[Federal Register Volume 62, Number 99 (Thursday, May 22, 1997)]
[Proposed Rules]
[Pages 28234-28245]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13379]



  Federal Register / Vol. 62, No. 99 / Thursday, May 22, 1997 / 
Proposed Rules  

[[Page 28234]]



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: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to 
authorize the use, on food labels and in food labeling, of health 
claims on the association between soluble fiber from psyllium husks and 
reduced risk of coronary heart disease (CHD). FDA is proposing this 
action in response to a petition filed by the Kellogg Co. (the 
petitioner). The agency has tentatively concluded that, based on the 
totality of publicly available scientific evidence, soluble fiber from 
psyllium 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. Therefore, the agency is proposing 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 husks.

DATES: Written comments by August 5, 1997. The agency is proposing that 
any final rule that may issue based upon this proposal become effective 
upon its publication.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Joyce J. Saltsman, Center for Food 
Safety and Applied Nutrition (HFS-165), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-5916.

SUPPLEMENTARY INFORMATION:

I. Background

The Nutrition Labeling and Education Act of 1990

    On November 8, 1990, the President signed into law the Nutrition 
Labeling and Education Act of 1990 (the 1990 amendments) (Pub. L. 101-
535). 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.
    In the Federal Register of January 6, 1993 (58 FR 2478), FDA 
adopted a final rule that implemented the health claim provisions of 
the act (hereinafter referred to as the 1993 health claims final rule). 
In that final rule, 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 (Sec. 101.70(a)) and sets out the types 
of information that any such petition must include (Sec. 101.70(d)). 
These regulations became effective on May 8, 1993.
    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 has authorized claims that relate to 8 
of these 10 relationships.
    In its review of the relationship between dietary fiber and 
cardiovascular disease (CVD), the agency reviewed all relevant 
scientific evidence on dietary fiber and its effects on serum 
cholesterol. The agency started by examining the conclusions and 
recommendations of the pertinent Federal Government reviews on this 
topic area: the 1988 ``Surgeon General's Report on Nutrition and 
Health'' (the Surgeon General's report) (Ref. 3) and the 1989 Food and 
Nutrition Board, National Academy of Sciences' (FNB/NAS) ``Diet and 
Health'' (Ref. 4). These two reports (Refs. 3 and 4) provided a 
comprehensive review of the role of a broad range of nutrients, 
including dietary fiber, in the development of a number of chronic 
diseases, including heart disease. Because the FNB/NAS and Surgeon 
General's report were done independently but concurrently, taken 
together, they provide an authoritative picture of the state of 
scientific opinion at the time that they were published in 1988 and 
1989. Therefore, the agency began its review of the dietary fiber 
evidence with studies that had been published since 1988. This evidence 
included studies on all fibers and did not focus on any particular 
individual fibers. While the agency denied the use in food labeling of 
health claims relating total dietary fiber to reduced risk of CVD (58 
FR 2552), it authorized a health claim relating diets low in saturated 
fat and cholesterol and high in fruits, vegetables, and grain products 
that contain dietary fiber (particularly soluble fiber) to a reduced 
risk of CHD, one of the most common, most frequently reported, and most 
serious forms of CVD.
    In denying the dietary fiber and CVD health claim, the agency 
stated that it is difficult to determine the relationship between 
dietary fiber and heart disease because dietary fiber is 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. Likewise, 
wheat bran, oat bran, and rice bran (all heterogeneous mixtures of 
fibers) are not similar in composition. The agency also noted that it 
is very difficult to chemically analyze dietary fiber components, and 
that, consequently, it is hard to correlate the role of specific fiber 
components to health effects.
    Based on its review of numerous authoritative documents, including 
Federal Government reports and recent research on dietary fiber and 
CHD, and on its consideration of comments received in response to the 
proposed rule entitled ``Health Claims; Dietary Fiber and 
Cardiovascular Disease'' (56 FR 60582, November 27, 1991) (hereinafter 
referred to as the 1991 dietary fiber and CVD proposal), FDA concluded 
that the publicly available scientific evidence supported an 
association between diets low in saturated fat and cholesterol and high 
in fruits, vegetables, and grain products (i.e., foods that are low in 
saturated fat and cholesterol and that are good sources of dietary 
fiber) and reduced risk of heart disease (58 FR 2552 at 2572). The 
agency further stated that, although the specific roles of the numerous 
potentially protective substances in such plant foods were not yet 
understood, populations with diets rich in these foods experience many 
health advantages, including lower rates of heart disease. The agency 
noted, however, that there was no scientific agreement as to whether 
the observed protective effects against heart disease were the result 
of the combination of nutrient components of the foods, including 
soluble fiber; of the other components of soluble fiber-rich diets (for 
example, potassium and magnesium); of the displacement of saturated fat 
and cholesterol from the diet; or of nonnutritive substances in these 
foods.
    For all these reasons, the agency stated that the fact that these 
foods contain dietary fiber, particularly soluble fiber, could serve as 
a useful marker for identifying those fruits, vegetables, and grain 
products that,

[[Page 28235]]

when added to diets low in saturated fat and cholesterol, may help in 
reducing blood low density lipoprotein (LDL)-cholesterol levels (58 FR 
2552 at 2572). Thus, the agency 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, fruit, and grain 
products that contain soluble fiber and a reduced risk of heart 
disease.
    In the 1993 dietary fiber and CVD final rule, in response to a 
comment regarding the apparent hypocholesterolemic properties of 
specific food fibers, e.g., oats, FDA agreed that the effectiveness of 
naturally occurring fibers in foods may be documented for specific food 
products (e.g., oat brans meeting specified parameters) (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 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 the Federal Register of January 23, 1997, FDA published a final 
rule on the relationship between soluble fiber from whole oats and 
reduced risk of coronary heart disease (the soluble fiber from whole 
oats final rule), Sec. 101.81 (21 CFR 101.81) (62 FR 3584 and modified 
at 62 FR 15343, March 31, 1997). In that document, the agency concluded 
that the type of soluble fiber in whole oats, -glucan soluble 
fiber, is the primary component responsible for the hypocholesterolemic 
properties associated with consumption of whole oat products as part of 
a diet that is low in saturated fat and cholesterol (62 FR 3584 at 
3585). The agency based its conclusions on the totality of publicly 
available evidence, taking into account evidence showing that 
consumption of -glucan soluble fiber from whole oats has the 
effect of lowering blood total- and LDL-cholesterol in both humans and 
animals (62 FR 3584 at 3586).
    The agency also acknowledged the likelihood that consumption of 
-glucan soluble fiber from sources other than whole oats, as 
well as that from certain other non -glucan soluble fibers, 
will affect, as part of an appropriate diet, blood lipid levels (62 FR 
3584 at 3587). Although the agency considered structuring the final 
rule as one on ``soluble fiber from certain foods'' and the risk of CHD 
to allow flexibility in expanding the claim to other sources of soluble 
fiber, it stated that it was premature to do so inasmuch as the agency 
had not reviewed the totality of evidence on other, non-whole oat 
sources of soluble fiber. However, FDA structured Sec. 101.81 in a way 
that, while the regulation covered -glucan soluble fiber from 
whole oats, would allow it to be amended as evidence becomes available 
to support the use of the claim for other sources of soluble fiber.
    The present rulemaking is in response to a manufacturer's health 
claim petition on the relationship between soluble fiber from psyllium 
and the risk of heart disease.

II. Petition for Health Claim on Psyllium and Reduced Risk of CHD

A. Background

    On June 12, 1996, the Kellogg Co. submitted a petition to FDA 
requesting that the agency authorize a health claim on the relationship 
between consumption of soluble fiber from psyllium (specifically from 
psyllium husks) and the risk of CHD (Ref. 1). On September 18, 1996, 
the agency sent the petitioner a letter stating that it had completed 
its initial review of the petition, and that the petition would be 
filed in accordance with section 403(r)(4) of the act (21 U.S.C. 
343(r)(4)) (Ref. 2). In this document, the agency will consider whether 
a health claim on this nutrient-disease relationship is justified under 
the standard in section 403(r)(3)(B)(i) of the act and in 
Sec. 101.14(c) of FDA's regulations. The following is a review of the 
health claim petition.

