Federal Register, 800 North Capitol St. NW., 
suite 700, Washington, DC;
    (iii) * * *
    (A) The food product shall include:
    (1) One or more of the whole oat foods from paragraph (c)(2)(ii)(A) 
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) Psyllium husk that complies with paragraph (c)(2)(ii)(B) of 
this section, and the psyllium food shall contain at least 1.7 g of 
soluble fiber per reference amount customarily consumed of the food 
product;
* * * * *
    (d) * * *
    (2) The claim may state that the relationship between intake of 
diets that are low in saturated fat and cholesterol and that include 
soluble fiber from the eligible food sources from paragraph (c)(2)(ii) 
of this section and reduced risk of heart disease is through the 
intermediate link of ``blood cholesterol'' or ``blood total- and LDL-
cholesterol;''
    (3) The claim may include information from paragraphs (a) and (b) 
of this section, which summarize the relationship between diets that 
are low in saturated fat and cholesterol and that include soluble fiber 
from certain foods and coronary heart disease and the significance of 
the relationship;
* * * * *
    (e) Model health claim. The following model health claims may be 
used in food labeling to describe the

[[Page 8120]]

relationship between diets that are low in saturated fat and 
cholesterol and that include soluble fiber from certain foods and 
reduced risk of heart disease:
    (1) Soluble fiber from foods such as [name of soluble fiber source 
from paragraph (c)(2)(ii) of this section and, if desired, the name of 
food product], as part of a diet low in saturated fat and cholesterol, 
may reduce the risk of heart disease. A serving of [ name of food] 
supplies ________ grams of the [grams of soluble fiber specified in 
paragraph (c)(2)(i)(G) of this section] soluble fiber from [name of the 
soluble fiber source from paragraph (c)(2)(ii) of this section] 
necessary per day to have this effect.
    (2) Diets low in saturated fat and cholesterol that include 
[________ grams of soluble fiber specified in paragraph (c)(2)(i)(G) of 
this section] of soluble fiber per day from [name of soluble fiber 
source from paragraph (c)(2)(ii) of this section and, if desired, the 
name of the food product] may reduce the risk of heart disease. One 
serving of [name of food] provides ________ grams of this soluble 
fiber.

    Dated: February 10, 1998

William B. Schultz,
Deputy Commissioner for Policy.

Note: The following table will not appear in the Code of Federal 
Regulations.

