21cfr101

Food and Drug Administration, HHS

§ 101.93

(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 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,’’ U.S. Department of Agriculture
(USDA) and Department of Health and
Human Services (DHHS), Government
Printing Office (GPO).
(e) Model health claim. The following
model health claims may be used in
food labeling to describe the relationship between diets that include plant
sterol or stanol esters and reduced risk
of heart disease:
(1) For plant sterol esters: (i) Foods
containing at least 0.65 g per serving of
plant sterol esters, eaten twice a day
with meals for a daily total intake of
at least 1.3 g, as part of a diet low in
saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of the food] supplies
lllgrams of vegetable oil sterol
esters.
(ii) Diets low in saturated fat and
cholesterol that include two servings of
foods that provide a daily total of at
least 1.3 g of vegetable oil sterol esters
in two meals may reduce the risk of
heart disease. A serving of [name of the
food] supplies lllgrams of vegetable
oil sterol esters.
(2) For plant stanol esters: (i) Foods
containing at least 1.7 g per serving of
plant stanol esters, eaten twice a day
with meals for a total daily intake of
at least 3.4 g, as part of a diet low in
saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of the food] supplies
lllgrams of plant stanol esters.
(ii) Diets low in saturated fat and
cholesterol that include two servings of
foods that provide a daily total of at

least 3.4 g of vegetable oil stanol esters
in two meals may reduce the risk of
heart disease. A serving of [name of the
food] supplies lllgrams of vegetable
oil stanol esters.
[65 FR 54717, Sept. 8, 2000; 65 FR 70466, Nov.
24, 2000, as amended at 66 FR 66742, Dec. 27,
2001; 68 FR 15355, Mar. 31, 2003; 70 FR 41958,
July 21, 2005]

Subpart F—Specific Requirements
for Descriptive Claims That
Are Neither Nutrient Content
Claims nor Health Claims
§ 101.93 Certain types of statements
for dietary supplements.
(a)(1) No later than 30 days after the
first marketing of a dietary supplement that bears one of the statements
listed in section 403(r)(6) or the Federal
Food, Drug, and Cosmetic Act, the
manufacturer, packer, or distributor of
the dietary supplement shall notify the
Office of Nutritional Products, Labeling and Dietary Supplements (HFS–
810), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park, MD 20740, that it has included such a statement on the label or
in the labeling of its product. An original and two copies of this notification
shall be submitted.
(2) The notification shall include the
following:
(i) The name and address of the manufacturer, packer, or distributor of the
dietary supplement that bears the
statement;
(ii) The text of the statement that is
being made;
(iii) The name of the dietary ingredient or supplement that is the subject
of the statement, if not provided in the
text of the statement; and
(iv) The name of the dietary supplement (including brand name), if not
provided in response to paragraph
(a)(2)(iii) on whose label, or in whose
labeling, the statement appears.
(3) The notice shall be signed by a responsible individual or the person who
can certify the accuracy of the information presented and contained in the
notice. The individual shall certify
that the information contained in the
notice is complete and accurate, and

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§ 101.93

21 CFR Ch. I (4–1–06 Edition)

that the notifying firm has substantiation that the statement is truthful
and not misleading.
(b) Disclaimer. The requirements in
this section apply to the label or labeling of dietary supplements where the
dietary supplement bears a statement
that is provided for by section 403(r)(6)
of the Federal Food, Drug, and Cosmetic Act (the act), and the manufacturer, packer, or distributor wishes to
take advantage of the exemption to
section 201(g)(1)(C) of the act that is
provided by compliance with section
403(r)(6) of the act.
(c) Text for disclaimer. (1) Where there
is one statement, the disclaimer shall
be placed in accordance with paragraph
(d) of this section and shall state:
This statement has not been evaluated by
the Food and Drug Administration. This
product is not intended to diagnose, treat,
cure, or prevent any disease.

(2) Where there is more than one such
statement on the label or in the labeling, each statement shall bear the disclaimer in accordance with paragraph
(c)(1) of this section, or a plural disclaimer may be placed in accordance
with paragraph (d) of this section and
shall state:
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to
diagnose, treat, cure, or prevent any
disease.
(d) Placement. The disclaimer shall be
placed adjacent to the statement with
no intervening material or linked to
the statement with a symbol (e.g., an
asterisk) at the end of each such statement that refers to the same symbol
placed adjacent to the disclaimer specified in paragraphs (c)(1) or (c)(2) of this
section. On product labels and in labeling (e.g., pamphlets, catalogs), the disclaimer shall appear on each panel or
page where there such is a statement.
The disclaimer shall be set off in a box
where it is not adjacent to the statement in question.
(e) Typesize. The disclaimer in paragraph (c) of this section shall appear in
boldface type in letters of a typesize no
smaller than one-sixteenth inch.
(f) Permitted structure/function statements. Dietary supplement labels or labeling may, subject to the requirements in paragraphs (a) through (e) of

