[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[S. 784 Committee Discharged Senate (CDS)]
103d CONGRESS
2d Session
S. 784
To amend the Federal Food, Drug, and Cosmetic Act to establish
standards with respect to dietary supplements, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
April 7 (legislative day, March 3), 1993
Mr. Hatch (for himself, Mr. Reid, Mr. Murkowski, Mr. Craig, Mr.
Durenberger, Mr. Gorton, Mr. Wallop, Mr. Grassley, Mr. Thurmond, Mr.
D'Amato, Mr. Coats, Mr. Simpson, Mr. Kempthorne, Mr. Bennett, Mr.
Domenici, Mr. Smith, Mr. Jeffords, Mr. Gregg, Mr. Burns, Mr. Nickles,
Mr. Pell, Mr. McCain, Mr. Faircloth, Ms. Mikulski, Mr. Helms, Mr. Dole,
Mr. Gramm, Mr. Bingaman, Mr. Campbell, Mr. Daschle, Mr. Inouye, Mr.
Mack, Mr. Coverdell, Mr. Simon, Ms. Moseley-Braun, Mr. Hatfield, Mr.
Hollings, Mr. Pressler, Mrs. Hutchison, Mr. Dorgan, Mr. McConnell, Mr.
Bond, Mr. Stevens, Mr. Specter, Mr. Heflin, Mr. Mathews, Mr. Lott, Mr.
Brown, Mr. DeConcini, Mr. Johnston, Mr. Akaka, Mr. Boren, Mr. Chafee,
Mrs. Boxer, Mr. Exon, Mr. Shelby, Mr. Ford, Mr. Sasser, Mr. Leahy, Mr.
Roth, Mr. Nunn, Mr. Danforth, Mr. Kohl, Mr. Wofford, Mr. Feingold, and
Mr. Harkin) introduced the following bill; which was read twice and
referred to the Committee on Labor and Human Resources
August 13 (legislative day, August 11), 1994
Committee discharged
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to establish
standards with respect to dietary supplements, and for other purposes.
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 Health and
Education Act of 1993''.
SEC. 2. FINDINGS AND PURPOSE.
(a) Findings.--Congress finds that--
(1) improving the health status of United States citizens
ranks at the top of the national priorities of the Federal
Government;
(2) the importance of nutrition and the benefits of dietary
supplements to health promotion and disease prevention have
been documented increasingly in scientific studies;
(3)(A) there is a definitive link between the ingestion of
certain nutrients or dietary supplements and the prevention of
chronic diseases such as cancer, heart disease, and
osteoporosis; and
(B) clinical research has shown that several chronic
diseases can be prevented simply with a healthful diet, such as
a diet that is low in fat, saturated fat, cholesterol, and
sodium, with a high proportion of plant-based foods;
(4) healthful diets may mitigate the need for expensive
medical procedures, such as coronary bypass surgery or
angioplasty;
(5) preventive health measures, including education, good
nutrition, and appropriate use of safe nutritional supplements
will limit the incidence of chronic diseases, and reduce long-
term health care expenditures;
(6)(A) promotion of good health and healthy lifestyles
improves and extends lives while reducing health care
expenditures; and
(B) reduction in health care expenditures is of paramount
importance to the future of the country and the economic well-
being of the country;
(7) there is a growing need for emphasis on the
dissemination of information linking nutrition and long-term
good health;
(8) consumers should be empowered to make choices about
preventive health care programs based on data from scientific
studies of health benefits related to particular dietary
supplements;
(9)(A) recent national surveys have revealed that almost 50
percent of the 260,000,000 Americans regularly consume dietary
supplements of vitamins, minerals, or herbs as a means of
improving their nutrition; and
(B) nearly all consumers indicate that dietary supplements
should not be regulated as drugs;
(10) studies indicate that consumers are placing increased
reliance on the use of nontraditional health care providers to
avoid the excessive costs of traditional medical services and
to obtain more holistic treatment of patients;
(11) the United States will spend over $900,000,000,000 on
health care in 1993, which is about 12 percent of the Gross
National Product of the United States, and this amount and
percent will continue to increase unless significant efforts
are undertaken to reverse the increase;
(12)(A) the nutritional supplement industry is an integral
part of the economy of the United States;
(B) the industry consistently projects a positive trade
balance; and
(C) the estimated 600 dietary supplement manufacturers in
the United States produce approximately 3,400 products, with
total annual sales of such products alone reaching
$4,000,000,000;
(13) although the Federal Government should take swift
action against products that are unsafe or adulterated, the
Federal Government should not take any actions to impose
regulatory barriers limiting or slowing the flow of safe
products and needed information to the marketplace and
consumers;
(14) dietary supplements are safe within a broad range of
intake, and safety problems with the supplements are relatively
rare; and
(15)(A) legislative action that protects the right of
access of consumers to safe dietary supplements is necessary in
order to promote wellness; and
(B) a rational Federal framework must be established to
supersede the current ad hoc, patchwork regulatory policy on
dietary supplements.
