[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2923 Introduced in House (IH)]

103d CONGRESS
  1st Session
                                H. R. 2923

    To amend the Federal Food, Drug, and Cosmetic Act to revise the 
                   regulation of dietary supplements.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             August 6, 1993

   Mrs. Collins of Illinois introduced the following bill; which was 
            referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
    To amend the Federal Food, Drug, and Cosmetic Act to revise the 
                   regulation of dietary supplements.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; REFERENCE.

    This Act may be cited as the ``Dietary Supplement Consumer 
Protection Act of 1993''.
    (b) Reference.--Whenever in this Act an amendment or repeal is 
expressed in terms of an amendment to, or repeal of, a section or other 
provision, the reference shall be considered to be made to a section or 
other provision of the Federal Food, Drug, and Cosmetic Act

SEC. 2. DEFINITIONS.

    Section 201 (21 U.S.C. 321) is amended by adding at the end the 
following:
    ``(gg) The term `dietary supplement' means an article that is--
            ``(1) intended to supplement the diet,
            ``(2) is, or contains, a vitamin, mineral, or an herb or 
        similar nutritional substance, including a concentrate or 
        extract of a vitamin, mineral, or other nutritional substance, 
        and
            ``(3)(A) is intended for ingestion in a form described in 
        paragraph (1)(B)(i) or (2) of section 411(c) or in another 
        similar form, or
            ``(B) complies with section 411(c)(1)(B)(ii).
    ``(hh) The term `dietary ingredient' means a vitamin, mineral, or 
herb or other similar nutritional substance the intended use of which 
results, or may reasonably be expected to result, directly or 
indirectly, in its becoming a component or otherwise affecting the 
characteristics of any dietary supplement.''.

SEC. 3. DEFINITIONS AND STANDARDS OF IDENTITY.

    Section 401 (21 U.S.C. 341) is amended--
            (1) in the first sentence, by inserting ``or dietary 
        supplement'' after ``establishing for any food'', and
            (2) in the fourth sentence, by inserting ``or dietary 
        supplement'' after ``any food'' and by inserting ``or dietary 
        supplements'' after ``class of food''.

SEC. 4. ADULTERATION.

    Section 402 (21 U.S.C. 342) is amended--
            (1) by inserting ``or dietary supplement'' after ``food'' 
        before paragraph (a), and
            (2) by adding at the end the following:
    ``(f) If it is a dietary supplement and it is, or contains, any 
dietary ingredient which is unsafe within the meaning of section 413.
    ``(g) If it is a dietary supplement and it does not meet the 
quality factor requirements prescribed by the Secretary under this 
paragraph. The Secretary shall, by regulation, establish requirements 
for quality factors for dietary supplements as appropriate.
    ``(h)(1) If it is a dietary supplement and the processing of such 
dietary supplement is not in compliance with the good manufacturing 
practices and the quality control procedures established by the 
Secretary under subparagraph (2).
    ``(2) The Secretary shall, by regulation, establish good 
manufacturing practices for dietary supplements, including quality 
control procedures that the Secretary determines are necessary to 
assure that a dietary supplement--
            ``(A) provides the vitamin, mineral, or herb or other 
        nutritional substance it claims to provide in its label or 
        labeling, and
            ``(B) is manufactured in a manner designed to prevent 
        adulteration.''.

SEC. 5. MISBRANDING.

    Section 403 (21 U.S.C. 343) is amended--
            (1) by inserting ``or dietary supplement'' after ``food'' 
        before paragraph (a),
            (2) in paragraph (a)(2), by inserting ``or dietary 
        supplement'' after ``food'',
            (3) in paragraph (b), by inserting ``or dietary 
        supplement'' after ``another food'',
            (4) in paragraph (g), by inserting ``or dietary 
        supplement'' after ``food'' each place it occurs,
            (5) in paragraph (h), by inserting ``or dietary 
        supplement'' after ``food'' each place it occurs,
            (6) in paragraph (i)(1), by inserting ``or dietary 
        supplement'' after ``food'',
            (7) in paragraph (r)(1), by inserting ``or dietary 
        supplement'' after ``food'' each place it occurs and by 
        inserting ``or dietary ingredient'' after ``nutrient'' each 
        place it occurs,
            (8) in paragraph (r)(1)(B), by inserting ``or any dietary 
        supplement'' after ``food'' and by striking out ``or (5)(D)'',
            (9) in paragraph (r)(3)(A)(ii), by inserting ``or dietary 
        supplement'' after ``food'' each place it occurs and by 
        inserting ``or dietary ingredient'' after ``nutrient'',
            (10) in paragraph (r)(3)(B)(ii)(I), by inserting ``or 
        dietary supplements'' after ``food'' and by inserting ``or 
        dietary ingredient'' after ``(q)(2)'',
            (11) in paragraph (r)(3)(B)(ii)(II), by inserting ``or 
        dietary ingredient'' after ``nutrient'',
            (12) in paragraph (r)(5), by striking out clause (D), and
            (13) by adding at the end the following:
    ``(s) If it is a dietary supplement, unless its label and labeling 
contain the date after which it should no longer be consumed as 
prescribed by the Secretary by regulation.
    ``(t) If it is a dietary supplement, unless its label and labeling 
contain, where appropriate, a statement regarding possible adverse 
effects as prescribed by the Secretary by regulation. Such a statement 
shall indicate the level, if any, at which a dietary supplement can 
cause adverse effects and the specific nature of any adverse effects 
and shall identify segments of the population, including the elderly 
and children, that may be affected.''.