B. Preliminary Requirements

1. The Substance Is Associated With a Disease for Which the U.S. 
Population Is at Risk
    The regulations authorizing claims on dietary saturated fat and 
cholesterol and risk of CHD (Sec. 101.75 (21 CFR 101.75)); fruits, 
vegetables, and grain products that contain soluble fiber and risk of 
CHD (Sec. 101.77); and soluble fiber from whole oats and risk of CHD 
(Sec. 101.81) establish that CHD is a disease for which the U.S. 
population is at risk. In adopting those regulations, FDA stated that 
CHD remains a major public health problem, the number one cause of 
death in the United States. Despite the decline in deaths from CHD over 
the past 30 years, this disease is still exacting a tremendous toll in 
morbidity and mortality (Refs. 3 through 5). There are more than 
500,000 deaths each year for which CHD is an underlying cause, and 
another 250,000 deaths for which CHD is a contributing cause. About 20 
percent of American adults ages 20 to 74 years have blood total 
cholesterol levels in the ``high'' category (total cholesterol greater 
than or equal to () 240 milligrams (mg) per (/) deciliter 
(dL) or LDL-cholesterol 160 mg/dL) (Ref. 6). Another 31 
percent have ``borderline'' cholesterol levels (total cholesterol 
between 200 to 239 mg/dL). Therefore, based on these facts as presented 
in Secs. 101.75, 101.77, and 101.81, FDA tentatively concludes that the 
requirement in Sec. 101.14(b)(1) has been met.
2. The Substance is a Food
    Psyllium is a harvestable grain from plants of the Plantago genus 
(Ref. 1, p. 5-6). Different types of psyllium are available, depending 
on the growing region. It is primarily cultivated in France, Spain, and 
India, with some small quantities grown in the American Southwest. 
Psyllium husk (also known as psyllium seed husk), which comes from the 
dried coat of the psyllium seed, is used as a food or food component in 
a number of foods in the United States (Ref. 1, p. 9-11) and is the 
source of psyllium soluble fiber that is the subject of the petition. 
Psyllium husk is a concentrated source of soluble fiber and contributes 
certain technical effects (e.g., as a stabilizer) that are retained 
when it is consumed at levels necessary to justify the petitioned 
claim.
    Therefore, FDA tentatively concludes that the substance satisfies 
the preliminary requirements of Sec. 101.14(b)(3)(i).
3. The Substance Is Safe and Lawful
    The petitioner has also submitted a petition requesting that FDA 
affirm that the use of psyllium husk in grain-based foods is generally 
recognized as safe (GRAS) (55 FR 4481, February 8, 1990). The agency 
notes that this GRAS affirmation petition (GRASP 0G0357) is still under 
review, and that authorization of a health claim should not be 
interpreted as affirmation that the petitioned uses of psyllium are 
GRAS. Such a determination can be made only after the agency has 
completed its review of the GRAS petition. A preliminary review of the 
GRAS affirmation petition, however, reveals that it contains 
significant evidence supporting the safety of the use of this substance 
at the levels necessary to justify a health claim.
    In its GRAS affirmation petition, the petitioner relied heavily on 
the conclusions about the safety of psyllium by the Life Sciences 
Research Office (LSRO) of the Federation of American Societies for 
Experimental Biology (FASEB) (Ref. 1, pp. 12-17). In its 1993 report 
entitled ``The Evaluation of the Safety of Using Psyllium Husk as a 
Food Ingredient,'' LSRO reviewed and

[[Page 28236]]

evaluated published data, unpublished studies that were in press at 
that time, and other information and data. Based on this review, LSRO 
concluded that:

    There is no evidence in the available information on psyllium 
that demonstrates or suggests reasonable grounds to suspect a hazard 
to the public when it is used in a number of food categories and at 
levels of addition that would result in total consumption of as much 
as 25 g/day of psyllium. However, it is not possible to determine 
without additional data whether a significant increase in 
consumption above 20 to 25 g/day would constitute a dietary hazard.

(Ref. 31, p. 57.) The agency is not prepared to disagree with LSRO's 
conclusions on the safety of psyllium husk.
    The agency points out, however, that some concerns about the safety 
of psyllium do exist. For example, available information suggests that 
long-term exposure to high levels of psyllium husk may enhance 
epithelial cell proliferation in the gastrointestinal tract. Rats 
consuming an elemental diet containing 30 percent fiber supplement, of 
which 10 percent was Ispaghula (psyllium), had increased cell 
proliferation in the stomach, distal small intestine, and colon when 
compared to rats consuming an elemental diet with no fiber supplement 
(Ref. 36). There is no agreement in the scientific community, however, 
whether such an increase in cell proliferation is related to an adverse 
health effect (Ref. 37). FDA requests comments on whether enhanced 
proliferation of gastrointestinal tract epithelial cells as a result of 
long-term exposure to psyllium husk is of concern, and whether it would 
provide a basis for not authorizing a claim.
    The agency is also aware that psyllium husk can cause allergic 
reactions in some people, such as health care professionals, who 
regularly dispense psyllium containing products in the course of their 
work. Information provided by the petitioner (Ref. 32) shows that there 
are at least 13 protein fractions present in psyllium husk 
preparations. Some of these protein fractions cross react with sera 
obtained from individuals who experienced allergic reactions to 
psyllium-containing foods. The information also shows that refinement 
of psyllium husk preparations, i.e., increasing the purity of psyllium 
husk, by mechanical sieving can reduce the level of antigenic protein 
fractions (Ref. 32).
    Because of concerns regarding the allergenic potential of products 
derived from psyllium seed, FDA is proposing specifications for the 
purity of the psyllium husk that is the subject of this health claim 
proposal to reduce the potential for allergic reactions to foods 
containing added psyllium. These specifications are based on 
information provided in the petition (Ref. 32) and on the 
specifications used by the petitioner (Ref. 1). FDA requests comments 
on the adequacy of these proposed specifications to reduce the 
allergenic potential of psyllium husk consumed as a component of food. 
Are other steps, such as requiring that a psyllium-containing product 
that bears a health claim declare on its prinicipal display panel that 
psyllium is present in the food, necessary?
    Additionally, the agency is aware of the potential for 
gastrointestinal obstruction to occur following consumption of psyllium 
husk in the absence of sufficient liquid to ensure thorough hydration. 
However, the 1993 report by LSRO noted that reports of gastrointestinal 
obstruction have been associated almost exclusively with consumption of 
bulk laxatives without proper hydration (Ref. 31). Moreover, LSRO 
stated that there have been no such reports associated with the 
consumption of psyllium-containing cereals consumed with milk. It also 
noted that there are no data regarding possible alimentary tract 
obstruction that could be associated with consumption of psyllium-
containing products such as poptarts, waffles, breads, and other foods 
that may be consumed without a liquid (Ref. 31). LSRO stated that the 
moderate amount of psyllium in these products would not be expected to 
cause gastrointestinal obstruction, and that any such possibility would 
be reduced by a suitable suggestion that these products be consumed 
with fluids (Ref. 31). The agency is asking for comments on whether 
psyllium-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-containing food.
    Based on the totality of the evidence, the agency is not prepared, 
at this time, to take issue with the petitioner's view that the use of 
psyllium husk is safe and lawful. Although FDA tentatively concludes 
that the petitioner has provided evidence that satisfies the 
requirement in Sec. 101.14(b)(3)(ii) that use of psyllium husk at the 
levels necessary to justify a claim is safe and lawful, the agency 
requests comment on this tentative conclusion. The agency recognizes 
that, should this proposed health claim be authorized, there may be an 
increase in the consumption of psyllium. Therefore, the agency also 
requests comments on actions, if any, that may be necessary to ensure 
that longterm consumption of psyllium will be at safe levels, such as 
establishing a maximum psyllium content that foods may contain to bear 
the health claim or limiting the kinds of foods that can contain 
psyllium and bear a claim.

