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Dietary Supplement Health and Education Act (DSHEA)
In 1994, DSHEA was passed in to law.
This act of Congress created a sub-category of special regulations for
dietary supplements, within the existing food laws. Yes, food laws, not drugs.
So, contrary to what is generally reported in the media, dietary supplements
are strictly regulated by the Food and Drug Administration (FDA) as well as by
state and local governments and authorities.
Below is a copy of DSHEA in the final form it was approved by Congress.
Note however that there are many specific regulations that were developed to
bring the conditions of this act in to practice. These include the development
of regulations specific to dietary supplements as well as the regulations for
conventional foods that dietary supplements also must comply with, in general
with few exceptions.
As an aside, one of the big deal points of DSHEA is that for the first time
manufacturers of dietary supplements could make claims about what their
supplements did to the body. The majority of these claims have become know as
structure function claims, that is, how a dietary supplement product affects the
structure or function of the body. There is one caveat though, the claims cannot
specify or imply that a dietary supplement can diagnose, treat, cure or prevent
any disease.
In fact, when structure function claims are presented on the labeling of a
dietary supplement product (including brochures and other promotional
materials), the following statement must appear in association with such claims:
"This statement has not been evaluated by the FDA. This product is not
intended to diagnose, treat, cure of prevent any disease."
However, be aware that their is an exception to the prevent a disease claim!
Under FDA's regulations for foods (and dietary supplements) the FDA has the
authority to approve what are called Health Claims. Health Claims are claims
that recognize the relationship between a nutrient and preventing or reducing
the risk of a disease. Calcium intake and reduction of osteoporosis is the
classic example of an approved Health Claim.
FDA has approved over a dozen health claims. There are different categories
of health claims, so if you are interested in this, please read the sections
about health claims.
There are other claims that can be made for dietary supplements, as listed in
DSHEA below.
What commonly confuses people about dietary supplement use is that most of
the research being conducted using dietary supplements is for the treatment of
diseases. In fact, based on FDA's own surveys about dietary supplement use, many
people take dietary supplements to help prevent or cure a disease.
Strictly speaking, a company would have to get formal drug approval to claim
that a supplement can be used to treat a disease. So even though the research
studies conclude that taking supplements can be effective to treat some
diseases, for example supplements containing glucosamine and chondroitin sulfate
can be effect to treat osteoarthritis, for a company to market a product with
this claim, they would need FDA's approval. Note that in Canada, Europe and
other countries glucosamine and chondroitin sulfate are approved to treat
osteoarthritis, as well as dozens of other natural ingredients commonly found in
dietary supplements. This is good, because these natural substances actually
heal the connective tissue problem, versus mask the pain that most drugs for
arthritis only do. When you heal the problem the pain goes away naturally.
Across the border, to recognize the disease treatment power that dietary
supplements have to offer, Canada has a special category of products called
Natural Health Products that are dietary supplements approved to treat diseases
similar to over-the-counter-drug products. Perhaps someday we will have such a
category in the U.S.A. so consumers can benefit from the healing properties that
dietary supplements have to offer.
In the meantime people are on their own when it comes to treating diseases
with dietary supplements, or for some, with the help of a naturopathic doctor,
nutritionist, medical doctors, or other health professional who prescribes
dietary supplements and nutrition to treat diseases.
Daniel Gastelu
Dietary Supplement Health and Education Act of 1994
Public Law 103-417
103rd Congress
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,
This Act
may be cited as the "Dietary Supplement Health and Education Act of 1994".
Whenever
in this Act an amendment or repeal is expressed in terms of an amendment to, or
repeal of, a section or other provision, the reference shall be considered to be
made to a section or other provision of the Federal Food, Drug, and Cosmetic
Act.
The table
of contents of this Act is as follows:
Sec. 1. Short
title; reference; table of contents.
Sec. 2. Findings.
Sec. 3. Definitions.
Sec. 4. Safety of dietary
supplements and burden of proof on FDA.
Sec. 5. Dietary supplement
claims.
Sec. 6. Statements of
nutritional support.
Sec. 7. Dietary supplement
ingredient labeling and nutrition information labeling.
Sec. 8. New dietary
ingredients.
Sec. 9. Good manufacturing
practices.
Sec. 10. Conforming
amendments.
Sec. 11. Withdrawal of the
regulations and notice.
Sec. 12. Commission on
dietary supplement labels.
Sec.
13. Office of dietary supplements.
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 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)
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;
-
(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 unreasonable regulatory barriers limiting or slowing the
flow of safe products and accurate 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.
-
(a) Definition of Certain Foods as Dietary Supplements.
Section 201 (21 U.S.C. 321) is amended by adding at the end the following:
"(ff)
The term "dietary supplement" -
which
was not before such approval, certification, licensing, or authorization
marketed as a dietary supplement or as a food unless the Secretary, in the
Secretary's discretion, has issued a regulation, after notice and comment,
finding that the article would be lawful under this Act.
