US: Dietary Supplement Health
And Education ACT of 1994

Supplementary Legislation U/S 411 of “ Federal Food, Drug and
Cosmetic Act 1976”

www.DuloMix.com 1

OBJECT and NEED

• Object: to establish standards with respect to dietary supplements, and for
other purposes.

• (1) improving the health status of United States
• (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 nutritionwawl wsu.DpuplolMemix.ceonmts will limit the incidence of 2

chronic diseases, and reduce long-term health care expenditures;

OBJECT and NEED
• (6)(A) promotion of good health and healthy lifestyles improves health and

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 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;

www.DuloMix.com 3

OBJECT and NEED
• (11) the United States will spend over $1,000,000,000,000(10Lcr) on health care
in 1994, which is about 12 percent of the Gross National Product of the United
States,
• (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; (400cr)
• (13) dietary supplements are safe within a broad range of intake, and safety
problems with the supplements are relatively rare; and
• (15) 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.

www.DuloMix.com 4

Introduction:

• Dietary supplements come in many forms, including tablets, capsules, powders,
energy bars, and liquids. These products are available in stores throughout the
United States, as well as on the Internet. They are labeled as dietary supplements
and include among others

a. vitamin and mineral products
b. botanical” or herbal products—These come in many forms and may include

plant materials, algae, macroscopic fungi, or a combination of these materials.
c. amino acid products—Amino acids are known as the building blocks of proteins

and play a role in metabolism.
d. enzyme supplements—Enzymes are complex proteins that speed up

biochemical reaction
• The Food and Drug Administration (FDA) suggests that you consult with a health

care professional before using any dietary supplement.

www.DuloMix.com 5

Definition:

The term “dietary supplement” –
means a product (other than tobacco) intended to supplement the diet 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)a 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), or (E);

www.DuloMix.com 6

Definition

“(2) means a product that –
“(A)(i) is intended for ingestion in a form described; or

“(ii) complies with standards specified;
“(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;

“(3) does include –
“(A) an article that is approved as a new drug, certified as an antibiotic, or licensed as a

biologic under and was, prior to such approval, certification, or license, marketed as a
dietary supplement or as a food unless the Secretary declared that, 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; and
“(B) not include –

“(i) an article that is approved as a new drug; or
“(ii) an article authorized for investigation as a new drug, antibiotic, or biological for

which substantial clinical investigations have been instituted unless secretory makes
regulation that it is lawful.

www.DuloMix.com 7

Dietary supplement labeling exemptions:

A publication, including an article, a chapter in a book, or an official abstract of a
peer-reviewed scientific publication shall not be defined as labeling when used in
connection with the sale of a dietary supplement to consumers when it –
(1)i s 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) does not have appended to it any information by sticker o r any other method.

www.DuloMix.com 8

Statements of nutritional support :

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.”.

www.DuloMix.com 9

Dietary supplement ingredient labeling and nutrition information
labeling:

(a) Misbranded supplements:
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 and
(ii)the quantity of each such ingredient; or
(II) with respect to a proprietary blend of such ingredient s, the total
quantity of all ingredients in the blend;
(B) the label or labeling of the dietary supplement f ails to identify the
product by using the term `dietary supplement’

www.DuloMix.com 10

(b) Supplement Listing on Nutrition Labeling

A dietary supplement product shall comply with the requirements of regulations of
the Secretary which shall provide that :
(i) nutrition information shall first list those dietary ingredients that are present in
the product in a significant amount
(ii) the listing of dietary ingredients shall include the quantity of each such
ingredient per serving;

(iii)the listing of dietary ingredients may include the source of a dietary ingredient;
and
(iv) the nutrition information shall immediately precede the ingredient information

www.DuloMix.com 11

(c)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.

www.DuloMix.com 12

New dietary ingredient:

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 i n 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, t he manufacturer or distributo r of the dietary ingredient or
dietary supplement provides the S ecretary 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.

www.DuloMix.com 13

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 an d
does not include any dietary ingredien t which was marketed in the United States
before October 15, 1994.

www.DuloMix.com 14

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.
(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 m edicine, or other related
sciences. www.DuloMix.com 15

• 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.

www.DuloMix.com 16

(d) Administrative powers of the commission:

• 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.

• 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.

• Authorization of appropriations: There are authorized to be appropriated such
sums as may be necessary to carry out this section.

www.DuloMix.com 17

(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 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,
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.
Such rulemaking shall be completed not later than 2 years after the date of

the issuance of such report.
www.DuloMix.com 18

Office of 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 i mprove health care; and
• (2) to promote scientific study o f the benefits of dietary supplements in

maintaining health and preventing chronic disease a nd 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, osteoporosisw,wcwa.tDaurloaMctixs.,comr prostatism; 19

(2) collect and compile the results of scientific research relating to dietary supplements,
including scientific data from foreign source s 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.

www.DuloMix.com 20

www.DuloMix.com 21