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U.S. Code as of:
01/19/04
Section 343. Misbranded food
A food shall be deemed to be misbranded -
(a) False or misleading label
If (1) its labeling is false or misleading in any particular, or
(2) in the case of a food to which section 350 of this title
applies, its advertising is false or misleading in a material
respect or its labeling is in violation of section 350(b)(2) of
this title.
(b) Offer for sale under another name
If it is offered for sale under the name of another food.
(c) Imitation of another food
If it is an imitation of another food, unless its label bears, in
type of uniform size and prominence, the word "imitation" and,
immediately thereafter, the name of the food imitated.
(d) Misleading container
If its container is so made, formed, or filled as to be
misleading.
(e) Package form
If in package form unless it bears a label containing (1) the
name and place of business of the manufacturer, packer, or
distributor; and (2) an accurate statement of the quantity of the
contents in terms of weight, measure, or numerical count, except
that under clause (2) of this paragraph reasonable variations shall
be permitted, and exemptions as to small packages shall be
established, by regulations prescribed by the Secretary.
(f) Prominence of information on label
If any word, statement, or other information required by or under
authority of this chapter to appear on the label or labeling is not
prominently placed thereon with such conspicuousness (as compared
with other words, statements, designs, or devices, in the labeling)
and in such terms as to render it likely to be read and understood
by the ordinary individual under customary conditions of purchase
and use.
(g) Representation as to definition and standard of identity
If it purports to be or is represented as a food for which a
definition and standard of identity has been prescribed by
regulations as provided by section 341 of this title, unless (1) it
conforms to such definition and standard, and (2) its label bears
the name of the food specified in the definition and standard, and,
insofar as may be required by such regulations, the common names of
optional ingredients (other than spices, flavoring, and coloring)
present in such food.
(h) Representation as to standards of quality and fill of container
If it purports to be or is represented as -
(1) a food for which a standard of quality has been prescribed
by regulations as provided by section 341 of this title, and its
quality falls below such standard, unless its label bears, in
such manner and form as such regulations specify, a statement
that it falls below such standard;
(2) a food for which a standard or standards of fill of
container have been prescribed by regulations as provided by
section 341 of this title, and it falls below the standard of
fill of container applicable thereto, unless its label bears, in
such manner and form as such regulations specify, a statement
that it falls below such standard; or
(3) a food that is pasteurized unless -
(A) such food has been subjected to a safe process or
treatment that is prescribed as pasteurization for such food in
a regulation promulgated under this chapter; or
(B)(i) such food has been subjected to a safe process or
treatment that -
(I) is reasonably certain to achieve destruction or
elimination in the food of the most resistant microorganisms
of public health significance that are likely to occur in the
food;
(II) is at least as protective of the public health as a
process or treatment described in subparagraph (A);
(III) is effective for a period that is at least as long as
the shelf life of the food when stored under normal and
moderate abuse conditions; and
(IV) is the subject of a notification to the Secretary,
including effectiveness data regarding the process or
treatment; and
(ii) at least 120 days have passed after the date of receipt
of such notification by the Secretary without the Secretary
making a determination that the process or treatment involved
has not been shown to meet the requirements of subclauses (I)
through (III) of clause (i).
For purposes of paragraph (3), a determination by the Secretary
that a process or treatment has not been shown to meet the
requirements of subclauses (I) through (III) of subparagraph (B)(i)
shall constitute final agency action under such subclauses.
(i) Label where no representation as to definition and standard of
identity
Unless its label bears (1) the common or usual name of the food,
if any there be, and (2) in case it is fabricated from two or more
ingredients, the common or usual name of each such ingredient and
if the food purports to be a beverage containing vegetable or fruit
juice, a statement with appropriate prominence on the information
panel of the total percentage of such fruit or vegetable juice
contained in the food; except that spices, flavorings, and colors
not required to be certified under section 379e(c) of this title
(!1) unless sold as spices, flavorings, or such colors, may be
designated as spices, flavorings, and colorings without naming
each. To the extent that compliance with the requirements of clause
(2) of this paragraph is impracticable, or results in deception or
unfair competition, exemptions shall be established by regulations
promulgated by the Secretary.
(j) Representation for special dietary use
If it purports to be or is represented for special dietary uses,
unless its label bears such information concerning its vitamin,
mineral, and other dietary properties as the Secretary determines
to be, and by regulations prescribes as, necessary in order fully
to inform purchasers as to its value for such uses.
(k) Artificial flavoring, artificial coloring, or chemical
preservatives
If it bears or contains any artificial flavoring, artificial
coloring, or chemical preservative, unless it bears labeling
stating that fact, except that to the extent that compliance with
the requirements of this paragraph is impracticable, exemptions
shall be established by regulations promulgated by the Secretary.