(b) Purpose.--It is the purpose of this Act to--
(1) improve the health status of the people of the United
States and help constrain runaway health care spending by
ensuring that the Federal Government erects no regulatory
barriers that impede the ability of consumers to improve their
nutrition through the free choice of safe dietary supplements;
(2) clarify that--
(A) dietary supplements are not drugs or food
additives;
(B) dietary supplements should not be regulated as
drugs; and
(C) regulations relating to food additives should
only be applied to dietary supplement ingredients used
for food additive purposes, such as stabilizers,
processing agents or preservatives;
(3) establish a new definition of a dietary supplement that
differentiates dietary supplements from conventional foods,
while recognizing the broad range of food ingredients used to
supplement the diet;
(4) strengthen the current enforcement authority of the
Food and Drug Administration by providing to the Administration
additional mechanisms to take enforcement action against unsafe
or fraudulent products;
(5) establish a series of labeling requirements that will
provide consumers with greater information and assurance about
the quality and content of dietary supplements, while at the
same time assuring the consumers the freedom to use the
supplements of their choice;
(6) establish dietary intake standards based on the amount
of nutrients needed to prevent disease;
(7) provide new administrative and judicial review
procedures to affected parties if the Administration takes
certain actions to enforce dietary supplement requirements;
(8) specify the standards applicable to disease and other
health-related claims for dietary supplements;
(9) reaffirm that dietary supplement labeling may bear
information, other than health claims, about the vitamin,
mineral, or other dietary properties of the supplement; and
(10) establish a new Office of Dietary Supplements within
the National Institutes of Health to initiate and coordinate
research on dietary supplements and advise the Secretary and
other officials of the Department of Health and Human Services
on dietary supplement issues.
SEC. 3. DEFINITIONS.
(a) Definition of Certain Foods as Dietary Supplements.--Section
201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is
amended by adding at the end the following:
``(gg) The term `dietary supplement' means a food for special
dietary use, as defined in section 411(c)(3), that--
``(1) includes--
``(A) a vitamin;
``(B) a mineral;
``(C) an herb;
``(D) an amino acid;
``(E) another ingredient for use by man to
supplement the diet by increasing the total dietary
intake; or
``(F) a concentrate or extract of any ingredient
described in clause (A), (B), (C), (D), or (E); and
``(2)(A) is intended for ingestion in a form described in
section 411(c)(1)(B)(i); or
``(B) complies with section 411(c)(1)(B)(ii).''.
(b) Exclusion From Definition of Drug.--Section 201(g)(1) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)) is amended by
adding at the end the following new sentence: ``The term `drug' does
not include a dietary supplement or an ingredient described in clause
(A), (B), (C), (D), (E), or (F) of paragraph (gg)(1) in, or intended
for use in, a dietary supplement.''.
