I
103D CONGRESS
1ST SESSION
H. R. 1709
To amend the Federal Food, Drug, and Cosmetic Act to establish provisions
regarding the composition and labeling of dietary supplements.
IN THE HOUSE OF REPRESENTATIVES
APRIL 7, 1993
Mr. RICHARDSON (for himself, Mr. INHOFE, Mr. TOWNS, Mr. BOEHLERT, Mr.
SCHIFF, Mr. FROST, Ms. NORTON, Mr. BOUCHER, Mr. BOEHNER, Mr.
PETERSON of Minnesota, Ms. PELOSI, Mr. HALL of Texas, Mr. UPTON,
and Mr. PALLONE) introduced the following bill; which was referred to
the Committee on Energy and Commerce
JUNE 8, 1993
Additional sponsors: Mr. LAROCCO, Mr. OLVER, Mr. KREIDLER, Mr. INGLIS
of South Carolina, Mr. DOOLITTLE, Mr. PASTOR, Mr. BURTON of Indi-
ana, Mr. HOCHBRUECKNER, Mr. PARKER, Mr. SENSENBRENNER, Mr.
SPENCE, Ms. VELA´ZQUEZ, Mrs. UNSOELD, and Mr. INSLEE
JULY 28, 1993
Additional sponsors: Mr. SKAGGS, Mr. JEFFERSON, Mr. LEWIS of Florida, Mr.
COMBEST, Mr. HERGER, Mr. ORTON, Mr. MANZULLO, Mr. RANGEL, Mr.
SHAYS, Mr. DEFAZIO, Mr. BARCIA of Michigan, Mr. SWETT, Mr.
ZELIFF, Mr. CANADY, Mr. LIPINSKI, Mr. CALLAHAN, Mr. FRANK of Mas-
sachusetts, Mr. FARR of California, Mr. NEAL of Massachusetts, Mr.
TAUZIN, Mr. MEEHAN, Mr. BEVILL, and Mr. MCHALE
AUGUST 23, 1993
Additional sponsors: Mr. BLUTE, Mr. COX, Mr. YATES, Mr. HASTERT, and
Mr. KINGSTON
SEPTEMBER 9, 1993
Additional sponsors: Mr. REYNOLDS, Mr. APPLEGATE, Mr. LINDER, Mrs.
KENNELLY, 
Mr. 
STEARNS, 
Mr. 
MURPHY, 
Ms. 
FURSE, 
Mr.
KNOLLENBERG, Mr. MICA, Mr. SARPALIUS, Mrs. FOWLER, Mr. ROTH,
Mr. THOMAS of Wyoming, Mr. BONILLA, Ms. WOOLSEY, Mr. GREEN-
WOOD, Mr. COYNE, Mr. DEAL, Mr. KING, Ms. SHEPHERD, Mr. BARLOW,
and Ms. ESHOO
OCTOBER 7, 1993
Additional sponsors: Mr. ALLARD, Mr. REGULA, Mr. GOODLATTE, Ms. MOL-
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INARI, Mr. CONDIT, Mr. SCHAEFER, Mr. HAMBURG, Mr. CAMP, Mr.
ARMEY, Mr. BAKER of California, Mr. DICKEY, Mr. BILBRAY, Mr.
MCCOLLUM, Mr. MCCRERY, Mr. TALENT, Mr. MACHTLEY, Mrs. VUCAN-
OVICH, Mr. CLEMENT, Mr. JACOBS, Mr. LEWIS of Georgia, Mr. BROOKS,
Mr. KOPETSKI, Mr. GORDON, Mr. PORTMAN, Mr. BROWN of Ohio, Mr.
MILLER of Florida, Mr. BROWN of California, Mr. HALL of Ohio, Mr.
HINCHEY, Mr. DARDEN, Mr. KILDEE, Mr. KASICH, Mr. MCINNIS, Mr.
DORNAN, Mr. FRANKS of Connecticut, Ms. DANNER, Mr. FISH, Ms.
MCKINNEY, Mr. REED, Mr. DIAZ-BALART, Mr. DEUTSCH, Mr. ROYCE,
Ms. KAPTUR, Mr. GILMAN, Mr. EWING, Mr. SHARP, Ms. DUNN, Mr.
LEVY, Mr. GUTIERREZ, Mr. FAWELL, Mr. CALVERT, Mr. DE LA GARZA,
Mr. ANDREWS of New Jersey, Mr. GEJDENSON, Mr. HASTINGS, Mr. TAY-
LOR of Mississippi, Mr. QUILLEN, Ms. BYRNE, Mr. MONTGOMERY, Mr.
JOHNSON of Georgia, and Mr. WASHINGTON
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to
establish provisions regarding the composition and label-
ing of 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 AND REFERENCE.
(a) SHORT TITLE.—This Act may be cited as the
‘‘Dietary Supplement Health and Education Act of 1993’’.
