Articles
Guides and Reference Materials
Cases
Statutes and Regulations
SalesWatch Newsletter
|
|
SUBCHAPTER IV - FOOD
§ 341. Definitions and standards for food.
Whenever in the judgment of the Secretary such action will promote honesty
and fair dealing in the interest of consumers, he shall promulgate regulations
fixing and establishing for any food, under its common or usual name so far as
practicable, a reasonable definition and standard of identity, a reasonable
standard of quality, or reasonable standards of fill of container. No definition
and standard of identity and no standard of quality shall be established for
fresh or dried fruits, fresh or dried vegetables, or butter, except that
definitions and standards of identity may be established for avocadoes,
cantaloupes, citrus fruits, and melons. In prescribing any standard of fill of
container, the Secretary shall give due consideration to the natural shrinkage
in storage and in transit of fresh natural food and to need for the necessary
packing and protective material. In the prescribing of any standard of quality
for any canned fruit or canned vegetable, consideration shall be given and due
allowance made for the differing characteristics of the several varieties of
such fruit or vegetable. In prescribing a definition and standard of identity
for any food or class of food in which optional ingredients are permitted, the
Secretary shall, for the purpose of promoting honesty and fair dealing in the
interest of consumers, designate the optional ingredients which shall be named
on the label. Any definition and standard of identity prescribed by the
Secretary for avocadoes, cantaloupes, citrus fruits, or melons shall relate only
to maturity and to the effects of freezing.
§ 342. Adulterated food.
A food shall be deemed to be adulterated -
- (a) Poisonous, insanitary, etc., ingredients
- (1) If it bears or contains any poisonous or deleterious substance which
may render it injurious to health; but in case the substance is not an added
substance such food shall not be considered adulterated under this clause if the
quantity of such substance in such food does not ordinarily render it injurious
to health. (FOOTNOTE 1) (2)(A) if it bears or contains any added poisonous or
added deleterious substance (other than one which is
- (i) a pesticide chemical in or on a raw agricultural commodity;
- (ii) a food additive;
- (iii) a color additive; or
- (iv) a new animal drug) which is unsafe within the meaning of section 346
of this title, or
- (B) if it is a raw agricultural commodity and it bears or contains a
pesticide chemical which is unsafe within the meaning of section 346a(a) of this
title, or
- (C) if it is, or if it bears or contains, any food additive which is unsafe
within the meaning of section 348 of this title: Provided, That where a
pesticide chemical has been used in or on a raw agricultural commodity in
conformity with an exemption granted or a tolerance prescribed under section
346a of this title and such raw agricultural commodity has been subjected to
processing such as canning, cooking, freezing, dehydrating, or milling, the
residue of such pesticide chemical remaining in or on such processed food shall,
notwithstanding the provisions of sections 346 and 348 of this title, not be
deemed unsafe if such residue in or on the raw agricultural commodity has been
removed to the extent possible in good manufacturing practice and the
concentration of such residue in the processed food when ready to eat is not
greater than the tolerance prescribed for the raw agricultural commodity, or
- (D) if it is, or it bears or contains, a new animal drug (or conversion
product thereof) which is unsafe within the meaning of section 360b of this
title;
- (3) If (FOOTNOTE 2) it consists in whole or in part of any filthy, putrid,
or decomposed substance, or if it is otherwise unfit for food; or
- (4) if it has been prepared, packed, or held under insanitary conditions
whereby it may have become contaminated with filth, or whereby it may have been
rendered injurious to health; or
- (5) if it is, in whole or in part, the product of a diseased animal or of
an animal which has died otherwise than by slaughter; or
- (6) if its container is composed, in whole or in part, of any poisonous or
deleterious substance which may render the contents injurious to health; or
- (7) if it has been intentionally subjected to radiation, unless the use of
the radiation was in conformity with a regulation or exemption in effect
pursuant to section 348 of this title. (FOOTNOTE 1) So in original. The period
probably should be ''; or''. (FOOTNOTE 2) So in original. Probably should be
''or (3) if''.
- (b) Absence, substitution, or addition of constituents
- (1) If any valuable constituent has been in whole or in part omitted or
abstracted therefrom; or
- (2) if any substance has been substituted wholly or in part therefor; or
- (3) if damage or inferiority has been concealed in any manner; or
- (4) if any substance has been added thereto or mixed or packed therewith so
as to increase its bulk or weight, or reduce its quality or strength, or make it
appear better or of greater value than it is.
If it is, or it bears or contains, a color additive which is unsafe within the
meaning of section 379e(a) of this title.
- (d) Confectionery containing alcohol or nonnutritive substance
If it is confectionery, and -
- (1) has partially or completely imbedded therein any nonnutritive
object, except that this subparagraph shall not apply in the case of any
nonnutritive object if, in the judgment of the Secretary as provided by
regulations, such object is of practical functional value to the confectionery
product and would not render the product injurious or hazardous to health;
- (2) bears or contains any alcohol other than alcohol not in excess of
one-half of 1 per centum by volume derived solely from the use of flavoring
extracts, except that this clause shall not apply to confectionery which is
introduced or delivered for introduction into, or received or held for sale in,
interstate commerce if the sale of such confectionery is permitted under the
laws of the State in which such confectionery is intended to be offered for
sale;
- (3) bears or contains any nonnutritive substance, except that this
subparagraph shall not apply to a safe nonnutritive substance which is in or on
confectionery by reason of its use for some practical functional purpose in the
manufacture, packaging, or storage of such confectionery if the use of the
substance does not promote deception of the consumer or otherwise result in
adulteration or misbranding in violation of any provision of this chapter,
except that the Secretary may, for the purpose of avoiding or resolving
uncertainty as to the application of this subparagraph, issue regulations
allowing or prohibiting the use of particular nonnutritive substances.
- (e) Oleomargarine containing filthy, putrid, etc., matter
If it is oleomargarine or margarine or butter and any of the raw material
used therein consisted in whole or in part of any filthy, putrid, or decomposed
substance, or such oleomargarine or margarine or butter is otherwise unfit for
food.
- (f) Dietary supplement or ingredient: safety
- (1) If it is a dietary supplement or contains a dietary ingredient that -
- (A) presents a significant or unreasonable risk of illness or injury under
-
- (i) conditions of use recommended or suggested in labeling, or
- (ii) if no conditions of use are suggested or recommended in the labeling,
under ordinary conditions of use;
- (B) is a new dietary ingredient for which there is inadequate information
to provide reasonable assurance that such ingredient does not present a
significant or unreasonable risk of illness or injury;
- (C) the Secretary declares to pose an imminent hazard to public health or
safety, except that the authority to make such declaration shall not be
delegated and the Secretary shall promptly after such a declaration initiate a
proceeding in accordance with sections 554 and 556 of title 5 to affirm or
withdraw the declaration; or
- (D) is or contains a dietary ingredient that renders it adulterated under
paragraph (a)(1) under the conditions of use recommended or suggested in the
labeling of such dietary supplement. In any proceeding under this subparagraph,
the United States shall bear the burden of proof on each element to show that a
dietary supplement is adulterated. The court shall decide any issue under this
paragraph on a de novo basis.