                          Table 1.--Summary of Clinical Trials with Hypercholesterolemics: Psyllium and Coronary Heart Disease                          
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                       Supplements         Diet Intake of                                               
    Study          Duration Treatment        Number of Subjects    (Psyllium, Placebo)  groups: Sat fat % E;    Magnitude of PSY    Magnitude of Placebo
                                                                    Soluble Fiber g/d         CHOL mg/d             Effect\1\              Effect       
--------------------------------------------------------------------------------------------------------------------------------------------------------
Anderson et    Base: 8 wk Step 1; Tx: 26   PSY: 131               10.2 g/d bulk         Sat fat: PSY- 8.3%;   CHOL: -5 mg/dL        CHOL: +5 (2.6%)     
 al.            wk Step 1+supplement       C: 28                   laxative, cellulose   C- 7.7%               (2.1%)\1\            LDL-C: +6 (3.9%)    
(Ref. 13)                                                         PSY: 7 g  CHOL: PSY- 164 mg; C- LDL-C: -5 mg/dL       HDL-C: no sig dif   
                                                                   SF                     146 mg               (2.9%)\1\             (grps)             
Bell et al.    Base: 12-wk Step 1; Tx: 8-  PSY: 40 (20 men)       10.2 g/d bulk         Sat fat: PSY- 8-10%;  CHOL: -9 mg/dL        CHOL: 0             
(Ref. 14)       wk Step 1+supplement       Pla: 35 (18 men)        laxative, cellulose   C- 7.7-8.6%           (4.2%)               LDL-C: -0.2%        
                                                                  PSY: 7 g  CHOL: PSY- 168 mg; C- LDL-C: -12 mg/dL      HDL-C: no sig dif   
                                                                   SF                     206 mg               (7.7%)                (grps)             
Davidson et    Base: 8-wk Step 1; Tx: 24-  PSY 1 56 (31 men)      3.4 g, 6.8 g, 10.2 g/ SAT fat: PSY- 7-      CHOL: -   CHOL: +1.7%; LDL-C: 
 al.            wk Step 1 + PSY or         PSY 2 40 (24 men)       d; incorporated       8.6%; C- 7-8.6%       3% (PSY 3)            +3%                
(Ref. 15)       control food (3 servings/  PSY 3 43 (28 men)       into foods: C        CHOL: PSY 1- 151 mg;  LDL-C: -  HDL-C: No sig dif   
                d)                         C 59                    foods: no PSY         PSY 2- 181; PSY 3-    5% (PSY 3)            (grps)             
                                                                  PSY 1:                 169                                                            
                                                                   2.3 g    C- 145 mg                                                       
                                                                   SF,                                                                                  
                                                                  PSY 2:                                                                                
                                                                   4.6 g;                                                                   
                                                                  PSY 3: 7                                                                  
                                                                   g                                                                                    
Everson et     Regular diet; 5-d Base; 2   20 men                 15.3 g/d bulk         SAT fat: PSY- 12%; C- CHOL: -14 mg/dL (-    CHOL: -1.9%; LDL-C: -
 al.            40-d periods; 11-d                                 laxative, cellulose    13.2 %               5%)                   2.7%               
(Ref. 16)       washout; crossover                                PSY: 10   CHOL: PSY- 296 mg; C- LDL-C: -15 mg/dL      HDL-C: No sig dif   
                                                                   g SF                   274 mg               (8%)                  (grps)             
Keane et al.   Base: 12 wk Step 1; Tx: 26  PSY: 40 (18m, 24f)     10.2 g/d bulk         SAT fat: PSY- 5%; C-  CHOL: -8.7 mg/dL      CHOL: +2 (1%)       
(Ref. 18)       wk Step 1+supplement       C: 39 (7m, 32f)         laxative, cellulose   5.3%                  (3%)                 LDL-C: 0            
                                                                  PSY: 7 g  CHOL: PSY- 145.2 mg;  LDL-C: -11.5 mg/dL    HDL-C: no sig dif   
                                                                   SF                    C- 151.1 mg           (5.9%)\1\             (grps)             
Levin et al.   Base: 8-wk Step 1; Tx: 16-  PSY: 30 (26 men)       10.2 g/d bulk         SAT fat: PSY- 6.7%;   CHOL: -13 mg/dL       CHOL: 0; LDL-C -    
(Ref. 19)       wk Step 1+supplement       Pla: 28 (23 men)        laxative, cellulose   C- 6.3%               (5.6%)                2.2%;              
                                                                  PSY: 7 g  CHOL: PSY- 166 mg; C- LDL-C: -13 mg/dL      HDL-C:              
                                                                   SF                     135 mg               (8.6%)                +6%    
                                                                                                                                     (sig from PSY)     
Stoy et al.    4-wk Step 1; Step 1 +       23 men                 Estimated 11.6 g/d    SAT fat: PSY: 5.1%    CHOL: -10 mg/dL (4%)  HDL-C: No sig dif   
(Ref. 23)       (8x5x5 wks): Grp 1: PSY-                           PSY from cereal:      (Grp 1) and 5.1%     LDL-C: -11 mg/dL       (grps)             
                Pla-PSY; Grp 2: Pla-PSY-                           8 g SF;   (Grp 2)               (6%)                                     
                Pla                                                Wheat cereal:        Wheat: 4.5% (Grp 1)                                             
                                                                   3 g SF    and 5.0% (Grp 2)                                               
                                                                                        CHOL: PSY 141-165 mg                                            
                                                                                        Wheat: 164 mg (Grp                                              
                                                                                         1), 117-170 (Grp 2)                                            
Stoy et al.    4-wk Step 1; Step 1 +       22 men                 Estimated 11.6 g/d    SAT fat: PSY: 4.8     CHOL: -10 mg/dL (4%)  HDL-C: No sig dif   
(Ref. 24)       (8x5x5 wks): Grp 1: PSY-                           PSY from cereal:      (Grp 1) and 5.2%     LDL-C: -11 mg/dL       (grps)             
                Pla-PSY; Grp 2: Pla-PSY-                           8 g SF;   (Grp 2)               (6%)                                     
                Pla                                                Wheat cereal:        Wheat: 4.7% (Grp 1)                                             
                                                                   3 g SF    and 5.6% (Grp 2)                                               
                                                                                        CHOL: PSY 155-163 mg                                            
                                                                                        Wheat: 133 mg (Grp                                              
                                                                                         1), 169-172 (Grp 2)                                            

