21 U.S.C. § 343 : US Code - Section 343: Misbranded food

      A food shall be deemed to be misbranded - 
    (a) False or misleading label
      If (1) its labeling is false or misleading in any particular, or
    (2) in the case of a food to which section 350 of this title
    applies, its advertising is false or misleading in a material
    respect or its labeling is in violation of section 350(b)(2) of
    this title.
    (b) Offer for sale under another name
      If it is offered for sale under the name of another food.
    (c) Imitation of another food
      If it is an imitation of another food, unless its label bears, in
    type of uniform size and prominence, the word "imitation" and,
    immediately thereafter, the name of the food imitated.
    (d) Misleading container
      If its container is so made, formed, or filled as to be
    misleading.
    (e) Package form
      If in package form unless it bears a label containing (1) the
    name and place of business of the manufacturer, packer, or
    distributor; and (2) an accurate statement of the quantity of the
    contents in terms of weight, measure, or numerical count, except
    that under clause (2) of this paragraph reasonable variations shall
    be permitted, and exemptions as to small packages shall be
    established, by regulations prescribed by the Secretary.
    (f) Prominence of information on label
      If any word, statement, or other information required by or under
    authority of this chapter to appear on the label or labeling is not
    prominently placed thereon with such conspicuousness (as compared
    with other words, statements, designs, or devices, in the labeling)
    and in such terms as to render it likely to be read and understood
    by the ordinary individual under customary conditions of purchase
    and use.
    (g) Representation as to definition and standard of identity
      If it purports to be or is represented as a food for which a
    definition and standard of identity has been prescribed by
    regulations as provided by section 341 of this title, unless (1) it
    conforms to such definition and standard, and (2) its label bears
    the name of the food specified in the definition and standard, and,
    insofar as may be required by such regulations, the common names of
    optional ingredients (other than spices, flavoring, and coloring)
    present in such food.
    (h) Representation as to standards of quality and fill of container
      If it purports to be or is represented as - 
        (1) a food for which a standard of quality has been prescribed
      by regulations as provided by section 341 of this title, and its
      quality falls below such standard, unless its label bears, in
      such manner and form as such regulations specify, a statement
      that it falls below such standard;
        (2) a food for which a standard or standards of fill of
      container have been prescribed by regulations as provided by
      section 341 of this title, and it falls below the standard of
      fill of container applicable thereto, unless its label bears, in
      such manner and form as such regulations specify, a statement
      that it falls below such standard; or
        (3) a food that is pasteurized unless - 
          (A) such food has been subjected to a safe process or
        treatment that is prescribed as pasteurization for such food in
        a regulation promulgated under this chapter; or
          (B)(i) such food has been subjected to a safe process or
        treatment that - 
            (I) is reasonably certain to achieve destruction or
          elimination in the food of the most resistant microorganisms
          of public health significance that are likely to occur in the
          food;
            (II) is at least as protective of the public health as a
          process or treatment described in subparagraph (A);
            (III) is effective for a period that is at least as long as
          the shelf life of the food when stored under normal and
          moderate abuse conditions; and
            (IV) is the subject of a notification to the Secretary,
          including effectiveness data regarding the process or
          treatment; and

          (ii) at least 120 days have passed after the date of receipt
        of such notification by the Secretary without the Secretary
        making a determination that the process or treatment involved
        has not been shown to meet the requirements of subclauses (I)
        through (III) of clause (i).

    For purposes of paragraph (3), a determination by the Secretary
    that a process or treatment has not been shown to meet the
    requirements of subclauses (I) through (III) of subparagraph (B)(i)
    shall constitute final agency action under such subclauses.
    (i) Label where no representation as to definition and standard of
      identity
      Unless its label bears (1) the common or usual name of the food,
    if any there be, and (2) in case it is fabricated from two or more
    ingredients, the common or usual name of each such ingredient and
    if the food purports to be a beverage containing vegetable or fruit
    juice, a statement with appropriate prominence on the information
    panel of the total percentage of such fruit or vegetable juice
    contained in the food; except that spices, flavorings, and colors
    not required to be certified under section 379e(c) of this title
    (!1) unless sold as spices, flavorings, or such colors, may be
    designated as spices, flavorings, and colorings without naming
    each. To the extent that compliance with the requirements of clause
    (2) of this paragraph is impracticable, or results in deception or
    unfair competition, exemptions shall be established by regulations
    promulgated by the Secretary.