SEC. 6. SAFETY PROVISIONS AND NOTIFICATION REQUIREMENTS FOR DIETARY 
              INGREDIENTS.

    Subchapter IV of chapter 4 is amended by adding at the end the 
following:

                      ``dietary ingredients safety

    ``Sec. 413. (a) A dietary ingredient shall, with respect to any 
particular or intended use of such ingredient, be deemed unsafe for the 
purposes of section 402(f) unless--
            ``(1) 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 dietary 
        ingredient may be safely used,
            ``(2) such ingredient is generally recognized, among 
        experts qualified by adequate training and experience to 
        evaluate its safety, as having been adequately shown through 
        scientific procedures to be safe under the conditions of its 
        intended use, or
            ``(3) in the case of a dietary ingredient in use in a 
        dietary supplement before August 5, 1993, it has been 
        adequately shown, through either scientific procedures or 
        experience based on common use in a dietary supplement, to be 
        safe under the conditions of its intended use pending 
        completion of the review required by subsection (f).
    ``(b) Any person may with respect to any intended use of a dietary 
ingredient file with the Secretary a petition proposing the issuance of 
a regulation prescribing the conditions under which such ingredient may 
be safely used. The Secretary shall by regulation establish 
requirements for petitions submitted under this subsection.
    ``(c) The Secretary shall by order--
            ``(1) establish a regulation (whether or not in accord with 
        the regulation proposed by the petitioner) prescribing, with 
        respect to one or more proposed uses of the dietary ingredient 
        involved, the conditions under which such ingredient may be 
        safely used, including specifications as to the--
                    ``(A) particular dietary supplement or classes of 
                dietary supplements in which such ingredient may be 
                used,
                    ``(B) the maximum quantity which may be used or 
                permitted in the dietary supplement,
                    ``(C) the manner in which such ingredient may be 
                added to or used in the dietary supplement, and
                    ``(D) any directions or other labeling or packaging 
                requirements for such ingredient deemed necessary by 
                the Secretary to assure the safety of its use, and
        notify the petitioner of such order and the reasons for it, or
            ``(2) deny the petition and notify the petitioner of such 
        order and the reasons for it.
    ``(d) The Secretary may at any time, upon the Secretary's own 
initiative, propose the issuance of a regulation prescribing, with 
respect to any particular use of a dietary ingredient, the conditions 
under which such ingredient may be safely used and the reasons 
therefor.
    ``(e) Each person who proposes to begin the introduction or 
delivery into interstate commerce of a dietary ingredient that it 
determines to be subject to subsection (a)(2) shall, at least 90 days 
before making such introduction or delivery, notify the Secretary, in 
such form and manner as the Secretary shall by regulation prescribe, of 
such introduction or delivery.
    ``(f) The Secretary shall commence a safety review of those dietary 
ingredients subject to subsection (a)(3) within 60 days of the date of 
the enactment of this section.''.

                             ``notification

    ``Sec. 414. If the manufacturer, distributor, or retailer of a 
dietary supplement or ingredient has knowledge which reasonably 
supports the conclusion that a dietary supplement or ingredient may be 
adulterated or misbranded, such manufacturer, distributor, or retailer 
shall promptly notify the Secretary of such knowledge.''.

SEC. 7. ADVISORY COMMITTEE.

    The Secretary of Health and Human Services shall establish an 
advisory committee, in accordance with the Federal Advisory Committee 
Act, to assist in the implementation of the amendments made by this 
Act.

SEC. 8. RESEARCH.

    (a) Establishment.--The Director of the National Institutes of 
Health shall expand and intensify programs with respect to research and 
related activities regarding dietary supplements.
    (b) Authorization of Appropriations.--For the purpose of carrying 
out subsection (a), there are authorized to be appropriated $10,000,000 
for fiscal year 1994 and such sums as may be necessary for each of the 
fiscal years 1995 through 1997.

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