§ 343. — Misbranded food.
[Laws in effect as of January 7, 2003]
[Document not affected by Public Laws enacted between
January 7, 2003 and December 19, 2003]
[CITE: 21USC343]
TITLE 21--FOOD AND DRUGS
CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV--FOOD
Sec. 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.
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\1\ So in original. Probably should be followed by a comma.
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(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.
(June 25, 1938, ch. 675, Sec. 403, 52 Stat. 1047; Pub. L. 86-537,
Sec. 1, June 29, 1960, 74 Stat. 251; Pub. L. 86-618, title I,
Sec. 102(a)(3), July 12, 1960, 74 Stat. 398; Pub. L. 91-601, Sec. 6(c),
formerly Sec. 7(c), Dec. 30, 1970, 84 Stat. 1673, renumbered Pub. L. 97-
35, title XII, Sec. 1205(c), Aug. 13, 1981, 95 Stat. 716; Pub. L. 94-
278, title V, Sec. 502(a)(1), Apr. 22, 1976, 90 Stat. 411; Pub. L. 95-
203, Sec. 4(a)(1), (b)(1), Nov. 23, 1977, 91 Stat. 1452, 1453; Pub. L.
101-535, Secs. 2(a), 3(a), 7, Nov. 8, 1990, 104 Stat. 2353, 2357, 2364;
Pub. L. 102-108, Sec. 2(a), (c), Aug. 17, 1991, 105 Stat. 549; Pub. L.
102-571, title I, Sec. 107(5), (6), Oct. 29, 1992, 106 Stat. 4499; Pub.
L. 103-80, Secs. 2(b), 3(j), Aug. 13, 1993, 107 Stat. 773, 776; Pub. L.
103-417, Secs. 6, 7(a)-(c), 10(c), Oct. 25, 1994, 108 Stat. 4329, 4330,
4332; Pub. L. 104-124, Sec. 1, Apr. 1, 1996, 110 Stat. 882; Pub. L. 105-
115, title III, Secs. 301-305, Nov. 21, 1997, 111 Stat. 2350-2353; Pub.
L. 106-554, Sec. 1(a)(1) [title V, Sec. 517], Dec. 21, 2000, 114 Stat.
2763, 2763A-73; Pub. L. 107-171, title X, Secs. 10806(a)(2), (b)(2),
10808(b), May 13, 2002, 116 Stat. 526, 527, 530; Pub. L. 107-188, title
III, Sec. 308(b), June 12, 2002, 116 Stat. 672.)
Amendments
2002--Subsec. (h). Pub. L. 107-171, Sec. 10808(b), added par. (3)
and concluding provisions.
Subsec. (t). Pub. L. 107-171, Sec. 10806(a)(2), added subsec. (t).
Subsec. (u). Pub. L. 107-171, Sec. 10806(b)(2), added subsec. (u).
Subsec. (v). Pub. L. 107-188 added subsec. (v).
2000--Par. (o). Pub. L. 106-554, which directed repeal of section
403(o) of the Food, Drug, and Cosmetic Act, was executed by repealing
par. (o) of this section, which is section 403 of the Federal Food,
Drug, and Cosmetic Act, to reflect the probable intent of Congress.
Prior to repeal, par. (o) provided that a food containing saccharin was
to be deemed misbranded unless a specified warning statement was placed
in a conspicuous place on its label.
1997--Par. (r)(2)(B). Pub. L. 105-115, Sec. 305, amended cl. (B)
generally. Prior to amendment, cl. (B) read as follows: ``If a claim
described in subparagraph (1)(A) is made with respect to a nutrient in a
food, the label or labeling of such food shall contain, prominently and
in immediate proximity to such claim, the following statement: `See
_____ for nutrition information.'. In the statement--
``(i) the blank shall identify the panel on which the
information described in the statement may be found, and
``(ii) if the Secretary determines that the food contains a
nutrient at a level 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, the statement shall also identify such
nutrient.''
Par. (r)(2)(G), (H). Pub. L. 105-115, Sec. 304, added cls. (G) and
(H).
Par. (r)(3)(C), (D). Pub. L. 105-115, Sec. 303, added cls. (C) and
(D).