    (j) Representation for special dietary use
      If it purports to be or is represented for special dietary uses,
    unless its label bears such information concerning its vitamin,
    mineral, and other dietary properties as the Secretary determines
    to be, and by regulations prescribes as, necessary in order fully
    to inform purchasers as to its value for such uses.
    (k) Artificial flavoring, artificial coloring, or chemical
      preservatives
      If it bears or contains any artificial flavoring, artificial
    coloring, or chemical preservative, unless it bears labeling
    stating that fact, except that to the extent that compliance with
    the requirements of this paragraph is impracticable, exemptions
    shall be established by regulations promulgated by the Secretary.
    The provisions of this paragraph and paragraphs (g) and (i) with
    respect to artificial coloring shall not apply in the case of
    butter, cheese, or ice cream. The provisions of this paragraph with
    respect to chemical preservatives shall not apply to a pesticide
    chemical when used in or on a raw agricultural commodity which is
    the produce of the soil.
    (l) Pesticide chemicals on raw agricultural commodities
      If it is a raw agricultural commodity which is the produce of the
    soil, bearing or containing a pesticide chemical applied after
    harvest, unless the shipping container of such commodity bears
    labeling which declares the presence of such chemical in or on such
    commodity and the common or usual name and the function of such
    chemical, except that no such declaration shall be required while
    such commodity, having been removed from the shipping container, is
    being held or displayed for sale at retail out of such container in
    accordance with the custom of the trade.
    (m) Color additives
      If it is a color additive, unless its packaging and labeling are
    in conformity with such packaging and labeling requirements,
    applicable to such color additive, as may be contained in
    regulations issued under section 379e of this title.
    (n) Packaging or labeling of drugs in violation of regulations
      If its packaging or labeling is in violation of an applicable
    regulation issued pursuant to section 1472 or 1473 of title 15.
    (o) Repealed. Pub. L. 106-554, Sec. 1(a)(1) [title V, Sec. 517],
      Dec. 21, 2000, 114 Stat. 2763, 2763A-73
    (p) Repealed. Pub. L. 104-124, Sec. 1, Apr. 1, 1996, 110 Stat. 882
    (q) Nutrition information
      (1) Except as provided in subparagraphs (3), (4), and (5), if it
    is a food intended for human consumption and is offered for sale,
    unless its label or labeling bears nutrition information that
    provides - 
        (A)(i) the serving size which is an amount customarily consumed
      and which is expressed in a common household measure that is
      appropriate to the food, or
        (ii) if the use of the food is not typically expressed in a
      serving size, the common household unit of measure that expresses
      the serving size of the food,
        (B) the number of servings or other units of measure per
      container,
        (C) the total number of calories - 
          (i) derived from any source, and
          (ii) derived from the total fat,

      in each serving size or other unit of measure of the food,
        (D) the amount of the following nutrients: Total fat, saturated
      fat, cholesterol, sodium, total carbohydrates, complex
      carbohydrates, sugars, dietary fiber, and total protein contained
      in each serving size or other unit of measure,
        (E) any vitamin, mineral, or other nutrient required to be
      placed on the label and labeling of food under this chapter
      before October 1, 1990, if the Secretary determines that such
      information will assist consumers in maintaining healthy dietary
      practices.

    The Secretary may by regulation require any information required to
    be placed on the label or labeling by this subparagraph or
    subparagraph (2)(A) to be highlighted on the label or labeling by
    larger type, bold type, or contrasting color if the Secretary
    determines that such highlighting will assist consumers in
    maintaining healthy dietary practices.
      (2)(A) If the Secretary determines that a nutrient other than a
    nutrient required by subparagraph (1)(C), (1)(D), or (1)(E) should
    be included in the label or labeling of food subject to
    subparagraph (1) for purposes of providing information regarding
    the nutritional value of such food that will assist consumers in
    maintaining healthy dietary practices, the Secretary may by
    regulation require that information relating to such additional
    nutrient be included in the label or labeling of such food.
      (B) If the Secretary determines that the information relating to
    a nutrient required by subparagraph (1)(C), (1)(D), or (1)(E) or
    clause (A) of this subparagraph to be included in the label or
    labeling of food is not necessary to assist consumers in
    maintaining healthy dietary practices, the Secretary may by
    regulation remove information relating to such nutrient from such
    requirement.
      (3) For food that is received in bulk containers at a retail
    establishment, the Secretary may, by regulation, provide that the
    nutrition information required by subparagraphs (1) and (2) be
    displayed at the location in the retail establishment at which the
    food is offered for sale.
      (4)(A) The Secretary shall provide for furnishing the nutrition
    information required by subparagraphs (1) and (2) with respect to
    raw agricultural commodities and raw fish by issuing voluntary
    nutrition guidelines, as provided by clause (B) or by issuing
    regulations that are mandatory as provided by clause (D).
      (B)(i) Upon the expiration of 12 months after November 8, 1990,
    the Secretary, after providing an opportunity for comment, shall
    issue guidelines for food retailers offering raw agricultural
    commodities or raw fish to provide nutrition information specified
    in subparagraphs (1) and (2). Such guidelines shall take into
    account the actions taken by food retailers during such 12-month
    period to provide to consumers nutrition information on raw
    agricultural commodities and raw fish. Such guidelines shall only
    apply - 
        (I) in the case of raw agricultural commodities, to the 20
      varieties of vegetables most frequently consumed during a year
      and the 20 varieties of fruit most frequently consumed during a
      year, and
        (II) to the 20 varieties of raw fish most frequently consumed
      during a year.