The provisions of this paragraph and paragraphs (g) and (i) with
respect to artificial coloring shall not apply in the case of
butter, cheese, or ice cream. The provisions of this paragraph with
respect to chemical preservatives shall not apply to a pesticide
chemical when used in or on a raw agricultural commodity which is
the produce of the soil.
(l) Pesticide chemicals on raw agricultural commodities
If it is a raw agricultural commodity which is the produce of the
soil, bearing or containing a pesticide chemical applied after
harvest, unless the shipping container of such commodity bears
labeling which declares the presence of such chemical in or on such
commodity and the common or usual name and the function of such
chemical, except that no such declaration shall be required while
such commodity, having been removed from the shipping container, is
being held or displayed for sale at retail out of such container in
accordance with the custom of the trade.
(m) Color additives
If it is a color additive, unless its packaging and labeling are
in conformity with such packaging and labeling requirements,
applicable to such color additive, as may be contained in
regulations issued under section 379e of this title.
(n) Packaging or labeling of drugs in violation of regulations
If its packaging or labeling is in violation of an applicable
regulation issued pursuant to section 1472 or 1473 of title 15.
(o) Repealed. Pub. L. 106-554, Sec. 1(a)(1) [title V, Sec. 517],
Dec. 21, 2000, 114 Stat. 2763, 2763A-73
(p) Repealed. Pub. L. 104-124, Sec. 1, Apr. 1, 1996, 110 Stat. 882
(q) Nutrition information
(1) Except as provided in subparagraphs (3), (4), and (5), if it
is a food intended for human consumption and is offered for sale,
unless its label or labeling bears nutrition information that
provides -
(A)(i) the serving size which is an amount customarily consumed
and which is expressed in a common household measure that is
appropriate to the food, or
(ii) if the use of the food is not typically expressed in a
serving size, the common household unit of measure that expresses
the serving size of the food,
(B) the number of servings or other units of measure per
container,
(C) the total number of calories -
(i) derived from any source, and
(ii) derived from the total fat,
in each serving size or other unit of measure of the food,
(D) the amount of the following nutrients: Total fat, saturated
fat, cholesterol, sodium, total carbohydrates, complex
carbohydrates, sugars, dietary fiber, and total protein contained
in each serving size or other unit of measure,
(E) any vitamin, mineral, or other nutrient required to be
placed on the label and labeling of food under this chapter
before October 1, 1990, if the Secretary determines that such
information will assist consumers in maintaining healthy dietary
practices.
The Secretary may by regulation require any information required to
be placed on the label or labeling by this subparagraph or
subparagraph (2)(A) to be highlighted on the label or labeling by
larger type, bold type, or contrasting color if the Secretary
determines that such highlighting will assist consumers in
maintaining healthy dietary practices.
(2)(A) If the Secretary determines that a nutrient other than a
nutrient required by subparagraph (1)(C), (1)(D), or (1)(E) should
be included in the label or labeling of food subject to
subparagraph (1) for purposes of providing information regarding
the nutritional value of such food that will assist consumers in
maintaining healthy dietary practices, the Secretary may by
regulation require that information relating to such additional
nutrient be included in the label or labeling of such food.
(B) If the Secretary determines that the information relating to
a nutrient required by subparagraph (1)(C), (1)(D), or (1)(E) or
clause (A) of this subparagraph to be included in the label or
labeling of food is not necessary to assist consumers in
maintaining healthy dietary practices, the Secretary may by
regulation remove information relating to such nutrient from such
requirement.
(3) For food that is received in bulk containers at a retail
establishment, the Secretary may, by regulation, provide that the
nutrition information required by subparagraphs (1) and (2) be
displayed at the location in the retail establishment at which the
food is offered for sale.
(4)(A) The Secretary shall provide for furnishing the nutrition
information required by subparagraphs (1) and (2) with respect to
raw agricultural commodities and raw fish by issuing voluntary
nutrition guidelines, as provided by clause (B) or by issuing
regulations that are mandatory as provided by clause (D).
(B)(i) Upon the expiration of 12 months after November 8, 1990,
the Secretary, after providing an opportunity for comment, shall
issue guidelines for food retailers offering raw agricultural
commodities or raw fish to provide nutrition information specified
in subparagraphs (1) and (2). Such guidelines shall take into
account the actions taken by food retailers during such 12-month
period to provide to consumers nutrition information on raw
agricultural commodities and raw fish. Such guidelines shall only
apply -
(I) in the case of raw agricultural commodities, to the 20
varieties of vegetables most frequently consumed during a year
and the 20 varieties of fruit most frequently consumed during a
year, and
(II) to the 20 varieties of raw fish most frequently consumed
during a year.