Par. (r)(4)(A)(i). Pub. L. 105-115, Sec. 302, inserted after second
sentence ``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.'', inserted ``or the
petition is deemed to be denied'' after ``If the Secretary denies the
petition'', and inserted at end ``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.''
Par. (r)(7). Pub. L. 105-115, Sec. 301, added subpar. (7).
1996--Par. (p). Pub. L. 104-124 struck out subsec. (p), which deemed
products containing saccharin and offered for sale, but not for
immediate consumption, by retail establishment, to be misbranded, unless
notice of information required by subsec. (o) was provided by
manufacturer and prominently displayed near product.
1994--Par. (q)(5)(F). Pub. L. 103-417, Sec. 7(b), amended cl. (F)
generally. Prior to amendment, cl. (F) read as follows: ``If a food to
which section 350 of this title applies (as defined in section 350(c) of
this title) contains one or more of the nutrients required by
subparagraph (1) or (2) to be in the label or labeling of the food, the
label or labeling of such food shall comply with the requirements of
subparagraphs (1) and (2) in a manner which is appropriate for such food
and which is specified in regulations of the Secretary.''
Par. (r)(2)(F). Pub. L. 103-417, Sec. 7(c), added cl. (F).
Par. (r)(6). Pub. L. 103-417, Sec. 6, added subpar. (6).
Par. (s). Pub. L. 103-417, Sec. 10(c), inserted at end: ``A dietary
supplement shall not be deemed misbranded solely because its label or
labeling contains directions or conditions of use or warnings.''
Pub. L. 103-417, Sec. 7(a), added par. (s).
1993--Par. (e). Pub. L. 103-80, Sec. 3(j)(1), substituted ``count,
except that'' for ``count: Provided, That''.
Par. (i). Pub. L. 103-80, Sec. 3(j)(2), substituted ``unless sold as
spices, flavorings, or such colors'' for ``, other than those sold as
such'' and ``naming each. To the extent'' for ``naming each: Provided,
That, to the extent''.
Par. (k). Pub. L. 103-80, Sec. 3(j)(3), substituted ``, except
that'' for ``: Provided, That''.
Par. (l). Pub. L. 103-80, Sec. 3(j)(4), substituted ``chemical,
except that'' for ``chemical: Provided, however, That''.
Par. (q)(5)(E) to (G). Pub. L. 103-80, Sec. 2(b), added cl. (E) and
redesignated former cls. (E) and (F) as (F) and (G), respectively.
Par. (r)(1)(B). Pub. L. 103-80, Sec. 3(j)(5), substituted ``(5)(D)''
for ``5(D)''.
Par. (r)(4)(B). Pub. L. 103-80, Sec. 3(j)(6), substituted
``paragraph'' for ``subsection''.
1992--Par. (i). Pub. L. 102-571, Sec. 107(5), substituted
``379e(c)'' for ``376(c)''.
Par. (m). Pub. L. 102-571, Sec. 107(6), substituted ``379e'' for
``376''.
1991--Par. (i). Pub. L. 102-108, Sec. 2(c), amended directory
language of Pub. L. 101-535, Sec. 7(1), (3). See 1990 Amendment note
below.
Par. (q)(4)(A). Pub. L. 102-108, Sec. 2(a), substituted ``(D)'' for
``(C)''.
1990--Par. (i). Pub. L. 101-535, Sec. 7, as amended by Pub. L. 102-
108, Sec. 2(c), substituted ``Unless'' for ``If it is not subject to the
provisions of paragraph (g) unless'', inserted ``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'', and substituted ``colors not required to be certified under
section 376(c) of this title'' for ``colorings'' the first time
appearing.
Par. (q). Pub. L. 101-535, Sec. 2(a), added par. (q).
Par. (r). Pub. L. 101-535, Sec. 3(a), added par. (r).
1977--Par. (o). Pub. L. 95-203, Sec. 4(a)(1), added par. (o).
Par. (p). Pub. L. 95-203, Sec. 4(b)(1), added par. (p).
1976--Par. (a). Pub. L. 94-278 inserted ``(1)'' after ``If'' and
inserted ``, 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'' after ``any particular''.
1970--Par. (n). Pub. L. 91-601 added par. (n).