    The vegetables, fruits, and raw fish to which such guidelines apply
    shall be determined by the Secretary by regulation and the
    Secretary may apply such guidelines regionally.
      (ii) Upon the expiration of 12 months after November 8, 1990, the
    Secretary shall issue a final regulation defining the circumstances
    that constitute substantial compliance by food retailers with the
    guidelines issued under subclause (i). The regulation shall provide
    that there is not substantial compliance if a significant number of
    retailers have failed to comply with the guidelines. The size of
    the retailers and the portion of the market served by retailers in
    compliance with the guidelines shall be considered in determining
    whether the substantial-compliance standard has been met.
      (C)(i) Upon the expiration of 30 months after November 8, 1990,
    the Secretary shall issue a report on actions taken by food
    retailers to provide consumers with nutrition information for raw
    agricultural commodities and raw fish under the guidelines issued
    under clause (A). Such report shall include a determination of
    whether there is substantial compliance with the guidelines.
      (ii) If the Secretary finds that there is substantial compliance
    with the guidelines, the Secretary shall issue a report and make a
    determination of the type required in subclause (i) every two
    years.
      (D)(i) If the Secretary determines that there is not substantial
    compliance with the guidelines issued under clause (A), the
    Secretary shall at the time such determination is made issue
    proposed regulations requiring that any person who offers raw
    agricultural commodities or raw fish to consumers provide, in a
    manner prescribed by regulations, the nutrition information
    required by subparagraphs (1) and (2). The Secretary shall issue
    final regulations imposing such requirements 6 months after issuing
    the proposed regulations. The final regulations shall become
    effective 6 months after the date of their promulgation.
      (ii) Regulations issued under subclause (i) may require that the
    nutrition information required by subparagraphs (1) and (2) be
    provided for more than 20 varieties of vegetables, 20 varieties of
    fruit, and 20 varieties of fish most frequently consumed during a
    year if the Secretary finds that a larger number of such products
    are frequently consumed. Such regulations shall permit such
    information to be provided in a single location in each area in
    which raw agricultural commodities and raw fish are offered for
    sale. Such regulations may provide that information shall be
    expressed as an average or range per serving of the same type of
    raw agricultural commodity or raw fish. The Secretary shall develop
    and make available to the persons who offer such food to consumers
    the information required by subparagraphs (1) and (2).
      (iii) Regulations issued under subclause (i) shall permit the
    required information to be provided in each area of an
    establishment in which raw agricultural commodities and raw fish
    are offered for sale. The regulations shall permit food retailers
    to display the required information by supplying copies of the
    information provided by the Secretary, by making the information
    available in brochure, notebook or leaflet form, or by posting a
    sign disclosing the information. Such regulations shall also permit
    presentation of the required information to be supplemented by a
    video, live demonstration, or other media which the Secretary
    approves.
      (E) For purposes of this subparagraph, the term "fish" includes
    freshwater or marine fin fish, crustaceans, and mollusks, including
    shellfish, amphibians, and other forms of aquatic animal life.
      (F) No person who offers raw agricultural commodities or raw fish
    to consumers may be prosecuted for minor violations of this
    subparagraph if there has been substantial compliance with the
    requirements of this paragraph.
      (5)(A) Subparagraphs (1), (2), (3), and (4) shall not apply to
    food - 
        (i) except as provided in clause (H)(ii)(III), 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) except as provided in clause (H)(ii)(III), 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.
      (H) Restaurants, Retail Food Establishments, and Vending
    Machines. - 
        (i) General requirements for restaurants and similar retail
      food establishments. - Except for food described in subclause
      (vii), in the case of food that is a standard menu item that is
      offered for sale in a restaurant or similar retail food
      establishment that is part of a chain with 20 or more locations
      doing business under the same name (regardless of the type of
      ownership of the locations) and offering for sale substantially
      the same menu items, the restaurant or similar retail food
      establishment shall disclose the information described in
      subclauses (ii) and (iii).
        (ii) Information required to be disclosed by restaurants and
      retail food establishments. - Except as provided in subclause
      (vii), the restaurant or similar retail food establishment shall
      disclose in a clear and conspicuous manner - 
          (I)(aa) in a nutrient content disclosure statement adjacent
        to the name of the standard menu item, so as to be clearly
        associated with the standard menu item, on the menu listing the
        item for sale, the number of calories contained in the standard
        menu item, as usually prepared and offered for sale; and
          (bb) a succinct statement concerning suggested daily caloric
        intake, as specified by the Secretary by regulation and posted
        prominently on the menu and designed to enable the public to
        understand, in the context of a total daily diet, the
        significance of the caloric information that is provided on the
        menu;
          (II)(aa) in a nutrient content disclosure statement adjacent
        to the name of the standard menu item, so as to be clearly
        associated with the standard menu item, on the menu board,
        including a drive-through menu board, the number of calories
        contained in the standard menu item, as usually prepared and
        offered for sale; and
          (bb) a succinct statement concerning suggested daily caloric
        intake, as specified by the Secretary by regulation and posted
        prominently on the menu board, designed to enable the public to
        understand, in the context of a total daily diet, the
        significance of the nutrition information that is provided on
        the menu board;
          (III) in a written form, available on the premises of the
        restaurant or similar retail establishment and to the consumer
        upon request, the nutrition information required under clauses
        (C) and (D) of subparagraph (1); and
          (IV) on the menu or menu board, a prominent, clear, and
        conspicuous statement regarding the availability of the
        information described in item (III).

        (iii) Self-service food and food on display. - Except as
      provided in subclause (vii), in the case of food sold at a salad
      bar, buffet line, cafeteria line, or similar self-service
      facility, and for self-service beverages or food that is on
      display and that is visible to customers, a restaurant or similar
      retail food establishment shall place adjacent to each food
      offered a sign that lists calories per displayed food item or per
      serving.
        (iv) Reasonable basis. - For the purposes of this clause, a
      restaurant or similar retail food establishment shall have a
      reasonable basis for its nutrient content disclosures, including
      nutrient databases, cookbooks, laboratory analyses, and other
      reasonable means, as described in section 101.10 of title 21,
      Code of Federal Regulations (or any successor regulation) or in a
      related guidance of the Food and Drug Administration.
        (v) Menu variability and combination meals. - The Secretary
      shall establish by regulation standards for determining and
      disclosing the nutrient content for standard menu items that come
      in different flavors, varieties, or combinations, but which are
      listed as a single menu item, such as soft drinks, ice cream,
      pizza, doughnuts, or children's combination meals, through means
      determined by the Secretary, including ranges, averages, or other
      methods.
        (vi) Additional information. - If the Secretary determines that
      a nutrient, other than a nutrient required under subclause
      (ii)(III), should be disclosed for the purpose of providing
      information to assist consumers in maintaining healthy dietary
      practices, the Secretary may require, by regulation, disclosure
      of such nutrient in the written form required under subclause
      (ii)(III).
        (vii) Nonapplicability to certain food. - 
          (I) In general. - Subclauses (i) through (vi) do not apply to
        - 
            (aa) items that are not listed on a menu or menu board
          (such as condiments and other items placed on the table or
          counter for general use);
            (bb) daily specials, temporary menu items appearing on the
          menu for less than 60 days per calendar year, or custom
          orders; or
            (cc) such other food that is part of a customary market
          test appearing on the menu for less than 90 days, under terms
          and conditions established by the Secretary.