The vegetables, fruits, and raw fish to which such guidelines apply
shall be determined by the Secretary by regulation and the
Secretary may apply such guidelines regionally.
(ii) Upon the expiration of 12 months after November 8, 1990, the
Secretary shall issue a final regulation defining the circumstances
that constitute substantial compliance by food retailers with the
guidelines issued under subclause (i). The regulation shall provide
that there is not substantial compliance if a significant number of
retailers have failed to comply with the guidelines. The size of
the retailers and the portion of the market served by retailers in
compliance with the guidelines shall be considered in determining
whether the substantial-compliance standard has been met.
(C)(i) Upon the expiration of 30 months after November 8, 1990,
the Secretary shall issue a report on actions taken by food
retailers to provide consumers with nutrition information for raw
agricultural commodities and raw fish under the guidelines issued
under clause (A). Such report shall include a determination of
whether there is substantial compliance with the guidelines.
(ii) If the Secretary finds that there is substantial compliance
with the guidelines, the Secretary shall issue a report and make a
determination of the type required in subclause (i) every two
years.
(D)(i) If the Secretary determines that there is not substantial
compliance with the guidelines issued under clause (A), the
Secretary shall at the time such determination is made issue
proposed regulations requiring that any person who offers raw
agricultural commodities or raw fish to consumers provide, in a
manner prescribed by regulations, the nutrition information
required by subparagraphs (1) and (2). The Secretary shall issue
final regulations imposing such requirements 6 months after issuing
the proposed regulations. The final regulations shall become
effective 6 months after the date of their promulgation.
(ii) Regulations issued under subclause (i) may require that the
nutrition information required by subparagraphs (1) and (2) be
provided for more than 20 varieties of vegetables, 20 varieties of
fruit, and 20 varieties of fish most frequently consumed during a
year if the Secretary finds that a larger number of such products
are frequently consumed. Such regulations shall permit such
information to be provided in a single location in each area in
which raw agricultural commodities and raw fish are offered for
sale. Such regulations may provide that information shall be
expressed as an average or range per serving of the same type of
raw agricultural commodity or raw fish. The Secretary shall develop
and make available to the persons who offer such food to consumers
the information required by subparagraphs (1) and (2).
(iii) Regulations issued under subclause (i) shall permit the
required information to be provided in each area of an
establishment in which raw agricultural commodities and raw fish
are offered for sale. The regulations shall permit food retailers
to display the required information by supplying copies of the
information provided by the Secretary, by making the information
available in brochure, notebook or leaflet form, or by posting a
sign disclosing the information. Such regulations shall also permit
presentation of the required information to be supplemented by a
video, live demonstration, or other media which the Secretary
approves.
(E) For purposes of this subparagraph, the term "fish" includes
freshwater or marine fin fish, crustaceans, and mollusks, including
shellfish, amphibians, and other forms of aquatic animal life.
(F) No person who offers raw agricultural commodities or raw fish
to consumers may be prosecuted for minor violations of this
subparagraph if there has been substantial compliance with the
requirements of this paragraph.
(5)(A) Subparagraphs (1), (2), (3), and (4) shall not apply to
food -
(i) which is served in restaurants or other establishments in
which food is served for immediate human consumption or which is
sold for sale or use in such establishments,
(ii) which is processed and prepared primarily in a retail
establishment, which is ready for human consumption, which is of
the type described in subclause (i), and which is offered for
sale to consumers but not for immediate human consumption in such
establishment and which is not offered for sale outside such
establishment,
(iii) which is an infant formula subject to section 350a of
this title,
(iv) which is a medical food as defined in section 360ee(b) of
this title, or
(v) which is described in section 345(2) of this title.
(B) Subparagraphs (1) and (2) shall not apply to the label of a
food if the Secretary determines by regulations that compliance
with such subparagraphs is impracticable because the package of
such food is too small to comply with the requirements of such
subparagraphs and if the label of such food does not contain any
nutrition information.
(C) If a food contains insignificant amounts, as determined by
the Secretary, of all the nutrients required by subparagraphs (1)
and (2) to be listed in the label or labeling of food, the
requirements of such subparagraphs shall not apply to such food if
the label, labeling, or advertising of such food does not make any
claim with respect to the nutritional value of such food. If a food
contains insignificant amounts, as determined by the Secretary, of
more than one-half the nutrients required by subparagraphs (1) and
(2) to be in the label or labeling of the food, the Secretary shall
require the amounts of such nutrients to be stated in a simplified
form prescribed by the Secretary.
(D) If a person offers food for sale and has annual gross sales
made or business done in sales to consumers which is not more than
$500,000 or has annual gross sales made or business done in sales
of food to consumers which is not more than $50,000, the
requirements of subparagraphs (1), (2), (3), and (4) shall not
apply with respect to food sold by such person to consumers unless
the label or labeling of food offered by such person provides
nutrition information or makes a nutrition claim.