III. Review of Scientific Evidence

A. Basis for Evaluating the Relationship Between Soluble Fiber from 
Psyllium and CHD

    In the 1991 dietary fiber and CVD proposal, the agency set forth 
the basis for the relationship between dietary fiber and CVD (56 FR 
60582 at 60583). In that document, the agency stated that there are 
many risk factors that contribute to the development of CVD, and 
specifically CHD, one of the most serious forms of CVD and the leading 
cause of disability. The agency also stated that there is general 
agreement that elevated blood cholesterol levels are one of the major 
``modifiable'' risk factors in the development of CVD and, more 
specifically, CHD.
    The Federal Government and others who have reviewed the matter have 
concluded that there is substantial epidemiologic evidence that high 
blood levels of total cholesterol and LDL-cholesterol are a cause of 
atherosclerosis (inadequate circulation of blood to the heart due to 
narrowing of the arteries) and represent major contributors to CHD (56 
FR 60582 at 60583, Refs. 3 through 5). Factors that decrease total 
cholesterol and LDL-cholesterol will also tend to decrease the risk of 
CHD. High intakes of saturated fat and, to a lesser degree, of dietary 
cholesterol are associated with elevated blood total and LDL-
cholesterol levels (56 FR 60727 at 60728, November 27, 1991). Thus, it 
is generally accepted that blood total cholesterol and LDL-cholesterol 
levels can influence the risk of developing CHD, and, therefore, that 
dietary factors affecting blood total cholesterol levels affect the 
risk of CHD (Refs. 3 through 5).
    When considering the effect that the diet or components of the diet 
have on blood (or serum) lipids, it is also important to consider the 
effect that these factors may have on blood levels of high density 
lipoprotein-cholesterol (HDL-cholesterol). HDL-cholesterol is involved 
in the regulation of cholesterol transport out of cells and to the 
liver, from which it is ultimately excreted (Refs. 3 and 33). 
Therefore, HDL-cholesterol has a protective effect in the body by 
helping to reduce the risk of CHD.

[[Page 28237]]

    For these reasons, FDA limited its review of the relationship 
between soluble fiber from the psyllium husk, hereinafter referred to 
as ``psyllium,'' and CHD to effects of dietary intake of this substance 
on blood lipid levels and on the risk of developing CHD. The agency 
based its evaluation of the relationship between consumption of this 
substance and CHD on changes in blood total cholesterol, LDL-
cholesterol, and HDL-cholesterol, resulting from dietary intervention 
with soluble fiber from psyllium and with psyllium-containing products. 
This focus is consistent with that used by the agency in response to 
the 1990 amendments in deciding on the dietary saturated fat and 
cholesterol and CHD health claim, Sec. 101.75 (56 FR 60727 and 58 FR 
2739); the fruits, vegetables, and grain products and CHD claim, 
Sec. 101.77 (56 FR 60582 and 58 FR 2552); and the soluble fiber from 
whole oats and CHD claim, Sec. 101.81 (61 FR 296 and 62 FR 3584).

B. Review of Scientific Evidence

1. Evidence Considered in Reaching the Decision
    The petitioner submitted scientific studies evaluating the 
relationship between soluble fiber from psyllium, consumed as a food 
and as an ingredient in foods, and serum lipid levels (Ref. 1). These 
studies were conducted between 1965 and 1996. The petition included 
tables that summarized the outcome of those studies and a summary of 
the evidence. Consistent with the approach taken in the dietary fiber/
CVD proposed rules, the agency began its review by considering those 
psyllium studies that were published since 1988 (date of publication of 
the Surgeon General's report). In addition, in its review of the 
petition, the agency considered the conclusions of two LSRO reports 
(Refs. 7 and 8) relative to studies involving psyllium.
2. Criteria for Selection of Human Studies
    The criteria that the agency used to select pertinent studies were 
that the studies: (1) Present data and adequate descriptions of the 
study design and methods; (2) be available in English; (3) include 
estimates of, or enough information to estimate, soluble dietary fiber 
intakes; (4) include direct measurement of blood total cholesterol and 
other blood lipids related to CHD; and (5) be conducted in persons who 
represent the general U.S. population (adults with blood total 
cholesterol levels less than (<) 300 mg/dL).
    In selecting human studies for review, the agency excluded studies 
that were published in abstract form because they lacked sufficient 
detail on study design and methodologies, and because they lacked 
necessary primary data. Studies using special population groups, such 
as insulin-dependent diabetics, individuals with very high serum 
cholesterol (mean greater than 300 mg/dL), individuals taking lipid-
lowering medication during treatment periods, children with 
hypercholesterolemia, and persons who had already experienced a 
myocardial infarction, were excluded because of questions about their 
relevance to the general healthy U.S. population. Studies in which 
psyllium was tested as part of a mixture of other soluble fibers, e.g., 
oat bran, were also excluded from review because it was not possible to 
evaluate the influence of psyllium alone on risk factors for heart 
disease. These criteria are consistent with those that the agency used 
to evaluate the relationship between other substances and CHD.
3. Criteria for Evaluating the Relationship Between Soluble Fiber from 
Psyllium and CHD
    FDA generally applied the same criteria in evaluating studies on 
the relationship between soluble fiber from psyllium and CHD that it 
used in evaluating studies on the relationship between dietary fiber 
and CVD in the 1991 proposed rule (56 FR 60582 at 60587) and in the 
January 1996 proposed rule on whole oats and CHD (61 FR 296). The 
criteria that the agency used in evaluating the studies for this 
rulemaking include: (1) Reliability and accuracy of the methods used in 
nutrient intake analysis, including measurements of total dietary 
soluble fiber and total dietary fiber; (2) estimates of intake of 
saturated fat and cholesterol; (3) available information on the soluble 
fiber content of the psyllium test products and control food; (4) 
measurement of study endpoints (i.e., total cholesterol, LDL-
cholesterol, and HDL-cholesterol); and (5) general study design 
characteristics.
    The general study design characteristics for which the agency 
looked included randomization of subjects, appropriateness of controls, 
selection criteria for subjects, attrition rates (including reasons for 
attrition), potential for misclassification of individuals with regard 
to dietary intakes, presence of recall bias and interviewer bias, 
recognition and control of confounding factors (for example, monitoring 
body weight and control of weight loss), appropriateness of statistical 
tests and comparisons, and statistical power of the studies. The agency 
considered whether the intervention studies that it evaluated had been 
of long enough duration to reasonably ensure stabilization of blood 
lipids (greater than or equal to 3 weeks duration). Finally, the agency 
considered it highly desirable if the available information on a study 
included information on total dietary soluble fiber content of 
baseline, treatment, and control diets and on the nutrient intakes of 
the subjects during the course of the study.

C. Review of Human Studies

    FDA has done a comprehensive review of 21 human studies on psyllium 
(Refs. 9 through 28 and 30) that were submitted with the petition and 
met the forementioned criteria for selection (Ref. 35). Of these, the 
agency gave particular weight to seven studies (Table 1 of this 
document) (Refs. 14, 15, 16, 19, 23, 24, and 30) that were well 
controlled, reported intakes of saturated fat and cholesterol, and 
avoided problems associated with small sample size, lack of placebo 
control, lack of blinding, and other design problems. The studies 
listed in Table 1 also had run-in periods of 4 or more weeks duration 
before the treatment period. During the run-in period, subjects 
consumed a low saturated fat and cholesterol diet without psyllium or 
placebo to allow time for serum lipid levels to stabilize to the change 
in dietary intake. Three of the studies in Table 1 were randomized, 
double blind, placebo-controlled, parallel trials (Refs. 14, 15, and 
19). One study was a randomized, double blind, placebo-controlled, 
crossover trial (Ref. 16), and three studies were randomized, single 
blind, placebo-controlled, crossover trials (Refs. 23, 24, and 30).
    Five of the studies (Refs. 14, 15, 19, 23, and 24) in Table 1 
evaluated the effect of psyllium on serum lipid levels in subjects 
consuming a Step 1 diet (Ref. 5) (i.e., a diet with no more than 30 
percent of calories from total fat, less than 10 percent calories from 
saturated fat, and less than 300 mg cholesterol daily,) and one study 
(Ref. 30) included psyllium as part of a Step 2 diet (i.e., a diet with 
no more than 30 percent of calories from total fat, <7 percent of 
calories from saturated fat, and <200 mg/day (d) cholesterol). One 
study (Ref. 16) evaluated the effects of psyllium in subjects consuming 
their usual diets. The source of psyllium in three studies (Refs. 14, 
16, and 19) was a bulk laxative. Subjects mixed the psyllium with a 
liquid (usually water) and consumed it before meals. The placebo in 
these studies was cellulose.
    Four studies (Refs. 15, 23, 24, and 30) incorporated psyllium into 
breakfast cereals or a variety of foods (e.g., breads,

