[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR101.81]
[Page 142-145]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--CONTINUED
PART 101--FOOD LABELING--Table of Contents
Subpart E--Specific Requirements for Health Claims
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. (1) Cardiovascular disease means diseases of the heart and
circulatory system. Coronary heart disease (CHD) is one of the most
common and serious forms of cardiovascular disease and refers to
diseases of the heart muscle and supporting blood vessels. High blood
total cholesterol and low density lipoprotein (LDL)-cholesterol levels
are associated with increased risk of developing coronary heart disease.
High CHD rates occur among people with high total cholesterol levels of
240 milligrams per deciliter (mg/dL) (6.21 (mmol/L)) or above and LDL-
cholesterol levels of 160 mg/dL (4.13 mmol/L) or above. Borderline high
risk total cholesterol levels range from 200 to 239 mg/dL (5.17 to 6.18
mmol/L) and 130 to 159 mg/dL (3.36 to 4.11 mmol/L) of LDL-cholesterol.
The scientific evidence establishes that diets high in saturated fat and
cholesterol are associated with increased levels of blood total- and
LDL-cholesterol and, thus, with increased risk of CHD.
(2) Populations with a low incidence of CHD tend to have relatively
low blood total cholesterol and LDL-cholesterol levels. These
populations also tend to have dietary patterns that are not only low in
total fat, especially saturated fat and cholesterol, but are also
relatively high in fiber-containing fruits, vegetables, and grain
products, such as whole oat products.
(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. (1) CHD is a major public health
concern in the United States. It accounts for more deaths than any other
disease or group of diseases. Early management of risk factors for CHD
is a major public health goal that can assist in reducing risk of CHD.
High blood total and LDL-cholesterol are major modifiable risk factors
in the development 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
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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.
(B) In specifying the disease, the claim uses the following terms:
``heart disease'' or ``coronary heart disease'';
(C) In specifying the substance, the claim uses the term ``soluble
fiber'' qualified by the name of the eligible source of soluble fiber
(provided in paragraph (c)(2)(ii)) of this section. Additionally, the
claim may use the name of the food product that contains the eligible
source of soluble fiber;
(D) In specifying the fat component, the claim uses the terms
``saturated fat'' and ``cholesterol'';
(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) Nature of the substance--Eligible sources of soluble fiber. (A)
Beta () glucan soluble fiber from the whole oat sources listed
below. -glucan soluble fiber will be determined by method No.
992.28 from the ``Official Methods of Analysis of the Association of
Official Analytical Chemists International,'' 16th ed. (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;
(1) Oat bran. Oat bran is produced by grinding clean oat groats or
rolled oats and separating the resulting oat flour by suitable means
into fractions such that the oat bran fraction is not more than 50
percent of the original starting material and provides at least 5.5
percent (dry weight basis (dwb)) -glucan soluble fiber and a
total dietary fiber content of 16 percent (dwb), and such that at least
one-third of the total dietary fiber is soluble fiber;
(2) Rolled oats. Rolled oats, also known as oatmeal, produced from
100 percent dehulled, clean oat groats by steaming, cutting, rolling,
and flaking, and provides at least 4 percent (dwb) of -glucan
soluble fiber and a total dietary fiber content of at least 10 percent.
(3) Whole oat flour. Whole oat flour is produced from 100 percent
dehulled, clean oat groats by steaming and grinding, such that there is
no significant loss of oat bran in the final product, and provides at
least 4 percent (dwb) of -glucan soluble fiber and a total
dietary fiber content of at least 10 percent (dwb).
(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
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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) Nature of the food eligible to bear the claim. (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;
(B) The amount of soluble fiber shall be declared in the nutrition
label, consistent with Sec. 101.9(c)(6)(i)(A).
(C) The food shall meet the nutrient content requirements in
Sec. 101.62 for a ``low saturated fat,'' ``low cholesterol,'' and ``low
fat'' food.
(d) Optional information. (1) The claim may state that the
development of heart disease depends on many factors and may identify
one or more of the following risk factors for heart disease about which
there is general scientific agreement: A family history of CHD; elevated
blood total and LDL-cholesterol; excess body weight; high blood
pressure; cigarette smoking; diabetes; and physical inactivity. The
claim may also provide additional information about the benefits of
exercise and management of body weight to help lower the risk of heart
disease;
(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;
(4) The claim may specify the name of the eligible soluble fiber;
(5) The claim may state that a diet low in saturated fat and
cholesterol that includes soluble fiber from whole oats is consistent
with ``Nutrition and Your Health: Dietary Guidelines for Americans,''
U.S. Department of Agriculture (USDA) and Department of Health and Human
Services (DHHS), Government Printing Office (GPO);
(6) The claim may state that individuals with elevated blood total-
and LDL-cholesterol should consult their physicians for medical advice
and treatment. If the claim defines high or normal blood total- and LDL-
cholesterol levels, then the claim shall state
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that individuals with high blood cholesterol should consult their
physicians for medical advice and treatment;
(7) The claim may include information on the number of people in the
United States who have heart disease. The sources of this information
shall be identified, and it shall be current information from the
National Center for Health Statistics, the National Institutes of
Health, or ``Nutrition and Your Health: Dietary Guidelines for
Americans,'' USDA and DHHS, GPO.
(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
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.
[62 FR 3600, Jan. 23, 1997, as amended at 62 FR 15344, Mar. 31, 1997; 63
FR 8119, Feb. 18, 1998]