(b) REFERENCE.—Whenever in this Act (other than
section 7) an amendment or repeal is expressed in terms
of an amendment to, or repeal of, a section or other provi-
sion, the reference shall be considered to be made to a
section or other provision of the Federal Food, Drug, and
Cosmetic Act.
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SEC. 2. DEFINITIONS.
(a) DIETARY SUPPLEMENT.—Section 201 (21 U.S.C.
321) is amended by adding at the end the following new
paragraph:
‘‘(gg) The term ‘dietary supplement’ means a food
for special dietary use, as defined in section 411(c)(3),
that—
‘‘(1) includes one or more—
‘‘(A) vitamins;
‘‘(B) minerals;
‘‘(C) herbs;
‘‘(D) amino acids; or
‘‘(E) other ingredients for use by man to
supplement the diet by increasing the total die-
tary intake, including a concentrate or extract
of any article listed in this paragraph; and
‘‘(2) is intended for use in tablet, capsule, pow-
der, softgel, or any other form (including liquid
form) that is not represented for use as conventional
food or as a sole item of a meal or of the diet.’’.
(b) FOOD ADDITIVE.—Section 201(s) (21 U.S.C.
321(s)) is amended—
(1) by striking out the period at the end of sub-
paragraph (5) and inserting in lieu thereof ‘‘; or’’;
and
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(2) by adding after subparagraph (5) the fol-
lowing:
‘‘(6) any dietary ingredients of the kind speci-
fied in paragraph (gg)(1) in, or intended for use in,
a dietary supplement.
For purposes of subparagraph (6) the term ‘dietary ingre-
dient’ means an ingredient that is in, or intended for use
in, a dietary supplement.’’.
SEC. 3. DIETARY SUPPLEMENT LABELING AND COMPOSI-
TION.
(a) ADULTERATION.—Section 402 (21 U.S.C. 342)
is amended by adding at the end the following:
‘‘(f) If it is a dietary supplement and—
‘‘(1) it contains an unsafe dietary ingredient
which is a substance that is intended to be
consumed for its dietary properties but which the
Secretary has found through rulemaking to present
a substantial and unreasonable risk of illness or in-
jury; or
‘‘(2) it contains a dietary ingredient that has
not been adequately substantiated for safety by the
person identified under section 403(e)(1) or by the
raw material manufacturer through—
‘‘(A) evidence of a history of safe use (as
part of any prior intended use) and the absence
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of substantial information that brings the safety
of the ingredient into question; or
‘‘(B) by well-designed scientific studies
conducted in a manner that is consistent with
generally recognized scientific procedures and
principles; or
‘‘(C) by other appropriate means.
A dietary ingredient that is found to be safe for use in
a dietary supplement or as a nutrient by the Secretary
or by the National Academy of Sciences through the estab-
lishment of a recommended dietary allowance or an esti-
mated safe and adequate dietary intake shall be deemed
to have met the requirements of this paragraph within the
scope of the determination by the Secretary or the Na-
tional Academy of Sciences.
‘‘(g)(1) If it is a dietary supplement and the Sec-
retary was not notified, in accordance with regulations is-
sued under subparagraph (2), about a significant change
in the manufacturing practice which produced the supple-
ment or of potential problems of safety or contamination
affecting such practice.
‘‘(2) The Secretary shall promulgate regulations
within 18 months of the date of the enactment of this sub-
paragraph to require notification to the Secretary by man-
ufacturers of raw materials utilized in dietary supplements
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of significant changes in manufacturing practices of such
materials or of any potential problems of safety or con-
tamination arising from any such changes to ensure the
safety of such materials.
‘‘(3) Subparagraphs (1) and (2) apply only to manu-
facturing changes that are substantial and have been
shown to present adverse safety consequences. These sec-
tions do not apply to routine changes in the formulating
and manufacturing of dietary supplements by dietary sup-
plement manufacturers that utilize good manufacturing
practices.’’.
(b) MISBRANDING.—Section 403 (21 U.S.C. 343) is
amended by adding at the end the following:
‘‘(s) If it is a dietary supplement and—
‘‘(1) its label fails to list the name and quantity
or proportion of each dietary ingredient included in
section 201(gg), except that proprietary blends of in-
gredients may declare the quantity of the total
blend;
‘‘(2) its label fails to identify the product as a
supplement, as a supplement modified with the
name of the ingredient of the kind specified in sec-
tion 201(gg)(1), or as a dietary supplement;
‘‘(3) it contains an ingredient of the kind speci-
fied in section 201(gg)(1)(C) and the labeling fails
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to identify the part of the plant from which the in-
gredient is derived;
‘‘(4) if it purports to be or is represented as a
dietary supplement the name of which is listed in a
compendium for foods recognized in regulations is-
sued by the Secretary and its composition or
strength differs from, or its quality or purity (in-
cluding tablet or capsule disintegration or dissolu-
tion) falls below, the standards set forth in such
compendium unless such difference in composition,
strength, quality, or purity from the applicable com-
pendium standards is plainly stated on the label; or
‘‘(5) it is not subject to subparagraph (4) and
its composition or strength differs from, or its purity
or quality (including tablet or capsule disintegration
or dissolution) falls below, that which it purports or
is represented to have.