[[Page 28238]]

cereal, pasta). In these studies, the placebo controls were the same or 
similar foods that did not contain psyllium (e.g., breads, cereal, 
pasta).
    The level of psyllium consumed in the 7 studies ranged from 3.4 
grams (g)/d (about 2.6 g/d soluble fiber) (Ref. 15) to about 11.6 g/d 
(an estimated 8 g/d soluble fiber) (Refs. 23 and 24). The duration of 
the treatment periods ranged from 4 weeks (Ref. 30) up to 24 weeks 
(Ref. 15). The male and female subjects in the 7 studies were 
moderately hypercholesterolemic and ranged in age from 20 to 80 years.
    The results of the studies that evaluated psyllium as a supplement 
to the diet (Refs. 14, 16, and 19) demonstrated that the subjects 
consuming psyllium daily experienced significant decreases in blood 
total cholesterol of about 4 percent (Refs. 14 and 16) and 5 percent 
(Ref. 19) compared to the control group, which consumed a placebo. LDL-
cholesterol decreased significantly, from about 5 percent (Ref. 16) to 
about 7 percent (Ref. 14), compared to the placebo control. In these 
three studies, the psyllium group consumed 10.2 g/d psyllium (about 7 
g/d soluble fiber) (Refs. 14 and 19) or 15.3 g/d (about 10 g/d soluble 
fiber) (Ref. 16).
    One study evaluated the effect of 3 levels of psyllium intake from 
foods on lipid levels in hypercholesterolemic men and women (Ref. 15). 
Three groups (Group 1, 2, and 3) consumed a variety of foods (cereal, 
bread, pasta, and snack bars) that provided 3.4 g, 6.8 g, or 10.2 g/d 
psyllium (Groups 1, 2, and 3, respectively) as part of a Step 1 diet 
for 24 weeks. A control group consumed the same foods with no psyllium. 
Blood total cholesterol was significantly lowered only in Group 3 from 
2 to 4 percent compared to the control group. LDL-cholesterol decreased 
significantly in Groups 1 and 3 (i.e., about 5 percent) compared to the 
control group. The total soluble fiber intakes for the control and 
Groups 1, 2, and 3 were 7 g, 10 g, 10.6 g, and 12.4 g/d, respectively. 
The authors stated that the difference in soluble fiber intake among 
the psyllium groups was less than expected and suggested that the 
subjects may have partially substituted psyllium-containing foods for 
other foods containing soluble fiber. The results of this study suggest 
that there is a dose-response relationship between psyllium intake and 
significant reductions in CHD risk factors, but no specific level can 
be determined from these data because of possible problems with subject 
compliance in Groups 1 and 2.
    The results of three other studies that tested psyllium-containing 
cereals (Refs. 23, 24, and 30) showed significant reductions in both 
blood total cholesterol (about 4 to 8 percent) and LDL-cholesterol 
(about 5 to 10 percent) compared to the placebo control. The subjects 
in these studies consumed 9.3 g/d psyllium (about 6.8 g soluble fiber) 
(Ref. 30) and 11 g/d psyllium (about 8 g soluble fiber) (Refs. 23 and 
24).
    There were no statistically significant differences between the 
psyllium and placebo groups in HDL-cholesterol in all but one of the 
studies in Table 1. In the one study (Ref. 19), post-treatment HDL-
cholesterol was significantly higher in the placebo group compared to 
the psyllium group.
    In summary, based on the totality of the evidence presented in 
randomized studies, consumption of psyllium helped to reduce the levels 
of blood total and LDL-cholesterol, and thus the risk of CHD, in 
subjects with moderately elevated to high blood total cholesterol who 
consumed either a Step 1 or Step 2 diet (low saturated fat and 
cholesterol) or their usual diets. Psyllium did not adversely affect 
HDL-cholesterol levels.

IV. Decision to Propose a Health Claim Relating Soluble Fiber from 
Psyllium to Reduction in Risk of CHD

    The results of 7 clinical trials with psyllium that were published 
between 1988 and 1996 (Table 1), as discussed in section III.C, above, 
consistently supported that there is a relationship between consumption 
of soluble fiber from psyllium, as part of a diet that is low in 
saturated fat and cholesterol, and reduced blood cholesterol levels, 
which in turn may reduce the risk of heart disease. Based on this 
evidence, FDA has tentatively concluded that there is significant 
scientific agreement that the available evidence supports that this 
nutrient/disease relationship is valid. Thus, the agency is proposing 
to authorize health claims on the relationship between soluble fiber 
from psyllium and reduced risk of CHD.
    FDA points out, however, that in preparing this document, as is its 
regular practice in health claim proceedings, the agency conferred with 
other Public Health Service (PHS) agencies with relevant expertise. 
These agencies have raised issues that merit consideration in this 
rulemaking.
    First, in the seven studies that met the criteria for evaluation, 
three involved administration of psyllium in the form of a bulk 
laxative (Refs. 14, 16, and 19), and in only four of the studies was 
psyllium incorporated into foods (Refs. 15, 23, 24, and 30). One PHS 
agency raised an issue about the appropriateness of reliance on the 
former studies, in which psyllium was not consumed as an ingredient of 
conventional food.
    The agency has tentatively decided that reliance on References 14, 
16, and 19, in which psyllium was administered in the form of a bulk 
laxative, is appropriate because in these studies the psyllium was fed 
at mealtimes, much in the manner of a dietary supplement, and in 
concentrations similar to those at which psyllium was incorporated into 
conventional foods in References 15, 23, 24, and 30. Moreover, the 
effect of consuming psyllium on the risk of heart disease (i.e., about 
3 to 5 percent reductions in blood total and LDL-cholesterol) observed 
in the studies in which this substance was consumed in conventional 
food, e.g., in cereal (Refs. 15, 23, 24, and 30), was similar to that 
seen in the studies (Refs. 14, 16, and 19) in which it was consumed as 
a bulk laxative. These results suggest that the form in which psyllium 
is consumed is not significant. However, the agency is asking for 
comments on whether it is appropriate to consider studies in which 
psyllium was fed in bulk form as evidence in evaluating this substance/
disease relationship.
    Second, the subject populations in the studies listed in Table 1 
had borderline to high blood cholesterol levels. One PHS agency 
questioned the relevance of these studies to the general population, 
which includes individuals with normal as well as elevated blood 
cholesterol levels. The agency has tentatively concluded that the 
hypercholesterolemic study populations in the studies listed in Table 1 
are relevant to the general population because, based on data from the 
National Health and Nutrition Examination Surveys (NHANES) III, the 
prevalence of individuals with elevated blood cholesterol (i.e., 200 
mg/dL or greater) is high (approximately 51 percent of adults) (Ref. 
6). The proportion of adults having moderately elevated blood 
cholesterol levels (i.e., between 200 and 239 mg/dL) was estimated to 
be approximately 31 percent, and the proportion of adults with high 
blood cholesterol levels (240 mg/dL or greater) was estimated to be 
approximately 20 percent (Ref. 6). It is also estimated that 52 million 
Americans 20 years of age and older would be candidates for dietary 
intervention to lower blood cholesterol (Ref. 6). The agency considers 
the high proportion of Americans that have elevated blood cholesterol 
levels (i.e., 51 percent) to make up a significant portion of the 
general population, thus making the subject population in the studies 
listed in Table 1 relevant to the general population. However, the

[[Page 28239]]

agency is asking for comments on this issue.