[[Page 8121]]

                                                                                                                                                        
Wein-          Base: 12 wk Step 1; Tx: 8   23 (16m, 7f)           10.2 g/d bulk         SAT fat: PSY- 8.7%;   CHOL: -9 mg/dL        HDL-C: sig higher in
gand et al.     wk Step 1+supplement,                              laxative, cellulose   C- 9%                 (3.8%)                PSY group          
(Ref. 26)       crossover                                         PSY: 7 g  CHOL: PSY- 162 mg; C- LDL-C: -11 mg/dL                          
                                                                   SF                     203-261 mg           (6.2%)\1\                                
Jenkins et     Base: 2 mo controlled Step  Study 1:               Study 1:              Study 1:              Study 1:              Study 1:            
 al.            2 diets; Tx: 2- 1 mo Step  32 (15m, 17f)          11.4 g/d PSY in       SAT fat: PSY- 4.6%;   CHOL: -27 mg/dL\1\    CHOL: -13.6 (5%)\2\ 
(Ref. 30)       2 diets+ cereal,                                   cereal                C -4.6%               (9.8%)               LDL-C: -10 (5.5%)   
                crossover                                          (7.8 g   CHOL: PSY- 31 mg; C-  LDL-C: -24 mg/dL\1\   HDL-C: -2 (3.3%)    
                                                                   SF), wheat bran       29 mg                 (12.6%)                                  
                                                                                        MUFA: PSY- 6%; C- 6%  HDL-C: -6.6 mg/dL                         
                                                                                                               (11.3%)\1\                               
                                           Study 2:               Study 2:              Study 2:              Study 2:              Study 2:            
                                           27 (12m, 15f)          12.4 g/d PSY in       SAT fat: PSY- 6%; C-  CHOL: -34 mg/dL\1\    CHOL: -29.5         
                                                                   cereal                6%                    (12.6%)               (10.7%)\2\         
                                                                   (8.4 g   CHOL: PSY- 22 mg; C-  LDL-C: -27.9 mg/      LDL-C: -17 (9%)\2\  
                                                                   SF), wheat bran       22 mg                 dL\1\ (14.9%)        HDL-C: -1.4 (2.6%)  
                                                                                        MUFA: PSY- 12%; C-    HDL-C: -4.3 mg/dL\1\                      
                                                                                         12%                   (8%)                                     
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Significant differences between treatment and placebo groups unless otherwise indicated.                                                            
\2\ Significant change across the diet phase.                                                                                                           


                      Abbreviations Used in Table 1                     
C                                Control                                
CHOL                             Blood total cholesterol                
d                                Day                                    
E                                Energy                                 
g                                Gram                                   
grp                              Group                                  
HDL-C                            High density lipoprotein cholesterol   
LDL-C                            Low density lipoprotein cholesterol    
m/f                              Number of males, number of females     
mg/dL                            Milligrams per deciliter               
Pla                              Placebo                                
PSY                              Psyllium                               
Sat fat                          Saturated fat                          
SF                               Soluble fiber                          
Sig Dif                          Statistically significant difference   
Step 1                            30% kcals fat, < 10% kcals sat fat, < 
                                  300 mg cholesterol                    
TDF                              Total dietary fiber                    
Tx                               Treatment                              
wk                               Week                                   
                     Approximately                          
%                                Percent                                
                                                                        

[FR Doc. 98-4074 Filed 2-12-98; 4:18 pm]
BILLING CODE 4160-01-F