          (II) Written forms. - Subparagraph (5)(C) shall apply to any
        regulations promulgated under subclauses (ii)(III) and (vi).

        (viii) Vending machines. - 
          (I) In general. - In the case of an article of food sold from
        a vending machine that - 
            (aa) does not permit a prospective purchaser to examine the
          Nutrition Facts Panel before purchasing the article or does
          not otherwise provide visible nutrition information at the
          point of purchase; and
            (bb) is operated by a person who is engaged in the business
          of owning or operating 20 or more vending machines,

        the vending machine operator shall provide a sign in close
        proximity to each article of food or the selection button that
        includes a clear and conspicuous statement disclosing the
        number of calories contained in the article.

        (ix) Voluntary provision of nutrition information. - 
          (I) In general. - An authorized official of any restaurant or
        similar retail food establishment or vending machine operator
        not subject to the requirements of this clause may elect to be
        subject to the requirements of such clause, by registering
        biannually the name and address of such restaurant or similar
        retail food establishment or vending machine operator with the
        Secretary, as specified by the Secretary by regulation.
          (II) Registration. - Within 120 days of March 23, 2010, the
        Secretary shall publish a notice in the Federal Register
        specifying the terms and conditions for implementation of item
        (I), pending promulgation of regulations.
          (III) Rule of construction. - Nothing in this subclause shall
        be construed to authorize the Secretary to require an
        application, review, or licensing process for any entity to
        register with the Secretary, as described in such item.

        (x) Regulations. - 
          (I) Proposed regulation. - Not later than 1 year after March
        23, 2010, the Secretary shall promulgate proposed regulations
        to carry out this clause.
          (II) Contents. - In promulgating regulations, the Secretary
        shall - 
            (aa) consider standardization of recipes and methods of
          preparation, reasonable variation in serving size and
          formulation of menu items, space on menus and menu boards,
          inadvertent human error, training of food service workers,
          variations in ingredients, and other factors, as the
          Secretary determines; and
            (bb) specify the format and manner of the nutrient content
          disclosure requirements under this subclause.

          (III) Reporting. - The Secretary shall submit to the
        Committee on Health, Education, Labor, and Pensions of the
        Senate and the Committee on Energy and Commerce of the House of
        Representatives a quarterly report that describes the
        Secretary's progress toward promulgating final regulations
        under this subparagraph.

        (xi) Definition. - In this clause, the term "menu" or "menu
      board" means the primary writing of the restaurant or other
      similar retail food establishment from which a consumer makes an
      order selection.
    (r) Nutrition levels and health-related claims
      (1) Except as provided in clauses (A) through (C) of subparagraph
    (5), if it is a food intended for human consumption which is
    offered for sale and for which a claim is made in the label or
    labeling of the food which expressly or by implication - 
        (A) characterizes the level of any nutrient which is of the
      type required by paragraph (q)(1) or (q)(2) to be in the label or
      labeling of the food unless the claim is made in accordance with
      subparagraph (2), or
        (B) characterizes the relationship of any nutrient which is of
      the type required by paragraph (q)(1) or (q)(2) to be in the
      label or labeling of the food to a disease or a health-related
      condition unless the claim is made in accordance with
      subparagraph (3) or (5)(D).

    A statement of the type required by paragraph (q) that appears as
    part of the nutrition information required or permitted by such
    paragraph is not a claim which is subject to this paragraph and a
    claim subject to clause (A) is not subject to clause (B).
      (2)(A) Except as provided in subparagraphs (4)(A)(ii) and
    (4)(A)(iii) and clauses (A) through (C) of subparagraph (5), a
    claim described in subparagraph (1)(A) - 
        (i) may be made only if the characterization of the level made
      in the claim uses terms which are defined in regulations of the
      Secretary,
        (ii) may not state the absence of a nutrient unless - 
          (I) the nutrient is usually present in the food or in a food
        which substitutes for the food as defined by the Secretary by
        regulation, or
          (II) the Secretary by regulation permits such a statement on
        the basis of a finding that such a statement would assist
        consumers in maintaining healthy dietary practices and the
        statement discloses that the nutrient is not usually present in
        the food,

        (iii) may not be made with respect to the level of cholesterol
      in the food if the food contains, as determined by the Secretary
      by regulation, fat or saturated fat in an amount which increases
      to persons in the general population the risk of disease or a
      health related condition which is diet related unless - 
          (I) the Secretary finds by regulation that the level of
        cholesterol is substantially less than the level usually
        present in the food or in a food which substitutes for the food
        and which has a significant market share, or the Secretary by
        regulation permits a statement regarding the absence of
        cholesterol on the basis of a finding that cholesterol is not
        usually present in the food and that such a statement would
        assist consumers in maintaining healthy dietary practices and
        the regulation requires that the statement disclose that
        cholesterol is not usually present in the food, and
          (II) the label or labeling of the food discloses the level of
        such fat or saturated fat in immediate proximity to such claim
        and with appropriate prominence which shall be no less than one-
        half the size of the claim with respect to the level of
        cholesterol,