1960--Par. (k). Pub. L. 86-537, Sec. 1(1), exempted pesticide
chemicals when used in or on a raw agricultural commodity which is the
produce of the soil.
Par. (l). Pub. L. 86-537, Sec. 1(2), added par. (l).
Par. (m). Pub. L. 86-618 added par. (m).
Change of Name
Committee on Commerce of House of Representatives changed to
Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and
insurance generally transferred to Committee on Financial Services of
House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.
Effective Date of 1997 Amendment
Amendment by Pub. L. 105-115 effective 90 days after Nov. 21, 1997,
except as otherwise provided, see section 501 of Pub. L. 105-115, set
out as a note under section 321 of this title.
Effective Date of 1994 Amendment
Section 7(e) of Pub. L. 103-417 provided that: ``Dietary
supplements--
``(1) may be labeled after the date of the enactment of this Act
[Oct. 25, 1994] in accordance with the amendments made by this
section [amending this section and section 350 of this title], and
``(2) shall be labeled after December 31, 1996, in accordance
with such amendments.''
Effective Date of 1990 Amendment
Section 10(a) of Pub. L. 101-535, as amended by Pub. L. 102-571,
title II, Sec. 202(a)(3), Oct. 29, 1992, 106 Stat. 4501, provided that:
``(1) Except as provided in paragraph (2)--
``(A) the amendments made by section 2 [amending this section]
shall take effect 6 months after--
``(i) the date of the promulgation of all final regulations
required to implement section 403(q) of the Federal Food, Drug,
and Cosmetic Act [21 U.S.C. 343(q)], or
``(ii) if such regulations are not promulgated, the date
proposed regulations are to be considered as such final
regulations [Nov. 8, 1992, see 57 F.R. 56347],
except that section 403(q)(4) of such Act shall take effect as
prescribed by such section,
``(B) the amendments made by section 3 [amending this section]
shall take effect 6 months after--
``(i) the date of the promulgation of final regulations to
implement section 403(r) of the Federal Food, Drug, and Cosmetic
Act, or
``(ii) if such regulations are not promulgated, the date
proposed regulations are to be considered as such final
regulations [Nov. 8, 1992, see 57 F.R. 56347], except that any
person marketing a food the brand name of which contains a term
defined by the Secretary under section 403(r)(2)(A)(i) of the
Federal Food, Drug, and Cosmetic Act shall be given an
additional 6 months to comply with section 3,
``(C) the amendments made by section 4 [amending section 337 of
this title] shall take effect 24 months after the date of the
enactment of this Act [Nov. 8, 1990], except that such amendments
shall take effect with respect to such dietary supplements [probably
means dietary supplements of vitamins, minerals, herbs, or other
similar nutritional substances, see section 202(a)(1) of Pub. L.
102-571, set out below] on December 31, 1993, and
``(D) the amendments made by section 5 [amending sections 321
and 345 of this title] shall take effect on the date the amendments
made by section 3 take effect.
``(2) Section 403(q) of the Federal Food, Drug, and Cosmetic Act (as
added by section 2) shall not apply with respect to food which was
labeled before the effective date of the amendments made by section 2
and section 403(r) of the Federal Food, Drug, and Cosmetic Act (as added
by section 3) shall not apply with respect to food which was labeled
before the effective date of the amendments made by section 3.
``(3)(A) If the Secretary finds that a person who is subject to
section 403(q)(4) of such Act is unable to comply with the requirements
of such section upon the effective date of final regulations to
implement section 403(q) of such Act or of proposed regulations to be
considered as such final regulations because the Secretary has not made
available to such person the information required by such section, the
Secretary shall delay the application of such section to such person for
such time as the Secretary may require to provide such information.
``(B) If the Secretary finds that compliance with section 403(q) or
403(r)(2) of such Act would cause an undue economic hardship, the
Secretary may delay the application of such sections for no more than
one year.''
Section 10(c) of Pub. L. 101-535, as amended by Pub. L. 102-108,
Sec. 1, Aug. 17, 1991, 105 Stat. 549; Pub. L. 102-571, title I,
Sec. 107(17), Oct. 29, 1992, 106 Stat. 4500, provided that:
``(1) Except as provided in paragraphs (2) and (3), the amendments
made by section 7 [amending this section] shall take effect one year
after the date of the enactment of this Act [Nov. 8, 1990].
