DIETARY SUPPLEMENT The purpose of dietary supplements, is to enhance or supplement the diet. Even though a product is marketed as a dietary supplement, it is still considered a medicine to the extent that it is meant to treat, diagnose, cure, or prevent diseases. Tablets, capsules, soft gels, powders, bars, gummies, and liquid supplements are just a few of the many different forms that supplements can take. It is a product that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid. A dietary substance use by human to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients. FDA Role Companies can often introduce a dietary supplement to the market without notifying FDA. FDA’s role in regulating dietary supplements primarily begins after products enter the marketplace. If a product is found to be unsafe or not otherwise in compliance with the law, FDA can work with the company to bring the product into compliance or possibly remove it from the market. FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods (edible fruits and vegetables) and drug products.  Role of DSHEA Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labelling of their products before marketing to ensure that they meet all the requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA) as amended by DSHEA and FDA regulations. FDA has the authority to take action against any adulterated or misbranded dietary supplement product after it reaches the market The Dietary Supplement Health and Education Act of 1994 was enacted to prohibit Dietary supplement manufacturers and distributors from making false claims (such as "natural" and "therapeutic," on supplement labels) The law also prohibits the manufacture and sale of adulterated dietary supplements. Aim of these act: To make dietary supplements safer by forbidding manufacturers and distributors from producing and selling mislabelled or adulterated products. Act requires that the manufacturer of the dietary supplement ensures their product meets DSHEA and FDA regulations. Table of Contents Short Title Reference Table Of Contents Findings Definitions Safety of Dietary Supplements and Burden of Proof on FDA Dietary Supplement Claims Statements of Nutritional Support Dietary supplement ingredient labeling and nutrition information labeling New dietary ingredients Good manufacturing practices Conforming amendments Withdrawal of the regulations and notice Commission on dietary supplement labels

1. DIETARY
SUPPLEMENT
HEALTH
AND
EDUCATION
ACT OF 1994
Presented by:
Vanshika Gupta
2nd sem M.Pharm (RA)
MRA204T (RAFN) Parul Institute Of Pharmacy

2. CONTENTS
• Introduction to Dietary Supplements
• Classification of Dietary Supplements
• Benefits of Dietary Supplements
• DSHEA 1994
Table of Contents
1. Short Title Reference Table Of Contents
2. Findings
3. Definitions
4. Safety of Dietary Supplements and Burden of
Proof on FDA
5. Dietary Supplement Claims
6. Statements of Nutritional Support
Presentation Title: Dietary Supplement Health and Education Act of 1994 2

3. Conti...
7. Dietary supplement ingredient labeling and nutrition information labeling
8. New dietary ingredients
9. Good manufacturing practices
10. Conforming amendments
11. Withdrawal of the regulations and notice
12. Commission on dietary supplement labels
13. Office of dietary supplements
Presentation Title: Dietary Supplement Health and Education Act of 1994 3

4. INTRODUCTION
DIETARY SUPPLEMENT
 The purpose of dietary supplements, is to enhance or supplement the diet. Even though a
product is marketed as a dietary supplement, it is still considered a medicine to the
extent that it is meant to treat, diagnose, cure, or prevent diseases.
 Tablets, capsules, soft gels, powders, bars, gummies, and liquid supplements are just a
few of the many different forms that supplements can take.
 It is a product that is intended to supplement the diet that bears or contains one or more
of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an
amino acid.
 A dietary substance use by human to supplement the diet by increasing the total daily
intake, or a concentrate, metabolite, constituent, extract, or combinations of these
ingredients.
Presentation Title: Dietary Supplement Health and Education Act of 1994 4

5. Common supplements
include:
Vitamins (such as multivitamins or individual vitamins like vitaminD
and biotin)
Minerals (such as calcium, magnesium, and iron)
Botanicals or herbs (such as echinacea and ginger)
Botanical compounds (such as caffeine and curcumin)
Amino acids (such as tryptophan and glutamine)
Live microbials (commonly referred to as “probiotics”)
Presentation Title: Dietary Supplement Health and Education Act of 1994 5

6. Classification of supplements, examples and contents
Class Example Contents
Activator Amino acids Growth hormone
Carbohydrate Dextrose Contain vitamins and electrolytes
Food and Food stuff Fish oils, mineral and vitamins Contain garlic, kelp, royal jelly, yeast
Herbs Ginseng, Fiber Contains amino acids, plant Source
Minerals Selenium, multi-mineral tablets Contains only minerals
Multivitamins and
multiminerals
Vitamin D, calcium supplement Contains both mineral and vitamins
Oil supplements Cod liver oil, primrose oil Contains oil base, with vit, minerals
Vitamins Vitamin C, vitamin B Contains only vitamin
Presentation Title: Dietary Supplement Health and Education Act of 1994 6

7. How are dietary supplements
regulated?
Companies must make sure that the dietary
supplements they sell are secure and correctly
identified in accordance with the Dietary
Supplement Health and Education Act
(DSHEA).
FDA does not have the authority to approve
dietary supplements or their labelling before they
are sold to the public
Presentation Title: Dietary Supplement Health and Education Act of 1994