        (iv) may not be made with respect to the level of saturated fat
      in the food if the food contains cholesterol unless the label or
      labeling of the food discloses the level of cholesterol in the
      food in immediate proximity to such claim and with appropriate
      prominence which shall be no less than one-half the size of the
      claim with respect to the level of saturated fat,
        (v) may not state that a food is high in dietary fiber unless
      the food is low in total fat as defined by the Secretary or the
      label or labeling discloses the level of total fat in the food in
      immediate proximity to such statement and with appropriate
      prominence which shall be no less than one-half the size of the
      claim with respect to the level of dietary fiber, and
        (vi) may not be made if the Secretary by regulation prohibits
      the claim because the claim is misleading in light of the level
      of another nutrient in the food.

      (B) If a claim described in subparagraph (1)(A) is made with
    respect to a nutrient in a food and the Secretary makes a
    determination that the food contains a nutrient at a level that
    increases to persons in the general population the risk of a
    disease or health-related condition that is diet related, the label
    or labeling of such food shall contain, prominently and in
    immediate proximity to such claim, the following statement: "See
    nutrition information for ___ content." The blank shall identify
    the nutrient associated with the increased disease or health-
    related condition risk. In making the determination described in
    this clause, the Secretary shall take into account the significance
    of the food in the total daily diet.
      (C) Subparagraph (2)(A) does not apply to a claim described in
    subparagraph (1)(A) and contained in the label or labeling of a
    food if such claim is contained in the brand name of such food and
    such brand name was in use on such food before October 25, 1989,
    unless the brand name contains a term defined by the Secretary
    under subparagraph (2)(A)(i). Such a claim is subject to paragraph
    (a).
      (D) Subparagraph (2) does not apply to a claim described in
    subparagraph (1)(A) which uses the term "diet" and is contained in
    the label or labeling of a soft drink if (i) such claim is
    contained in the brand name of such soft drink, (ii) such brand
    name was in use on such soft drink before October 25, 1989, and
    (iii) the use of the term "diet" was in conformity with section
    105.66 of title 21 of the Code of Federal Regulations. Such a claim
    is subject to paragraph (a).
      (E) Subclauses (i) through (v) of subparagraph (2)(A) do not
    apply to a statement in the label or labeling of food which
    describes the percentage of vitamins and minerals in the food in
    relation to the amount of such vitamins and minerals recommended
    for daily consumption by the Secretary.
      (F) Subclause (i) clause (A) does not apply to a statement in the
    labeling of a dietary supplement that characterizes the percentage
    level of a dietary ingredient for which the Secretary has not
    established a reference daily intake, daily recommended value, or
    other recommendation for daily consumption.
      (G) A claim of the type described in subparagraph (1)(A) for a
    nutrient, for which the Secretary has not promulgated a regulation
    under clause (A)(i), shall be authorized and may be made with
    respect to a food if - 
        (i) a scientific body of the United States Government with
      official responsibility for public health protection or research
      directly relating to human nutrition (such as the National
      Institutes of Health or the Centers for Disease Control and
      Prevention) or the National Academy of Sciences or any of its
      subdivisions has published an authoritative statement, which is
      currently in effect, which identifies the nutrient level to which
      the claim refers;
        (ii) a person has submitted to the Secretary, at least 120 days
      (during which the Secretary may notify any person who is making a
      claim as authorized by clause (C) that such person has not
      submitted all the information required by such clause) before the
      first introduction into interstate commerce of the food with a
      label containing the claim, (I) a notice of the claim, which
      shall include the exact words used in the claim and shall include
      a concise description of the basis upon which such person relied
      for determining that the requirements of subclause (i) have been
      satisfied, (II) a copy of the statement referred to in subclause
      (i) upon which such person relied in making the claim, and (III)
      a balanced representation of the scientific literature relating
      to the nutrient level to which the claim refers;
        (iii) the claim and the food for which the claim is made are in
      compliance with clauses (A) and (B), and are otherwise in
      compliance with paragraph (a) and section 321(n) of this title;
      and
        (iv) the claim is stated in a manner so that the claim is an
      accurate representation of the authoritative statement referred
      to in subclause (i) and so that the claim enables the public to
      comprehend the information provided in the claim and to
      understand the relative significance of such information in the
      context of a total daily diet.

    For purposes of this clause, a statement shall be regarded as an
    authoritative statement of a scientific body described in subclause
    (i) only if the statement is published by the scientific body and
    shall not include a statement of an employee of the scientific body
    made in the individual capacity of the employee.
      (H) A claim submitted under the requirements of clause (G) may be
    made until - 
        (i) such time as the Secretary issues a regulation - 
          (I) prohibiting or modifying the claim and the regulation has
        become effective, or
          (II) finding that the requirements of clause (G) have not
        been met, including finding that the petitioner had not
        submitted all the information required by such clause; or

        (ii) a district court of the United States in an enforcement
      proceeding under subchapter III of this chapter has determined
      that the requirements of clause (G) have not been met.