(E)(i) During the 12-month period for which an exemption from
subparagraphs (1) and (2) is claimed pursuant to this subclause,
the requirements of such subparagraphs shall not apply to any food
product if -
(I) the labeling for such product does not provide nutrition
information or make a claim subject to paragraph (r),
(II) the person who claims for such product an exemption from
such subparagraphs employed fewer than an average of 100
full-time equivalent employees,
(III) such person provided the notice described in subclause
(iii), and
(IV) in the case of a food product which was sold in the
12-month period preceding the period for which an exemption was
claimed, fewer than 100,000 units of such product were sold in
the United States during such preceding period, or in the case of
a food product which was not sold in the 12-month period
preceding the period for which such exemption is claimed, fewer
than 100,000 units of such product are reasonably anticipated to
be sold in the United States during the period for which such
exemption is claimed.
(ii) During the 12-month period after the applicable date
referred to in this sentence, the requirements of subparagraphs (1)
and (2) shall not apply to any food product which was first
introduced into interstate commerce before May 8, 1994, if the
labeling for such product does not provide nutrition information or
make a claim subject to paragraph (r), if such person provided the
notice described in subclause (iii), and if -
(I) during the 12-month period preceding May 8, 1994, the
person who claims for such product an exemption from such
subparagraphs employed fewer than an average of 300 full-time
equivalent employees and fewer than 600,000 units of such product
were sold in the United States,
(II) during the 12-month period preceding May 8, 1995, the
person who claims for such product an exemption from such
subparagraphs employed fewer than an average of 300 full-time
equivalent employees and fewer than 400,000 units of such product
were sold in the United States, or
(III) during the 12-month period preceding May 8, 1996, the
person who claims for such product an exemption from such
subparagraphs employed fewer than an average of 200 full-time
equivalent employees and fewer than 200,000 units of such product
were sold in the United States.
(iii) The notice referred to in subclauses (i) and (ii) shall be
given to the Secretary prior to the beginning of the period during
which the exemption under subclause (i) or (ii) is to be in effect,
shall state that the person claiming such exemption for a food
product has complied with the applicable requirements of subclause
(i) or (ii), and shall -
(I) state the average number of full-time equivalent employees
such person employed during the 12 months preceding the date such
person claims such exemption,
(II) state the approximate number of units the person claiming
the exemption sold in the United States,
(III) if the exemption is claimed for a food product which was
sold in the 12-month period preceding the period for which the
exemption was claimed, state the approximate number of units of
such product which were sold in the United States during such
preceding period, and, if the exemption is claimed for a food
product which was not sold in such preceding period, state the
number of units of such product which such person reasonably
anticipates will be sold in the United States during the period
for which the exemption was claimed, and
(IV) contain such information as the Secretary may require to
verify the information required by the preceding provisions of
this subclause if the Secretary has questioned the validity of
such information.
If a person is not an importer, has fewer than 10 full-time
equivalent employees, and sells fewer than 10,000 units of any food
product in any year, such person is not required to file a notice
for such product under this subclause for such year.
(iv) In the case of a person who claimed an exemption under
subclause (i) or (ii), if, during the period of such exemption, the
number of full-time equivalent employees of such person exceeds the
number in such subclause or if the number of food products sold in
the United States exceeds the number in such subclause, such
exemption shall extend to the expiration of 18 months after the
date the number of full-time equivalent employees or food products
sold exceeded the applicable number.
(v) For any food product first introduced into interstate
commerce after May 8, 2002, the Secretary may by regulation lower
the employee or units of food products requirement of subclause (i)
if the Secretary determines that the cost of compliance with such
lower requirement will not place an undue burden on persons subject
to such lower requirement.
(vi) For purposes of subclauses (i), (ii), (iii), (iv), and (v) -
(I) the term "unit" means the packaging or, if there is no
packaging, the form in which a food product is offered for sale
to consumers,
(II) the term "food product" means food in any sized package
which is manufactured by a single manufacturer or which bears the
same brand name, which bears the same statement of identity, and
which has similar preparation methods, and
(III) the term "person" in the case of a corporation includes
all domestic and foreign affiliates of the corporation.