- (2) Before the Secretary may report to a United States attorney a violation
of paragraph (FOOTNOTE 3) (1)(A) for a civil proceeding, the person against whom
such proceeding would be initiated shall be given appropriate notice and the
opportunity to present views, orally and in writing, at least 10 days before
such notice, with regard to such proceeding. (FOOTNOTE 3) So in original.
Probably should be ''subparagraph''.
- (g) Dietary supplement: manufacturing practices
- (1) If it is a dietary supplement and it has been prepared, packed, or held
under conditions that do not meet current good manufacturing practice
regulations, including regulations requiring, when necessary, expiration date
labeling, issued by the Secretary under subparagraph (2).
- (2) The Secretary may by regulation prescribe good manufacturing practices
for dietary supplements. Such regulations shall be modeled after current good
manufacturing practice regulations for food and may not impose standards for
which there is no current and generally available analytical methodology. No
standard of current good manufacturing practice may be imposed unless such
standard is included in a regulation promulgated after notice and opportunity
for comment in accordance with chapter 5 of title 5.
§ 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.
If its container is so made, formed, or filled as to be misleading.
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; or
- (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.
- (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
(FOOTNOTE 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. (FOOTNOTE 1) So in
original. Probably should be followed by a comma.
- (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.
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) Saccharin for immediate consumption
- (1) If it contains saccharin, unless, except as provided in subparagraph
(2), its label and labeling bear the following statement: ''USE OF THIS PRODUCT
MAY BE HAZARDOUS TO YOUR HEALTH. THIS PRODUCT CONTAINS SACCHARIN WHICH HAS BEEN
DETERMINED TO CAUSE CANCER IN LABORATORY ANIMALS''. Such statement shall be
located in a conspicuous place on such label and labeling as proximate as
possible to the name of such food and shall appear in conspicuous and legible
type in contrast by typography, layout, and color with other printed matter on
such label and labeling.
- (2) The Secretary may by regulation review and revise or remove the
requirement of subparagraph (1) if the Secretary determines such action is
necessary to reflect the current state of knowledge concerning saccharin.
- (p) Saccharin not for immediate consumption
- (1) If it contains saccharin and is offered for sale, but not for immediate
consumption, at a retail establishment, unless such retail establishment
displays prominently, where such food is held for sale, notice (provided by the
manufacturer of such food pursuant to subparagraph (2) for consumers respecting
the information required by paragraph (o) to be on food labels and labeling.
- (2) Each manufacturer of food which contains saccharin and which is offered
for sale by retail establishments but not for immediate consumption shall, in
accordance with regulations promulgated by the Secretary pursuant to
subparagraph (4), take such action as may be necessary to provide such retail
establishments with the notice required by subparagraph (1).
- (3) The Secretary may by regulation review and revise or remove the
requirement of subparagraph (1) if he determines such action is necessary to
reflect the current state of knowledge concerning saccharin.
- (4) The Secretary shall by regulation prescribe the form, text, and manner
of display of the notice required by subparagraph (1) and such other matters as
may be required for the implementation of the requirements of that subparagraph
and subparagraph (2). Regulations of the Secretary under this subparagraph shall
be promulgated after an oral hearing but without regard to the National
Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.) and chapter 5 of title
5. In any action brought for judicial review of any such regulation, the
reviewing court may not postpone the effective date of such regulation.
- (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, 1990¹, 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, 1990², 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
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.
- (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.
§ 343-1. National uniform nutrition labeling.
- (a) Except as provided in subsection (b) of this section, no State or
political subdivision of a State may directly or indirectly establish under any
authority or continue in effect as to any food in interstate commerce -
- (1) any requirement for a food which is the subject of a standard of
identity established under section 341 of this title that is not identical to
such standard of identity or that is not identical to the requirement of section
343(g) of this title, except that this paragraph does not apply to a standard of
identity of a State or political subdivision of a State for maple syrup that is
of the type required by sections 341 and 343(g) of this title,
- (2) any requirement for the labeling of food of the type required by
section 343(c), 343(e), or 343(i)(2) of this title that is not identical to the
requirement of such section, except that this paragraph does not apply to a
requirement of a State or political subdivision of a State that is of the type
required by section 343(c) of this title and that is applicable to maple syrup,
- (3) any requirement for the labeling of food of the type required by
section 343(b), 343(d), 343(f), 343(h), 343(i)(1), or 343(k) of this title that
is not identical to the requirement of such section, except that this paragraph
does not apply to a requirement of a State or political subdivision of a State
that is of the type required by section 343(h)(1) of this title and that is
applicable to maple syrup,
- (4) any requirement for nutrition labeling of food that is not identical to
the requirement of section 343(q) of this title, except a requirement for
nutrition labeling of food which is exempt under subclause (i) or (ii) of
section 343(q)(5)(A) of this title, or
- (5) any requirement respecting any claim of the type described in section
343(r)(1) of this title made in the label or labeling of food that is not
identical to the requirement of section 343(r) of this title, except a
requirement respecting a claim made in the label or labeling of food which is
exempt under section 343(r)(5)(B) of this title. Paragraph (3) shall take effect
in accordance with section 6(b) of the Nutrition Labeling and Education Act of
1990.
- (b) Upon petition of a State or a political subdivision of a State,
the Secretary may exempt from subsection (a) of this section, under such
conditions as may be prescribed by regulation, any State or local requirement
that -
- (1) would not cause any food to be in violation of any applicable
requirement under Federal law,
- (2) would not unduly burden interstate commerce, and
- (3) is designed to address a particular need for information which need is
not met by the requirements of the sections referred to in subsection (a) of
this section.
§ 343-2. Dietary supplement labeling exemptions.
A publication, including an article, a chapter in a book, or an official
abstract of a peer-reviewed scientific publication that appears in an article
and was prepared by the author or the editors of the publication, which is
reprinted in its entirety, shall not be defined as labeling when used in
connection with the sale of a dietary supplement to consumers when it -
- (1) is not false or misleading;
- (2) does not promote a particular manufacturer or brand of a dietary
supplement;
- (3) is displayed or presented, or is displayed or presented with other such
items on the same subject matter, so as to present a balanced view of the
available scientific information on a dietary supplement;
- (4) if displayed in an establishment, is physically separate from the
dietary supplements; and
- (5) does not have appended to it any information by sticker or any other
method.
Subsection (a) of this section shall not apply to or restrict a retailer or
wholesaler of dietary supplements in any way whatsoever in the sale of books or
other publications as a part of the business of such retailer or wholesaler.