(c) Exclusion From Definition of Food Additive.--Section 201(s) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(s)) is
amended--
(1) by striking ``or'' at the end of subparagraph (4);
(2) by striking the period at the end of subparagraph (5)
and inserting ``; or''; and
(3) by adding at the end the following:
``(6) an ingredient described in clause (A), (B), (C), (D),
(E), or (F) of paragraph (gg)(1) in, or intended for use in, a
dietary supplement.''.
(d) Form of Ingestion.--Section 411(c)(1)(B) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 350(c)(1)(B)) is amended--
(1) in clause (i), by inserting ``powder, softgel,'' after
``capsule,''; and
(2) in clause (ii), by striking ``does not simulate and''.
SEC. 4. SAFETY OF DIETARY SUPPLEMENTS.
Section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
342) is amended by adding at the end the following:
``(f) If it is a dietary supplement that contains an ingredient
that is intended to be consumed for its dietary properties and--
``(1) the Secretary finds, after rulemaking, that the
ingredient presents a substantial and unreasonable risk of
illness or injury; or
``(2) no manufacturer of the supplement, or manufacturer of
the raw material comprising the ingredient, has adequately
substantiated the safety of the ingredient--
``(A) through evidence of a history of safe use of
the ingredient (as part of any intended use prior to
the use of the ingredient in such dietary supplement),
and through the absence of substantial information that
brings the safety of the ingredient into question;
``(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,
unless--
``(i) the Secretary has established, in consultation with
the Director of the Centers for Disease Control and Prevention,
the Director of the National Institutes of Health, and the
National Academy of Sciences, a recommended dietary allowance,
or an estimated safe and adequate dietary intake level, with
respect to the ingredient;
``(ii) the Secretary has determined, prior to the date of
enactment of this paragraph, that the ingredient has been
generally recognized as safe; or
``(iii) the ingredient is used in conformity with a
regulation relating to food additives that is described in
section 409(a)(2) and is issued prior to the date of enactment
of this paragraph.''.
SEC. 5. REPORT ON IMPACT OF SIGNIFICANT CHANGES IN MANUFACTURING
PRACTICES.
(a) Study.--The Director of the Office of Dietary Supplements shall
conduct a study relating to significant changes in the manufacturing
practices of manufacturers of raw materials utilized in dietary
supplements. In conducting the study, the Director shall analyze the
extent to which such changes pose a risk to public safety.
(b) Report.--Not later than 3 years after the date of enactment of
this Act, the Director of the Office of Dietary Supplements shall
prepare and submit to the Committee on Energy and Commerce of the House
of Representatives and the Committee on Labor and Human Resources of
the Senate a report containing--
(1) the results of the study described in subsection (a);
and
(2) any recommendations for legislative reform.
SEC. 6. DIETARY INTAKE STANDARDS.
(a) Nutrition Information.--Section 403(q)(1) (21 U.S.C. 343(q)(1))
is amended--
(1) by striking the period at the end of clause (E) and
inserting ``, or''; and
(2) by adding after clause (E) the following:
``(F) a declaration of the percent of a daily reference
amount for each nutrient specified in clauses (D) and (E),
stated as a `Percent Daily Value' provided by a serving of the
food.''.
(b) Regulations.--
(1) In general.--
(A) Daily value.--Subject to subparagraph (B), the
Secretary of Health and Human Services shall, by
regulation, determine, based on the dietary guidance
provided by the Department of Agriculture, the
Department of Health and Human Services, the Centers
for Disease Control and Prevention, the National
Institutes of Health, and other authoritative public
health organizations, a daily value for each nutrient
specified in clauses (D) and (E) of section 403(q)(1)
of the Federal Food, Drug, and Cosmetic Act. The daily
value shall reflect the daily intake of each such
nutrient that will promote optimal health and minimize
the risk of disease or other health-related conditions.
