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108th CONGRESS
1st Session
H. R. 3377
To amend the Federal Food, Drug, and Cosmetic Act with respect to
dietary supplements.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
October 28, 2003
Mrs. Davis of California (for herself, Mr. Waxman, and Mr. Dingell)
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 with respect to
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.
This Act may be cited as the ``Dietary Supplement Access and
Awareness Act''.
SEC. 2. DIETARY SUPPLEMENTS; PRODUCT LISTING; REPORTING, POSTMARKET
SURVEILLANCE, AND OTHER PROVISIONS REGARDING SAFETY.
(a) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 341 et seq.) is amended by adding at the end the
following section:
``SEC. 416. DIETARY SUPPLEMENTS; PRODUCT LISTING; REPORTING, POSTMARKET
SURVEILLANCE, AND OTHER PROVISIONS REGARDING SAFETY.
``(a) Limitation on Applicability.--Notwithstanding the other
subsections of this section, this section does not apply to any dietary
supplement that meets the conditions described in paragraphs (1) and
(2), as follows:
``(1) The supplement bears or contains one or more of the
following dietary ingredients:
``(A) A vitamin.
``(B) A mineral.
``(C) A concentrate, metabolite, constituent,
extract, or combination of any vitamin or mineral.
``(2) The supplement does not bear or contain--
``(A) an herb or other botanical, an amino acid, or
a dietary substance for use by man to supplement the
diet by increasing the total dietary intake; or
``(B) a concentrate, metabolite, constituent,
extract, or combination of any ingredient specified in
subparagraph (A).
``(b) Product Listing.--Every person who is required under section
415 to register with the Secretary with respect to manufacturing or
processing a dietary supplement shall, in the form and manner
prescribed by the Secretary, report to the Secretary twice each year,
once during the month of June and once during the month of December,
the following information:
``(1) A list of each dietary supplement manufactured or
processed by the person for commercial distribution in the
United States, other than dietary supplements previously
included on a list reported under this subsection by the
person.
``(2) The labeling for each of the dietary supplements on
the list.
``(3) A listing of the major ingredients of each dietary
supplement on the list (including active ingredients, as
applicable), except that the Secretary may require the
submission of a quantitative listing of all ingredients in such
a supplement if the Secretary finds that such submission is
necessary to carry out the purposes of this Act.
``(4) If, since the date the person last made a report
under this subsection (or if the person has not previously made
such a report, since the effective date of this section), the
person has discontinued the manufacture or processing of a
dietary supplement included on a list reported under this
subsection by the person--
``(A) notice of such discontinuance;
``(B) the date of such discontinuance; and
``(C) the identity of such supplement.
``(5) Such other information describing the dietary
supplements as the Secretary may by regulation require.
``(c) Reporting of Information on Adverse Experiences.--
``(1) Serious experiences.--Each person who is a
manufacturer or distributor of a dietary supplement shall
report to the Secretary any information received by such person
on serious adverse experiences regarding the supplement. Such a
report shall be submitted to the Secretary not later than 15
days after the date on which the person receives such
information.
``(2) Investigation and follow-up.--A person submitting a
report under paragraph (1) on a serious adverse experience
shall promptly investigate the experience, and if additional
information is obtained, shall report the information to the
Secretary not later than 15 days after obtaining the
information. If no additional information is obtained, records
of the steps taken to seek additional information shall be
maintained by the person.
``(3) Authority of secretary.--In addition to requirements
established in this subsection, the Secretary may establish
such requirements regarding the reporting of information on
adverse experiences as the Secretary determines to be
appropriate to protect the public health. The Secretary may
establish waivers from requirements under this subsection
regarding such information if the Secretary determines that
compliance with the requirement involved is not necessary to
protect the public health regarding such supplements.
``(4) Definitions.--For purposes of this subsection:
``(A) The term `adverse experience regarding a
dietary supplement' means any adverse event associated
with the use of such supplement in humans, whether or
not such event is considered to be related to the
supplement by a person referred to in paragraph (1) who
obtains the information.
``(B) The term `serious', with respect to an
adverse experience regarding a dietary supplement,
means an adverse experience that--
``(i) results in death; a life-threatening
condition; inpatient hospitalization or
prolongation of hospitalization; a persistent
or significant disability or incapacity; or a
congenital anomaly, birth defect, or other
effect regarding pregnancy, including premature
labor or low birth weight; or
``(ii) requires medical or surgical
intervention to prevent one of the outcomes
described in clause (i).
``(d) Postmarket Surveillance.--The Secretary may by order require
a manufacturer of a dietary supplement to conduct postmarket
surveillance for the supplement if the Secretary determines that there
is a reasonable possibility that a use or expected use of the
supplement may have serious adverse health consequences.
``(e) Authority to Order Demonstration of Safety.--
``(1) In general.--If the Secretary has reasonable grounds
for believing that a dietary supplement may be adulterated
under section 402(f)(1), the Secretary may by order require the
manufacturer to demonstrate to the Secretary that the
supplement is not so adulterated.
``(2) Distribution of product pending completion of
process.--
``(A) In general.--Subject to subparagraph (B), a
dietary supplement may not be considered adulterated
under section 402(f)(1) during the pendency of a
demonstration under paragraph (1) by the manufacturer
of the supplement and during the pendency of the review
under paragraph (4) by the Secretary with respect to
the demonstration.
``(B) Imminent hazard to public health or safety.--
This subsection does not affect the authority of the
Secretary under section 402(f)(1)(C).