``(2)(A) If a food subject to section 403(g) of the Federal Food,
Drug, and Cosmetic Act [21 U.S.C. 343(g)] or a food with one or more
colors required to be certified under section 721(c) [of the Federal
Food, Drug, and Cosmetic Act, 21 U.S.C. 379e(c)] bears a label which was
printed before July 1, 1991, and which is attached to the food before
May 8, 1993, such food shall not be subject to the amendments made by
section 7(1) and section 7(3) [amending this section].
``(B) If a food described in subparagraph (A)--
``(i) bears a label which was printed after July 1, 1991, but
before the date the proposed regulation described in clause (ii)
takes effect as a final regulation and which was attached to the
food before May 8, 1993, and
``(ii) meets the requirements of the proposed regulation of the
Secretary of Health and Human Services published in 56 Fed. Reg.
28592-28636 (June 21, 1991) as it pertains to the amendments made by
this Act [see Short Title of 1990 Amendment note set out under
section 301 of this title],
such food shall not be subject to the amendments made by section 7(1)
and section 7(3) [amending this section].
``(3) A food purported to be a beverage containing a vegetable or
fruit juice which bears a label attached to the food before May 8, 1993,
shall not be subject to the amendments made by section 7(2) [amending
this section].''
Effective Date of 1977 Amendment
Section 4(a)(2) of Pub. L. 95-203 provided that: ``The amendment
made by paragraph (1) [amending this section] shall apply only with
respect to food introduced or delivered for introduction in interstate
commerce on and after the 90th day after the date of the enactment of
this Act [Nov. 23, 1977].''
Section 4(b)(2) of Pub. L. 95-203 provided that: ``The amendment
made by paragraph (1) [amending this section] shall apply with respect
to food which is sold in retail establishments on or after the 90th day
after the effective date of the regulations of the Secretary of Health,
Education, and Welfare [now Secretary of Health and Human Services]
under paragraph (p)(4) of the Federal Food, Drug, and Cosmetic Act [21
U.S.C. 343(p)(4)].''
Effective Date of 1976 Amendment
Amendment by Pub. L. 94-278 effective 180 days after Apr. 22, 1976,
see section 502(c) of Pub. L. 94-278, set out as a note under section
334 of this title.
Effective Date of 1970 Amendment
Amendment by Pub. L. 91-601 effective Dec. 30, 1970, and regulations
establishing special packaging standards effective no sooner than 180
days or later than one year from date regulations are final, or an
earlier date published in Federal Register, see section 8 of Pub. L. 91-
601, set out as an Effective Date note under section 1471 of Title 15,
Commerce and Trade.
Effective Date of 1960 Amendment
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to the
provisions of section 203 of Pub. L. 86-618, see section 202 of Pub. L.
86-618, set out as a note under section 379e of this title.
Effective Date; Postponement
Subsecs. (e)(1) and (g) to (k) effective Jan. 1, 1940, and such
subsections effective July 1, 1940, as provided by regulations for
certain lithographed labeling and containers bearing certain labeling,
see act June 23, 1939, ch. 242, 53 Stat. 853, set out as an Effective
Date; Postponement in Certain Cases note under section 301 of this
title.
Construction of Amendment by Pub. L. 107-188
Nothing in amendment by Pub. L. 107-188 to be construed to limit
authority of Secretary of Health and Human Services or Secretary of the
Treasury to require marking of articles of food imported or offered for
import into the United States which are refused admission, see section
308(c) of Pub. L. 107-188, set out as a note under section 381 of this
title.
Construction of Amendments by Pub. L. 101-535
Section 9 of Pub. L. 101-535 provided that: ``The amendments made by
this Act [enacting section 343-1 of this title and amending this section
and sections 321, 337, 345, and 371 of this title] shall not be
construed to alter the authority of the Secretary of Health and Human
Services and the Secretary of Agriculture under the Federal Food, Drug,
and Cosmetic Act [21 U.S.C. 301 et seq.], the Federal Meat Inspection
Act [21 U.S.C. 601 et seq.], the Poultry Products Inspection Act [21
U.S.C. 451 et seq.], and the Egg Products Inspection Act [21 U.S.C. 1031
et seq.].''