      (3)(A) Except as provided in subparagraph (5), a claim described
    in subparagraph (1)(B) may only be made - 
        (i) if the claim meets the requirements of the regulations of
      the Secretary promulgated under clause (B), and
        (ii) if the food for which the claim is made does not contain,
      as determined by the Secretary by regulation, any nutrient in an
      amount which increases to persons in the general population the
      risk of a disease or health-related condition which is diet
      related, taking into account the significance of the food in the
      total daily diet, except that the Secretary may by regulation
      permit such a claim based on a finding that such a claim would
      assist consumers in maintaining healthy dietary practices and
      based on a requirement that the label contain a disclosure of the
      type required by subparagraph (2)(B).

      (B)(i) The Secretary shall promulgate regulations authorizing
    claims of the type described in subparagraph (1)(B) only if the
    Secretary determines, based on the totality of publicly available
    scientific evidence (including evidence from well-designed studies
    conducted in a manner which is consistent with generally recognized
    scientific procedures and principles), that there is significant
    scientific agreement, among experts qualified by scientific
    training and experience to evaluate such claims, that the claim is
    supported by such evidence.
      (ii) A regulation described in subclause (i) shall describe - 
        (I) the relationship between a nutrient of the type required in
      the label or labeling of food by paragraph (q)(1) or (q)(2) and a
      disease or health-related condition, and
        (II) the significance of each such nutrient in affecting such
      disease or health-related condition.

      (iii) A regulation described in subclause (i) shall require such
    claim to be stated in a manner so that the claim is an accurate
    representation of the matters set out in subclause (ii) and so that
    the claim enables the public to comprehend the information provided
    in the claim and to understand the relative significance of such
    information in the context of a total daily diet.
      (C) Notwithstanding the provisions of clauses (A)(i) and (B), a
    claim of the type described in subparagraph (1)(B) which is not
    authorized by the Secretary in a regulation promulgated in
    accordance with clause (B) shall be authorized and may be made with
    respect to a food if - 
        (i) a scientific body of the United States Government with
      official responsibility for public health protection or research
      directly relating to human nutrition (such as the National
      Institutes of Health or the Centers for Disease Control and
      Prevention) or the National Academy of Sciences or any of its
      subdivisions has published an authoritative statement, which is
      currently in effect, about the relationship between a nutrient
      and a disease or health-related condition to which the claim
      refers;
        (ii) a person has submitted to the Secretary, at least 120 days
      (during which the Secretary may notify any person who is making a
      claim as authorized by clause (C) that such person has not
      submitted all the information required by such clause) before the
      first introduction into interstate commerce of the food with a
      label containing the claim, (I) a notice of the claim, which
      shall include the exact words used in the claim and shall include
      a concise description of the basis upon which such person relied
      for determining that the requirements of subclause (i) have been
      satisfied, (II) a copy of the statement referred to in subclause
      (i) upon which such person relied in making the claim, and (III)
      a balanced representation of the scientific literature relating
      to the relationship between a nutrient and a disease or health-
      related condition to which the claim refers;
        (iii) the claim and the food for which the claim is made are in
      compliance with clause (A)(ii) and are otherwise in compliance
      with paragraph (a) and section 321(n) of this title; and
        (iv) the claim is stated in a manner so that the claim is an
      accurate representation of the authoritative statement referred
      to in subclause (i) and so that the claim enables the public to
      comprehend the information provided in the claim and to
      understand the relative significance of such information in the
      context of a total daily diet.

    For purposes of this clause, a statement shall be regarded as an
    authoritative statement of a scientific body described in subclause
    (i) only if the statement is published by the scientific body and
    shall not include a statement of an employee of the scientific body
    made in the individual capacity of the employee.
      (D) A claim submitted under the requirements of clause (C) may be
    made until - 
        (i) such time as the Secretary issues a regulation under the
      standard in clause (B)(i) - 
          (I) prohibiting or modifying the claim and the regulation has
        become effective, or
          (II) finding that the requirements of clause (C) have not
        been met, including finding that the petitioner has not
        submitted all the information required by such clause; or

        (ii) a district court of the United States in an enforcement
      proceeding under subchapter III of this chapter has determined
      that the requirements of clause (C) have not been met.