(B) Limitation.--The daily value determined by the
Secretary under subparagraph (A) shall, in every
appropriate case, be no less than the United States
Recommended Daily Allowances established by the Food
and Nutrition Board of the National Academy of Sciences
for the age and sex group most at risk of nutritional
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 after
the date of the enactment of this Act and shall issue final
regulations no later than 24 months after such date.
(3) Pending daily values.--Pending the issuance 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 Cosmetic Act shall be the values specified in
sections 101.9(c)(8) and 101.9(c)(9) of title 21, Code of
Federal Regulations, as in effect on the date of the enactment
of this Act.
(4) Assistance.--
(A) Review and studies.--To assist the Secretary of
Health and Human Services in issuing regulations under
paragraph (1), the Director of the Congressional
Research Service, in consultation with the Director of
the Office of Technology Assessment, shall review
existing scientific data and conduct any necessary
studies.
(B) Purpose.--Such review and studies shall
determine the amount of each nutrient specified in
clauses (D) and (E) of section 403(q)(1) of the Federal
Food, Drug, and Cosmetic Act that would be provided by
the diets recommended by the Department of Agriculture,
the Department of Health and Human Services, the
Centers for Disease Control and Prevention, 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.
(C) Timing.--Such review and studies shall be
completed no later than 9 months after the date of the
enactment of this Act. If the Congressional Research
Service does not complete such review and studies
within 9 months after the date of enactment of this
Act, the time prescribed by paragraph (2) for the
issuance of proposed and final regulations shall be
extended by a period equal to the additional time
required by such Office to complete such review and
studies.
SEC. 7. DIETARY SUPPLEMENT CLAIMS.
Section 403(r) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 343(r)) is amended by striking subparagraph (5)(D) and inserting
the following:
``(D) A subparagraph (1)(B) claim made with respect to a dietary
supplement shall not be subject to subparagraph (3).
``(6)(A) A claim made in the label or labeling of a dietary
supplement may characterize the relationship between the supplement and
a disease or other health-related condition if--
``(i)(I) the Secretary has authorized, under subparagraph
(3)(B), a claim of the type described in subparagraph (1)(B)
for any nutrient contained in the supplement, with respect to
the disease or other health-related condition;
``(II) such characterization is consistent with the claim
authorized by the Secretary; and
``(III) the Secretary has not determined, after rulemaking
based on the totality of scientific evidence (including
evidence from well-designed studies conducted in a manner
consistent with generally recognized scientific principles),
that consumption of the nutrient in a dietary supplement would
not tend to reduce the risk of the disease or other health-
related condition in a similar manner as would consumption of
the nutrient in conventional foods; or
``(ii) such characterization accurately represents the
state of scientific evidence, as of the date of the evaluation
of the claim, concerning the relationship between the
supplement or ingredient of the supplement and the disease or
other health-related condition, taking into account the
totality of scientific evidence (including evidence from well-
designed studies conducted in a manner consistent with
generally recognized scientific principles).
``(B) Nothing in this subparagraph shall--
``(i) prohibit the inclusion, in the label or labeling of a
dietary supplement, of truthful and nonmisleading information
concerning the vitamin, mineral, or other dietary properties of
the supplement (including nutritional information about the
manner in which the dietary properties affect processes of the
body, or prevent or repair damage caused by diet or other
environmental factors); or
``(ii) permit the Secretary to establish any requirement
that such a claim made in the label or labeling of a dietary
supplement be approved by the Secretary before the claim may be
used.''.
SEC. 8. REPORT ON NOTIFICATION REGARDING NEW CLAIMS.
(a) Study.--
(1) In general.--The Director of the Office of Dietary
Supplements shall conduct a study regarding the desirability of
a notification requirement relating to new claims about dietary
supplements.