8.  Companies can often introduce a dietary supplement to the market without
notifying FDA.
 FDA’s role in regulating dietary supplements primarily begins after products
enter the marketplace.
 If a product is found to be unsafe or not otherwise in compliance with the law,
FDA can work with the company to bring the product into compliance or possibly
remove it from the market.
 FDA regulates both finished dietary supplement products and dietary ingredients.
 FDA regulates dietary supplements under a different set of regulations than those
covering "conventional" foods (edible fruits and vegetables) and drug products.
Presentation Title: Dietary Supplement Health and Education Act of 1994 8
FDA Role

9. Benefits of dietary supplements
Presentation Title: Dietary Supplement Health and Education Act of 1994 9
Probiotics- balance good
bacteria in digestive system
Vitamin D help build strong bones,
and fiber maintain bowel regularity
Ensure your body is getting
enough of proper nutrients
Provide you with better
athletic performance
Multivitamins- Healthy B.P,
essential for brain and eye health
Decrease your chances of
dealing with heart diseases
Give your immune system a
big boost
Improve physical performance
build muscle, and delay fatigue

10. Dietary Supplement
Health and
Education Act
of 1994
(DSHEA)
Presentation Title: Dietary Supplement Health and Education Act of 1994 10

11. Role of DSHEA
Presentation Title: Dietary Supplement Health and Education Act of 1994
11
 Manufacturers and distributors of dietary supplements and dietary ingredients are
prohibited from marketing products that are adulterated or misbranded.
 That means that these firms are responsible for evaluating the safety and labelling
of their products before marketing to ensure that they meet all the requirements of
the Federal Food, Drug, and Cosmetic Act (FFDCA) as amended by DSHEA and
FDA regulations.
 FDA has the authority to take action against any adulterated or misbranded dietary
supplement product after it reaches the market

12. Presentation Title: Dietary Supplement Health and Education Act of 1994
12
 The Dietary Supplement Health and Education Act of 1994 was enacted to
prohibit
1. Dietary supplement manufacturers and distributors from making false claims
(such as "natural" and "therapeutic," on supplement labels)
2. The law also prohibits the manufacture and sale of adulterated dietary
supplements.
 Aim of these act:
1. To make dietary supplements safer by forbidding manufacturers and
distributors from producing and selling mislabelled or adulterated products.
2. Act requires that the manufacturer of the dietary supplement ensures their
product meets DSHEA and FDA regulations.
Conti...

13. Presentation Title: Dietary Supplement Health and Education Act of 1994
13
An Act To Establish Standards Regarding Dietary Supplements Under The Federal
Food, Drug, and Cosmetic Act And For Other Purposes.
Section 1
a) Short Title
Dietary Supplement Health and Education Act of 1994
b) Reference
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.
c) Table of Contents
Conti...

14. Conti...
Section 2 Findings
• The importance of nutrition and the
benefits of dietary supplements
• There is a link between the ingestion
of certain nutrients or dietary
supplements and the prevention of
chronic diseases
• Consumers should be empowered to
make choices about preventive health
care programs
• Preventive health measures, including
education, good nutrition, and
appropriate use of safe nutritional
supplements
• Promotion of good health and healthy
lifestyles improves and extends lives
• Improving the health status of United
States citizens
Presentation Title: Dietary Supplement Health and Education Act of 1994 14

15. Conti...
Section 3 Definitions
Dietary supplement
Presentation Title: Dietary Supplement Health and Education Act of 1994 15
Section 4 Safety of Dietary Supplements and Burden of Proof on FDA
 The DSHEA must use either the conditions of use recommended or suggested
on the product label or, in the absence of such recommendations or
suggestions, the customary conditions of use to assess whether dietary
supplements are adulterated.
 If there is insufficient knowledge to provide a reasonable assurance may be
determined to be adulterated.
 The federal government is required to provide evidence before drawing such a
determination.

16. Conti...
Section 5 Dietary Supplement Claims
Dietary Supplement Labeling Exemptions
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.
Used in connection with marketing of dietary supplements to consumers when it is...
• Is not false or misleading
• Does not promote a particular manufacturer or brand of a dietary supplement
• Is displayed or presented with other such items on the same subject matter
Presentation Title: Dietary Supplement Health and Education Act of 1994 16

17. Presentation Title: Dietary Supplement Health and Education Act of 1994 17
Conti...
• B. Application: Shall not apply to or in any way prevent a retailer or distributor of
dietary supplements from selling books or other publications as a part of their line of
work.
• C. Burden of proof: The burden of proving that an article or other similar matter is
inaccurate or misleading must be on the United States in any process instituted under
paragraph
Section 6 Statements of Nutritional Support
DSHEA amends the Nutrition Labeling and Education Act of 1990 (NLEA) health
claims provisions of FDCA to allow dietary supplement labels to carry any of four
types of statements of nutritional support without obtaining premarketing
authorization from FDA.

18. Presentation Title: Dietary Supplement Health and Education Act of 1994 18
Conti...
The legislation requires supplement manufacturers to have substantiation of such
label claims and to notify FDA within 30 days after first marketing a product with a
statement of nutritional support that such a statement is being made.
The label must also carry a disclaimer “prominently displayed and in boldface type”
that states:
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.