In any proceeding brought under subsection (a) of this section, the burden
of proof shall be on the United States to establish that an article or other
such matter is false or misleading.
§ 343a. Health risks presented by use of saccharin.
- (a) Statement on vending machines dispensing food containing
saccharin respecting health risk; regulations
The Secretary may by regulation require vending machines through which food
containing saccharin is sold to bear a statement of the risks to health which
may be presented by the use of saccharin. A regulation under this subsection
shall require such statement to be located in a conspicuous place on such
vending machine and as proximate as possible to the name of each food containing
saccharin which is sold through such machine. Any food containing saccharin
which is sold in a vending machine which does not meet any applicable
requirement promulgated under this subsection shall, for purposes of this
chapter, be considered a misbranded food.
- (b) Availability and distribution of information; review and
revision
The Secretary shall (1) prepare information respecting the nature of the
controversy surrounding the use of food containing saccharin, and (2) provide
for the distribution of such information for display by retail establishments
where such food is sold but not for immediate consumption. The Secretary may
review and revise such information if he determines such action is necessary to
reflect the current state of knowledge concerning the risks to health presented
by the use of saccharin.
§ 344. Emergency permit control.
- (a) Conditions on manufacturing, processing, etc., as health
measure
Whenever the Secretary finds after investigation that the distribution in
interstate commerce of any class of food may, by reason of contamination with
micro-organisms during the manufacture, processing, or packing thereof in any
locality, be injurious to health, and that such injurious nature cannot be
adequately determined after such articles have entered interstate commerce, he
then, and in such case only, shall promulgate regulations providing for the
issuance, to manufacturers, processors, or packers of such class of food in such
locality, of permits to which shall be attached such conditions governing the
manufacture, processing, or packing of such class of food, for such temporary
period of time, as may be necessary to protect the public health; and after the
effective date of such regulations, and during such temporary period, no person
shall introduce or deliver for introduction into interstate commerce any such
food manufactured, processed, or packed by any such manufacturer, processor, or
packer unless such manufacturer, processor, or packer holds a permit issued by
the Secretary as provided by such regulations.
- (b) Violation of permit; suspension and reinstatement
The Secretary is authorized to suspend immediately upon notice any permit
issued under authority of this section if it is found that any of the conditions
of the permit have been violated. The holder of a permit so suspended shall be
privileged at any time to apply for the reinstatement of such permit, and the
Secretary shall, immediately after prompt hearing and an inspection of the
establishment, reinstate such permit if it is found that adequate measures have
been taken to comply with and maintain the conditions of the permit, as
originally issued or as amended.
- (c) Inspection of permit-holding establishments
Any officer or employee duly designated by the Secretary shall have access
to any factory or establishment, the operator of which holds a permit from the
Secretary, for the purpose of ascertaining whether or not the conditions of the
permit are being complied with, and denial of access for such inspection shall
be ground for suspension of the permit until such access is freely given by the
operator.
§ 345. Regulations making exemptions.
The Secretary shall promulgate regulations exempting from any labeling
requirement of this chapter (1) small open containers of fresh fruits and fresh
vegetables and (2) food which is, in accordance with the practice of the trade,
to be processed, labeled, or repacked in substantial quantities at
establishments other than those where originally processed or packed, on
condition that such food is not adulterated or misbranded under the provisions
of this chapter upon removal from such processing, labeling, or repacking
establishment. This section does not apply to the labeling requirements of
sections 343(q) and 343(r) of this title.
§ 346. Tolerances for poisonous or deleterious substances in food;
regulations.
Any poisonous or deleterious substance added to any food, except where such
substance is required in the production thereof or cannot be avoided by good
manufacturing practice shall be deemed to be unsafe for purposes of the
application of clause (2)(A) of section 342(a) of this title; but when such
substance is so required or cannot be so avoided, the Secretary shall promulgate
regulations limiting the quantity therein or thereon to such extent as he finds
necessary for the protection of public health, and any quantity exceeding the
limits so fixed shall also be deemed to be unsafe for purposes of the
application of clause (2)(A) of section 342(a) of this title. While such a
regulation is in effect limiting the quantity of any such substance in the case
of any food, such food shall not, by reason of bearing or containing any added
amount of such substance, be considered to be adulterated within the meaning of
clause (1) of section 342(a) of this title. In determining the quantity of such
added substance to be tolerated in or on different articles of food the
Secretary shall take into account the extent to which the use of such substance
is required or cannot be avoided in the production of each such article, and the
other ways in which the consumer may be affected by the same or other poisonous
or deleterious substances.
§ 346a. Tolerances for pesticide chemicals in or on raw
agricultural commodities.
Any poisonous or deleterious pesticide chemical, or any pesticide chemical
which is not generally recognized, among experts qualified by scientific
training and experience to evaluate the safety of pesticide chemicals, as safe
for use, added to a raw agricultural commodity, shall be deemed unsafe for the
purposes of the application of clause (2) of section 342(a) of this title unless
-
- (1) a tolerance for such pesticide chemical in or on the raw
agricultural commodity has been prescribed by the Administrator of the
Environmental Protection Agency (hereinafter in this section referred to as the
''Administrator'') under this section and the quantity of such pesticide
chemical in or on the raw agricultural commodity is within the limits of the
tolerance so prescribed; or
- (2) with respect to use in or on such raw agricultural commodity, the
pesticide chemical has been exempted from the requirement of a tolerance by the
Administrator under this section. While a tolerance or exemption from tolerance
is in effect for a pesticide chemical with respect to any raw agricultural
commodity, such raw agricultural commodity shall not, by reason of bearing or
containing any added amount of such pesticide chemical, be considered to be
adulterated within the meaning of clause (1) of section 342(a) of this title.
- (b) Establishment of tolerances
The Administrator shall promulgate regulations establishing tolerances with
respect to the use in or on raw agricultural commodities of poisonous or
deleterious pesticide chemicals and of pesticide chemicals which are not
generally recognized, among experts qualified by scientific training and
experience to evaluate the safety of pesticide chemicals, as safe for use, to
the extent necessary to protect the public health. In establishing any such
regulation, the Administrator shall give appropriate consideration, among other
relevant factors, (1) to the necessity for the production of an adequate,
wholesome, and economical food supply; (2) to the other ways in which the
consumer may be affected by the same pesticide chemical or by other related
substances that are poisonous or deleterious; and (3) to the opinion of the
Secretary of Agriculture (FOOTNOTE 1) as submitted with a certification of
usefulness under subsection (l) of this section. Such regulations shall be
promulgated in the manner prescribed in subsection (d) or (e) of this section.
In carrying out the provisions of this section relating to the establishment of
tolerances, the Administrator may establish the tolerance applicable with
respect to the use of any pesticide chemical in or on any raw agricultural
commodity at zero level if the scientific data before the Administrator does not
justify the establishment of a greater tolerance. (FOOTNOTE 1) See Transfer of
Functions note below.
