Be it hereby declared that the citizenry of the
United States is
at war with its elected officials over free access to dietary
supplements without interference by federal health agencies that now
distribute misinformation regarding these products.
HR 3156 IH
109th CONGRESS
1st Session
H. R. 3156
To amend the Federal Food, Drug, and Cosmetic Act with respect to
dietary
supplements.
IN THE HOUSE OF REPRESENTATIVES
June 30, 2005
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 a
dditional 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; DETERMINATION OF UNREASONABLE RISK-
Section
402(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(f))
is amended--
(i) in subparagraph (1), by striking the matter after and below clause
(D) of
such subparagraph; and
(ii) by adding at the end the following subparagraph:
`(3)(A) For purposes of clause (A) or (B) of subparagraph (1), the
Secretary
shall consider a dietary supplement or dietary ingredient as presenting
an
unreasonable risk of illness or injury if the Secretary determines that
the risks
of such product outweighs its benefits, as indicated by a relative
weighing
of the known and reasonably likely risks of the product against its
known and
reasonably likely benefits. In the absence of a sufficient benefit, the
presence of even a relatively small risk of a serious adverse health
effect to a user
may be considered by the Secretary as unreasonable.
`(B) A determination by the Secretary under clause (A) with respect to
the
risk of a product may be made on the basis of any science-based
evidence of
risk, without the need to prove that the substance has actually caused
harm in
particular cases. The Secretary shall consider any relevant evidence
including
but not limited to scientific data about the toxicological properties
of a
dietary ingredient or its mechanism of action; known effects of
pharmacologically
related compounds, including those regulated as drugs; the results of
clinical
studies, including observational studies; and adverse event reports.
`(C) A determination that a product presents an unreasonable risk may
be made
under clause (A) by the Secretary even though there are uncertainties
as to
the levels of a dietary ingredient that may present a risk.'.
(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 2006,
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 Commissioner of Food
and
Drugs, shall carry out a program to educate consumers of dietary
supplements on
the importance of informing their health professionals of the dietary
supplements and drugs the consumers are taking.
(2) AUTHORIZATION OF APPROPRIATIONS- For the purpose of carrying out
paragrap
h (1), there is authorized to be appropriated $5,000,000 for fiscal
year 2006,
in addition to any other authorization of appropriations that is
available
with respect to such purpose.