Regulations
Section 2(b) of Pub. L. 101-535, as amended by Pub. L. 102-571,
title II, Sec. 202(a)(2)(A), (B), Oct. 29, 1992, 106 Stat. 4500, 4501,
provided that:
``(1) The Secretary of Health and Human Services shall issue
proposed regulations to implement section 403(q) of the Federal Food,
Drug, and Cosmetic Act [21 U.S.C. 343(q)] within 12 months after the
date of the enactment of this Act [Nov. 8, 1990], except that the
Secretary shall issue, not later than June 15, 1993, proposed
regulations that are applicable to dietary supplements of vitamins,
minerals, herbs, or other similar nutritional substances to implement
such section. Not later than 24 months after the date of the enactment
of this Act, the Secretary shall issue final regulations to implement
the requirements of such section, except that the Secretary shall issue,
not later than December 31, 1993, such a final regulation applicable to
dietary supplements of vitamins, minerals, herbs, or other similar
nutritional substances..[sic] Such regulations shall--
``(A) require the required information to be conveyed to the
public in a manner which enables the public to readily observe and
comprehend such information and to understand its relative
significance in the context of a total daily diet,
``(B) include regulations which establish standards, in
accordance with paragraph (1)(A), to define serving size or other
unit of measure for food,
``(C) permit the label or labeling of food to include nutrition
information which is in addition to the information required by such
section 403(q) and which is of the type described in subparagraph
(1) or (2) of such section, and
``(D) permit the nutrition information on the label or labeling
of a food to remain the same or permit the information to be stated
as a range even though (i) there are minor variations in the
nutritional value of the food which occur in the normal course of
the production or processing of the food, or (ii) the food is
comprised of an assortment of similar foods which have variations in
nutritional value.
``(2) If the Secretary of Health and Human Services does not
promulgate final regulations under paragraph (1) upon the expiration of
24 months after the date of the enactment of this Act, the proposed
regulations issued in accordance with paragraph (1) shall be considered
as the final regulations upon the expiration of such 24 months, except
that the proposed regulations applicable to dietary supplements of
vitamins, minerals, herbs, or other similar nutritional substances shall
not be considered to be final regulations until December 31, 1993. There
shall be promptly published in the Federal Register notice of new status
of the proposed regulations [see 57 F.R. 56347].
``(3) If the Secretary of Health and Human Services does not
promulgate final regulations under section 403(q)(4) of the Federal
Food, Drug, and Cosmetic Act upon the expiration of 6 months after the
date on which the Secretary makes a finding that there has been no
substantial compliance with section 403(q)(4)(C) of such Act, the
proposed regulations issued in accordance with such section shall be
considered as the final regulations upon the expiration of such 6
months. There shall be promptly published in the Federal Register notice
of new status of the proposed regulations.''
[Section 202(a)(2)(C) of Pub. L. 102-571 provided that: ``The
amendments made by subparagraph (B) [amending sections 2(b) and 3(b) of
Pub. L. 101-535, set out above and below] shall not be construed to
modify the effective date of final regulations under sections 2(b) and
3(b) of the Nutrition Labeling and Education Act of 1990 [Pub. L. 101-
535] (21 U.S.C. 343 note) with respect to foods that are not such
dietary supplements.'']