(F) A dietary supplement product (including a food to which
section 350 of this title applies) shall comply with the
requirements of subparagraphs (1) and (2) in a manner which is
appropriate for the product and which is specified in regulations
of the Secretary which shall provide that -
(i) nutrition information shall first list those dietary
ingredients that are present in the product in a significant
amount and for which a recommendation for daily consumption has
been established by the Secretary, except that a dietary
ingredient shall not be required to be listed if it is not
present in a significant amount, and shall list any other dietary
ingredient present and identified as having no such
recommendation;
(ii) the listing of dietary ingredients shall include the
quantity of each such ingredient (or of a proprietary blend of
such ingredients) per serving;
(iii) the listing of dietary ingredients may include the source
of a dietary ingredient; and
(iv) the nutrition information shall immediately precede the
ingredient information required under subclause (i), except that
no ingredient identified pursuant to subclause (i) shall be
required to be identified a second time.
(G) Subparagraphs (1), (2), (3), and (4) shall not apply to food
which is sold by a food distributor if the food distributor
principally sells food to restaurants or other establishments in
which food is served for immediate human consumption and does not
manufacture, process, or repackage the food it sells.
(r) Nutrition levels and health-related claims
(1) Except as provided in clauses (A) through (C) of subparagraph
(5), if it is a food intended for human consumption which is
offered for sale and for which a claim is made in the label or
labeling of the food which expressly or by implication -
(A) characterizes the level of any nutrient which is of the
type required by paragraph (q)(1) or (q)(2) to be in the label or
labeling of the food unless the claim is made in accordance with
subparagraph (2), or
(B) characterizes the relationship of any nutrient which is of
the type required by paragraph (q)(1) or (q)(2) to be in the
label or labeling of the food to a disease or a health-related
condition unless the claim is made in accordance with
subparagraph (3) or (5)(D).
A statement of the type required by paragraph (q) that appears as
part of the nutrition information required or permitted by such
paragraph is not a claim which is subject to this paragraph and a
claim subject to clause (A) is not subject to clause (B).
(2)(A) Except as provided in subparagraphs (4)(A)(ii) and
(4)(A)(iii) and clauses (A) through (C) of subparagraph (5), a
claim described in subparagraph (1)(A) -
(i) may be made only if the characterization of the level made
in the claim uses terms which are defined in regulations of the
Secretary,
(ii) may not state the absence of a nutrient unless -
(I) the nutrient is usually present in the food or in a food
which substitutes for the food as defined by the Secretary by
regulation, or
(II) the Secretary by regulation permits such a statement on
the basis of a finding that such a statement would assist
consumers in maintaining healthy dietary practices and the
statement discloses that the nutrient is not usually present in
the food,
(iii) may not be made with respect to the level of cholesterol
in the food if the food contains, as determined by the Secretary
by regulation, fat or saturated fat in an amount which increases
to persons in the general population the risk of disease or a
health related condition which is diet related unless -
(I) the Secretary finds by regulation that the level of
cholesterol is substantially less than the level usually
present in the food or in a food which substitutes for the food
and which has a significant market share, or the Secretary by
regulation permits a statement regarding the absence of
cholesterol on the basis of a finding that cholesterol is not
usually present in the food and that such a statement would
assist consumers in maintaining healthy dietary practices and
the regulation requires that the statement disclose that
cholesterol is not usually present in the food, and
(II) the label or labeling of the food discloses the level of
such fat or saturated fat in immediate proximity to such claim
and with appropriate prominence which shall be no less than
one-half the size of the claim with respect to the level of
cholesterol,
(iv) may not be made with respect to the level of saturated fat
in the food if the food contains cholesterol unless the label or
labeling of the food discloses the level of cholesterol in the
food in immediate proximity to such claim and with appropriate
prominence which shall be no less than one-half the size of the
claim with respect to the level of saturated fat,
(v) may not state that a food is high in dietary fiber unless
the food is low in total fat as defined by the Secretary or the
label or labeling discloses the level of total fat in the food in
immediate proximity to such statement and with appropriate
prominence which shall be no less than one-half the size of the
claim with respect to the level of dietary fiber, and
(vi) may not be made if the Secretary by regulation prohibits
the claim because the claim is misleading in light of the level
of another nutrient in the food.
(B) If a claim described in subparagraph (1)(A) is made with
respect to a nutrient in a food and the Secretary makes a
determination that the food contains a nutrient at a level that
increases to persons in the general population the risk of a
disease or health-related condition that is diet related, the label
or labeling of such food shall contain, prominently and in
immediate proximity to such claim, the following statement: "See
nutrition information for ___ content." The blank shall identify
the nutrient associated with the increased disease or
health-related condition risk. In making the determination
described in this clause, the Secretary shall take into account the
significance of the food in the total daily diet.
(C) Subparagraph (2)(A) does not apply to a claim described in
subparagraph (1)(A) and contained in the label or labeling of a
food if such claim is contained in the brand name of such food and
such brand name was in use on such food before October 25, 1989,
unless the brand name contains a term defined by the Secretary
under subparagraph (2)(A)(i). Such a claim is subject to paragraph
(a).