V. Decision to Propose to Amend Sec. 101.81

    As discussed in section I.B of this document, FDA authorized a 
claim for soluble fiber from whole oats and CHD on January 23, 1997 (62 
FR 3584). In that document, the agency stated that it is very likely 
that soluble fiber from certain foods, in addition to -glucan 
soluble fiber from whole oats, may affect serum lipid levels and thus 
help to reduce the risk of CHD (62 FR 3584 at 3587). The agency further 
stated that if a manufacturer can document, through appropriate human 
and laboratory studies, that a soluble fiber has an effect on blood 
total- and LDL-cholesterol levels, and thereby can be useful in 
reducing the risk of CHD, the manufacturer may petition to amend 
Sec. 101.81 to include that source of soluble fiber among the food 
sources about which claims are authorized (62 FR 3584 at 3587 and 
3588). The agency explained that it was necessary to evaluate each 
source of soluble fiber individually because soluble fiber is a family 
of very heterogeneous substances that vary greatly in their effect on 
the risk of CHD.
    The agency tentatively concludes that the soluble fiber in 
psyllium, like -glucan soluble fiber from whole oats, when 
consumed as part of a diet low in saturated fat and cholesterol, may 
help to reduce the risk of heart disease, and that a health claim 
describing this relationship is warranted. To this end, the agency is 
proposing to amend Sec. 101.81, as discussed below, to include soluble 
fiber from psyllium and to broaden the subject of the claim to 
``soluble fiber from certain foods'' and risk of CHD.
    As discussed in the preamble to the soluble fiber from whole oats 
final rule, an umbrella regulation for ``soluble fiber from certain 
foods'' and CHD will provide flexibility for the inclusion of other 
food sources of soluble fiber when adequate data are provided to 
demonstrate that consumption of those foods may help to reduce the risk 
of heart disease (62 FR 3584 at 3588). Moreover, such an umbrella 
regulation has the advantage of minimizing consumer confusion in that 
the claim could not be used on the label of all foods that contain 
soluble fiber. Rather, the claim will be limited to those soluble fiber 
sources whose consumption has been demonstrated to have a relationship 
to the risk of CHD.

VI. Description of Modifications to Sec. 101.81

A. Eligible Sources of Soluble Fiber

    Section 101.81(c)(2)(ii) (``Nature of the substance. Eligible 
sources of soluble fiber'') lists the types and sources of soluble 
fiber that have been demonstrated to the satisfaction of FDA to have a 
relationship to the risk of CHD. In Sec. 101.81(c)(2)(ii)(A), FDA lists 
-glucan soluble fiber from the whole oat sources, along with 
the method of analysis for -glucan soluble fiber by the 
Association of Official Analytical Chemists. Section 
101.81(c)(2)(ii)(A)(1) through (c)(2)(ii)(A)(3) identify the whole oat 
sources that are eligible to bear the claim. FDA reserved 
Sec. 101.81(c)(2)(ii)(B) for future use.
    In this document, FDA is proposing 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. As discussed in 
section II.B.3 of this document, the agency is aware that psyllium has 
been associated with allergic reactions in some people, especially in 
health care professionals who dispense psyllium containing products in 
the course of their work. The petitioner stated that using psyllium 
with a purity of 95 percent in cereal significantly reduced the 
potential for allergenic responses following consumption of psyllium-
containing food (Ref. 1, pp. 85-86). Information provided by the 
petitioner showed that psyllium husk that has a purity of 95 percent 
has a maximum protein content of 3 percent and total extraneous matter 
not to exceed 4.9 percent (i.e., 4.5 percent or less of light 
extraneous matter and 0.5 percent or less of heavy extraneous matter, 
as determined by USP methods (Ref. 34)).
    In this document, the agency is proposing to adopt these 
specifications for psyllium husk that may be the subject of a claim. 
Therefore, proposed Sec. 101.81(c)(2)(ii)(B)(1) states that ``to 
qualify for this claim, psyllium husk shall have a purity of no less 
than 95 percent, such that it has a 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'' that are incorporated by reference (Ref. 1, pp. 5-6, and Ref. 
34). The agency requests comments on whether the requirements proposed 
in Sec. 101.81(c)(2)(ii)(B)(1) are sufficient to reduce the potential 
for allergenic responses in individuals sensitive to psyllium.
    Proposed Sec. 101.81(c)(2)(ii)(B)(1) identifies psyllium husk as 
the dried seed coat (epidermis) of the seed of Plantago (P) ovata, 
known as blond psyllium or Indian psyllium; P. indica; or P. psyllium. 
This information is consistent with that provided by the petitioner 
(Ref. 1, pp. 5 and 6) and the description of psyllium husk given in the 
U.S. Pharmacopeia's (USP) ``The National Formulary'' (Ref. 34).
    In proposed Sec. 101.81(c)(2)(ii)(B)(2), FDA identifies the 
analytical method that it intends to use to determine the amount of 
soluble fiber that is provided by psyllium. Because psyllium-containing 
food products are highly viscous in aqueous solutions and may not be 
easily filtered, a method for analyzing for soluble and insoluble 
dietary fiber from psyllium was developed by Lee et al. (Ref. 29). The 
assay, a modification of method No. 991.31 from ``Official Methods of 
Analysis of the Association of Official Analytical Chemists'' (AOAC), 
appeared in the Journal of the AOAC International, volume 78, page 724, 
1995, and FDA is proposing to incorporate it by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51 in this document.

B. Nature of the Food Eligible to Bear the Claim

    Section 101.81(c)(2)(iii)(A) (as modified at 62 FR 15342) states 
that ``the food product shall include one or more of the whole oat 
foods from paragraph (c)(2)(ii) 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'' (RACC). FDA arrived 
at this amount of soluble fiber by dividing an intake of 3 g/d soluble 
fiber from whole oats by 4 eating occasions per day (62 FR 3584 at 
3592). The daily intake of 3 g soluble fiber was based on an analysis 
of data from a dose-response study that showed that an intake of 3 g/d 
-glucan soluble fiber from whole oats was associated with a 
significant reduction (5 percent) in blood total- and LDL-cholesterol 
levels, and the results of a meta-analysis and other oat studies (61 FR 
296 at 308). Based on four eating occasions per day, each serving of 
the eligible whole oat product would have to provide a minimum of 0.75 
g per RACC as part of the requirements to qualify to bear the CHD 
claim.
    The petitioner for the psyllium claim stated that ``the 
hypocholesterolemic dose-responsiveness of soluble fiber from psyllium 
(i.e., psyllium husk) has not been extensively studied, but there is 
evidence to suggest that the greater

[[Page 28240]]