      (4)(A)(i) Any person may petition the Secretary to issue a
    regulation under subparagraph (2)(A)(i) or (3)(B) relating to a
    claim described in subparagraph (1)(A) or (1)(B). Not later than
    100 days after the petition is received by the Secretary, the
    Secretary shall issue a final decision denying the petition or file
    the petition for further action by the Secretary. If the Secretary
    does not act within such 100 days, the petition shall be deemed to
    be denied unless an extension is mutually agreed upon by the
    Secretary and the petitioner. If the Secretary denies the petition
    or the petition is deemed to be denied, the petition shall not be
    made available to the public. If the Secretary files the petition,
    the Secretary shall deny the petition or issue a proposed
    regulation to take the action requested in the petition not later
    than 90 days after the date of such decision. If the Secretary does
    not act within such 90 days, the petition shall be deemed to be
    denied unless an extension is mutually agreed upon by the Secretary
    and the petitioner. If the Secretary issues a proposed regulation,
    the rulemaking shall be completed within 540 days of the date the
    petition is received by the Secretary. If the Secretary does not
    issue a regulation within such 540 days, the Secretary shall
    provide the Committee on Commerce of the House of Representatives
    and the Committee on Labor and Human Resources of the Senate the
    reasons action on the regulation did not occur within such 540
    days.
      (ii) Any person may petition the Secretary for permission to use
    in a claim described in subparagraph (1)(A) terms that are
    consistent with the terms defined by the Secretary under
    subparagraph (2)(A)(i). Within 90 days of the submission of such a
    petition, the Secretary shall issue a final decision denying the
    petition or granting such permission.
      (iii) Any person may petition the Secretary for permission to use
    an implied claim described in subparagraph (1)(A) in a brand name.
    After publishing notice of an opportunity to comment on the
    petition in the Federal Register and making the petition available
    to the public, the Secretary shall grant the petition if the
    Secretary finds that such claim is not misleading and is consistent
    with terms defined by the Secretary under subparagraph (2)(A)(i).
    The Secretary shall grant or deny the petition within 100 days of
    the date it is submitted to the Secretary and the petition shall be
    considered granted if the Secretary does not act on it within such
    100 days.
      (B) A petition under clause (A)(i) respecting a claim described
    in subparagraph (1)(A) or (1)(B) shall include an explanation of
    the reasons why the claim meets the requirements of this paragraph
    and a summary of the scientific data which supports such reasons.
      (C) If a petition for a regulation under subparagraph (3)(B)
    relies on a report from an authoritative scientific body of the
    United States, the Secretary shall consider such report and shall
    justify any decision rejecting the conclusions of such report.
      (5)(A) This paragraph does not apply to infant formulas subject
    to section 350a(h) of this title and medical foods as defined in
    section 360ee(b) of this title.
      (B) Subclauses (iii) through (v) of subparagraph (2)(A) and
    subparagraph (2)(B) do not apply to food which is served in
    restaurants or other establishments in which food is served for
    immediate human consumption or which is sold for sale or use in
    such establishments.
      (C) A subparagraph (1)(A) claim made with respect to a food which
    claim is required by a standard of identity issued under section
    341 of this title shall not be subject to subparagraph (2)(A)(i) or
    (2)(B).
      (D) A subparagraph (1)(B) claim made with respect to a dietary
    supplement of vitamins, minerals, herbs, or other similar
    nutritional substances shall not be subject to subparagraph (3) but
    shall be subject to a procedure and standard, respecting the
    validity of such claim, established by regulation of the Secretary.
      (6) For purposes of paragraph (r)(1)(B), a statement for a
    dietary supplement may be made if - 
        (A) the statement claims a benefit related to a classical
      nutrient deficiency disease and discloses the prevalence of such
      disease in the United States, describes the role of a nutrient or
      dietary ingredient intended to affect the structure or function
      in humans, characterizes the documented mechanism by which a
      nutrient or dietary ingredient acts to maintain such structure or
      function, or describes general well-being from consumption of a
      nutrient or dietary ingredient,
        (B) the manufacturer of the dietary supplement has
      substantiation that such statement is truthful and not
      misleading, and
        (C) the statement contains, prominently displayed and in
      boldface type, the following: "This statement has not been
      evaluated by the Food and Drug Administration. This product is
      not intended to diagnose, treat, cure, or prevent any disease.".

    A statement under this subparagraph may not claim to diagnose,
    mitigate, treat, cure, or prevent a specific disease or class of
    diseases. If the manufacturer of a dietary supplement proposes to
    make a statement described in the first sentence of this
    subparagraph in the labeling of the dietary supplement, the
    manufacturer shall notify the Secretary no later than 30 days after
    the first marketing of the dietary supplement with such statement
    that such a statement is being made.
      (7) The Secretary may make proposed regulations issued under this
    paragraph effective upon publication pending consideration of
    public comment and publication of a final regulation if the
    Secretary determines that such action is necessary - 
        (A) to enable the Secretary to review and act promptly on
      petitions the Secretary determines provide for information
      necessary to - 
          (i) enable consumers to develop and maintain healthy dietary
        practices;
          (ii) enable consumers to be informed promptly and effectively
        of important new knowledge regarding nutritional and health
        benefits of food; or
          (iii) ensure that scientifically sound nutritional and health
        information is provided to consumers as soon as possible; or

        (B) to enable the Secretary to act promptly to ban or modify a
      claim under this paragraph.

    Such proposed regulations shall be deemed final agency action for
    purposes of judicial review.
    (s) Dietary supplements
      If - 
        (1) it is a dietary supplement; and
        (2)(A) the label or labeling of the supplement fails to list - 
          (i) the name of each ingredient of the supplement that is
        described in section 321(ff) of this title; and
          (ii)(I) the quantity of each such ingredient; or
          (II) with respect to a proprietary blend of such ingredients,
        the total quantity of all ingredients in the blend;

        (B) the label or labeling of the dietary supplement fails to
      identify the product by using the term "dietary supplement",
      which term may be modified with the name of such an ingredient;
        (C) the supplement contains an ingredient described in section
      321(ff)(1)(C) of this title, and the label or labeling of the
      supplement fails to identify any part of the plant from which the
      ingredient is derived;
        (D) the supplement - 
          (i) is covered by the specifications of an official
        compendium;
          (ii) is represented as conforming to the specifications of an
        official compendium; and
          (iii) fails to so conform; or

        (E) the supplement - 
          (i) is not covered by the specifications of an official
        compendium; and
          (ii)(I) fails to have the identity and strength that the
        supplement is represented to have; or
          (II) fails to meet the quality (including tablet or capsule
        disintegration), purity, or compositional specifications, based
        on validated assay or other appropriate methods, that the
        supplement is represented to meet.