(D) Subparagraph (2) does not apply to a claim described in
subparagraph (1)(A) which uses the term "diet" and is contained in
the label or labeling of a soft drink if (i) such claim is
contained in the brand name of such soft drink, (ii) such brand
name was in use on such soft drink before October 25, 1989, and
(iii) the use of the term "diet" was in conformity with section
105.66 of title 21 of the Code of Federal Regulations. Such a claim
is subject to paragraph (a).
(E) Subclauses (i) through (v) of subparagraph (2)(A) do not
apply to a statement in the label or labeling of food which
describes the percentage of vitamins and minerals in the food in
relation to the amount of such vitamins and minerals recommended
for daily consumption by the Secretary.
(F) Subclause (i) clause (A) does not apply to a statement in the
labeling of a dietary supplement that characterizes the percentage
level of a dietary ingredient for which the Secretary has not
established a reference daily intake, daily recommended value, or
other recommendation for daily consumption.
(G) A claim of the type described in subparagraph (1)(A) for a
nutrient, for which the Secretary has not promulgated a regulation
under clause (A)(i), shall be authorized and may be made with
respect to a food if -
(i) a scientific body of the United States Government with
official responsibility for public health protection or research
directly relating to human nutrition (such as the National
Institutes of Health or the Centers for Disease Control and
Prevention) or the National Academy of Sciences or any of its
subdivisions has published an authoritative statement, which is
currently in effect, which identifies the nutrient level to which
the claim refers;
(ii) a person has submitted to the Secretary, at least 120 days
(during which the Secretary may notify any person who is making a
claim as authorized by clause (C) that such person has not
submitted all the information required by such clause) before the
first introduction into interstate commerce of the food with a
label containing the claim, (I) a notice of the claim, which
shall include the exact words used in the claim and shall include
a concise description of the basis upon which such person relied
for determining that the requirements of subclause (i) have been
satisfied, (II) a copy of the statement referred to in subclause
(i) upon which such person relied in making the claim, and (III)
a balanced representation of the scientific literature relating
to the nutrient level to which the claim refers;
(iii) the claim and the food for which the claim is made are in
compliance with clauses (A) and (B), and are otherwise in
compliance with paragraph (a) and section 321(n) of this title;
and
(iv) the claim is stated in a manner so that the claim is an
accurate representation of the authoritative statement referred
to in subclause (i) and so that the claim enables the public to
comprehend the information provided in the claim and to
understand the relative significance of such information in the
context of a total daily diet.
For purposes of this clause, a statement shall be regarded as an
authoritative statement of a scientific body described in subclause
(i) only if the statement is published by the scientific body and
shall not include a statement of an employee of the scientific body
made in the individual capacity of the employee.
(H) A claim submitted under the requirements of clause (G) may be
made until -
(i) such time as the Secretary issues a regulation -
(I) prohibiting or modifying the claim and the regulation has
become effective, or
(II) finding that the requirements of clause (G) have not
been met, including finding that the petitioner had not
submitted all the information required by such clause; or
(ii) a district court of the United States in an enforcement
proceeding under subchapter III of this chapter has determined
that the requirements of clause (G) have not been met.
(3)(A) Except as provided in subparagraph (5), a claim described
in subparagraph (1)(B) may only be made -
(i) if the claim meets the requirements of the regulations of
the Secretary promulgated under clause (B), and
(ii) if the food for which the claim is made does not contain,
as determined by the Secretary by regulation, any nutrient in an
amount which increases to persons in the general population the
risk of a disease or health-related condition which is diet
related, taking into account the significance of the food in the
total daily diet, except that the Secretary may by regulation
permit such a claim based on a finding that such a claim would
assist consumers in maintaining healthy dietary practices and
based on a requirement that the label contain a disclosure of the
type required by subparagraph (2)(B).
(B)(i) The Secretary shall promulgate regulations authorizing
claims of the type described in subparagraph (1)(B) only if the
Secretary determines, based on the totality of publicly available
scientific evidence (including evidence from well-designed studies
conducted in a manner which is consistent with generally recognized
scientific procedures and principles), that there is significant
scientific agreement, among experts qualified by scientific
training and experience to evaluate such claims, that the claim is
supported by such evidence.
(ii) A regulation described in subclause (i) shall describe -
(I) the relationship between a nutrient of the type required in
the label or labeling of food by paragraph (q)(1) or (q)(2) and a
disease or health-related condition, and
(II) the significance of each such nutrient in affecting such
disease or health-related condition.
(iii) A regulation described in subclause (i) shall require such
claim to be stated in a manner so that the claim is an accurate
representation of the matters set out in subclause (ii) and so that
the claim enables the public to comprehend the information provided
in the claim and to understand the relative significance of such
information in the context of a total daily diet.
