[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[S. 784 Engrossed in Senate (ES)]
103d CONGRESS
2d Session
S. 784
_______________________________________________________________________
AN ACT
To amend the Federal Food, Drug, and Cosmetic Act to establish
standards with respect to dietary supplements, and for other purposes.
103d CONGRESS
2d Session
S. 784
_______________________________________________________________________
AN ACT
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 1994''.
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) 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 consideration of their needs;
(11) the United States will spend over $1,000,000,000,000
on health care in 1994, which is about 12 percent of the Gross
National Product of the United States, and this amount and
percentage 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 4,000 products, with
total annual sales of such products alone reaching at least
$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 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;
(C) regulations relating to food additives are not
applicable to dietary supplements and their ingredients
used for food additive purposes, including stabilizers,
processing agents, or preservatives; and
(D) the burden of proof is on the Food and Drug
Administration to prove that a product is unsafe before
it can be removed from the marketplace;
(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) provide new administrative and judicial review
procedures to affected parties if the Food and Drug
Administration takes certain actions to enforce dietary
supplement requirements; and
(7) establish a Commission on Dietary Supplement Labels
within the executive branch to develop recommendations on a
procedure to evaluate health claims for dietary supplements and
provide recommendations to the President and the Congress.
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:
``(ff) The term `dietary supplement' means--
``(1) a product intended to supplement the diet by
increasing the total dietary intake that bears or contains one
or more of the following dietary ingredients:
``(A) a vitamin;
``(B) a mineral;
``(C) an herb or other botanical;
``(D) an amino acid;
``(E) another dietary substance for use by man to
supplement the diet by increasing the total dietary
intake; or
``(F) a concentrate, metabolite, constituent,
extract, or combination of any ingredient described in
clause (A), (B), (C), (D), (E) or (F);
``(2) a product that--
``(A)(i) is intended for ingestion in a form
described in section 411(c)(1)(B)(i); or
``(ii) complies with section 411(c)(1)(B)(ii); and
``(B) is not represented for use as a conventional
food or as a sole item of a meal or the diet; and
``(C) is labeled as a dietary supplement.''.
(b) Exclusion From Definition of Drug.--Section 201(g) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)) is amended by
adding at the end the following new subparagraph:
``(3) The term `drug' does not include a dietary supplement as
defined in paragraph (ff), except that--
``(A) an article that is approved as a new drug, certified
as an antibiotic (under section 355 or 357), or licensed as a
biologic (under section 351 of the Public Health Service Act
(42 U.S.C. 262 et seq.)) and was, prior to such approval,
certification or license, marketed as a dietary supplement or
as a food, may continue to be offered for sale as a dietary
supplement unless the Secretary has issued a regulation, after
notice and comment, finding that the article when used as or in
a dietary supplement under the conditions of use and dosages
set forth in the labeling for such dietary supplement, is
unlawful under section 402(f); and
``(B) an article that is approved as a new drug, certified
as an antibiotic (under section 355 or 357), or licensed as a
biologic (under section 351 of the Public Health Service Act
(42 U.S.C. 262 et seq.)) and was not prior thereto marketed as
a dietary supplement or as a food, may not be considered as a
dietary ingredient or dietary supplement unless the Secretary
has issued a regulation, after notice and comment, finding that
the article would be lawful under section 402(f) under the
conditions of use and dosages set forth in the recommended
labeling for such article.''.
(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 new subparagraph:
``(6) an ingredient described in paragraph (ff) 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,
gelcap,'' after ``capsule,''; and
(2) in clause (ii), by striking ``does not simulate and''.
SEC. 4. SAFETY OF DIETARY SUPPLEMENTS AND BURDEN OF PROOF ON FDA.
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--
``(1) the Secretary finds, after rulemaking, presents a
substantial and unreasonable risk of illness or injury under
conditions of use recommended or suggested in labeling;
``(2) the Secretary declares to pose an imminent and
substantial hazard to public health or safety, except that the
authority to make such declaration shall not be delegated and
the Secretary shall promptly thereafter convene rulemaking
pursuant to section 701(e), (f), and (g) to affirm or withdraw
the declaration; or
``(3) is or contains a dietary ingredient that renders it
adulterated under paragraph (a)(1) under the conditions of use
recommended or suggested in the labeling of such dietary
supplement.
In any proceeding under this section, the United States bears the
burden of proof on each element to show that a dietary supplement is
adulterated.''.
SEC. 5. DIETARY SUPPLEMENT CLAIMS.