Section 3(b) of Pub. L. 101-535, as amended by Pub. L. 102-571,
title II, Sec. 202(a)(2)(A), (B), Oct. 29, 1992, 106 Stat. 4500, 4501,
provided that:
``(1)(A) Within 12 months of the date of the enactment of this Act
[Nov. 8, 1990], the Secretary of Health and Human Services shall issue
proposed regulations to implement section 403(r) of the Federal Food,
Drug, and Cosmetic Act [21 U.S.C. 343(r)], except that the Secretary
shall issue, not later than June 15, 1993, proposed regulations that are
applicable to dietary supplements of vitamins, minerals, herbs, or other
similar nutritional substances to implement such section. Such
regulations--
``(i) shall identify claims described in section 403(r)(1)(A) of
such Act which comply with section 403(r)(2) of such Act,
``(ii) shall identify claims described in section 403(r)(1)(B)
of such Act which comply with section 403(r)(3) of such Act,
``(iii) shall, in defining terms used to characterize the level
of any nutrient in food under section 403(r)(2)(A)(i) of such Act,
define--
``(I) free,
``(II) low,
``(III) light or lite,
``(IV) reduced,
``(V) less, and
``(VI) high,
unless the Secretary finds that the use of any such term would be
misleading,
``(iv) shall permit statements describing the amount and
percentage of nutrients in food which are not misleading and are
consistent with the terms defined in section 403(r)(2)(A)(i) of such
Act,
``(v) shall provide that if multiple claims subject to section
403(r)(1)(A) of such Act are made on a single panel of the food
label or page of a labeling brochure, a single statement may be made
to satisfy section 403(r)(2)(B) of such Act,
``(vi) shall determine whether claims respecting the following
nutrients and diseases meet the requirements of section 403(r)(3) of
such Act: Calcium and osteoporosis, dietary fiber and cancer, lipids
and cardiovascular disease, lipids and cancer, sodium and
hypertension, and dietary fiber and cardiovascular disease,
``(vii) shall not require a person who proposes to make a claim
described in section 403(r)(1)(B) of such Act which is in compliance
with such regulations to secure the approval of the Secretary before
making such claim,
``(viii) may permit a claim described in section 403(r)(1)(A) of
such Act to be made for butter,
``(ix) may, in defining terms under section 403(r)(2)(A)(i),
include similar terms which are commonly understood to have the same
meaning, and
``(x) shall establish, as required by section 403(r)(5)(D), the
procedure and standard respecting the validity of claims made with
respect to a dietary supplement of vitamins, minerals, herbs, or
other similar nutritional substances and shall determine whether
claims respecting the following nutrients and diseases meet the
requirements of section 403(r)(5)(D) of such Act: folic acid and
neural tube defects, antioxident [sic] vitamins and cancer, zinc and
immune function in the elderly, and omega-3 fatty acids and heart
disease.
``(B) Not later than 24 months after the date of the enactment of
this Act, the Secretary shall issue final regulations to implement
section 403(r) of the Federal Food, Drug, and Cosmetic Act, except that
the Secretary shall issue, not later than December 31, 1993, such a
final regulation applicable to dietary supplements of vitamins,
minerals, herbs, or other similar nutritional substances..[sic]
``(2) If the Secretary does not promulgate final regulations under
paragraph (1)(B) upon the expiration of 24 months after the date of the
enactment of this Act, the proposed regulations issued in accordance
with paragraph (1)(A) shall be considered as the final regulations upon
the expiration of such 24 months, except that the proposed regulations
applicable to dietary supplements of vitamins, minerals, herbs, or other
similar nutritional substances shall not be considered to be final
regulations until December 31, 1993. There shall be promptly published
in the Federal Register notice of the new status of the proposed
regulations [see 57 F.R. 56347].''
[For construction of amendment made by section 202(a)(2)(B) of Pub.
L. 102-571 to section 3(b) of Pub. L. 101-535 set out above, see section
202(a)(2)(C) of Pub. L. 102-571 set out above following section 2(b) of
Pub. L. 101-535.]
Transfer of Functions
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see note set out under section
41 of this title.
Rulemaking on Labeling of Irradiated Food; Certain Petitions
Pub. L. 107-171, title X, Sec. 10809, May 13, 2002, 116 Stat. 531,
provided that: ``The Secretary of Health and Human Services (referred to
in this section as the `Secretary') shall publish a proposed rule and,
with due consideration to public comment, a final rule to revise, as
appropriate, the current regulation governing the labeling of foods that
have been treated to reduce pest infestation or pathogens by treatment
by irradiation using radioactive isotope, electronic beam, or x-ray.