(C) Notwithstanding the provisions of clauses (A)(i) and (B), a
claim of the type described in subparagraph (1)(B) which is not
authorized by the Secretary in a regulation promulgated in
accordance with clause (B) shall be authorized and may be made with
respect to a food if -
(i) a scientific body of the United States Government with
official responsibility for public health protection or research
directly relating to human nutrition (such as the National
Institutes of Health or the Centers for Disease Control and
Prevention) or the National Academy of Sciences or any of its
subdivisions has published an authoritative statement, which is
currently in effect, about the relationship between a nutrient
and a disease or health-related condition to which the claim
refers;
(ii) a person has submitted to the Secretary, at least 120 days
(during which the Secretary may notify any person who is making a
claim as authorized by clause (C) that such person has not
submitted all the information required by such clause) before the
first introduction into interstate commerce of the food with a
label containing the claim, (I) a notice of the claim, which
shall include the exact words used in the claim and shall include
a concise description of the basis upon which such person relied
for determining that the requirements of subclause (i) have been
satisfied, (II) a copy of the statement referred to in subclause
(i) upon which such person relied in making the claim, and (III)
a balanced representation of the scientific literature relating
to the relationship between a nutrient and a disease or
health-related condition to which the claim refers;
(iii) the claim and the food for which the claim is made are in
compliance with clause (A)(ii) and are otherwise in compliance
with paragraph (a) and section 321(n) of this title; and
(iv) the claim is stated in a manner so that the claim is an
accurate representation of the authoritative statement referred
to in subclause (i) and so that the claim enables the public to
comprehend the information provided in the claim and to
understand the relative significance of such information in the
context of a total daily diet.
For purposes of this clause, a statement shall be regarded as an
authoritative statement of a scientific body described in subclause
(i) only if the statement is published by the scientific body and
shall not include a statement of an employee of the scientific body
made in the individual capacity of the employee.
(D) A claim submitted under the requirements of clause (C) may be
made until -
(i) such time as the Secretary issues a regulation under the
standard in clause (B)(i) -
(I) prohibiting or modifying the claim and the regulation has
become effective, or
(II) finding that the requirements of clause (C) have not
been met, including finding that the petitioner has not
submitted all the information required by such clause; or
(ii) a district court of the United States in an enforcement
proceeding under subchapter III of this chapter has determined
that the requirements of clause (C) have not been met.
(4)(A)(i) Any person may petition the Secretary to issue a
regulation under subparagraph (2)(A)(i) or (3)(B) relating to a
claim described in subparagraph (1)(A) or (1)(B). Not later than
100 days after the petition is received by the Secretary, the
Secretary shall issue a final decision denying the petition or file
the petition for further action by the Secretary. If the Secretary
does not act within such 100 days, the petition shall be deemed to
be denied unless an extension is mutually agreed upon by the
Secretary and the petitioner. If the Secretary denies the petition
or the petition is deemed to be denied, the petition shall not be
made available to the public. If the Secretary files the petition,
the Secretary shall deny the petition or issue a proposed
regulation to take the action requested in the petition not later
than 90 days after the date of such decision. If the Secretary does
not act within such 90 days, the petition shall be deemed to be
denied unless an extension is mutually agreed upon by the Secretary
and the petitioner. If the Secretary issues a proposed regulation,
the rulemaking shall be completed within 540 days of the date the
petition is received by the Secretary. If the Secretary does not
issue a regulation within such 540 days, the Secretary shall
provide the Committee on Commerce of the House of Representatives
and the Committee on Labor and Human Resources of the Senate the
reasons action on the regulation did not occur within such 540
days.
(ii) Any person may petition the Secretary for permission to use
in a claim described in subparagraph (1)(A) terms that are
consistent with the terms defined by the Secretary under
subparagraph (2)(A)(i). Within 90 days of the submission of such a
petition, the Secretary shall issue a final decision denying the
petition or granting such permission.
(iii) Any person may petition the Secretary for permission to use
an implied claim described in subparagraph (1)(A) in a brand name.
After publishing notice of an opportunity to comment on the
petition in the Federal Register and making the petition available
to the public, the Secretary shall grant the petition if the
Secretary finds that such claim is not misleading and is consistent
with terms defined by the Secretary under subparagraph (2)(A)(i).
The Secretary shall grant or deny the petition within 100 days of
the date it is submitted to the Secretary and the petition shall be
considered granted if the Secretary does not act on it within such
100 days.
(B) A petition under clause (A)(i) respecting a claim described
in subparagraph (1)(A) or (1)(B) shall include an explanation of
the reasons why the claim meets the requirements of this paragraph
and a summary of the scientific data which supports such reasons.