(a) Supplement Claims.--Chapter IV of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 341 et seq.) is amended by inserting after
section 403A the following new section:
``dietary supplement labeling exemptions
``Sec. 403B. An article, another publication, a chapter in books,
or the official abstract of a peer-reviewed scientific publication that
appears in the article and was prepared by the author or the editors of
the publication, reprinted in its entirety, shall not be defined as
labeling when used in connection with the sale of dietary supplements
to consumers when it--
``(1) is not false or misleading;
``(2) does not promote a particular brand of a dietary
supplement;
``(3) is displayed or presented, or is displayed or
presented with other such items on the same subject matter, so
as to present a balanced view of the available scientific
information on a dietary supplement; and
``(4) if displayed in an establishment, is physically
separate from the dietary supplements.
This section shall not apply to or restrict a retailer or wholesaler of
dietary supplements in any way whatsoever in the sale of books or other
publications as a part of the business of such retailer or wholesaler.
In any proceeding under this section, the burden of proof shall be on
the United States to establish that an article or other such matter is
false or misleading.''.
SEC. 6. STATEMENTS OF NUTRITIONAL SUPPORT.
Section 403(r)(1) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 343(r)(1)) is amended by adding the following new sentence at
the end:``For purposes of this subparagraph, a statement for a dietary
supplement shall not be considered a claim of the relationship of a
nutrient or dietary ingredient to a disease or health-related condition
if the statement does not claim to diagnose, prevent, mitigate, treat,
or cure a specific disease or class of diseases. A statement for a
dietary supplement may be made if the statement claims a benefit
related to a classical nutrient deficiency disease and discloses the
prevalence of such disease in the United States, describes the role of
a nutrient or dietary ingredient intended to affect the structure or
function in humans, characterizes the documented mechanism by which a
nutrient or dietary ingredient acts to maintain such structure or
function, or describes general well-being from consumption of a
nutrient or dietary ingredient.''.
SEC. 7. CONFORMING AMENDMENTS.
(a) Section 201.--The next to the last sentence of section
201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321(g)(1)) (as amended by section 3(b)) is amended to read as follows:
``A food or dietary supplement for which a claim, subject to section
403(r)(1)(B) and 403(r)(3) or section 403(r)(1)(B) and 403(r)(5)(D), is
made in accordance with the requirements of section 403(r) is not a
drug solely because the label or the labeling contains such a claim. A
food, dietary ingredient, or dietary supplement for which a truthful
and nonmisleading statement is made in accordance with section
403(r)(1) is not a drug solely because the label or the labeling
contains such a statement.''.
(b) Section 403.--Section 403 (21 U.S.C. 343) is amended by adding
at the end the following:
``A dietary supplement shall not be deemed misbranded solely because
its label or labeling contains directions or conditions of use or
warnings.''.
SEC. 8. 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 new
section:
``SEC. 311. WARNING LETTERS.
``Any warning letter or similar written threat of enforcement under
the Federal Food, Drug, and Cosmetic Act constitutes final agency
action for the purpose of obtaining judicial review under chapter 7 of
title 5, United States Code, if the matter with respect to such letter
or threat is not resolved within 60 days from the date such letter or
threat is delivered to any person subject to this Act. In any
proceeding for judicial review of a warning letter or similar written
threat of enforcement under the Act, the United States bears the burden
of proof on each element of each alleged violation of law described.''.
SEC. 9. WITHDRAWAL OF THE REGULATIONS AND NOTICE.
(a) In General.--The advance notice of proposed rulemaking
concerning dietary supplements published in the Federal Register of
June 18, 1993 (58 FR 33690-33700), the notices of proposed rulemaking
concerning nutrition labeling for dietary supplements and nutrient
content claims for dietary supplements published in the Federal
Register of June 18, 1993 (58 FR 33715-33731 and 58 FR 33731-33751),
and the final rules and notices published in the Federal Register of
January 4, 1994 concerning nutrition labeling for dietary supplements
and nutrient content claims for dietary supplements (59 FR 354-378 and
378-395) are null and void and of no force or effect insofar as they
apply to dietary supplements. Final regulations and notices published
in the Federal Register of January 4, 1994 concerning health claims for
dietary supplements under the Nutrition Labeling and Education Act of
1990 (59 FR 395-426) shall not be affected by this section and shall
remain in effect until 120 days after the date of the submission of the
final report of the Commission established under section 11 to the
President and to Congress, or 28 months after the date of enactment of
this Act, whichever is earlier.
(b) Notice of Revocation.--The Secretary of Health and Human
Services shall publish notices in the Federal Register to revoke all of
the items declared to be null and void and of no force or effect under
subsection (a).
(c) Issuance of Regulations.--Notwithstanding any provision of the
Nutrition Labeling and Education Act of 1990--
(1) no regulation is required to be issued pursuant to such
Act with respect to dietary supplements of vitamins, minerals,
herbs, amino acids, or other similar nutritional substances;
and
(2) no regulation that is issued in whole or in part
pursuant to such Act shall have any force or effect with
respect to any dietary supplement of vitamins, minerals, herbs,
amino acids, or other similar nutritional substances unless
such regulation is issued pursuant to rulemaking proceedings
that are initiated by an advance notice of proposed rulemaking
that is published no earlier than 2 years after the date of
enactment of this Act, and followed by, at least, a notice of
proposed rulemaking prior to issuance of the final regulation,
except insofar as the regulation authorizes the use of labeling
about calcium, folic acid, or other matters and does not
prohibit the use of any labeling.
