USFDA Dietary
Supplements

Class : F.Y.M.Pharm (DRA)

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Dietary supplements

As per DSHEA, Dietary supplements

• 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)

▪ Not intended to treat, diagnose, mitigate, prevent, or cure diseases
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Dietary Supplements Are In Many Forms Such As:

 Tablet,

 Capsules,

 Softgels ,

 Gelcaps,

 Liquids,

 Powder,

FDA regulates dietary supplements under a different set of regulations than those covering
“conventional” foods and drug products. Under the Dietary Supplement Health and Education
Act of 1994 (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 labeling of their products before marketing to ensure
that they meet all the requirements of the Federal Food, Drug, and Cosmetic Act 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.

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DSHEA

▪ Dietary Supplement Health & Education Act

▪ (15 Oct 1994)

▪ Current Framework for dietary supplements

▪ “New dietary ingredient (NDI)” means a dietary ingredient that was not marketed in
the US in a dietary supplement before October 15, 1994.

▪ To be an NDI, a substance must be a dietary ingredient.

▪ Pre-DSHEA dietary ingredient: A dietary ingredient that was marketed in the U.S.
before October 15, 1994.

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New Dietary Ingredient

 The term “new dietary ingredient” means a dietary ingredient that was not marketed in
the United States in a dietary supplement before October 15, 1994.

 There is no authoritative list of dietary ingredients that were marketed in dietary
supplements before October 15, 1994.

 Therefore, manufacturers and distributors (you) are responsible for determining if an
ingredient is a “new dietary ingredient” and, if not, for documenting either that a dietary
supplement that contained the dietary ingredient was marketed before October 15,
1994, or that the dietary ingredient was marketed for use in dietary supplements before
that date.

 If you want to market a “new dietary ingredient” in a dietary supplement, you must be
sure that the substance is considered to be a “dietary ingredient.

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Drug , Medical Device Require Premarket
mem

Notification

Not Require Premarket
Dietary Supplement i.e

Notification
Pre-DSHEA

Dietary Supplement Require PremRarket

Containing NDI Notification

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NDI NDI
NDI Notification adulteration

standard

A dietary ingredient that was marketed in the No No No
U.S. before October 15, 1994

A dietary ingredient that was NOT marketed
in the U.S. before October 15, 1994, AND was
present in the food supply as an article used
for food which has

1. Not chemically altered Yes No Yes

2. Chemically altered Yes Yes Yes

A dietary ingredient that was NOT marketed Yes Yes Yes
in the U.S. before October 15, 1994, AND was
NOT present in the food supply as an article
used for food.

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PreMarket Notification
Must submit a premarket safety notification to FDA at least 75 days before introducing
the product into market.

Commonly referred to as NDI Notification.

It Contains Data and information related to comprehensive safety profile provide a basis for
a safety

Not Contain General data or information that is used primarily to substance a claim about
the efficacy

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What should be included in an NDI notification –

Identity information

o The name of the NDI, and complete address of the manufacturer or distributor

o A description of the physical properties, chemical or molecular composition or structure
of the NDI, or both

o Basis for your conclusion that the substance is an NDI

o Controls and/or acceptable ranges for batch-to-batch variability,

o The identity and level of any impurities and contaminants

o A description of the identity of the other dietary ingredients in the dietary supplement
product.

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History of Use or Other Evidence of Safety

o Published data and information, such as peer-reviewed scientific literature, reports from
authoritative bodies, survey data on food or nutrient composition and consumption,
advertisements or other published promotional material describing the composition of
products, published agricultural or food production data

Summary of the Basis for Your Conclusion of Safety

o Concise summary of it will reasonably be expected to be safe when used under the
conditions recommended or suggested in the supplement’s labeling.

The signature of a person authorized by the manufacturer or distributor to sign the
notification on its behalf.

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Procedure –

Each subject area begin with a new page to facilitate division of the notification among
reviewers.