(2) Content.--Such study shall examine--
(A) the need for a requirement that a person
responsible for marketing a dietary supplement provide
notification to the Secretary of Health and Human
Services before making such a claim;
(B) the feasibility of such a requirement;
(C) the effect of such a requirement on the
marketing of dietary supplements and on the ability of
consumers to purchase dietary supplements; and
(D) such other issues related to the desirability
of such a requirement as the Director of the Office of
Dietary Supplements may determine to be appropriate.
(b) Report.--Not later than 3 years after the date of enactment of
this Act, the Director of the Office of Dietary Supplements shall
prepare and submit to the Committee on Energy and Commerce of the House
of Representatives and the Committee on Labor and Human Resources of
the Senate a report containing--
(1) the results of the study described in subsection (a);
and
(2) any recommendations for legislative reform.
SEC. 9. DIETARY SUPPLEMENT LABELING.
Section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
343) is amended by adding at the end the following:
``(s) If--
``(1) it is a dietary supplement; and
``(2)(A) the label or labeling of the supplement fails to
list--
``(i) the name of each ingredient of the supplement
that is described in clause (A), (B), (C), (D), (E), or
(F) of section 201(gg)(1); and
``(ii)(I) the quantity of each such ingredient; or
``(II) with respect to a proprietary blend of such
ingredients, the total quantity of all ingredients in
the blend;
``(B) the label or labeling of the supplement fails to
identify the product by using the term `supplement', which term
may be modified with--
``(i) the name of such an ingredient; or
``(ii) by a general term such as the term
`dietary';
``(C) the supplement contains an ingredient described in
section 201(gg)(1)(C), and the label or labeling of the
supplement fails to identify any part of the plant from which
the ingredient is derived;
``(D) the supplement--
``(i) is covered by the specifications of an
official compendium;
``(ii) is represented as conforming to the
specifications of an official compendium; and
``(iii) fails to so conform; or
``(E) the supplement--
``(i) is not covered by the specifications of an
official compendium; and
``(ii)(I) fails to have the identity and strength
that the supplement is represented to have; or
``(II) fails to meet the quality (including tablet
or capsule disintegration), purity, or compositional
specifications, based on validated assay or other
appropriate methods, that the supplement is represented
to meet.''.
SEC. 10. PROHIBITION ON CERTAIN REGULATORY ACTIONS.
Section 411 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
350) is amended--
(1) in the title, by striking ``vitamins and minerals'' and
inserting ``vitamins, minerals, and dietary supplements''; and
(2) by adding at the end the following:
``(d)(1) Except as provided in paragraph (2)--
``(A) the Secretary may not establish, under section
201(n), 401, or 403, maximum limits on the potency of any
dietary supplement, or any ingredient that is described in
clause (A), (B), (C), (D), (E), or (F) of section 201(gg)(1)
within such a supplement;
``(B) the Secretary may not classify any dietary supplement
or any such ingredient as a drug; and
``(C) the Secretary may not limit, under section 201(n),
401, or 403, the combination or number of such ingredients
within a dietary supplement.
``(2)(A) Subparagraphs (A) and (C) of paragraph (1) shall not apply
in the case of such a dietary supplement or such an ingredient that is
represented for use by--
``(i) individuals in the treatment or management of
specific diseases or disorders;
``(ii) children; or
``(iii) pregnant or lactating women.
``(B) For purposes of this paragraph, the term `children' means
individuals who are under the age of 12 years.''.
SEC. 11. ADMINISTRATIVE AND JUDICIAL REVIEW.
The Federal Food, Drug, and Cosmetic Act is amended by adding at
the end of chapter III (21 U.S.C. 331 et seq.) the following:
``SEC. 311. ADMINISTRATIVE AND JUDICIAL REVIEW.
``(a) Definition.--As used in this subsection, the term `affected
party' means a manufacturer, processor, packer, distributor, or
retailer, of a dietary supplement, or another appropriate person.