the dose, the more pronounced the cholesterol-lowering effects will 
be'' (Ref. 1, p. 100). The petitioner noted LSRO's (Ref. 7) 
recommendations for soluble fiber intake for the general U.S. 
population. LSRO stated that soluble fiber should account for 25 to 30 
percent of the total dietary fiber intake and recommended a daily 
intake of total dietary fiber intake of between 20 to 35 g/d (Ref. 7). 
Based on these values, an optimal intake of soluble fiber intake would 
range from 5 g/d to about 10.5 g/d.
    The petitioner also reviewed the results of studies that evaluated 
the effects of different intake levels of psyllium and considered the 
conclusions of reviews of the literature on psyllium (Ref. 1, pp. 100 
through 102). It noted that some overviews of the literature on 
psyllium and serum cholesterol levels have suggested intake ranges of 
10 to 30 g/d of psyllium (Ref. 1, p. 100). The petitioner also noted 
that the results of the dose-response study by Davidson et al. (Ref. 
15) showed that the group consuming 10.2 g/d of psyllium had 
differences of approximately 4.6 percent for LDL-cholesterol and 3.3 
percent for total cholesterol when compared to controls (Ref. 1, p. 
101). Based on all of the evidence, the petitioner asserted that an 
intake of about 7 g/d soluble fiber from 10.2 g/d psyllium may help to 
reduce the risk of CHD (Ref. 1, p. 102).
    The petitioner suggested that, based on a daily intake level of 
10.2 g of psyllium, which provides about 7 g soluble fiber, the level 
in a food to qualify to bear the CHD claim should be 2.5 g of psyllium 
per RACC (10.2 g/d divided by 4 eating occasions per day), which 
provides 1.7 g soluble fiber (7 g/d of soluble fiber divided by 4) per 
RACC. The petitioner noted that the agency has usually assumed that 
food consumption patterns generally reflect three meals and a snack (58 
FR 2302 at 2379, January 3, 1993).
    After review of data from studies submitted with the petition, the 
agency notes that, with the exception of the dose-response study by 
Davidson et al. (Ref. 15), psyllium was consumed in these studies at 
levels of 10 or more g/d (soluble fiber was approximately 7 g/10 g of 
psyllium) (see Table 1 and Ref. 35). In those placebo-controlled 
studies that tested an intake of psyllium of 10.2 g, the effect on 
serum blood lipids was consistent, i.e., blood total and LDL-
cholesterol levels were significantly lowered, and HDL-cholesterol 
levels were not affected (Refs. 10, 11, 13 through 15, 18, 19, 22, and 
26).
    As noted earlier, Davidson et al. (Ref. 15) evaluated the effect of 
psyllium at levels of 3.4 g (Group 1), 6.8 g (Group 2), and 10.2 g 
(Group 3) per day from foods consumed as part of a Step 1 diet. The 
results of the study showed significant lowering of serum lipids in 
subjects consuming 10.2 g/d psyllium in food. The authors stated, 
however, that the subjects in the first two groups may not have 
complied with study protocol, thus confounding the results for them. 
Because of the potential for confounding in this study, the agency 
finds that the results of the Davidson study do not provide the 
information needed to determine a dose-response between the level of 
psyllium intake, and therefore the level of soluble fiber from 
psyllium, and the degree of change in blood lipid levels.
    In this document, the agency is proposing to amend Sec. 101.81 to 
add soluble fiber from psyllium, but it does not have the data that 
were available for -glucan soluble fiber from whole oats on 
which to establish a dose-response based qualifying level for the 
amount of soluble fiber from psyllium necessary for a food to be 
eligible to bear the claim. As discussed above, relative to whole oat 
soluble fiber qualifying levels, analysis of data from a dose-response 
study showed that an intake of 3 g/d whole oat soluble fiber was 
associated with a 5 percent reduction in blood lipids (61 FR 296 at 
308). In the whole oat proposal, the agency explained that a 
significant reduction in serum lipids of 5 percent is associated with 
the level that was achieved as a result of a dietary fat and 
cholesterol-focused intervention in the Multiple Risk Factor 
Intervention Trial and Lipid Research Council clinical trials (61 FR 
296 at 308). The agency does not have similar data from which to 
determine the amount of soluble fiber from psyllium that is associated 
with a 5 percent reduction in serum lipids.
    In the absence of such data, the agency is tentatively proposing to 
base the qualifying level of soluble fiber from psyllium on a total 
daily intake of 10.2 g (about 7 g of soluble fiber), as suggested by 
the petitioner. This level of intake was shown in the clinical studies 
to be consistently associated with significant reductions in serum 
lipids.
    Therefore, FDA is proposing that the qualifying level of soluble 
fiber for foods to bear this claim be 1.7 g soluble fiber from psyllium 
per RACC (7 g divided by 4 eating occasions per day). The agency does 
not consider it necessary to propose a qualifying amount of psyllium as 
suggested in the petition (2.5 g) because the qualifying level of 
soluble fiber will determine the amount of psyllium that is required. 
Based on estimates from figures provided in the petition and in the 
studies, psyllium is about 68 percent or more soluble fiber. Therefore, 
1.7 g/RACC of soluble fiber from psyllium would relate to about 2.5 g/
RACC of psyllium husk. The agency is asking for comments on whether 
this approach for establishing a qualifying soluble fiber level for 
psyllium-containing products is appropriate or for data to support 
another qualifying level for psyllium.
    Health claims help consumers to identify those products that will 
help them achieve a healthy diet (see, e.g., section 403(r)(3)(B)(iii) 
of the act). Expanding Sec. 101.81 to include psyllium-containing foods 
will give consumers an opportunity to select from a wider variety of 
foods containing those soluble fibers that have been shown to help 
reduce the risk of CHD. The availability of a variety of foods, in 
turn, should help consumers increase their daily intake of soluble 
fiber.
    To reflect the agency's tentative decision to propose a qualifying 
level of soluble fiber from psyllium that is different from that 
required for whole oats, the agency is proposing to amend 
Sec. 101.81(c)(2)(iii)(A) (as modified at 62 FR 15342) to set out the 
qualifying level of soluble fiber from whole oat and psyllium foods. 
Therefore, in this document, proposed Sec. 101.81(c)(2)(iii)(A) is 
modified to state ``[T]he food product shall include:'' followed by 
paragraphs (1) and (2). Paragraph (c)(2)(iii)(A)(1) is modified to 
state ``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.'' FDA is proposing to state in 
Sec. 101.81(c)(2)(iii)(A)(2): ``psyllium 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.''
    The agency recognizes that foods could be produced with a blend of 
the eligible soluble fibers listed in paragraph (c)(2)(ii) and would be 
willing to consider whether such foods should be eligible to bear the 
health claim. An example of a product that contains a blend of the 
eligible soluble fibers might be one that contains 75 percent of the 
qualifying level of -glucan soluble fiber from whole oats and 
25 percent of the qualifying level of soluble fiber from psyllium. 
However, the agency does not have the data on which to evaluate the 
relationship between consumption of foods containing both psyllium and 
whole oats and risk of heart disease. Although

[[Page 28241]]

both soluble fiber sources affect the same CHD risk factor (i.e., blood 
lipid levels), the agency cannot assume that foods containing a blend 
of these grains would have the same ability to affect blood total and 
LDL-cholesterol levels that a product containing either whole oats or 
psyllium apparently has. Therefore, if a manufacturer can demonstrate 
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)(A) and (c)(2)(ii)(B) has an effect on the risk of 
heart disease, the manufacturer should petition to amend Sec. 101.81 
further. In addition, because the qualifying level that FDA is 
proposing for soluble fiber from psyllium differs from that which it 
adopted for -glucan soluble fiber from whole oats, the issue 
of an appropriate qualifying level for a blended product should be 
addressed in any petition.
    In the preamble to the final rule in which it adopted Sec. 101.81, 
the agency explained that the approach it used to derive the qualifying 
level of 0.75 g per RACC for whole oat products is somewhat different 
from the one that it used in authorizing other health claims (62 FR 
3584 at 3592). The agency explained that the guiding principle for 
other health claims was to use the established definition for ``good 
source'' or ``high in,'' which characterize the amount of a nutrient 
based on a percentage of the Daily Reference Value (DRV) for the 
nutrient, in a serving of food as the qualifying level. 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. However, there is no DRV for soluble 
fiber. While the agency concluded that the approach it took to 
establish the qualifying level in Sec. 101.81 was appropriate, it 
stated that it intends to propose to establish a DRV for soluble fiber, 
and, once that rulemaking is completed, assuming it results in a DRV, 
it would revisit the requirements in Sec. 101.81 and propose any 
changes in its provisions that are necessary. For the purposes of any 
final rule that results from this rulemaking, the agency will also 
revisit the requirements of Sec. 101.81(c)(2)(iii) if a DRV is 
established for soluble fiber.

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

    In light of the agency's tentative decision to broaden Sec. 101.81 
to include soluble fiber from psyllium, the agency is proposing to 
modify the section heading of Sec. 101.81 from ``Soluble fiber from 
whole oats and risk of coronary heart disease'' to ``Health claims: 
soluble fiber from certain foods and risk of coronary heart disease.'' 
The statement ``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., -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.
    The statement ``soluble fiber from whole oats'' also appears in 
several paragraphs of Sec. 101.81. The agency is proposing to revise 
this statement where it appears to state ``soluble fiber from certain 
foods.'' The paragraphs of Sec. 101.81 that will be affected by this 
change, if it is adopted, include: (a), (a)(3), (b), (b)(2), (c)(2)(i), 
(c)(2)(i)(A), (d)(3), and (e).
    The agency is proposing to revise the statement ``soluble fiber 
from whole oats'' in three paragraphs of Sec. 101.81, paragraphs 
(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.'' 
The agency tentatively finds that the statement ``soluble fiber from 
the eligible food sources * * *'' more accurately identifies the 
particular sources of soluble fibers that may be the subject of the 
claim. For example, Sec. 101.81(c)(2)(i)(E) now specifies that the 
claim must not attribute any degree of risk reduction for coronary 
heart disease to diets low in saturated fat and cholesterol that 
include soluble fiber from whole oats. The eligible food sources in 
this proposed rule include whole oats and psyllium, so FDA is proposing 
to revise Sec. 101.81(c)(2)(i)(E) to reflect the broader coverage of 
the claim.
    The agency notes, however, that it is not proposing changes to the 
model claims in Sec. 101.81(e) (modified at 62 FR 15342). In both 
example claims, the name of the soluble fiber source from 
Sec. 101.81(c)(2)(ii) (Eligible source of soluble fiber) is provided, 
and, if desired, the name of the food product may be provided. For 
example, Sec. 101.81(e)(1) states ``Soluble fiber from foods such as 
[name of soluble fiber source from section (c)(2)(ii) of this section 
and, if desired, the name of the food product], as part of a diet low 
in saturated fat and cholesterol, may reduce the risk of heart 
disease.'' Therefore, a claim for a psyllium-containing food may state 
``Soluble fiber from foods such as psyllium, as part of a diet low in 
saturated fat and cholesterol, may reduce the risk of heart disease,'' 
and thus no change in Sec. 101.81(e)(1) or (e)(2) is necessary to 
reflect the addition of psyllium to the list of substances eligible to 
bear the claim.
    The agency is proposing to make some minor editorial changes in 
Sec. 101.81, which have no substantive effect on this regulation.