The Administrator shall promulgate regulations exempting any pesticide
chemical from the necessity of a tolerance with respect to use in or on any or
all raw agricultural commodities when such a tolerance is not necessary to
protect the public health. Such regulations shall be promulgated in the manner
prescribed in subsection (d) or (e) of this section.
- (d) Regulations pursuant to petition; publication of notice; time
for issuance; referral to advisory committees; effective date; hearings
- (e) Regulations pursuant to Administrator's proposals
The Administrator may at any time, upon his own initiative or upon the
request of any interested person, propose the issuance of a regulation
establishing a tolerance for a pesticide chemical or exempting it from the
necessity of a tolerance. Thirty days after publication of such a proposal, the
Administrator may by order publish a regulation based upon the proposal which
shall become effective upon publication unless within such thirty-day period a
person who has registered, or who has submitted an application for the
registration of, a pesticide under the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136 et seq.) containing the pesticide chemical named
in the proposal, requests that the proposal be referred to an advisory
committee. In the event of such a request, the Administrator shall forthwith
submit the proposal and other relevant data before him to an advisory committee
to be appointed in accordance with subsection (g) of this section. As soon as
practicable after such referral, but not later than sixty days thereafter,
unless extended as hereinafter provided, the committee shall, after independent
study of the data submitted to it by the Administrator and other data before it,
certify to the Administrator a report and recommendations on the proposal
together with all underlying data and a statement of the reasons or basis for
the recommendations. The sixty-day period provided for herein may be extended by
the advisory committee for an additional thirty days if the advisory committee
deems this necessary. Within thirty days after such certification, the
Administrator may, after giving due consideration to all data before him,
including such report, recommendations, underlying data and statement, by order
publish a regulation establishing a tolerance for the pesticide chemical named
in the proposal or exempting it from the necessity of a tolerance which shall
become effective upon publication. Regulations issued under this subsection
shall upon publication be subject to paragraph (5) of subsection (d) of this
section.
- (f) Data submitted as confidential
All data submitted to the Administrator or to an advisory committee in
support of a petition under this section shall be considered confidential by the
Administrator and by such advisory committee until publication of a regulation
under paragraph (2) or (3) of subsection (d) of this section. Until such
publication, such data shall not be revealed to any person other than those
authorized by the Administrator or by an advisory committee in the carrying out
of their official duties under this section.
- (g) Advisory committees; appointment; composition; compensation;
clerical assistance
Whenever the referral of a petition or proposal to an advisory committee is
requested under this section, or the Administrator otherwise deems such referral
necessary the Administrator shall forthwith appoint a committee of competent
experts to review the petition or proposal and to make a report and
recommendations thereon. Each such advisory committee shall be composed of
experts, qualified in the subject matter of the petition and of adequately
diversified professional background selected by the National Academy of Sciences
and shall include one or more representatives from land-grant colleges. The size
of the committee shall be determined by the Administrator. Members of an
advisory committee shall receive compensation and travel expenses in accordance
with subsection (b)(5)(D) of section 379e of this title. The members shall not
be subject to any other provision of law regarding the appointment and
compensation of employees of the United States. The Administrator shall furnish
the Committee with adequate clerical and other assistance, and shall by rules
and regulations prescribe the procedure to be followed by the committee.
§ 346b. Authorization of appropriations.
There are authorized to be appropriated, out of any moneys in the Treasury
not otherwise appropriated, such sums as may be necessary for the purpose and
administration of sections 321(q), (r), 342(a)(2), and 346a of this title.
§ 347. Intrastate sales of colored oleomargarine.
Colored oleomargarine or colored margarine which is sold in the same State
or Territory in which it is produced shall be subject in the same manner and to
the same extent to the provisions of this chapter as if it had been introduced
in interstate commerce.
- (b) Labeling and packaging requirements
No person shall sell, or offer for sale, colored oleomargarine or colored
margarine unless -
- (1) such oleomargarine or margarine is packaged,
- (2) the net weight of the contents of any package sold in a retail
establishment is one pound or less,
- (3) there appears on the label of the package (A) the word
''oleomargarine'' or ''margarine'' in type or lettering at least as large as any
other type or lettering on such label, and (B) a full and accurate statement of
all the ingredients contained in such oleomargarine or margarine, and
- (4) each part of the contents of the package is contained in a wrapper
which bears the word ''oleomargarine'' or ''margarine'' in type or lettering not
smaller than 20-point type. The requirements of this subsection shall be in
addition to and not in lieu of any of the other requirements of this chapter.
- (c) Sales in public eating places
No person shall possess in a form ready for serving colored oleomargarine or
colored margarine at a public eating place unless a notice that oleomargarine or
margarine is served is displayed prominently and conspicuously in such place and
in such manner as to render it likely to be read and understood by the ordinary
individual being served in such eating place or is printed or is otherwise set
forth on the menu in type or lettering not smaller than that normally used to
designate the serving of other food items. No person shall serve colored
oleomargarine or colored margarine at a public eating place, whether or not any
charge is made therefor, unless (1) each separate serving bears or is
accompanied by labeling identifying it as oleomargarine or margarine, or (2)
each separate serving thereof is triangular in shape.
- (d) Exemption from labeling requirements
Colored oleomargarine or colored margarine when served with meals at a
public eating place shall at the time of such service be exempt from the
labeling requirements of section 343 of this title (except paragraphs (a) and
(f)) if it complies with the requirements of subsection (b) of this section.
- (e) Color content of oleomargarine
For the purpose of this section colored oleomargarine or colored margarine
is oleomargarine or margarine having a tint or shade containing more than one
and six-tenths degrees of yellow, or of yellow and red collectively, but with an
excess of yellow over red, measured in terms of Lovibond tintometer scale or its
equivalent.
§ 347a. Congressional declaration of policy regarding oleomargarine
sales.
The Congress finds and declares that the sale, or the serving in public
eating places, of colored oleomargarine or colored margarine without clear
identification as such or which is otherwise adulterated or misbranded within
the meaning of this chapter depresses the market in interstate commerce for
butter and for oleomargarine or margarine clearly identified and neither
adulterated nor misbranded, and constitutes a burden on interstate commerce in
such articles. Such burden exists, irrespective of whether such oleomargarine or
margarine originates from an interstate source or from the State in which it is
sold.
§ 347b. Contravention of State laws.
Nothing in this Act shall be construed as authorizing the possession, sale,
or serving of colored oleomargarine or colored margarine in any State or
Territory in contravention of the laws of such State or Territory.
§ 348. Food additives.