Subparagraph (4) is not to be construed as prohibiting
a dietary supplement from representing that it meets U.S.
Pharmacopeia standards for dietary supplements if it
meets such standards. Such a supplement shall not be
deemed a drug because of such a representation.’’.
(c) COMPOSITIONAL
LIMITS.—Section 411 (21
U.S.C. 350) is amended by adding at the end the follow-
ing:
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‘‘(D)(i) A subparagraph (1)(B) claim made with re-
spect to a dietary supplement shall not be subject to sub-
paragraph (3).
‘‘(ii) Labeling of a dietary supplement may character-
ize the relationship between the supplement and a disease
or other condition of the body if—
‘‘(I) the supplement contains one or more nutri-
ents for which a claim of the type described in sub-
paragraph (1)(B) has been authorized by the Sec-
retary pursuant to subparagraph (3)(B) and such
characterization is consistent with the claim author-
ized by the Secretary, unless the Secretary deter-
mines, through rulemaking based upon the totality
of publicly available scientific evidence, that con-
sumption of the nutrient in a dietary supplement
would not tend to reduce the risk of disease or other
health-related condition in a manner similar to the
consumption of such nutrient in conventional foods;
or
‘‘(II) such characterization accurately rep-
resents the current state of scientific evidence con-
cerning the relationship between the supplement or
dietary ingredient of the supplement and a disease
or other health-related condition, taking into account
the totality of scientific evidence (including evidence
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from well-designed studies conducted in a manner
consistent with generally recognized scientific prin-
ciples).
This clause does not prohibit the labeling of a dietary sup-
plement from providing truthful and non-misleading infor-
mation, measured by the standard set forth in subclause
(II), concerning its vitamin, mineral, or other dietary
properties, including nutritional information about the
manner in which those dietary properties affect physio-
logical processes of the body or prevent or repair damage
caused by diet or other environmental factors and does
not authorize the Secretary to establish a prior restraint
on the use of any labeling that is subject to subclause (II).
‘‘(iii) At least 30 days before the introduction into
interstate commerce of any label, consumer package, or
literature in the package containing a claim described in
subclause (ii), or before the making of such a claim
through any other means, a person responsible for market-
ing the dietary supplement to which such claim refers shall
provide notification to the Secretary of the wording of
such claim if such claim has not previously been made for
such dietary supplement by such person. Documentation
that is intended to support such claim may be submitted
with such notice. The Secretary may not impose any addi-
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tional pre-market requirement, including requirements or
requests for further documentation.’’.
SEC. 5. DIETARY INTAKE STANDARDS.
(a) NUTRITION INFORMATION.—Section 403(q)(1)
(21 U.S.C. 343(q)(1)) is amended by striking the period
at the end of subparagraph (E) and inserting in lieu there-
of ‘‘, or’’ and by adding after that subparagraph the fol-
lowing:
‘‘(F) a declaration of the percent of a daily ref-
erence amount for each nutrient specified in sub-
paragraphs (D) and (E), stated as a ‘Percent Daily
Value’ provided by a serving of that food.’’.
(b) REGULATIONS.—
(1) IN GENERAL.—
(A) DAILY
VALUE.—Subject to subpara-
graph (B), the Secretary of Health and Human
Services shall, by regulation, determine, based
on the dietary guidance provided by the Depart-
ment of Agriculture, the Department of Health
and Human Services, the Centers for Disease
Control, the National Institutes of Health, and
other authoritative public health organizations,
a daily value for each nutrient specified in sub-
paragraphs (1)(D) and (1)(E) of section 403(q)
of the Federal Food, Drug, and Cosmetic Act
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which shall reflect the daily intake of each such
nutrient that will promote optimal health and
minimize the risk of disease or other health-re-
lated condition.
(B) LIMITATION.—The daily value deter-
mined by the Secretary under subparagraph (A)
shall be no less than the Recommended Daily
Allowances established by the Food and Nutri-
tion Board of the National Academy of Sciences
for the age and sex group most at risk of nutri-
tional deficiencies of any particular nutrient.
(2) TIMING.—Except as provided in paragraph
(4), the Secretary of Health and Human Services
shall issue proposed regulations under paragraph (1)
no later than 12 months from the date of the enact-
ment of this Act and shall issue final regulations no
later than 24 months from such date.