VII. Environmental Impact

    The agency has determined under 21 CFR 25.24(a)(11) that this 
action is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required. This finding is based on information submitted by the 
petitioner in an environmental assessment prepared using the format 
described in 21 CFR 25.31a(b)(5).

VIII. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). Executive Order 12866 
classifies a rule as significant if it meets any one of a number of 
specified conditions, including having an annual effect on the economy 
of $100 million or adversely affecting in a material way a sector of 
the economy, competition, or jobs, or if it raises novel legal or 
policy issues. 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. FDA finds that this 
proposed rule is not a significant rule as defined by Executive Order 
12866 and finds under the Regulatory Flexibility Act that the proposed 
rule will not have a significant impact on a substantial number of 
small entities.
    The establishment of this health claim results in benefits and in 
costs only to the extent that food manufacturers elect to take 
advantage of the opportunity to use the claim. This rule will not 
require that any labels be redesigned or that any product be 
reformulated.
    Some manufacturers are currently using FDA's approved health claim 
regarding the benefits of fruits, vegetables, and grain products. This 
proposed health claim will allow them to specifically highlight the 
role of

[[Page 28242]]

soluble fiber from psyllium. The benefit of establishing this health 
claim is to provide for new information in the market regarding the 
relationship of soluble fiber from psyllium and CHD.
    Costs will be incurred by small entities 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 Commissioner of Food 
and Drugs certifies that the proposed rule will not have a significant 
economic impact on a substantial number of small entities. Therefore, 
under the Regulatory Flexibility Act, no further analysis is required.

IX. Paperwork Reduction Act

    FDA tentatively concludes that this proposed rule contains no 
reporting, recordkeeping, labeling, or other third party disclosure 
requirement. Thus, there is no ``information collection'' necessitating 
clearance by the Office of Management and Budget. However, to ensure 
the accuracy of this tentative conclusion, FDA is seeking comment on 
whether this proposed rule to permit health claims on the association 
between soluble fiber from psyllium and reduced risk of CHD imposes any 
paperwork burden.

X. Effective Date

    FDA is proposing to make these regulations effective upon 
publication of a final rule based on this proposal.

XI. Comments

    Interested persons may, on or before August 5, 1997, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday.

XII. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Kellogg Co., ``Petition for Health Claim--Soluble Fiber from 
Psyllium and Coronary Heart Disease,'' June 12, 1996 [CP1].
    2. Scarbrough, F. Edward, Center for Food Safety and Applied 
Nutrition, FDA, Letter to Richard M. Clark, Kellogg Co., September 
18, 1996.
    3. DHHS, 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. DHHS, PHS and the National Institutes of Health, ``National 
Cholesterol Education Program: Population Panel Report,'' Bethesda, 
MD, pp. 1-40, 1990.
    6. Sempos, C. T., J. I. Cleeman, M. D. Carroll, C. L. Johnson, 
P. S. Bachorik, D. J. Gordon, V. L. Burt, R. R. Briefel, C. D. 
Brown, K. Lippel, and B. M. Rifkind, ``Prevalence of High Blood 
Cholesterol Among U.S. Adults. An Update Based on Guidelines From 
the Second Report of the National Cholesterol Education Program 
Adult Treatment Panel,'' Journal of the American Medical 
Association, 269:3009-3014, 1993.
    7. LSRO, FASEB, ``Physiological Effects and Health Consequences 
of Dietary Fiber,'' Bethesda, MD, 1987.
    8. LSRO, FASEB, ``Evaluation of Publicly Available Scientific 
Evidence Regarding Certain Nutrient-Disease Relationships: 6. 
Dietary Fiber and Cardiovascular Disease,'' Bethesda, MD, 1991.
    9. 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.
    10. 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.
    11. Anderson, J. W, T. L. Floore, P. B. Geil, D. Spencer, and T. 
K. Balm, ``Hypercholesterolemic 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.
    12. 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.
    13. 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,'' Unpublished, 
1994.
    14. 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, 261:3419-3423, 1989.
    15. Davidson, M. H., ``Long-term Influence of Psyllium-enriched 
Foods on Serum Lipids among Subjects with Hypercholesterolemia 
Consuming a Low Fat Diet,'' Unpublished study, 1996.
    16. 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.
    17. 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.
    18. Keane, W. F., V. T. Miller, L. P. Bell, C. E. Halstenson, L. 
D. Allgood, H. Tully, 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.
    19. 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.
    20. Neal, G. W. and T. K. Balm, ``Synergistic Effects of 
Psyllium in the Dietary Treatment of Hypercholesterolemia,'' 
Southern Medical Journal, 83:1131-1137, 1990.
    21. Schectman, G., J. Hiatt, 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.
    22. 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.
    23. Stoy, D. B., J. C. LaRosa, B. K. Brewer, M. Mackey, R. A. 
Muesing, ``Cholesterol-lowering Effects of Ready-to-eat Cereal 
Containing Psyllium,'' Journal of the American Dietetic Association, 
93:910-912, 1993.
    24. Stoy, D. B., J. C. LaRosa, B. K. Brewer, L. G. Saldhanda, R. 
A. Muesing, ``Lipid Lowering Effects of Ready-to-eat Cereal 
Containing Psyllium: a Randomized Crossover Trial,'' Unpublished, 
1993.
    25. Summerbell, C. D., P. Manley, D. Barnes, and A. Leeds, ``The 
Effects of Psyllium on Blood Lipids in Hypercholesterolemic 
Subjects,'' Journal of Human Nutrition and Dietetics, 7:147-151, 
1994.
    26. Weingand, K. W., N-A. Le, B. R. Kuzmak, W. V. Brown, B. P. 
Daggy, T. A.

[[Page 28243]]

Miettinen, B. V. Howard, and W. J. Howard, ``Effects of Psyllium on 
Cholesterol and Low-density Lipoprotein Metabolism in Subjects with 
Hypercholesterolemia,'' Unpublished, no date.
    27. 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.
    28. 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.
    29. Lee, S. C., E. Farmakalidis, and L. Prosky, ``Determination 
of Soluble and Insoluble Dietary Fiber in Psyllium-containing Cereal 
Products,'' Journal of the AOAC International, 78:724-729, 1995.
    30. Jenkins, D. J. A., S. Mueller, T. M. S. Wolever, V. Rao, T. 
Ransom, D. Boctor, P. Spadafor, C. Mehling, L. K. Relle, E. Chow, K. 
MacMillan, and V. Fulgoni, ``High Soluble Fiber Foods Reduce Serum 
Lipids Even When Diets Are Already Low in Saturated Fat and 
Cholesterol,'' Unpublished study, 1992.
    31. LSRO, ``The Evaluation of the Safety of Using Psyllium Seed 
Husk as a Food Ingredient,'' Bethesda, MD, December 1993.
    32. James, J. M., S. K. Cooke, A. Barnett, and H. A. Sampson, 
``Anaphylactic Reactions to a Psyllium-containing Cereal,'' Journal 
of Allergy and Clinical Immunology, 88:402-408, 1991.
    33. Ross, R., ``Atherosclerosis,'' in Cecil - Textbook of 
Medicine, J. B. Wyngaarden, L. H. Smith, and J. C. Bennett, editors, 
Harcourt Brace Jovanevich, Inc., Philadelphia, p. 293, 1992.
    34. USP, ``The National Formulary,'' US Parmacopeial Convention, 
Inc., Rockville, MD, UPS 23, NF 18, p. 1341, 1995.
    35. Saltsman, J., Memo to file with Table 1: ``Summary of 
clinical trials: psyllium and CHD,'' and Table 2: ``Psyllium and 
CHD,'' January 28, 1997.
    36. Goodlad, R. A., B. Ratcliffe, C. Y. Lee, and N. A. Wright, 
``Dietary Fibre and the Gastrointestinal Tract: Differing Trophic 
Effects on Muscle and Mucosa of the Stomach, Small Intestine, and 
Colon,'' European Journal of Clinical Nutrition, 49(Suppl. 3):S178-
S181, 1995.
    37. Wasan, H. S. and R. A. Goodlad, ``Fibre-supplemented Foods 
May Damage Your Health, Lancet, 348:319-320, 1996.