- (a) Unsafe food additives; exception for conformity with exemption
or regulation
A food additive shall, with respect to any particular use or intended use of
such additives, be deemed to be unsafe for the purposes of the application of
clause (2)(C) of section 342(a) of this title, unless -
- (1) it and its use or intended use conform to the terms of an
exemption which is in effect pursuant to subsection (i) of this section; or
- (2) there is in effect, and it and its use or intended use are in
conformity with, a regulation issued under this section prescribing the
conditions under which such additive may be safely used.
While such a regulation relating to a food additive is in effect, a food
shall not, by reason of bearing or containing such an additive in accordance
with the regulation, be considered adulterated within the meaning of clause (1)
of section 342(a) of this title.
- (b) Petition for regulation prescribing conditions of safe use;
contents; description of production methods and controls; samples; notice of
regulation
- (1) Any person may, with respect to any intended use of a food additive,
file with the Secretary a petition proposing the issuance of a regulation
prescribing the conditions under which such additive may be safely used.
- (2) Such petition shall, in addition to any explanatory or supporting data,
contain -
- (A) the name and all pertinent information concerning such food additive,
including, where available, its chemical identity and composition;
- (B) a statement of the conditions of the proposed use of such additive,
including all directions, recommendations, and suggestions proposed for the use
of such additive, and including specimens of its proposed labeling;
- (C) all relevant data bearing on the physical or other technical effect
such additive is intended to produce, and the quantity of such additive required
to produce such effect;
- (D) a description of practicable methods for determining the quantity of
such additive in or on food, and any substance formed in or on food, because of
its use; and
- (E) full reports of investigations made with respect to the safety for use
of such additive, including full information as to the methods and controls used
in conducting such investigations.
- (3) Upon request of the Secretary, the petitioner shall furnish (or, if the
petitioner is not the manufacturer of such additive, the petitioner shall have
the manufacturer of such additive furnish, without disclosure to the petitioner)
a full description of the methods used in, and the facilities and controls used
for, the production of such additive.
- (4) Upon request of the Secretary, the petitioner shall furnish samples of
the food additive involved, or articles used as components thereof, and of the
food in or on which the additive is proposed to be used.
- (5) Notice of the regulation proposed by the petitioner shall be published
in general terms by the Secretary within thirty days after filing.
- (c) Approval or denial of petition; time for issuance of order;
evaluation of data; factors
- (1) The Secretary shall -
- (A) by order establish a regulation (whether or not in accord with that
proposed by the petitioner) prescribing, with respect to one or more proposed
uses of the food additive involved, the conditions under which such additive may
be safely used (including, but not limited to, specifications as to the
particular food or classes of food in or in which such additive may be used, the
maximum quantity which may be used or permitted to remain in or on such food,
the manner in which such additive may be added to or used in or on such food,
and any directions or other labeling or packaging requirements for such additive
deemed necessary by him to assure the safety of such use), and shall notify the
petitioner of such order and the reasons for such action; or
- (B) by order deny the petition, and shall notify the petitioner of such
order and of the reasons for such action.
- (2) The order required by paragraph (1)(A) or (B) of this subsection shall
be issued within ninety days after the date of filing of the petition, except
that the Secretary may (prior to such ninetieth day), by written notice to the
petitioner, extend such ninety-day period to such time (not more than one
hundred and eighty days after the date of filing of the petition) as the
Secretary deems necessary to enable him to study and investigate the petition.
- (3) No such regulation shall issue if a fair evaluation of the data before
the Secretary -
- (A) fails to establish that the proposed use of the food additive, under
the conditions of use to be specified in the regulation, will be safe: Provided,
That no additive shall be deemed to be safe if it is found to induce cancer when
ingested by man or animal, or if it is found, after tests which are appropriate
for the evaluation of the safety of food additives, to induce cancer in man or
animal, except that this proviso shall not apply with respect to the use of a
substance as an ingredient of feed for animals which are raised for food
production, if the Secretary finds
- (i) that, under the conditions of use and feeding specified in proposed
labeling and reasonably certain to be followed in practice, such additive will
not adversely affect the animals for which such feed is intended, and
- (ii) that no residue of the additive will be found (by methods of
examination prescribed or approved by the Secretary by regulations, which
regulations shall not be subject to subsections (f) and (g) of this section) in
any edible portion of such animal after slaughter or in any food yielded by or
derived from the living animal; or
- (B) shows that the proposed use of the additive would promote deception of
the consumer in violation of this chapter or would otherwise result in
adulteration or in misbranding of food within the meaning of this chapter.
- (4) If, in the judgment of the Secretary, based upon a fair evaluation of
the data before him, a tolerance limitation is required in order to assure that
the proposed use of an additive will be safe, the Secretary -
- (A) shall not fix such tolerance limitation at a level higher than he finds
to be reasonably required to accomplish the physical or other technical effect
for which such additive is intended; and
- (B) shall not establish a regulation for such proposed use if he finds upon
a fair evaluation of the data before him that such data do not establish that
such use would accomplish the intended physical or other technical effect.
- (5) In determining, for the purposes of this section, whether a proposed
use of a food additive is safe, the Secretary shall consider among other
relevant factors -
- (A) the probable consumption of the additive and of any substance formed in
or on food because of the use of the additive;
- (B) the cumulative effect of such additive in the diet of man or animals,
taking into account any chemically or pharmacologically related substance or
substances in such diet; and
- (C) safety factors which in the opinion of experts qualified by scientific
training and experience to evaluate the safety of food additives are generally
recognized as appropriate for the use of animal experimentation data.
- (d) Regulation issued on Secretary's initiative
The Secretary may at any time, upon his own initiative, propose the issuance
of a regulation prescribing, with respect to any particular use of a food
additive, the conditions under which such additive may be safely used, and the
reasons therefor. After the thirtieth day following publication of such a
proposal, the Secretary may by order establish a regulation based upon the
proposal.
- (e) Publication and effective date of orders
Any order, including any regulation established by such order, issued under
subsection (c) or (d) of this section, shall be published and shall be effective
upon publication, but the Secretary may stay such effectiveness if, after
issuance of such order, a hearing is sought with respect to such order pursuant
to subsection (f) of this section.
- (f) Objections and public hearing; basis and contents of order;
statement
- (1) Within thirty days after publication of an order made pursuant to
subsection (c) or (d) of this section, any person adversely affected by such an
order may file objections thereto with the Secretary, specifying with
particularity the provisions of the order deemed objectionable, stating
reasonable grounds therefor, and requesting a public hearing upon such
objections. The Secretary shall, after due notice, as promptly as possible hold
such public hearing for the purpose of receiving evidence relevant and material
to the issues raised by such objections. As soon as practicable after completion
of the hearing, the Secretary shall by order act upon such objections and make
such order public.
- (2) Such order shall be based upon a fair evaluation of the entire record
at such hearing, and shall include a statement setting forth in detail the
findings and conclusions upon which the order is based.