(C) If a petition for a regulation under subparagraph (3)(B)
relies on a report from an authoritative scientific body of the
United States, the Secretary shall consider such report and shall
justify any decision rejecting the conclusions of such report.
(5)(A) This paragraph does not apply to infant formulas subject
to section 350a(h) of this title and medical foods as defined in
section 360ee(b) of this title.
(B) Subclauses (iii) through (v) of subparagraph (2)(A) and
subparagraph (2)(B) do not apply to food which is served in
restaurants or other establishments in which food is served for
immediate human consumption or which is sold for sale or use in
such establishments.
(C) A subparagraph (1)(A) claim made with respect to a food which
claim is required by a standard of identity issued under section
341 of this title shall not be subject to subparagraph (2)(A)(i) or
(2)(B).
(D) A subparagraph (1)(B) claim made with respect to a dietary
supplement of vitamins, minerals, herbs, or other similar
nutritional substances shall not be subject to subparagraph (3) but
shall be subject to a procedure and standard, respecting the
validity of such claim, established by regulation of the Secretary.
(6) For purposes of paragraph (r)(1)(B), a statement for a
dietary supplement may be made if -
(A) the statement claims a benefit related to a classical
nutrient deficiency disease and discloses the prevalence of such
disease in the United States, describes the role of a nutrient or
dietary ingredient intended to affect the structure or function
in humans, characterizes the documented mechanism by which a
nutrient or dietary ingredient acts to maintain such structure or
function, or describes general well-being from consumption of a
nutrient or dietary ingredient,
(B) the manufacturer of the dietary supplement has
substantiation that such statement is truthful and not
misleading, and
(C) the statement contains, prominently displayed and in
boldface type, the following: "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.".
A statement under this subparagraph may not claim to diagnose,
mitigate, treat, cure, or prevent a specific disease or class of
diseases. If the manufacturer of a dietary supplement proposes to
make a statement described in the first sentence of this
subparagraph in the labeling of the dietary supplement, the
manufacturer shall notify the Secretary no later than 30 days after
the first marketing of the dietary supplement with such statement
that such a statement is being made.
(7) The Secretary may make proposed regulations issued under this
paragraph effective upon publication pending consideration of
public comment and publication of a final regulation if the
Secretary determines that such action is necessary -
(A) to enable the Secretary to review and act promptly on
petitions the Secretary determines provide for information
necessary to -
(i) enable consumers to develop and maintain healthy dietary
practices;
(ii) enable consumers to be informed promptly and effectively
of important new knowledge regarding nutritional and health
benefits of food; or
(iii) ensure that scientifically sound nutritional and health
information is provided to consumers as soon as possible; or
(B) to enable the Secretary to act promptly to ban or modify a
claim under this paragraph.
Such proposed regulations shall be deemed final agency action for
purposes of judicial review.
(s) Dietary supplements
If -
(1) it is a dietary supplement; and
(2)(A) the label or labeling of the supplement fails to list -
(i) the name of each ingredient of the supplement that is
described in section 321(ff) of this title; and
(ii)(I) the quantity of each such ingredient; or
(II) with respect to a proprietary blend of such ingredients,
the total quantity of all ingredients in the blend;
(B) the label or labeling of the dietary supplement fails to
identify the product by using the term "dietary supplement",
which term may be modified with the name of such an ingredient;
(C) the supplement contains an ingredient described in section
321(ff)(1)(C) of this title, and the label or labeling of the
supplement fails to identify any part of the plant from which the
ingredient is derived;
(D) the supplement -
(i) is covered by the specifications of an official
compendium;
(ii) is represented as conforming to the specifications of an
official compendium; and
(iii) fails to so conform; or
(E) the supplement -
(i) is not covered by the specifications of an official
compendium; and
(ii)(I) fails to have the identity and strength that the
supplement is represented to have; or
(II) fails to meet the quality (including tablet or capsule
disintegration), purity, or compositional specifications, based
on validated assay or other appropriate methods, that the
supplement is represented to meet.
A dietary supplement shall not be deemed misbranded solely because
its label or labeling contains directions or conditions of use or
warnings.
(t) Catfish
If it purports to be or is represented as catfish, unless it is
fish classified within the family Ictaluridae.
(u) Ginseng
If it purports to be or is represented as ginseng, unless it is
an herb or herbal ingredient derived from a plant classified within
the genus Panax.
(v) Failure to label; health threat
If -
(1) it fails to bear a label required by the Secretary under
section 381(n)(1) of this title (relating to food refused
admission into the United States);
(2) the Secretary finds that the food presents a threat of
serious adverse health consequences or death to humans or
animals; and
(3) upon or after notifying the owner or consignee involved
that the label is required under section 381 of this title, the
Secretary informs the owner or consignee that the food presents
such a threat.
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