I 
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) intro-
duced 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 Representa-
tives 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; RE-
PORTING, 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 amend-
ed by adding at the end the following section: 
‘‘SEC. 416. DIETARY SUPPLEMENTS; PRODUCT LISTING; RE-
PORTING, POSTMARKET SURVEILLANCE, AND 
OTHER PROVISIONS REGARDING SAFETY. 
‘‘(a) LIMITATION
ON
APPLICABILITY.—Notwith-
standing 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, 
con-
stituent, extract, or combination of any vitamin 
or mineral. 
‘‘(2) The supplement does not bear or con-
tain—
‘‘(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 die-
tary intake; or
‘‘(B) 
a 
concentrate, 
metabolite, 
con-
stituent, extract, or combination of any ingre-
dient specified in subparagraph (A). 
‘‘(b) PRODUCT LISTING.—Every person who is re-
quired under section 415 to register with the Secretary 
with respect to manufacturing or processing a dietary sup-
plement 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 manufac-
tured or processed by the person for commercial dis-
tribution 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 supple-
ments on the list. 
‘‘(3) A listing of the major ingredients of each 
dietary supplement on the list (including active in-
gredients, as applicable), except that the Secretary 
may require the submission of a quantitative listing 
of all ingredients in such a supplement if the Sec-
retary 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 die-
tary supplements as the Secretary may by regulation 
require. 
‘‘(c) REPORTING OF INFORMATION ON ADVERSE EX-
PERIENCES.—
‘‘(1) SERIOUS
EXPERIENCES.—Each person 
who is a manufacturer or distributor of a dietary 
supplement shall report to the Secretary any infor-
mation 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 per-
son submitting a report under paragraph (1) on a
serious adverse experience shall promptly investigate 
the experience, and if additional information is ob-
tained, shall report the information to the Secretary 
not later than 15 days after obtaining the informa-
tion. If no additional information is obtained, 
records of the steps taken to seek additional infor-
mation 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 estab-
lish waivers from requirements under this subsection 
regarding such information if the Secretary deter-
mines that compliance with the requirement involved 
is not necessary to protect the public health regard-
ing such supplements. 
‘‘(4) DEFINITIONS.—For purposes of this sub-
section: 
‘‘(A) The term ‘adverse experience regard-
ing a dietary supplement’ means any adverse 
event associated with the use of such supple-
ment 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 supple-
ment, means an adverse experience that—
‘‘(i) results in death; a life-threatening 
condition; inpatient hospitalization or pro-
longation of hospitalization; a persistent or 
significant disability or incapacity; or a 
congenital anomaly, birth defect, or other 
effect regarding pregnancy, including pre-
mature 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 supple-
ment to conduct postmarket surveillance for the supple-
ment 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 rea-
sonable grounds for believing that a dietary supple-
ment may be adulterated under section 402(f)(1), 
the Secretary may by order require the manufac-
turer to demonstrate to the Secretary that the sup-
plement is not so adulterated. 
‘‘(2) DISTRIBUTION
OF
PRODUCT
PENDING 
COMPLETION OF PROCESS.—
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (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 sup-
plement and during the pendency of the review 
under paragraph (4) by the Secretary with re-
spect to the demonstration. 
‘‘(B) 
IMMINENT
HAZARD
TO
PUBLIC 
HEALTH OR SAFETY.—This subsection does not 
affect the authority of the Secretary under sec-
tion 402(f)(1)(C). 
‘‘(3) TIMEFRAME FOR DEMONSTRATION.—
‘‘(A) IN GENERAL.—An order under para-
graph (1) shall provide that the demonstration 
under such paragraph by a manufacturer is re-
quired to be completed not later than the expi-
ration 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 informa-
tion submitted for such purpose by the manu-
facturer after the expiration of the applicable 
period under the preceding sentence may not be 
considered by the Secretary, except to the ex-
tent that the Secretary requests the manufac-
turer to provide additional information after 
such period. 
‘‘(B) COMPLETION DATE OF DEMONSTRA-
TION.—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 manufac-
turer informs the Secretary that the manufac-
turer 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 dem-
onstration under paragraph (1) by a manufacturer is 
completed, the Secretary shall review all relevant in-
formation received by the Secretary pursuant to the 
demonstration or otherwise available to the Sec-
retary and make a determination of whether the 
Secretary considers the dietary supplement involved 
to be adulterated under section 402(f)(1). Such de-
termination shall be made not later than 180 days 
after the completion of the demonstration. 
‘‘(5) REQUIREMENTS REGARDING DEMONSTRA-
TIONS.—The Secretary may, by order or by regula-
tion, 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 sub-
section. In the case of a dietary supplement with re-
spect to which the Secretary has issued an order 
under paragraph (1), a determination under para-
graph (4) that the supplement is not adulterated 
under section 402(f)(1) does not prevent the Sec-
retary 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 es-
tablish criteria for making a determination that a di-
etary supplement may pose a significant risk to indi-
viduals 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 Sec-
retary in publishing such determination in the Fed-
eral Register, the act of selling the dietary supple-
ment 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 deter-
mination 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 reg-
ulation require manufacturers of dietary supple-
ments to maintain records regarding reports of seri-
ous 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 re-
quired to be retained, except that, if under section 
402(g)(1) the Secretary makes a determination that 
expiration date labeling is necessary for dietary sup-
plements, 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 re-
quirement 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 manufac-
turer 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; DE-
TERMINATION OF UNREASONABLE RISK.—Sec-
tion 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 subpara-
graph (1), the Secretary shall consider a dietary supple-
ment 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 indi-
cated by a relative weighing of the known and reasonably 
likely risks of the product against its known and reason-
ably 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 ingre-
dient or its mechanism of action; known effects of pharma-
cologically related compounds, including those regulated 
as drugs; the results of clinical studies, including observa-
tional studies; and adverse event reports. 
‘‘(C) A determination that a product presents an un-
reasonable risk may be made under clause (A) by the Sec-
retary 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 sec-
ond sentence the following: ‘‘In the case of any per-
son 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 ex-
tend to all records, files, papers, processes, controls, 
and facilities bearing on whether the dietary supple-
ment 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 SUP-
PLEMENTS. 
(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 edu-
cate health professionals on the importance of re-
porting to the Food and Drug Administration ad-
verse health experiences that are associated with die-
tary 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 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.
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