SEC. 10. DIETARY SUPPLEMENT INGREDIENT LABELING AND NUTRITION
INFORMATION LABELING.
(a) Misbranded Supplements.--Section 403 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the
following new paragraph:
``(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 section 201(ff); 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 dietary supplement fails
to identify the product by using the term `dietary supplement',
which term may be modified with the name of such an ingredient;
``(C) the supplement contains an ingredient described in
section 201(ff) (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.''.
(b) Supplement Listing on Nutrition Labeling.--Section 403(q)(1) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(1)) is
amended by adding at the end the following: ``A dietary supplement may
bear on the nutrition label or in labeling a listing and quantity of
ingredients that have not been deemed essential nutrients by the
Secretary if such ingredients are prominently identified as not having
been shown to be essential or not having an established daily value.''.
(c) Dietary Supplement Labeling Exemptions.--Section 403(q)(5) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(5)) is
amended by adding at the end the following new clause:
``(H) The labels of dietary supplements shall not be required to
bear the nutrition information under subparagraph (1), but shall be
required to list immediately above the ingredient listing the amount of
nutrients required by the Secretary to be listed pursuant to clause
(C), (D) or (E) of subparagraph (1) or clause (A) of subparagraph (2)
that are present in significant amounts in the supplement.''.
(d) Vitamins and Minerals.--Section 411(b)(2) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 350(b)(2)) is amended--
(1) by striking ``vitamins and minerals'' and inserting
``dietary supplement ingredients described in section
201(ff)'';
(2) by striking ``(2)(A)'' and inserting ``(2)''; and
(3) by striking subparagraph (B).
SEC. 11. COMMISSION ON DIETARY SUPPLEMENT LABELS.
(a) Establishment.--There shall be established as an independent
agency within the executive branch a commission to be known as the
Commission on Dietary Supplement Labels (hereafter in this section
referred to as the ``Commission'').
(b) Membership.--
(1) Composition.--The Commission shall be composed of 7
members who shall be appointed by the President.
(2) Expertise requirement.--The members of the Commission
shall consist of individuals with expertise and experience in
dietary supplements and in the manufacture, regulation,
distribution, and use of such supplements. At least three of
the members of the Commission shall be qualified by scientific
training and experience to evaluate the benefits to health of
the use of dietary supplements and one of such three members
shall have experience in pharmacognosy, medical botany,
traditional herbal medicine, or other related sciences. No
member of the Commission shall be biased against dietary
supplements.
(c) Functions of the Commission.--The Commission shall conduct a
study on, and provide recommendations for, the regulation of label
claims for dietary supplements, including procedures for the evaluation
of such claims. In making such recommendations, the Commission shall
evaluate how best to provide truthful and nonmisleading information to
consumers so that such consumers may make informed health care choices
for themselves and their families.
(d) Reports and Recommendations.--
(1) Final report required.--Not later than 24 months after
the date of enactment of this Act, the Commission shall prepare
and submit to the President and to the Congress a final report
on the study required by this section.
(2) Recommendations.--The report described in paragraph (1)
shall contain such recommendations, including recommendations
for legislation, as the Commission deems appropriate.
(e) Administrative Powers of the Commission.--
(1) Hearings.--The Commission may hold hearings, sit and
act at such times and places, take such testimony, and receive
such evidence as the Commission considers advisable to carry
out the purposes of this section.
(2) Information from federal agencies.--The Commission may
secure directly from any Federal department or agency such
information as the Commission considers necessary to carry out
the provisions of this section.
(3) Authorization of appropriations.--There are authorized
to be appropriated such sums as may necessary to carry out the
provisions of this section.
SEC. 12. GOOD MANUFACTURING PRACTICES.
Section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
342) (as amended by section 4) is further amended by adding at the end
the following:
``(g)(1) If it is a dietary supplement and it has been prepared,
packed, or held under conditions that do not meet current good
manufacturing practice regulations issued by the Secretary under
subparagraph (2).
``(2) The Secretary may by regulation prescribe good manufacturing
practices for dietary supplements. Such regulations shall be modeled
after current good manufacturing practice regulations for food and may
not impose standards for which there is no current and generally
available analytical methodology. No standard of current good
manufacturing practice may be imposed unless such standard is included
in a regulation promulgated after notice and opportunity for comment in
accordance with the Administrative Procedure Act.''.
SEC. 13. 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(ff) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff)).
``(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.''.
Passed the Senate August 13 (legislative day, August 11),
1994.
Attest:
Secretary.
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