(3) PENDING DAILY VALUES.—Pending the is-
suance of final regulations under paragraph (1), the
daily values for the nutrients declared under section
403(q)(1)(F) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 343(q)(1)(F)) shall be those
specified in sections 101.9(8) and 101.9(9) of regu-
lations published in title 21 of the Code of Federal
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Regulations, as in effect on the date of the enact-
ment of this Act.
(4) ASSISTANCE.—To assist the Secretary of
Health and Human Services in issuing regulations
under paragraph (1), the Director of the Congres-
sional Research Office, in consultation with the Di-
rector of the Office of Technology Assessment, shall
arrange for that office to review existing scientific
data and conduct one or more studies, if necessary,
to be completed no later than 9 months from the
date of the enactment of this Act, to determine what
amount of each nutrient specified in subparagraphs
(1)(D) and (1)(E) of section 403(q) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)
would be provided by the diets recommended by the
Department of Agriculture, the Department of
Health and Human Services, the Centers for Dis-
ease Control, the National Institutes of Health, and
other authoritative public health organizations to
minimize the risk of disease and other health-related
conditions and to promote optimal health. If the Of-
fice of Technology Assessment does not complete the
studies determined to be necessary within 9 months
from the date of the enactment of this Act, the time
prescribed by paragraph (2) for the issuance of pro-
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posed and final regulations shall be extended by a
period equal to the additional time required by such
Office to complete such studies.
SEC. 6. APPEAL.
Section 411 (21 U.S.C. 350), as amended by section
3(c), is amended by adding at the end the following:
‘‘(e)(1) If the Secretary asserts that a dietary supple-
ment is in violation of any provision of this Act, whether
the assertion is made in a warning letter issued by an offi-
cer or employee of the Department of Health and Human
Services or in any other manner, the manufacturer, proc-
essor, packer, distributor, or retailer of the dietary supple-
ment or any other person to whom the assertion is ad-
dressed may, within 60 days, appeal to the Secretary or
to an officer or employee of the Department of Health and
Human Services assigned by the Secretary to hear such
an appeal showing that the assertion is incorrect and
should be withdrawn. During the 60-day period after such
assertion is made by the Secretary and during pendency
of such an appeal, the United States shall not initiate liti-
gation on the matter unless the Secretary concludes that
such litigation is required because of an imminent hazard
to health. If such an appeal is not resolved to the satisfac-
tion of the appellant, the appellant may—
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‘‘(A) bring an action in a United States district
court in any appropriate judicial district under sec-
tion 1391 of title 28, United States Code, to secure
a declaratory judgment in which all factual deter-
minations regarding the validity of the assertion in
question shall be made de novo; or
‘‘(B) obtain any other means of judicial review
authorized by law.
The absence of an action described in subparagraph (A)
or (B) shall not establish any inference that an assertion
is valid.
‘‘(2) The institution by the United States of a libel
of information to condemn a dietary supplement shall con-
stitute final agency action on the part of the Secretary.’’.
SEC. 7. OFFICE FOR DIETARY SUPPLEMENTS.
(a) IN GENERAL.—Title IV of the Public Health
Service Act is amended by inserting after section 486 (42
U.S.C. 287c–3) the following:
‘‘Subpart 4—Office for Dietary Supplements
‘‘SEC. 486E. OFFICE OF DIETARY SUPPLEMENTS.
‘‘(a) ESTABLISHMENT.—The Secretary shall estab-
lish an Office of Dietary Supplements within the National
Institutes of Health.
‘‘(b) DUTIES.—The Office for Dietary Supplements
shall—
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‘‘(D) scientific issues arising in connection
with the labeling and composition of dietary
supplements;
‘‘(4) compile a database of scientific research
on dietary supplements and individual nutrients;
‘‘(5) coordinate funding relating to dietary sup-
plements for the National Institutes of Health;
‘‘(6) explore more fully the potential role of die-
tary supplements as a significant part of the efforts
of the United States to improve health care; and
‘‘(7) promote scientific study of the benefits of
dietary supplements in maintaining health and pre-
venting chronic disease and other health-related con-
ditions.
‘‘(c) DEFINITION.—As used in this section, the term
‘dietary supplement’ has the meaning given the term in
section 201(gg) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321(gg)).
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There
are authorized to be appropriated to carry out this section
$5,000,000 for fiscal year 1994 and such sums as may
be necessary for each subsequent fiscal year.’’.
(b) CONFORMING AMENDMENT.—Section 401(b)(2)
of the Public Health Service Act (42 U.S.C. 281(b)(2))
is amended by adding at the end the following:
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‘‘(E) The Office for Dietary Supplements.’’.
SEC. 8. EFFECTIVE DATE.
The amendments made by this Act shall take effect
on the date of the enactment of this Act, except that the
amendments made by section 3 shall take effect 18
months after such date with respect to products labeled
after such date.
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