- (3) The Secretary shall specify in the order the date on which it shall
take effect, except that it shall not be made to take effect prior to the
ninetieth day after its publication, unless the Secretary finds that emergency
conditions exist necessitating an earlier effective date, in which event the
Secretary shall specify in the order his findings as to such conditions.
- (g) Judicial review
- (1) In a case of actual controversy as to the validity of any order issued
under subsection (f) of this section, including any order thereunder with
respect to amendment or repeal of a regulation issued under this section, any
person who will be adversely affected by such order may obtain judicial review
by filing in the United States Court of Appeals for the circuit wherein such
person resides or has his principal place of business, or in the United States
Court of Appeals for the District of Columbia Circuit, within sixty days after
the entry of such order, a petition praying that the order be set aside in whole
or in part.
- (2) A copy of such petition shall be forthwith transmitted by the clerk of
the court to the Secretary, or any officer designated by him for that purpose,
and thereupon the Secretary shall file in the court the record of the
proceedings on which he based his order, as provided in section 2112 of title
28. Upon the filing of such petition the court shall have jurisdiction, which
upon the filing of the record with it shall be exclusive, to affirm or set aside
the order complained of in whole or in part. Until the filing of the record the
Secretary may modify or set aside his order. The findings of the Secretary with
respect to questions of fact shall be sustained if based upon a fair evaluation
of the entire record at such hearing.
- (3) The court, on such judicial review, shall not sustain the order of the
Secretary if he failed to comply with any requirement imposed on him by
subsection (f)(2) of this section.
- (4) If application is made to the court for leave to adduce additional
evidence, the court may order such additional evidence to be taken before the
Secretary and to be adduced upon the hearing in such manner and upon such terms
and conditions as to the court may seem proper, if such evidence is material and
there were reasonable grounds for failure to adduce such evidence in the
proceedings below. The Secretary may modify his findings as to the facts and
order by reason of the additional evidence so taken, and shall file with the
court such modified findings and order.
- (5) The judgment of the court affirming or setting aside, in whole or in
part, any order under this section shall be final, subject to review by the
Supreme Court of the United States upon certiorari or certification as provided
in section 1254 of title 28. The commencement of proceedings under this section
shall not, unless specifically ordered by the court to the contrary, operate as
a stay of an order.
- (h) Amendment or repeal of regulations
The Secretary shall by regulation prescribe the procedure by which
regulations under the foregoing provisions of this section may be amended or
repealed, and such procedure shall conform to the procedure provided in this
section for the promulgation of such regulations. •(i) Exemptions for
investigational use Without regard to subsections (b) to (h), inclusive, of
this section, the Secretary shall by regulation provide for exempting from the
requirements of this section any food additive, and any food bearing or
containing such additive, intended solely for investigational use by qualified
experts when in his opinion such exemption is consistent with the public health.
§ 349. Bottled drinking water standards; publication in Federal
Register.
Whenever the Administrator of the Environmental Protection Agency prescribes
interim or revised national primary drinking water regulations under section
300g-1 of title 42, the Secretary shall consult with the Administrator and
within 180 days after the promulgation of such drinking water regulations either
promulgate amendments to regulations under this chapter applicable to bottled
drinking water or publish in the Federal Register his reasons for not making
such amendments.
§ 350. Vitamins and minerals.
- (a) Authority and limitations of Secretary; applicability
- (1) Except as provided in paragraph (2) -
- (A) the Secretary may not establish, under section 321(n), 341, or 343 of
this title, maximum limits on the potency of any synthetic or natural vitamin or
mineral within a food to which this section applies;
- (B) the Secretary may not classify any natural or synthetic vitamin or
mineral (or combination thereof) as a drug solely because it exceeds the level
of potency which the Secretary determines is nutritionally rational or useful;
- (C) the Secretary may not limit, under section 321(n), 341, or 343 of this
title, the combination or number of any synthetic or natural -
- (i) vitamin,
- (ii) mineral, or
- (iii) other ingredient of food, within a food to which this section
applies.
- (2) Paragraph (1) shall not apply in the case of a vitamin, mineral, other
ingredient of food, or food, which is represented for use by individuals in the
treatment or management of specific diseases or disorders, by children, or by
pregnant or lactating women. For purposes of this subparagraph, (FOOTNOTE 1) the
term ''children'' means individuals who are under the age of twelve years.
(FOOTNOTE 1) So in original. Probably should be ''paragraph''.
- (b) Labeling and advertising requirements for foods
- (1) A food to which this section applies shall not be deemed under section
343 of this title to be misbranded solely because its label bears, in accordance
with section 343(i)(2) of this title, all the ingredients in the food or its
advertising contains references to ingredients in the food which are not
vitamins or minerals.
- (2) The labeling for any food to which this section applies may not list
its ingredients which are not dietary supplement ingredients described in
section 321(ff) of this title (i) except as a part of a list of all the
ingredients of such food, and (ii) unless such ingredients are listed in
accordance with applicable regulations under section 343 of this title. To the
extent that compliance with clause (i) of this subparagraph is impracticable or
results in deception or unfair competition, exemptions shall be established by
regulations promulgated by the Secretary.
- (c) Definitions
- (1) For purposes of this section, the term ''food to which this section
applies'' means a food for humans which is a food for special dietary use -
- (A) which is or contains any natural or synthetic vitamin or mineral, and
- (B) which -
- (i) is intended for ingestion in tablet, capsule, powder, softgel, gelcap,
or liquid form, or
- (ii) if not intended for ingestion in such a form, is not represented as
conventional food and is not represented for use as a sole item of a meal or of
the diet.
- (2) For purposes of paragraph (1)(B)(i), a food shall be considered as
intended for ingestion in liquid form only if it is formulated in a fluid
carrier and it is intended for ingestion in daily quantities measured in drops
or similar small units of measure.
- (3) For purposes of paragraph (1) and of section 343(j) of this title
insofar as that section is applicable to food to which this section applies, the
term ''special dietary use'' as applied to food used by man means a particular
use for which a food purports or is represented to be used, including but not
limited to the following:
- (A) Supplying a special dietary need that exists by reason of a physical,
physiological, pathological, or other condition, including but not limited to
the condition of disease, convalescence, pregnancy, lactation, infancy, allergic
hypersensitivity to food, underweight, overweight, or the need to control the
intake of sodium.
- (B) Supplying a vitamin, mineral, or other ingredient for use by man to
supplement his diet by increasing the total dietary intake.
- (C) Supplying a special dietary need by reason of being a food for use as
the sole item of the diet.
§ 350a. Infant formulas.
An infant formula, including an infant formula powder, shall be deemed to be
adulterated if -
- (1) such infant formula does not provide nutrients as required by
subsection (i) of this section,
- (2) such infant formula does not meet the quality factor requirements
prescribed by the Secretary under subsection (b)(1) of this section, or
- (3) the processing of such infant formula is not in compliance with the
good manufacturing practices and the quality control procedures prescribed by
the Secretary under subsection (b)(2) of this section.