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, it is 
proposed that 21 CFR part 101 be amended as follows:

PART 101--FOOD LABELING

    1. The authority citation for 21 CFR part 101 continues to read as 
follows:

    Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act 
(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342, 
343, 348, 371).

    2. Section 101.81 is amended by revising the section heading, the 
heading for paragraphs (a) and (b), and paragraphs (a)(3), (b)(2), 
(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), and by adding paragraph 
(c)(2)(ii)(B) 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 
less than 300 mg 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) * * *
    (2) * * *
    (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.
    (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 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 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

[[Page 28244]]

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 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 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 
the food product], as part of a diet low in saturated fat and 
cholesterol, may reduce the risk of heart disease.
    (2) Diets low in saturated fat and cholesterol that include soluble 
fiber 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.

    Dated: May 15, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-13379 Filed 5-21-97; 8:45 am]
BILLING CODE 4160-01-F
    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                                              
                                                        (Psyllium,    Diet Intake                   Magnitude of
  Study        Duration Treatment        Number of       Placebo)      of groups:    Magnitude of     Placebo   
                                          Subjects    Soluble Fiber   Sat fat % E;   PSY Effect*       Effect   
                                                           g/d         CHOL mg/d                                
----------------------------------------------------------------------------------------------------------------
Levin et   Base: 8-wk Step 1; Tx: 16-  PSY: 30 (26    10.2 g/d bulk  Sat fat: PSY-  CHOL: -13 mg/  CHOL: 0; LDL-
 al.        wk Step 1+supplement        men)           laxative,      6.7%; C-       dL (5.6%)      C -2.2%; HDL-
(Ref. 19)                              Pla: 28 (23     cellulose      6.3%          LDL-C: -13 mg/  C:          
                                        men)          PSY:           CHOL: PSY-      dL (8.6%)      
                                                          166 mg; C-                    +6% (sig    
                                                       7 g SF         135 mg                        from PSY)   
Bell et    Base: 12-wk Step 1; Tx: 8-  PSY: 40 (20    10.2 g/d bulk  Sat fat: PSY-  CHOL: -9 mg/   CHOL: 0; LDL-
 al.        wk Step 1+supplement        men)           laxative,      8-10%; C-      dL (4.2%)      C -0.2%; HDL-
(Ref. 14)                              Pla: 35 (18     cellulose      7.7-8.6%      LDL-C: -12 mg/  C no sig dif
                                        men)          PSY:           CHOL: PSY-      dL (7.7%)      (grps)      
                                                          168 mg; C-                                
                                                       7 g SF         206 mg                                    
Davidson   Base: 8-wk Step 1; Tx: 24-  PSY 1 56 (31   3.4 g, 6.8 g,  Sat fat: PSY-  CHOL: -3%      CHOL: +1.7%; 
 et al.     wk Step 1 + PSY or          men)           10.2 g/d;      7-8.6%; C- 7-  (PSY 3)        LDL-C: +3%  
(Ref. 15)   control food (3 servings/  PSY 2 40 (24    incorporated   8.6%          LDL-C: -5%     HDL-C: No sig
            d)                          men)           into foods:   CHOL: PSY 1-    (PSY 3)        dif (grps)  
                                       PSY 3 43 (28    C foods: no    151 mg; PSY                               
                                        men)           PSY            2- 181; PSY                               
                                       C 59           PSY 1:          3- 169C- 145                              
                                                          mg                                        
                                                       2.3 g SF,                                                
                                                      PSY 2:                                                    
                                                                                                    
                                                       .6 g;                                                    
                                                      PSY 3:                                                    
                                                                                                    
                                                       7 g                                                      
Everson    Regular diet; 5-d Base; 2   20 men         15.3 g/d bulk  Sat fat: PSY-  CHOL: -14 mg/  CHOL: -1.9%; 
 et al.     40-d periods; 11-d                         laxative,      12%; C- 13.2   dL (-5%)       LDL-C: -2.7%
(Ref. 16)   washout; crossover                         cellulose      %             LDL-C: -15 mg/ HDL-C: No sig
                                                      PSY:           CHOL: PSY-      dL (8%)        dif (grps)  
                                                          296 mg; C-                                
                                                       10 g SF        274 mg                                    
Jenkins    Base: 2-mo Step 2; Tx: 2 1- 12 Ss (3m/9f)  Mean intake:   Sat fat: 4%    CHOL: -16.6    HDL-C: No sig
 et al.     mo Step 2 metabolic                        9.35 g/d PSY   all grps       mg/dL          dif (grps)  
(Ref. 30)   diets, crossover, washout                  in cereal     PSY: 36 mg;    Tx                          
                                                      PSY: 6.8 g SF   C: 29 mg       difference:                
                                                                     CHOL PSY- 36    3.4%                       
                                                                      mg; C-29 mg   LDL-C: -9.3                 
                                                                                     mg/dL                      
                                                                                    Tx                          
                                                                                     difference:                
                                                                                     5.1%                       
Stoy et    4-wk Step 1; Step 1 +       23 men         Estimated      Sat fat: PSY:  CHOL: -10 mg/  HDL-C: No sig
 al.        (8x5x5 wks): Grp 1: PSY-                   11.6 g/d PSY   5.1% (Grp 1)   dL (4%)        dif (grps)  
(Ref. 23)   Pla-PSY; Grp 2: Pla-PSY-                   from cereal:   and 5.1%      LDL-C: -11 mg/              
            Pla                                           (Grp 2)        dL (6%)                    
                                                       8 g SF;       Wheat: 4.5%                                
                                                       Wheat          (Grp 1) and                               
                                                       cereal:        5.0% (Grp 2)                              
                                                         CHOL: PSY 141-                             
                                                       3 g SF         165 mg                                    
                                                                     Wheat: 164 mg                              
                                                                      (Grp 1), 117-                             
                                                                      170 (Grp 2)                               

[[Page 28245]]

                                                                                                                
Stoy et    4-wk Step 1; Step 1 +       22 men         Estimated      Sat fat: PSY:  CHOL: -10 mg/  HDL-C: No sig
 al.        (8x5x5 wks): Grp 1: PSY-                   11.6 g/d PSY   4.8 (Grp 1)    dL (4%)        dif (grps)  
(Ref. 24)   Pla-PSY; Grp 2: Pla-PSY-                   from cereal:   and 5.2%      LDL-C: -11 mg/              
            Pla                                           (Grp 2)        dL (6%)                    
                                                       8 g SF;       Wheat: 4.7%                                
                                                       Wheat          (Grp 1) and                               
                                                       cereal:        5.6% (Grp 2)                              
                                                         CHOL: PSY 155-                             
                                                       3 g SF         163 mg                                    
                                                                     Wheat: 133 mg                              
                                                                      (Grp 1), 169-                             
                                                                      172 (Grp 2)                               
----------------------------------------------------------------------------------------------------------------
* Significant differences between treatment and placebo groups unless otherwise indicated.                      


                      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               
mo                               Months                                 
oz                               Ounces                                 
Pla                              Placebo                                
Pro                              Protein                                
PSY                              Psyllium                               
Sat fat                          Saturated fat                          
SF                               Soluble fiber                          
Sig Dif                          Statistically significant difference   
Step 1                            30% kcals fat, 55% CHO, 15% Pro, <300 
                                  mg cholesterol                        
Tx                               Treatment                              
wk                               week                                   
                     approximately                          
%                                Percent                                
                                                                        

[FR Doc. 97-13379 Filed 5-21- 97; 8:45 am]
BILLING CODE 4160-01-F