    A dietary supplement shall not be deemed misbranded solely because
    its label or labeling contains directions or conditions of use or
    warnings.
    (t) Catfish
      If it purports to be or is represented as catfish, unless it is
    fish classified within the family Ictaluridae.
    (u) Ginseng
      If it purports to be or is represented as ginseng, unless it is
    an herb or herbal ingredient derived from a plant classified within
    the genus Panax.
    (v) Failure to label; health threat
       If - 
        (1) it fails to bear a label required by the Secretary under
      section 381(n)(1) of this title (relating to food refused
      admission into the United States);
        (2) the Secretary finds that the food presents a threat of
      serious adverse health consequences or death to humans or
      animals; and
        (3) upon or after notifying the owner or consignee involved
      that the label is required under section 381 of this title, the
      Secretary informs the owner or consignee that the food presents
      such a threat.
    (w) Major food allergen labeling requirements
      (1) If it is not a raw agricultural commodity and it is, or it
    contains an ingredient that bears or contains, a major food
    allergen, unless either - 
        (A) the word "Contains", followed by the name of the food
      source from which the major food allergen is derived, is printed
      immediately after or is adjacent to the list of ingredients (in a
      type size no smaller than the type size used in the list of
      ingredients) required under subsections (g) and (i) of this
      section; or
        (B) the common or usual name of the major food allergen in the
      list of ingredients required under subsections (g) and (i) of
      this section is followed in parentheses by the name of the food
      source from which the major food allergen is derived, except that
      the name of the food source is not required when - 
          (i) the common or usual name of the ingredient uses the name
        of the food source from which the major food allergen is
        derived; or
          (ii) the name of the food source from which the major food
        allergen is derived appears elsewhere in the ingredient list,
        unless the name of the food source that appears elsewhere in
        the ingredient list appears as part of the name of a food
        ingredient that is not a major food allergen under section
        321(qq)(2)(A) or (B) of this title.

      (2) As used in this subsection, the term "name of the food source
    from which the major food allergen is derived" means the name
    described in section 321(qq)(1) of this title; provided that in the
    case of a tree nut, fish, or Crustacean shellfish, the term "name
    of the food source from which the major food allergen is derived"
    means the name of the specific type of nut or species of fish or
    Crustacean shellfish.
      (3) The information required under this subsection may appear in
    labeling in lieu of appearing on the label only if the Secretary
    finds that such other labeling is sufficient to protect the public
    health. A finding by the Secretary under this paragraph (including
    any change in an earlier finding under this paragraph) is effective
    upon publication in the Federal Register as a notice.
      (4) Notwithstanding subsection (g), (i), or (k) of this section,
    or any other law, a flavoring, coloring, or incidental additive
    that is, or that bears or contains, a major food allergen shall be
    subject to the labeling requirements of this subsection.
      (5) The Secretary may by regulation modify the requirements of
    subparagraph (A) or (B) of paragraph (1), or eliminate either the
    requirement of subparagraph (A) or the requirements of subparagraph
    (B) of paragraph (1), if the Secretary determines that the
    modification or elimination of the requirement of subparagraph (A)
    or the requirements of subparagraph (B) is necessary to protect the
    public health.
      (6)(A) Any person may petition the Secretary to exempt a food
    ingredient described in section 321(qq)(2) of this title from the
    allergen labeling requirements of this subsection.
      (B) The Secretary shall approve or deny such petition within 180
    days of receipt of the petition or the petition shall be deemed
    denied, unless an extension of time is mutually agreed upon by the
    Secretary and the petitioner.
      (C) The burden shall be on the petitioner to provide scientific
    evidence (including the analytical method used to produce the
    evidence) that demonstrates that such food ingredient, as derived
    by the method specified in the petition, does not cause an allergic
    response that poses a risk to human health.
      (D) A determination regarding a petition under this paragraph
    shall constitute final agency action.
      (E) The Secretary shall promptly post to a public site all
    petitions received under this paragraph within 14 days of receipt
    and the Secretary shall promptly post the Secretary's response to
    each.
      (7)(A) A person need not file a petition under paragraph (6) to
    exempt a food ingredient described in section 321(qq)(2) of this
    title from the allergen labeling requirements of this subsection,
    if the person files with the Secretary a notification containing - 
        (i) scientific evidence (including the analytical method used)
      that demonstrates that the food ingredient (as derived by the
      method specified in the notification, where applicable) does not
      contain allergenic protein; or
        (ii) a determination by the Secretary that the ingredient does
      not cause an allergic response that poses a risk to human health
      under a premarket approval or notification program under section
      348 of this title.

      (B) The food ingredient may be introduced or delivered for
    introduction into interstate commerce as a food ingredient that is
    not a major food allergen 90 days after the date of receipt of the
    notification by the Secretary, unless the Secretary determines
    within the 90-day period that the notification does not meet the
    requirements of this paragraph, or there is insufficient scientific
    evidence to determine that the food ingredient does not contain
    allergenic protein or does not cause an allergenic response that
    poses a risk to human health.
      (C) The Secretary shall promptly post to a public site all
    notifications received under this subparagraph within 14 days of
    receipt and promptly post any objections thereto by the Secretary.
    (x) Nonmajor food allergen labeling requirements
      Notwithstanding subsection (g), (i), or (k) of this section, or
    any other law, a spice, flavoring, coloring, or incidental additive
    that is, or that bears or contains, a food allergen (other than a
    major food allergen), as determined by the Secretary by regulation,
    shall be disclosed in a manner specified by the Secretary by
    regulation.
    (y) Dietary supplements
      If it is a dietary supplement that is marketed in the United
    States, unless the label of such dietary supplement includes a
    domestic address or domestic phone number through which the
    responsible person (as described in section 379aa-1 of this title)
    may receive a report of a serious adverse event with such dietary
    supplement.