Pending promulgation of the final rule required by this subsection
[probably should be ``this section''], any person may petition the
Secretary for approval of labeling, which is not false or misleading in
any material respect, of a food which has been treated by irradiation
using radioactive isotope, electronic beam, or x-ray. The Secretary
shall approve or deny such a petition within 180 days of receipt of the
petition, or the petition shall be deemed denied, except to the extent
additional agency review is mutually agreed upon by the Secretary and
the petitioner. Any denial of a petition under this subsection shall
constitute final agency action subject to judicial review by the United
States Court of Appeals for the District of Columbia Circuit. Any
labeling approved through the foregoing petition process shall be
subject to the provisions of the final rule referred to in the first
sentence of the subparagraph on the effective date of such final rule.''
Commission on Dietary Supplement Labels
Section 12 of Pub. L. 103-417 provided that:
``(a) Establishment.--There shall be established as an independent
agency within the executive branch a commission to be known as the
Commission on Dietary Supplement Labels (hereafter in this section
referred to as the `Commission').
``(b) Membership.--
``(1) Composition.--The Commission shall be composed of 7
members who shall be appointed by the President.
``(2) Expertise requirement.--The members of the Commission
shall consist of individuals with expertise and experience in
dietary supplements and in the manufacture, regulation,
distribution, and use of such supplements. At least three of the
members of the Commission shall be qualified by scientific training
and experience to evaluate the benefits to health of the use of
dietary supplements and one of such three members shall have
experience in pharmacognosy, medical botany, traditional herbal
medicine, or other related sciences. Members and staff of the
Commission shall be without bias on the issue of dietary
supplements.
``(c) Functions of the Commission.--The Commission shall conduct a
study on, and provide recommendations for, the regulation of label
claims and statements for dietary supplements, including the use of
literature in connection with the sale of dietary supplements and
procedures for the evaluation of such claims. In making such
recommendations, the Commission shall evaluate how best to provide
truthful, scientifically valid, and not misleading information to
consumers so that such consumers may make informed and appropriate
health care choices for themselves and their families.
``(d) Administrative Powers of the Commission.--
``(1) Hearings.--The Commission may hold hearings, sit and act
at such times and places, take such testimony, and receive such
evidence as the Commission considers advisable to carry out the
purposes of this section.
``(2) Information from federal agencies.--The Commission may
secure directly from any Federal department or agency such
information as the Commission considers necessary to carry out the
provisions of this section.
``(3) Authorization of appropriations.--There are authorized to
be appropriated such sums as may be necessary to carry out this
section.
``(e) Reports and Recommendations.--
``(1) Final report required.--Not later than 24 months after the
date of enactment of this Act [Oct. 25, 1994], the Commission shall
prepare and submit to the President and to the Congress a final
report on the study required by this section.
``(2) Recommendations.--The report described in paragraph (1)
shall contain such recommendations, including recommendations for
legislation, as the Commission deems appropriate.
``(3) Action on recommendations.--Within 90 days of the issuance
of the report under paragraph (1), the Secretary of Health and Human
Services shall publish in the Federal Register a notice of any
recommendation of Commission for changes in regulations of the
Secretary for the regulation of dietary supplements and shall
include in such notice a notice of proposed rulemaking on such
changes together with an opportunity to present views on such
changes. Such rulemaking shall be completed not later than 2 years
after the date of the issuance of such report. If such rulemaking is
not completed on or before the expiration of such 2 years,
regulations of the Secretary published in 59 FR 395-426 on January
4, 1994, shall not be in effect.''
Extension of Compliance Deadline for Certain Food Products Packaged
Prior to August 8, 1994
Pub. L. 103-261, May 26, 1994, 108 Stat. 705, provided: ``That
before August 8, 1994, sections 403(q) and 403(r)(2) of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 343(q), (r)(2)] and the
provision of section 403(i) of such Act added by section 7(2) of the
Nutrition Labeling and Education Act of 1990 [Pub. L. 101-535], shall
not apply with respect to a food product which is contained in a package
for which the label was printed before May 8, 1994 (or before August 8,
1994, in the case of a juice or milk food product if the person
responsible for the labeling of such food product exercised due
diligence in obtaining before such date labels which are in compliance
with such sections 403(q) and 403(r)(2) and such provision of section
403(i)), if, before June 15, 1994, the person who introduces or delivers
for introduction such food product into interstate commerce submits to
the Secretary of Health and Human Services a certification that such
person will comply with this section and will comply with such sections
403(q) and 403(r)(2) and such provision of section 403(i) after August
8, 1994.''