- (b) Requirements for quality factors, good manufacturing practices,
and retention of records
- (1) The Secretary shall by regulation establish requirements for quality
factors for infant formulas to the extent possible consistent with current
scientific knowledge, including quality factor requirements for the nutrients
required by subsection (i) of this section.
- (2)
- (3)
- (A) At the final product stage, each batch of infant formula shall be
tested for vitamin A, vitamin B1, vitamin C, and vitamin E to ensure that such
infant formula is in compliance with the requirements of this subsection and
subsection (i) of this section relating to such vitamins.
- (B) Each nutrient premix used in the manufacture of an infant formula shall
be tested for each relied upon nutrient required by subsection (i) of this
section which is contained in such premix to ensure that such premix is in
compliance with its specifications or certifications by a premix supplier.
- (C) During the manufacturing process or at the final product stage and
before distribution of an infant formula, an infant formula shall be tested for
all nutrients required to be included in such formula by subsection (i) of this
section for which testing has not been conducted pursuant to subparagraph (A) or
(B). Testing under this subparagraph shall be conducted to -
- (i) ensure that each batch of such infant formula is in compliance with the
requirements of subsection (i) of this section relating to such nutrients, and
- (ii) confirm that nutrients contained in any nutrient premix used in such
infant formula are present in each batch of such infant formula in the proper
concentration.
- (D) If the Secretary adds a nutrient to the list of nutrients in the table
in subsection (i) of this section, the Secretary shall by regulation require
that the manufacturer of an infant formula test each batch of such formula for
such new nutrient in accordance with subparagraph (A), (B), or (C).
- (E) For purposes of this paragraph, the term ''final product stage'' means
the point in the manufacturing process, before distribution of an infant
formula, at which an infant formula is homogenous and is not subject to further
degradation.
- (4)
- (A) The Secretary shall by regulation establish requirements respecting the
retention of records. Such requirements shall provide for -
- (i) the retention of all records necessary to demonstrate compliance with
the good manufacturing practices and quality control procedures prescribed by
the Secretary under paragraph (2), including records containing the results of
all testing required under paragraph (2)(B),
- (ii) the retention of all certifications or guarantees of analysis by
premix suppliers,
- •(iii) the retention by a premix supplier of all records necessary to
confirm the accuracy of all premix certifications and guarantees of analysis,
- (iv) the retention of -
- (I) all records pertaining to the microbiological quality and purity of raw
materials used in infant formula powder and in finished infant formula, and
- (II) all records pertaining to food packaging materials which show that
such materials do not cause an infant formula to be adulterated within the
meaning of section 342(a)(2)(C) of this title,
- (v) the retention of all records of the results of regularly scheduled
audits conducted pursuant to the requirements prescribed by the Secretary under
paragraph (2)(B)(iv), and
- (vi) the retention of all complaints and the maintenance of files with
respect to, and the review of, complaints concerning infant formulas which may
reveal the possible existence of a hazard to health.
- (B)
- (i) Records required under subparagraph (A) with respect to an infant
formula shall be retained for at least one year after the expiration of the
shelf life of such infant formula. Except as provided in clause (ii), such
records shall be made available to the Secretary for review and duplication upon
request of the Secretary.
- (ii) A manufacturer need only provide written assurances to the Secretary
that the regularly scheduled audits required by paragraph (2)(B)(iv) are being
conducted by the manufacturer, and need not make available to the Secretary the
actual written reports of such audits.
- (c) Registration of persons distributing new infant formula
- (1) No person shall introduce or deliver for introduction into interstate
commerce any new infant formula unless -
- (A) such person has, before introducing such new infant formula, or
delivering such new infant formula for introduction, into interstate commerce,
registered with the Secretary the name of such person, the place of business of
such person, and all establishments at which such person intends to manufacture
such new infant formula, and
- (B) such person has at least 90 days before marketing such new infant
formula, made the submission to the Secretary required by subsection (c)(1) of
this section.
- (2) For purposes of paragraph (1), the term ''new infant formula'' includes
-
- (A) an infant formula manufactured by a person which has not previously
manufactured an infant formula, and
- (B) an infant formula manufactured by a person which has previously
manufactured infant formula and in which there is a major change, in processing
or formulation, from a current or any previous formulation produced by such
manufacturer.
- For purposes of this paragraph, the term ''major change'' has the meaning
given to such term in section 106.30(c)(2) of title 21, Code of Federal
Regulations (as in effect on August 1, 1986), and guidelines issued thereunder.
- (d) Submission of information about new infant formula required
- (1) A person shall, with respect to any infant formula subject to
subsection (c) of this section, make a submission to the Secretary which shall
include -
- (A) the quantitative formulation of the infant formula,
- (B) a description of any reformulation of the formula or change in
processing of the infant formula,
- (C) assurances that the infant formula will not be marketed unless it meets
the requirements of subsections (b)(1) and (i) of this section, as demonstrated
by the testing required under subsection (b)(3) of this section, and
- (D) assurances that the processing of the infant formula complies with
subsection (b)(2) of this section.
- (2) After the first production of an infant formula subject to subsection
(c) of this section, and before the introduction into interstate commerce of
such formula, the manufacturer of such formula shall submit to the Secretary, in
such form as may be prescribed by the Secretary, a written verification which
summarizes test results and records demonstrating that such formula complies
with the requirements of subsections (b)(1), (b)(2)(A), (b)(2)(B)(i),
(b)(2)(B)(iii), (b)(3)(A), (b)(3)(C), and (i) of this section.
- (3) If the manufacturer of an infant formula for commercial or charitable
distribution for human consumption determines that a change in the formulation
of the formula or a change in the processing of the formula may affect whether
the formula is adulterated under subsection (a) of this section, the
manufacturer shall, before the first processing of such formula, make the
submission to the Secretary required by paragraph (1).
- (e) Additional notice requirements for manufacturer
- (1) If the manufacturer of an infant formula has knowledge which reasonably
supports the conclusion that an infant formula which has been processed by the
manufacturer and which has left an establishment subject to the control of the
manufacturer -
- (A) may not provide the nutrients required by subsection (i) of this
section, or
- (B) may be otherwise adulterated or misbranded, the manufacturer shall
promptly notify the Secretary of such knowledge.
- If the Secretary determines that the infant formula presents a risk to
human health, the manufacturer shall immediately take all actions necessary to
recall shipments of such infant formula from all wholesale and retail
establishments, consistent with recall regulations and guidelines issued by the
Secretary.
- (2) For purposes of paragraph (1), the term ''knowledge'' as applied to a
manufacturer means (A) the actual knowledge that the manufacturer had, or (B)
the knowledge which a reasonable person would have had under like circumstances
or which would have been obtained upon the exercise of due care.