Except
for purposes of section 201(g), a dietary supplement shall be deemed to be a
food within the meaning of this Act.
-
(b) Exclusion from Definition of Food Additive.
Section 201(s) (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.".
-
(c) Form of Ingestion. Section 411(c)(1)(B) (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".
Section
402 (21 U.S.C. 342) is amended by adding at the end the following:
-
"(f)(1) If it is a dietary supplement or contains a dietary ingredient that
-
-
"(A) presents a significant or unreasonable risk of illness or injury
under -
-
"(i) conditions of use recommended or suggested in
labeling, or
-
"(ii) if no conditions of use are suggested or
recommended in the labeling, under ordinary conditions of use;
-
"(B) is a new dietary ingredient for which there is inadequate
information to provide reasonable assurance that such ingredient does
not present a significant or unreasonable risk of illness or injury;
-
"(C) the Secretary declares to pose an imminent hazard to public health
or safety, except that the authority to make such declaration shall not
be delegated and the Secretary shall promptly after such a declaration
initiate a proceeding in accordance with sections 554 and 556 of title
5, United States Code, to affirm or withdraw the declaration; or
-
"(D) 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 subparagraph, the United States shall bear the
burden of proof on each element to show that a dietary supplement is
adulterated. The court shall decide any issue under this paragraph on a de
novo basis.
-
(2)
Before the Secretary may report to a United States attorney a violation of
paragraph (1)(A) for a civil proceeding, the person against whom such
proceeding would be initiated shall be given appropriate notice and the
opportunity to present views, orally and in writing, at least 10 days before
such notice, with regard to such proceeding.
Chapter
IV (21 U.S.C. 341 et seq.) is amended by inserting after section 403A the
following new section:
DIETARY SUPPLEMENT LABELING EXEMPTIONS
-
"Sec.
403B. (a) IN GENERAL.- A publication, including an article, a chapter in
a book, or an official abstract of a peer-reviewed scientific publication
that appears in an article and was prepared by the author or the editors of
the publication, which is reprinted in its entirety, shall not be defined as
labeling when used in connection with the sale of a dietary supplement to
consumers when it -
-
"(1) is not false or misleading;
-
"(2) does not promote a particular manufacturer or 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;
-
"(4) if displayed in an establishment, is physically separate from the
dietary supplements; and
-
"(5) does not have appended to it any information by sticker or any
other method.
-
"(b)
APPLICATION. - Subsection (a) 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.
-
"(c)
BURDEN OF PROOF. - In any proceeding brought under subsection (a), the
burden of proof shall be on the United States to establish that an article
or other such matter is false or misleading.".
Section
403(r) (21 U.S.C. 343(r)) is amended by adding at the end the following:
-
"(6)
For purposes of paragraph (r)(1)(B), a statement for a dietary supplement
may be made if -
-
"(A) 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,
-
"(B) the manufacturer of the dietary supplement has substantiation that
such statement is truthful and not misleading, and
-
"(C) the statement contains, prominently displayed and in boldface type,
the following: "This statement has not been evaluated by the Food and
Drug Administration. This product is not intended to diagnose, treat,
cure, or prevent any disease.".
A
statement under this subparagraph may not claim to diagnose, mitigate,
treat, cure, or prevent a specific disease or class of diseases. If the
manufacturer of a dietary supplement proposes to make a statement described
in the first sentence of this subparagraph in the labeling of the dietary
supplement, the manufacturer shall notify the Secretary no later than 30
days after the first marketing of the dietary supplement with such statement
that such a statement is being made.".
-
(a) MISBRANDED SUPPLEMENTS. - Section 403 (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 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)(5)(F) (21 U.S.C. 343(q)(5)(F)) is amended to read as follows:
-
(c) Percentage Level Claims. Section 403(r)(2) (21
U.S.C. 343(r)(2)) is amended by adding after clause (E) the following:
-
"(F) Subclause (i) clause (A) does not apply to a statement in the
labeling of a dietary supplement that characterizes the percentage level
of a dietary ingredient for which the Secretary has not established a
reference daily intake, daily recommended value, or other recommendation
for daily consumption.".
-
(d) Vitamins and Minerals. Section 411(b)(2) (21
U.S.C. 350(b)(2)) is amended -
-
(1) by striking "vitamins or 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).
-
(e) Effective Date. Dietary supplements -
-
(1) may be labeled after the date of the enactment of this Act in
accordance with the amendments made by this section, and
-
(2) shall be labeled after December 31, 1996, in accordance with such
amendments.
Chapter
IV of the Federal Food, Drug, and Cosmetic Act is amended by adding at the end
the following:
"NEW
DIETARY INGREDIENTS
-
"SEC.