Limitations on Application of Small Business Exemption
Section 2(a) of Pub. L. 103-80 provided that:
``(1) Before may 8, 1995.--Before May 8, 1995, the exemption
provided by section 403(q)(5)(D) of the Federal Food, Drug, and Cosmetic
Act [21 U.S.C. 343(q)(5)(D)] shall be available in accordance with the
regulations of the Secretary of Health and Human Services published at
21 C.F.R. 101.9(j)(1)(i)(1993).
``(2) After may 8, 1995.--After May 8, 1995, the exemption provided
by section 403(q)(5)(D) of the Federal Food, Drug, and Cosmetic Act
shall only be available with respect to food when it is sold to
consumers.''
Prohibition on Implementation of Pub. L. 101-535 With Respect to Dietary
Supplements
Section 202(a)(1) of Pub. L. 102-571 provided that:
``Notwithstanding any other provision of law and except as provided in
subsection (b) [set out as a note below] and in the amendment made by
paragraph (2)(A) [amending provisions set out as notes above], the
Secretary of Health and Human Services may not implement the Nutrition
Labeling and Education Act of 1990 (Public Law 101-535; 104 Stat. 2353)
[see Short Title of 1990 Amendments note set out under section 301 of
this title], or any amendment made by such Act, earlier than December
15, 1993, with respect to dietary supplements of vitamins, minerals,
herbs, or other similar nutritional substances.''
Health Claims Made With Respect to Dietary Supplements
Section 202(b) of Pub. L. 102-571 provided that: ``Notwithstanding
section 403(r)(5)(D) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 343(r)(5)(D)) and subsection (a) [enacting provisions set out as
notes above and amending provisions set out as notes above and under
section 343-1 of this title], the Secretary of Health and Human Services
may, earlier than December 15, 1993, approve claims made with respect to
dietary supplements of vitamins, minerals, herbs, or other similar
nutritional substances that are claims described in clauses (vi) and (x)
of section 3(b)(1)(A) of the Nutrition Labeling and Education Act of
1990 [Pub. L. 101-535] (21 U.S.C. 343 note).''
United States Recommended Daily Allowances of Vitamins or Minerals
Section 203 of Pub. L. 102-571 provided that: ``Notwithstanding any
other provision of Federal law, no regulations that require the use of,
or are based upon, recommended daily allowances of vitamins or minerals
may be promulgated before November 8, 1993 (other than regulations
establishing the United States recommended daily allowances specified at
section 101.9(c)(7)(iv) of title 21, Code of Federal Regulations, as in
effect on October 6, 1992, or regulations under section 403(r)(1)(A) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(r)(1)(A)) that
are based on such recommended daily allowances).''
Consumer Education
Section 2(c) of Pub. L. 101-535 provided that: ``The Secretary of
Health and Human Services shall carry out activities which educate
consumers about--
``(1) the availability of nutrition information in the label or
labeling of food, and
``(2) the importance of that information in maintaining healthy
dietary practices.''
Studies Concerning Carcinogenic and Other Toxic Substances in Food and
Impurities in and Toxicity of Saccharin
Section 2 of Pub. L. 95-203 directed Secretary of Health, Education,
and Welfare to conduct a study concerning carcinogenic and other toxic
substances in food and impurities in and toxicity of saccharin and make
a report respecting the carcinogenic and other substances to Committee
on Human Resources of the Senate within 12 months of Nov. 23, 1977, and
a report respecting saccharin to such committee within 15 months of Nov.
23, 1977.
Report to Congressional Committees Respecting Action Taken Pursuant to
Former Par. (o)(2)
Section 4(a)(3) of Pub. L. 95-203 provided that the Secretary was to
report to specified congressional committees any action taken under
former par. (o)(2) of this section.
State or Territorial Requirements
Section 2 of Pub. L. 86-537 provided that: ``Nothing in the
amendments made by the first section of this Act [amending this section]
shall affect any requirement of the laws of any State or Territory.''
Section Referred to in Other Sections
This section is referred to in sections 321, 333, 334, 337, 343-1,
343-3, 345, 347, 350, 371 of this title.