- (f) Procedures applicable to recalls by manufacturer; regulatory
oversight
- (1) If a recall of infant formula is begun by a manufacturer, the recall
shall be carried out in accordance with such requirements as the Secretary shall
prescribe under paragraph (2) and -
- (A) the Secretary shall, not later than the 15th day after the beginning of
such recall and at least once every 15 days thereafter until the recall is
terminated, review the actions taken under the recall to determine whether the
recall meets the requirements prescribed under paragraph (2), and
- (B) the manufacturer shall, not later than the 14th day after the beginning
of such recall and at least once every 14 days thereafter until the recall is
terminated, report to the Secretary the actions taken to implement the recall.
- (2) The Secretary shall by regulation prescribe the scope and extent of
recalls of infant formulas necessary and appropriate for the degree of risks to
human health presented by the formula subject to the recall.
- (3) The Secretary shall by regulation require each manufacturer of an
infant formula who begins a recall of such formula because of a risk to human
health to request each retail establishment at which such formula is sold or
available for sale to post at the point of purchase of such formula a notice of
such recall at such establishment for such time that the Secretary determines
necessary to inform the public of such recall.
- (g) Recordkeeping requirements for manufacturer; regulatory
oversight and enforcement
- (1) Each manufacturer of an infant formula shall make and retain such
records respecting the distribution of the infant formula through any
establishment owned or operated by such manufacturer as may be necessary to
effect and monitor recalls of the formula. Such records shall be retained for at
least one year after the expiration of the shelf life of the infant formula.
- (2) To the extent that the Secretary determines that records are not being
made or maintained in accordance with paragraph (1), the Secretary may by
regulation prescribe the records required to be made under paragraph (1) and
requirements respecting the retention of such records under such paragraph. Such
regulations shall take effect on such date as the Secretary prescribes but not
sooner than the 180th day after the date such regulations are promulgated. Such
regulations shall apply only with respect to distributions of infant formulas
made after such effective date.
- (h) Exemptions; regulatory oversight
- (1) Any infant formula which is represented and labeled for use by an
infant -
- (A) who has an inborn error of metabolism or a low birth weight, or
- (B) who otherwise has an unusual medical or dietary problem, is exempt from
the requirements of subsections (a), (b), and (c) of this section. The
manufacturer of an infant formula exempt under this paragraph shall, in the case
of the exempt formula, be required to provide the notice required by subsection
(e)(1) of this section only with respect to adulteration or misbranding
described in subsection (e)(1)(B) of this section and to comply with the
regulations prescribed by the Secretary under paragraph (2).
- (2) The Secretary may by regulation establish terms and conditions for the
exemption of an infant formula from the requirements of subsections (a), (b),
and (c) of this section. An exemption of an infant formula under paragraph (1)
may be withdrawn by the Secretary if such formula is not in compliance with
applicable terms and conditions prescribed under this paragraph.
- (i) Nutrient requirements
- (1) An infant formula shall contain nutrients in accordance with the table
set out in this subsection or, if revised by the Secretary under paragraph (2),
as so revised.
- (2) The Secretary may by regulation -
- (A) revise the list of nutrients in the table in this subsection, and
- (B) revise the required level for any nutrient required by the table.
NUTRIENTS| Nutrient | Minimum¹ | Maximum¹ | | Protein (gm) | 1.8² | 4.5 |
Fat:
gm
percent cal |
3.3
30.0 |
6.0
54.0 | Essential fatty acids
(linoeate):
percent cal
mg |
2.7
300.0 | | Vitamins:
A (IU)
D (IU)
K (µg)
E (IU)
C (ascorbic acid) (mg)
B1 (thiamine) (µg)
B2 (riboflavin)(µg)
B6 (pyridoxine)
B12 (µg)
Niacin (µg)
Folic acid (µg)
Pantothenic
acid (µg)
Biotin (µg)
Choline (mg)
Inositol (mg)
|
250.0 (75 µg)³
40.0
4.0
0.7 :(with 0.7 IU/gm
linoleic acid)
8.0
40.0
60.0
35.0 (with 15µg/gm of protein
in formula)
0.15
250.0
4.0
300.0
1.5(d)
7.0(d)
4.0(d) |
750.0 (225 µg)³
100.0
| Minerals:
Calcium (mg)
Phosphorus (mg)
Magnesium (mg)
Iron (mg)
Iodine (µg)
Zinc (mg)
Copper (µg)
Manganese (µg)
Sodium (mg)
Potassium (mg)
Chloride (mg) |
50.0(e)
25.0(e)
6.0
0.15
5.0
0.5
60.0
5.0
20.0
80.0
55.0 |
60.0
200.0
150.0 |
¹Stated per 100 kilocalories.
²The source of protein shall be at least nutritionally equivalent to
casein.
³Retinol equivalents.
(d) Required to be included in this amount only in formulas which are not
milk-based.
(e) Calcium to phosphorus ratio must be no less than 1.1 nor more than 2.0.
§ 350b. New dietary ingredients.
A dietary supplement which contains a new dietary ingredient shall be deemed
adulterated under section 342(f) of this title unless it meets one of the
following requirements:
- (1) The dietary supplement contains only dietary ingredients which
have been present in the food supply as an article used for food in a form in
which the food has not been chemically altered.
- (2) There is a history of use or other evidence of safety establishing that
the dietary ingredient when used under the conditions recommended or suggested
in the labeling of the dietary supplement will reasonably be expected to be safe
and, at least 75 days before being introduced or delivered for introduction into
interstate commerce, the manufacturer or distributor of the dietary ingredient
or dietary supplement provides the Secretary with information, including any
citation to published articles, which is the basis on which the manufacturer or
distributor has concluded that a dietary supplement containing such dietary
ingredient will reasonably be expected to be safe.
The Secretary shall keep confidential any information provided under
paragraph (2) for 90 days following its receipt. After the expiration of such 90
days, the Secretary shall place such information on public display, except
matters in the information which are trade secrets or otherwise confidential,
commercial information.
Any person may file with the Secretary a petition proposing the issuance of
an order prescribing the conditions under which a new dietary ingredient under
its intended conditions of use will reasonably be expected to be safe. The
Secretary shall make a decision on such petition within 180 days of the date the
petition is filed with the Secretary. For purposes of chapter 7 of title 5, the
decision of the Secretary shall be considered final agency action.
- (c) ''New dietary ingredient'' defined
For purposes of this section, the term ''new dietary ingredient'' means a
dietary ingredient that was not marketed in the United States before October 15,
1994 and does not include any dietary ingredient which was marketed in the
United States before October 15, 1994.
Main Page | About Grimes & Reese | Practice Areas | MLM Law Clients | MLM Articles
MLM Law Library | What Our Clients Say | What's New | Search MLM Law | MLM Law Blog | Site Map
|