``(b) Review of Violations.--
``(1) Determination of violation.--
``(A) Informal hearing.--If the Secretary
determines that an affected party has violated a
provision of this Act with respect to a dietary
supplement, whether the Secretary makes the
determination in a warning letter issued by an officer
or employee of the Department or in connection with
another action to enforce a provision of this Act, the
Secretary shall provide notice to the affected party of
the opportunity to obtain a determination on the record
after opportunity for an agency hearing regarding the
alleged violation. The affected party may request such
a hearing not later than 60 days after receiving the
notice.
``(B) Notification.--Not later than 30 days after
the date on which the hearing is held, the Secretary
shall notify the affected party whether the
determination of the violation has been affirmed,
modified, or revoked. Such notification shall
constitute final agency action.
``(C) Prohibition on action.--The United States may
not bring an action in any Federal court relating to
the matter that is the subject of the determination
until 60 days after the Secretary provides notification
under subparagraph (B), unless the Secretary
demonstrates that the dietary supplement involved in
the matter poses an imminent hazard to health.
``(D) Right of action.--Not later than 60 days
after receipt of the notification under subparagraph
(B), an affected party who receives notification of an
adverse decision under subparagraph (B) may--
``(i) bring an action in a district court
of the United States in any appropriate
judicial district under section 1391 of title
28, United States Code, seeking de novo review
of the final agency action regarding the
validity of the determination; or
``(ii) bring any other action authorized by
law seeking judicial review of the final agency
action.
``(E) Inference.--The absence of any request for a
hearing under subparagraph (A), or of an action
described in subparagraph (D), with respect to such a
determination shall not establish any inference that
the determination is valid.
``(2) Seizures.--
``(A) Institution of libel of information.--The
institution by the United States of a libel of
information for condemnation of a dietary supplement,
on the basis of a determination that an affected party
has violated a provision of this Act with respect to
the supplement, shall constitute final agency action by
the Secretary or the delegate of the Secretary.
``(B) Right of action.--Not later than 60 days
after the United States institutes such a libel of
information with respect to a dietary supplement, the
affected party may--
``(i) bring an action described in
paragraph (1)(D)(i) seeking de novo review of
the final agency action regarding the validity
of the determination; or
``(ii) obtain any other means authorized by
law of judicial review of the final agency
action.''.
SEC. 12. OFFICE OF 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 of Dietary Supplements
``SEC. 486E. DIETARY SUPPLEMENTS.
``(a) Establishment.--The Secretary shall establish an Office of
Dietary Supplements within the National Institutes of Health.
``(b) Purpose.--The purposes of the Office are--
``(1) to explore more fully the potential role of dietary
supplements as a significant part of the efforts of the United
States to improve health care; and
``(2) to promote scientific study of the benefits of
dietary supplements in maintaining health and preventing
chronic disease and other health-related conditions.
``(c) Duties.--The Director of the Office of Dietary Supplements
shall--
``(1) conduct and coordinate scientific research within the
National Institutes of Health relating to dietary supplements
and the extent to which the use of dietary supplements can
limit or reduce the risk of diseases such as heart disease,
cancer, birth defects, osteoporosis, cataracts, or prostatism;
``(2) collect and compile the results of scientific
research relating to dietary supplements, including scientific
data from foreign sources or the Office of Alternative Medical
Practice;
``(3) serve as the principal advisor to the Secretary and
to the Assistant Secretary for Health, and to provide advice to
the Director of the National Institutes of Health, the Director
of the Centers for Disease Control and Prevention, and the
Commissioner of Food and Drugs, on issues relating to dietary
supplements including--
``(A) dietary intake regulations;
``(B) the safety of dietary supplements;
``(C) claims characterizing the relationship
between--
``(i) dietary supplements; and
``(ii)(I) prevention of disease or other
health-related conditions; and
``(II) maintenance of health; and
``(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; and
``(5) coordinate funding relating to dietary supplements
for the National Institutes of Health.
``(d) 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)).
``(e) 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:
``(E) The Office of Dietary Supplements.''.
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S 784 CDS----2