413. (a) IN GENERAL.- A dietary supplement which contains a new dietary
ingredient shall be deemed adulterated under section 402(f) unless it meets
one of the following requirements:
-
"(1) The dietary supplement contains only dietary ingredients which have
been present in the food supply as an article used for food in a form in
which the food has not been chemically altered.
-
"(2) There is a history of use or other evidence of safety establishing
that the dietary ingredient when used under the conditions recommended
or suggested in the labeling of the dietary supplement will reasonably
be expected to be safe and, at least 75 days before being introduced or
delivered for introduction into interstate commerce, the manufacturer or
distributor of the dietary ingredient or dietary supplement provides the
Secretary with information, including any citation to published
articles, which is the basis on which the manufacturer or distributor
has concluded that a dietary supplement containing such dietary
ingredient will reasonably be expected to be safe.
The
Secretary shall keep confidential any information provided under paragraph
(2) for 90 days following its receipt. After the expiration of such 90 days,
the Secretary shall place such information on public display, except matters
in the information which are trade secrets or otherwise confidential,
commercial information.
-
"(b)
PETITION. - Any person may file with the Secretary a petition proposing
the issuance of an order prescribing the conditions under which a new
dietary ingredient under its intended conditions of use will reasonably be
expected to be safe. The Secretary shall make a decision on such petition
within 180 days of the date the petition is filed with the Secretary. For
purposes of chapter 7 of title 5, United States Code, the decision of the
Secretary shall be considered final agency action.
-
"(c)
DEFINITION. - For purposes of this section, the term "new dietary
ingredient" means a dietary ingredient that was not marketed in the United
States before October 15, 1994 and does not include any dietary ingredient
which was marketed in the United States before October 15, 1994.".
Section
402 (21 U.S.C. 342), as amended by section 4, is 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, including regulations requiring, when necessary, expiration
date labeling, 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 chapter 5 of title 5, United
States Code.".
-
(a) SECTION 201 - The last sentence of section
201(g)(1) (21 U.S.C. 321(g)(1)) is amended to read as follows: "A food or
dietary supplement for which a claim, subject to sections 403(r)(1)(B) and
403(r)(3) or sections 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 not misleading statement is made
in accordance with section 403(r)(6) is not a drug under clause (C) solely
because the label or the labeling contains such a statement.".
-
(b) SECTION 301 - Section 301 (21 U.S.C. 331) is
amended by adding at the end the following: (u) The introduction or delivery
for introduction into interstate commerce of a dietary supplement that is
unsafe under section 413.".
-
(c) SECTION 403 - Section 403 (21 U.S.C. 343), as
amended by section 7, is amended by adding after paragraph (s) the
following: "A dietary supplement shall not be deemed misbranded solely
because its label or labeling contains directions or conditions of use or
warnings.".
The
advance notice of proposed rulemaking concerning dietary supplements published
in the Federal Register of June 18, 1993 (58 FR 33690-33700) is null and void
and of no force or effect insofar as it applies to dietary supplements. The
Secretary of Health and Human Services shall publish a notice in the Federal
Register to revoke the item declared to be null and void and of no force or
effect under subsection (a).
-
(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. Members and
staff of the Commission shall be without bias on the issue of dietary
supplements.
-
(c) FUNCTIONS OF THE COMMISSION. - The Commission
shall conduct a study on, and provide recommendations for, the regulation of
label claims and statements for dietary supplements, including the use of
literature in connection with the sale of dietary supplements and procedures
for the evaluation of such claims. In making such recommendations, the
Commission shall evaluate how best to provide truthful, scientifically
valid, and not misleading information to consumers so that such consumers
may make informed and appropriate health care choices for themselves and
their families.
-
(d) 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 be necessary to carry out this section.
-
(e) 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.
-
(3) ACTION ON RECOMMENDATIONS. - Within 90 days of the issuance of the
report under paragraph (1), the Secretary of Health and Human Services
shall publish in the Federal Register a notice of any recommendation of
Commission for changes in regulations of the Secretary for the
regulation of dietary supplements and shall include in such notice a
notice of proposed rulemaking on such changes together with an
opportunity to present views on such changes. Such rulemaking shall be
completed not later than 2 years after the date of the issuance of such
report. If such rulemaking is not completed on or before the expiration
of such 2 years, regulations of the Secretary published in 59 FR 395-426
on January 4, 1994, shall not be in effect.
-
(a) IN GENERAL. - Title IV of the Public Health
Service Act is amended by inserting after section 485B (42 U.S.C. 287c-3)
the following:
"
SUBPART 4--OFFICE OF DIETARY SUPPLEMENTS SEC. 485C. 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 Medicine;
-
"(3) serve as the principal advisor to the Secretary
and to the Assistant Secretary for Health and 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.
-
"(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:
Approved
October 25, 1994.
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