U.S.A

REGULATORYASPECTS OF
FOOD AND NUTRACEUTICALS
PRA204T
TOPIC : U.S.A
PRESENTED BY :- KANCHAN RAM
(M. Pharmacy 1st Year DRA)
GUIDE BY:- LOKESH .P. KOTHARI
(Assistant professor)
SNJB’s S.S.D.J.COLLEGE OF PHARMACY
CHANDWAD

Contents
What is Dietary Supplement….?
Dietary Supplement Health and Education
Act (DSHEA)
 Dietary Supplements Labelling
Dietary Supplements – Claims
Nutrient Content Claims
Health Claims
Structure and Function Claims
Drug Claim
Recommended Dietary Allowances (RDA)
in U.S.A
12 August 2023 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik)

What is a Dietary Supplement…..?
In the Dietary Supplement Health and Education Act
(DSHEA) of 1994, A dietary supplement is a product
taken by mouth that contains a "dietary ingredient"
intended to supplement the diet.
The "dietary ingredients" in these products may include:
vitamins, minerals, herbs or other botanicals, amino
acids, and substances such as enzymes, organ tissues,
glandular , and metabolites.

• Dietary supplements can also be extracts or
concentrates, and may be found in many forms such as
tablets, capsules, soft gels, gel caps, liquids, or powders

Dietary Supplement Health and
Education Act (DSHEA)
The Dietary Supplement Health and Education Act
(DSHEA) of 1994 defined both of the terms "dietary
ingredient" and "new dietary ingredient" as components
of dietary supplements.
In October 1994, the Dietary Supplement Health and
Education Act (DSHEA) was signed into law by
President Clinton.
Before this time, dietary
supplements were subject
to the same regulatory
requirements as were other
foods.

In order for an ingredient of a dietary supplement to be
a "dietary ingredient," it must be one or any combination
of the following substances: a vitamin, a mineral, an
herb or other botanical, an amino acid, a dietary
substance for use by man to supplement the diet by
increasing the total dietary intake (e.g., enzymes or
tissues from organs or glands), or a concentrate,
metabolite, or extract.

• A “new dietary ingredient” is one that meets the above
definition for a “dietary ingredient’’ and was not sold in
the U.S. in a dietary supplement before October 15,
1994

Dietary Supplements Labelling
 Required :-
Statement of identity (product name)
Supplement facts chart
Name of each ingredient
Quality of each Ingredient
Total weight of all ingredient if a blend
Must contain nutritional labeling information
Manufacturer , packer, or distributor name and address
Domestic U.S, phone number or mailing address to
which a consumer can report a serious adverse event

Dietary Supplement- Claims
 Nutrients content claims-
21CFR 101.13-General principle.
Characterize the level of a nutrients such as high in fiber
and low sodium as defined by FDA.
Types of claims governed.
Good source more and high potency
Light or lite
Fat, fatty acid and cholesterol content.

 Health claims-
21 CFR 101.70.
Describes the risk reduction of a disease related to
consumption of certain nutrient(must be authorized by
FDA)
 Examples:-
Sodium and hypertension.
Calcium and osteoporosis.
Fibers and cancers
Floated and neural tube defects(e.g. spina bifida)

Structure/function claims-
Describe the role or mechanism of nutrient to affect the
structure or function of the body.
May describe general well being from consumption of
the supplement
Its describe effect on condition that are commonly
associated with natural states.
Require label disclaimer
Don’t have to submit data to FDA, but you do have to
in form FDA 30 days before making nutritional support
claims.

Drug claims-
Dietary supplements may not claim to diagnose,
mitigates, treat, cure, or prevent a specific disease or
class of disease.
May not claim effect that imply disease treatment
relieves crushing chest pain (i.e: heart attack)
Drug claims on a dietary supplement label can cause
FDA to regulate the product as a drug.

Recommemded Dietary Allowances
(RDA) in U.S.A.

Multivitamins, vitamin D, fish oil are among the many
dietary supplements lining store shelves or available
online.
Supplements are ingested and come in many forms,
including tablets, capsules, soft gels, gel caps, powders,
bars, gummies, and liquids.
Dietary supplements can be beneficial to your health,
but they can also involve health risks. So, it’s important
that you talk with a health care professional to help you
decide if a supplement is right for you.

what dietary supplements are what role the U.S. Food
and Drug Administration has in regulating them, and
how to make sure you and your family use supplements
safely.
 Common supplements include:
Vitamins (such as multivitamins or individual vitamins
like vitamin D 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”).

REFERENCES
1. https://www.fda.gov/food/guidance-regulation-food-
and-dietary-supplements/food-safety-modernization-
act-fsma
2. https://www.fda.gov/food/dietary-supplements
3. https://voisinconsulting.com/resources/blog/microbio
me-health-products-drugs-or-foods/
4. https://www.fda.gov/food/guidance-documents-
regulatory-information-topic-food-and-dietary-
supplements/dietary-supplements-guidance-
documents-regulatory-information

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