this section, bear statements that describe the role of a nutrient or dietary
ingredient intended to affect the structure or function in humans or that
characterize the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, provided that such
statements are not disease claims
under paragraph (g) of this section. If
the label or labeling of a product marketed as a dietary supplement bears a
disease claim as defined in paragraph
(g) of this section, the product will be
subject to regulation as a drug unless
the claim is an authorized health claim
for which the product qualifies.
(g) Disease claims. (1) For purposes of
21 U.S.C. 343(r)(6), a ‘‘disease’’ is damage to an organ, part, structure, or system of the body such that it does not
function properly (e.g., cardiovascular
disease), or a state of health leading to
such
dysfunctioning
(e.g.,
hypertension); except that diseases resulting
from essential nutrient deficiencies
(e.g., scurvy, pellagra) are not included
in this definition.
(2) FDA will find that a statement
about a product claims to diagnose,
mitigate, treat, cure, or prevent disease (other than a classical nutrient
deficiency disease) under 21 U.S.C.
343(r)(6) if it meets one or more of the
criteria listed below. These criteria are
not intended to classify as disease
claims statements that refer to the
ability of a product to maintain
healthy structure or function, unless
the statement implies disease prevention or treatment. In determining
whether a statement is a disease claim
under these criteria, FDA will consider
the context in which the claim is presented. A statement claims to diagnose, mitigate, treat, cure, or prevent
disease if it claims, explicitly or implicitly, that the product:
(i) Has an effect on a specific disease
or class of diseases;
(ii) Has an effect on the characteristic signs or symptoms of a specific disease or class of diseases, using
scientific or lay terminology;
(iii) Has an effect on an abnormal
condition associated with a natural
state or process, if the abnormal condition is uncommon or can cause significant or permanent harm;

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Food and Drug Administration, HHS

§ 101.95

(iv) Has an effect on a disease or diseases through one or more of the following factors:
(A) The name of the product;
(B) A statement about the formulation of the product, including a claim
that the product contains an ingredient (other than an ingredient that is
an article included in the definition of
‘‘dietary supplement’’ under 21 U.S.C.
321(ff)(3)) that has been regulated by
FDA as a drug and is well known to
consumers for its use or claimed use in
preventing or treating a disease;
(C) Citation of a publication or reference, if the citation refers to a disease use, and if, in the context of the
labeling as a whole, the citation implies treatment or prevention of a disease, e.g., through placement on the
immediate product label or packaging,
inappropriate prominence, or lack of
relationship to the product’s express
claims;
(D) Use of the term ‘‘disease’’ or
‘‘diseased,’’ except in general statements about disease prevention that do
not refer explicitly or implicitly to a
specific disease or class of diseases or
to a specific product or ingredient; or
(E) Use of pictures, vignettes, symbols, or other means;
(v) Belongs to a class of products
that is intended to diagnose, mitigate,
treat, cure, or prevent a disease;
(vi) Is a substitute for a product that
is a therapy for a disease;
(vii) Augments a particular therapy
or drug action that is intended to diagnose, mitigate, treat, cure, or prevent a
disease or class of diseases;
(viii) Has a role in the body’s response to a disease or to a vector of
disease;
(ix) Treats, prevents, or mitigates adverse events associated with a therapy
for a disease, if the adverse events constitute diseases; or
(x) Otherwise suggests an effect on a
disease or diseases.
[62 FR 49886, Sept. 23, 1997, as amended at 62
FR 49867, Sept. 23, 1997; 65 FR 1050, Jan. 6,
2000; 66 FR 17358, Mar. 30, 2001; 66 FR 56035,
Nov. 6, 2001]

§ 101.95 ‘‘Fresh,’’
‘‘freshly
frozen,’’
‘‘fresh frozen,’’ ‘‘frozen fresh.’’
The terms defined in this section
may be used on the label or in labeling

of a food in conformity with the provisions of this section. The requirements
of the section pertain to any use of the
subject terms as described in paragraphs (a) and (b) of this section that
expressly or implicitly refers to the
food on labels or labeling, including
use in a brand name and use as a sensory modifier. However, the use of the
term ‘‘fresh’’ on labels or labeling is
not subject to the requirements of
paragraph (a) of this section if the
term does not suggest or imply that a
food is unprocessed or unpreserved. For
example, the term ‘‘fresh’’ used to describe pasteurized whole milk is not
subject to paragraph (a) of this section
because the term does not imply that
the food is unprocessed (consumers
commonly understand that milk is
nearly always pasteurized). However,
the term ‘‘fresh’’ to describe pasta
sauce that has been pasteurized or that
contains pasteurized ingredients would
be subject to paragraph (a) of this section because the term implies that the
food is not processed or preserved. Uses
of fresh not subject to this regulation
will be governed by the provisions of
403(a) of the Federal Food, Drug, and
Cosmetic Act (the act).
(a) The term ‘‘fresh,’’ when used on
the label or in labeling of a food in a
manner that suggests or implies that
the food is unprocessed, means that the
food is in its raw state and has not
been frozen or subjected to any form of
thermal processing or any other form
of preservation, except as provided in
paragraph (c) of this section.
(b) The terms ‘‘fresh frozen’’ and
‘‘frozen fresh,’’ when used on the label
or in labeling of a food, mean that the
food was quickly frozen while still
fresh (i.e., the food had been recently
harvested when frozen). Blanching of
the food before freezing will not preclude use of the term ‘‘fresh frozen’’ to
describe the food. ‘‘Quickly frozen’’
means frozen by a freezing system such
as blast-freezing (sub-zero Fahrenheit
temperature with fast moving air directed at the food) that ensures the
food is frozen, even to the center of the
food, quickly and that virtually no deterioration has taken place.
(c) Provisions and restrictions. (1) The
following do not preclude the food from
use of the term ‘‘fresh:’’

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