``(3) Timeframe for demonstration.--
``(A) In general.--An order under paragraph (1)
shall provide that the demonstration under such
paragraph by a manufacturer is required to be completed
not later than the expiration of 180 days after the
date on which the order is issued, except that the
Secretary may extend such period if the Secretary
determines that an extension is appropriate. Any
information submitted for such purpose by the
manufacturer after the expiration of the applicable
period under the preceding sentence may not be
considered by the Secretary, except to the extent that
the Secretary requests the manufacturer to provide
additional information after such period.
``(B) Completion date of demonstration.--A
demonstration under paragraph (1) shall be considered
complete on the expiration of the applicable period
under subparagraph (A), or on such earlier date as the
manufacturer informs the Secretary that the
manufacturer has completed the demonstration, or on
such earlier date as the Secretary reasonably concludes
that the manufacturer has no further information to
provide to the Secretary as part of the demonstration
or that the manufacturer is not in substantial
compliance with the order under paragraph (1).
``(4) Review by secretary.--Once a demonstration under
paragraph (1) by a manufacturer is completed, the Secretary
shall review all relevant information received by the Secretary
pursuant to the demonstration or otherwise available to the
Secretary and make a determination of whether the Secretary
considers the dietary supplement involved to be adulterated
under section 402(f)(1). Such determination shall be made not
later than 180 days after the completion of the demonstration.
``(5) Requirements regarding demonstrations.--The Secretary
may, by order or by regulation, establish requirements for
demonstrations under paragraph (1).
``(6) Relation to other procedures.--In the case of a
dietary supplement with respect to which the Secretary has not
issued an order under paragraph (1), this subsection may not be
construed as preventing the Secretary from acting pursuant to
section 402(f)(1) to the same extent and in the same manner as
would apply in the absence of this subsection. In the case of a
dietary supplement with respect to which the Secretary has
issued an order under paragraph (1), a determination under
paragraph (4) that the supplement is not adulterated under
section 402(f)(1) does not prevent the Secretary from making a
determination, on the basis of additional information obtained
by the Secretary, that the supplement is so adulterated.
``(f) Sales to Minors; Significant Risk.--
``(1) Criteria.--Not later than the expiration of the two-
year period beginning on the date of the enactment of the
Dietary Supplement Access and Awareness Act, the Secretary
shall by regulation establish criteria for making a
determination that a dietary supplement may pose a significant
risk to individuals who are under the age of 18 (referred to in
this section individually as a `minor').
``(2) Product determination; prohibited act.--The Secretary
may, by order or by regulation, make a determination described
in paragraph (1) with respect to a dietary supplement.
Effective upon the expiration of a period designated by the
Secretary in publishing such determination in the Federal
Register, the act of selling the dietary supplement to a minor
shall be deemed to be an act which results in such supplement
being misbranded while held for sale. During the two-year
period referred to in paragraph (1), an order making such a
determination may be issued notwithstanding that criteria have
not yet been established in accordance with such paragraph.
``(g) Recordkeeping on Safety Issues.--
``(1) In general.--The Secretary shall by regulation
require manufacturers of dietary supplements to maintain
records regarding reports of serious adverse experiences under
subsection (c) and records regarding compliance with section
402.
``(2) Retention period.--Regulations under paragraph (1)
shall specify the number of years for which records required in
such paragraph are required to be retained, except that, if
under section 402(g)(1) the Secretary makes a determination
that expiration date labeling is necessary for dietary
supplements, records regarding dietary supplements in a lot
shall be retained for not less than one year after the
expiration date of supplements in the lot.''.
(b) Prohibited Acts.--
(1) In general.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end
the following:
``(hh) The failure of a person to comply with any requirement under
section 416, other than an order under subsection (e)(1) of such
section.''.
(2) Adulterated dietary supplements.--
(A) Order regarding demonstration of safety.--
Section 402 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 342) is amended by adding at the end the
following:
``(i) If it is a dietary supplement and the manufacturer of the
supplement fails to comply with an order of the Secretary under section
416(e)(1) that is issued with respect to the supplement.''.
(B) Certain court procedures.--Section 402(f) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
342(f)) is amended in subparagraph (1) by striking the
matter after and below clause (D) of such subparagraph.
(3) Trade secrets.--Section 301(j) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331(j)) is amended by
inserting ``416,'' after ``414,''.
(c) Inspection Authority.--Section 704(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 374(a)) is amended--
(1) in paragraph (1), by inserting after the second
sentence the following: ``In the case of any person who
manufactures, processes, packs, transports, distributes, holds,
or imports a dietary supplement with respect to which an order
under section 416(e)(1) has been issued, the inspection shall
extend to all records, files, papers, processes, controls, and
facilities bearing on whether the dietary supplement is
adulterated under section 402(f)(1).''; and
(2) in paragraph (2), in the matter preceding subparagraph
(A), by striking ``third sentence'' and inserting ``fourth
sentence''.
SEC. 3. EDUCATION PROGRAMS REGARDING DIETARY SUPPLEMENTS.
(a) Health Care Professionals.--
(1) In general.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary''), acting
through the Commissioner of Food and Drugs, shall carry out a
program to educate health professionals on the importance of
reporting to the Food and Drug Administration adverse health
experiences that are associated with dietary supplements.
(2) Authorization of appropriations.--For the purpose of
carrying out paragraph (1), there is authorized to be
appropriated $5,000,000 for fiscal year 2004, in addition to
any other authorization of appropriations that is available
with respect to such purpose.
(b) Consumers.--
(1) In general.--The Secretary, acting through the
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