Either the manufacturer or distributor of a dietary supplement that contains an NDI, or the
manufacturer or distributor of the NDI, must notify FDA at least 75 days before
marketing the article in the U.S.

If the NDI notification is a paper submission, the original should be a paper document. For
the copy, FDA accepts either paper or an exact copy of the original scanned into an
electronic file in PDF format on a CD-ROM disk.

Submit NDI notification to: Consumer Safety Officer, Office of Dietary Supplement
Programs (HFS-810), Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5001 Campus Drive, College Park, MD 20740.

For electronic submission:- https://www.access.fda.gov.

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The date when FDA receives a complete notification is the date of filing.

The date of filing is the start of the 75-day premarket review period

(during which the manufacturer or distributor may not market the dietary supplement)

After 90th day, information in notification is available through FDA’s Division of Dockets
Management at http://www.regulations.gov (Except confidential)

If the notification does not meet the requirements, a member of FDA’s Office of Dietary
Supplement (ODS) Programs will contact the notifier.

Notifier has to provide the missing information within 14 days.

If the notifier cannot provide the missing information within 14 days, FDA will consider
the notification incomplete and will mail a letter so informing the notifier.

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GMP

Require that proper controls are in place to ensure the identity, purity, strength, and
composition.

Processed in a consistent manner, and meet quality standards.

Requirements include provisions related to:

o the design and construction of physical plants that facilitate maintenance

o cleaning, proper manufacturing operations,

o QC procedures,

o testing final product or incoming and in process materials,

o handling consumer complaints, and maintaining records.

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Interim Final Rule:

Petition process for a manufacturer to apply for exemption from the 100 percent identity
testing requirements for dietary ingredients used in manufacturing dietary supplements.

If manufacture is granted an exemption the manufacture would still be responsible for
ensuring the quality of final dietary supplement product .

The manufacture would have to provide data in its petition .

The IFR is effective From june 2008 .

Consumer Benefits :

Consumer should have access to dietary supplements that meet quality standard and that are
free from contamination and are accurately labelled .

The rule will give consumers greater confidence that the dietary supplement use has been
manufactured to ensure its identity , purity , strength , and composition.

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Manufacture :
Under the dietary supplement Health And Education Act , manufacture have essential
responsibility the safety of their product .

The cGMP will help to ensure manufacture produce unadulterated and properly labbeld
dietary supplement .

Under a cGMP rule the manufacture have required to :

o Employ qualified employees and supervisiors .

o Design and construct their physical plant in a manner to protect dietary ingredient and
dietary supplement from becoming adulterated during manufacturing , packaging ,
labeling and holding .

o Use equipment and utensils that are of appropriate design , construction, and
workmanship for the intended use.

o Establish and use master manufacturing and batch production records.

o Establish procedure for quality control operation .

o Keep a written record of each product complaint related to cGMP

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o Storage and distribute dietary supplement and materials used to manufacture dietary
supplements under appropriate conditions of temperature , humidity , light , and
sanitation so that the quality of the dietary supplement is not be affected .

o Retain record for 1 year past the shelf life date , if self life dating is used , or 2 years
beyond the date of distribution of the last batch of dietary supplement associated with
those records.

Labelling :

Dietary supplement labels may include certain types of health-related claims.

Manufacturers are permitted to say, for example, that a supplement promotes health or

supports a body function (like immunity or heart health).

Label must include –

Claims must be followed by the words, “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.”

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o Name of each ingredient

o Quantity of each ingredient

o Total weight of all ingredients if a blend

o Nutritional labelling information – Calories, fat, sodium

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REFERENCE :

o Dietary Supplements: New Dietary Ingredient Notifications and Related
Issues: Guidance for Industry, Draft Guidance, U.S. Department of Health and
Human Services, Food and Drug Administration, Center for Food Safety and
Applied Nutrition, August 2016

o Dietary Supplement Current Good Manufacturing Practices (CGMPs) and
Interim Final Rule (IFR) Facts, June 22, 2007

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