[Congressional Record Volume 140, Number 113 (Saturday, August 13, 1994)]
[House]
[Page H]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]
[Congressional Record: August 13, 1994]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]
AMENDMENTS SUBMITTED
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DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT OF 1994
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HATCH (AND HARKIN) AMENDMENT NO. 2562
Mr. HATCH (for himself and Mr. Harkin) proposed an amendment to the
bill (S. 784) to amend the Federal Food, Drug, and Cosmetic Act to
establish standards with respect to dietary supplements, and for other
purposes; as follows:
Strike out all after the enacting clause and insert the
following:
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.''.
____________________