19. CONTI...
Section 7 Dietary Supplement Ingredient Labeling and Nutrition Information
Labeling
Section 7 of the Act imposes specific requirements for supplement labels. It specifies some
circumstances under which dietary supplements would be misbranded. It provides that
supplement labels must list the name and quantity of each ingredient. In the case of a
proprietary blend, the “total quantity of all ingredients in the blend” may be provided.
Section 8. New Dietary Ingredients
This section describes the conditions under which a new dietary ingredient may be used in
a dietary supplement. Unless an ingredient has been “present in the food supply as an
article used for food in a form in which the food has not been chemically altered,” the
manufacturer must provide FDA with information, based on a history of use or other
evidence of safety, supporting the conclusion that the product “will reasonably be
expected to be safe.”
Presentation Title: Dietary Supplement Health and Education Act of 1994 19

20. Section 9. Good Manufacturing Practices
In addition to laying the foundation for a regulatory framework for dietary supplements
and their ingredients, DSHEA, under Section 9, provides FDA with the authority to
promulgate good manufacturing practice (GMP) regulations for supplements. The Act
stipulates that any new GMP regulations must be modelled after current food GMP
regulations and go through the required rulemaking process, allowing for public notice and
comment.
Section 10. Conforming Amendments
Section 10 of DSHEA makes changes necessary for conformance in relevant
sections of FDCA. It amends Section 201 of FDCA to provide that a food or dietary
supplement that bears a statement of nutritional support in accordance with
DSHEA is not a drug solely because the label or labeling bears such a statement.
Presentation Title: Dietary Supplement Health and Education Act of 1994 20

21. Section 11. Withdrawal of the Regulations and Notice
Under Section 11 of DSHEA, the Secretary of the Department of Health and Human
supporting the conclusion that the product Services (HHS) is directed to issue “will
reasonably be expected to be safe.” regulations rendering null and void the June This
information must be provided at least 1993 Advance Notice of Proposed 75 days before
introducing a new dietary Rulemaking (ANPR) concerning dietary ingredient into
interstate commerce. Supplements
Section 12. Commission on Dietary Supplement Labels Section 12 of DSHEA
mandates the appointment by the President of a commission to study and make
recommendations concerning label claims and statements for dietary supplements.
Section 13. Office of Dietary Supplements Section 13 of DSHEA establishes an Office
of Dietary Supplements (ODS) within the National Institutes of Health (NIH). According
to the Act, the purpose of ODS is 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 to promote scientific study of the benefits of dietary supplements
Presentation Title: Dietary Supplement Health and Education Act of 1994 21

22. Summary
The fundamental objective of the DSHEA is
to make sure that People have access to
dietary supplements that are safe and have
accurate labels.
Dietary supplements must be labelled with
particular information, such as the contents,
how much of each component is in each
serving, and the suggested daily dosing size,
according to the law.
The FDA is only permitted by law to take
action against dangerous supplements once
they are already on the market, not before
they are offered for sale to consumers.
Presentation Title: Dietary Supplement Health and Education Act of 1994 22

23. References
Presentation Title: Dietary Supplement Health and Education Act of 1994 23
1. Supplement your knowledge [Internet]. U.S. Food and Drug Administration.
FDA; [cited 2023 Apr 8]. Available from:
https://www.fda.gov/food/information-consumers-using-dietary-
supplements/supplement-your-knowledge
2. Hassan S, Egbuna C, Tijjani H, Ifemeje JC, Olisah MC, Patrick-Iwuanyanwu
KC, Onyeike PC, Ephraim-Emmanuel BC. Dietary supplements: Types, health
benefits, industry and regulation. Functional Foods and Nutraceuticals:
Bioactive Components, Formulations and Innovations. 2020:23-38.
3. Dietary supplements [Internet]. U.S. Food and Drug Administration. FDA;
[cited 2023 Apr 8]. Available from: https://www.fda.gov/food/dietary-
supplements

24. Presentation Title: Dietary Supplement Health and Education Act of 1994 24
3. Dietary Supplement Health and Education Act (DSHEA) [Internet].
Painscale.com. [cited 2023 Apr 8]. Available from:
https://www.painscale.com/article/dietary-supplement-health-and-education-
act-dshea
4. Nesheim MC, Dickinson A, Shiriki K, Farnsworth NR, Gilhooley M,
Associates LLBP, et al. MEMBERSHIP OF THE COMMISSION ON
DIETARY SUPPLEMENT LABELS chair [Internet]. Nih.gov. [cited 2023 Apr
8]. Available from: https://ods.od.nih.gov/pubs/DSHEA1997report.pdf
5. FDA 101: Dietary supplements [Internet]. U.S. Food and Drug Administration.
FDA; [cited 2023 Apr 8]. Available from:
https://www.fda.gov/consumers/consumer-updates/fda-101-dietary-
supplements.
References...

25. THANK YOU
Presentation Title: Dietary Supplement Health and Education Act of 1994 25