Transcript Vedic Lifesciences Pvt Ltd

Vedic Lifesciences Pvt Ltd
Regulatory Requirements for Dietary
Supplements in USA
Mansi Ahuja
www.vediclifesciences.com
Health Regulators Worldwide
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Status of AYUSH Products in USA
In USA
In INDIA

AYUSH Products

Dietary Supplements

Traditional Indian
Medicine

Herbal Supplements

Food Supplements

Patent & Proprietary or
Shastrokta Drugs


Can claim disease cure /
treatment
Cannot claim disease
cure, but only health
maintenance

Only OTC

Not reimbursed by
insurance

Can be prescribed or
OTC
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Types of Health Regulations
“How To Enter” Regulations
(Pre-Market)
“What to Submit” Regulations
(Guidelines)
“What To Do” Regulations
(Marketing, Post-marketing)
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“How To Enter” Regulations
Pre-Market
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DSHEA,1994

The Dietary Supplement Health and Education Act was
signed into law in October, 1994.

Under DSHEA, a firm is responsible for
 Safety of the dietary supplement
 Claim Substantiation
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Definition of Dietary Supplements

“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).”

Note: A dietary supplement is limited to products that are intended for
ingestion in tablet, capsule, powder, softgel, gelcap, and liquid form
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Definition of Dietary Ingredient

New Dietary Ingredient (NDI): The term ‘new dietary
ingredient’ means a dietary ingredient that was not
marketed in the United States before October, 1994.

Old Dietary Ingredient (ODI): It means a dietary ingredient
that was marketed in the United States before October,
1994. (Grandfathered Ingredients)

In case of ODI, NO PRE MARKETING APPROVAL
REQUIRED from FDA.

However, pre marketing notification is required in case of NDI.
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Dietary Supplement
ODI
NDI
Marketing
Success
OF
Marketin
g
Claims
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Pre Market
Notification
Difference between Dietary Supplement,
Foods & Drugs
Dietary Supplement:
Supplements diet by
increasing the total
dietary intake
Drugs:
Diagnosis, Cure,
Mitigation, Treatment
or prevention of a
disease
Foods:
Principal Item of a
Person’s Diet
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“What to Submit” Regulations
Guidelines
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Notification Requirement for NDI
A pre – marketing notification is required in case of

Manufacturer who intends to market a new dietary
ingredient or dietary supplement that contains a new
dietary ingredient;

Distributor who intends to market a new dietary
ingredient or dietary supplement that contains a new
dietary ingredient.
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Prerequisite for NDI

In order to market Dietary Supplement
containing NDI, the basic requirement is
 pre marketing notification that must be
submitted 75 days prior to entry in the
market.

On September 23, 1997, FDA published in
the Federal Register a final rule that established
safety regulations.
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Submission Information

Submit an original and two (2) copies of the
notification with Safety documents.

Notification should also contain the following data: Your name and complete address.
 The name of the new dietary ingredient.
 A description of the dietary supplement or
supplements that contain the NDI, including:
 Amount of NDI in the dietary supplement.
 Conditions of use as per Label
 History of use or other evidence of safety.
 A signature by a responsible authority from the
company.
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Warning

Dietary Supplement with NDI can only reach the
market after 75 days of notification period.
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“What to Do” Regulations
Marketing & Post Marketing rules
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cGMP Requirements as per August 24, 2007
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Regulations of cGMP ensure the quality through out
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Manufacturing operations
In process Quality Control procedures
Packaging & labeling
Storage
Cleaning
Designing & Construction of Manufacturing Plants
Testing methods
Handling Customer Complaints
Documentation
As per regulations, manufacturers are required to evaluate
the identity, purity, strength, and composition of their
dietary supplements.
Final cGMP will effective from
 June, 2008 for Large companies with employee strength of more
than 500
 June, 2009 for companies with less than 500 or more than 20
employees.
 June, 2010 for companies with less than 20 employees.
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cGMP Requirements as per August 24, 2007

Under the cGMP rule, manufacturers are required to:
 Employ qualified employees and supervisors;
 Design and construct their physical plant in a manner to protect
dietary ingredients and dietary supplements from becoming
adulterated during manufacturing, packaging, labeling and holding;
 Use equipment and utensils that are of appropriate design,
construction, and workmanship for the intended use;
 Establish and use master manufacturing and batch production
records;
 Establish procedures for quality control operations;
 Proper Storage & Distribution in order to maintain efficacy & quality
of product.
 Keep a written record of each product complaint related to cGMPs.
 Retain records for 1 year past the shelf life date, if shelf life dating is
used, or 2 years beyond the date of distribution of the last batch of
dietary supplements associated with those records
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Claims That Can Be Made for Dietary
Supplements
Claims that can be used on food and
dietary supplement labels fall into three
categories:
1) Health claims
2) Qualified Health claims
3) Structure/Function claims

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Health Claims

A "health claim" by definition has two essential components:
 a substance (whether a food, food component, or dietary ingredient)
 a disease or health-related condition.

A statement lacking either one of these components does not meet the
regulatory definition of a health claim.

Nutrition Labeling and Education Act (NLEA), 1990 regulates the
Health claim petitions.

Examples of Health Claims:
 “Development of cancer depends on many factors. Eating a diet low in fat
and high in grain products, fruits and vegetables that contain dietary fiber
may reduce your risk of some cancers.”
 "diets high in calcium may reduce the risk of osteoporosis"
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Qualified Health Claims
 Consumer Health Information for Better Nutrition Initiative 2003
provides for the use of qualified health claims to substantiate evidence
for a relationship between a dietary supplement and reduced risk of a
disease or health-related condition.
 Label claim should be clear & concise to point limitation of the
Evidence supporting Health Claim.
 Both conventional foods and dietary supplements may use qualified
health claims
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Structure/Function Claims

Structure/function claims describe
 Role of a nutrient or dietary ingredient intended to affect normal
structure or function in humans. Such as, "calcium builds strong bones."
 The means by which a nutrient or dietary ingredient acts to maintain
such structure or function, Such as, "fiber maintains bowel regularity,“
 General well-being from consumption of a nutrient or dietary ingredient
 Benefit related to a nutrient deficiency disease (like vitamin C and
scurvy), with the prevalence of disease in US.

As Structure/Function claims are not pre-approved by FDA,
manufacturers are solely responsible for
 Claims are truthful, accurate & not misleading.
 Notification to FDA within first 30 days for the usage of claims for the
marketing of product.
 A mandatory disclaimer statement as per law.
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Claims Substantiation

“Truth in Advertising” is regulated more by FTC (not FDA)

Several Penalties have been levied already

Company is responsible for expressed and implied claims
(thru images, video, etc.)

Randomized Controlled Trials (RCT) are gold standard for
substantiation

Animal studies, Epidemiological studies, meta analyses
may be considered.
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Tips for Good Clinical Trials

Follow Good Clinical Practices (ICH GCP)
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Qualified, Trained and Professional Team
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Scientifically Strong Protocol with a valid Statistical Plan
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Maintain Audit trail
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Third Party Monitoring by trained Professionals
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Internal + External Audit, Quality Assurance
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Central Lab for multi-centric trials
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AE and SAE reporting
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Compliant Data Management
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High Quality Unbiased Medical Report and Manuscript Writing
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Publication
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Follow all available drug guidelines
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Outsource / offshore the study to a CRO if required
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Label Information
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Required label information must appear on:
 Principal Display Panel (PDP): It must contain
 Statement of identity (name of DS)- Name of DS should Placed
on label parallel to base of package and Should stand out Bold
type and At least 1/2 the size of the largest print on label.
 Net quantity of contents statement
 Information Panel: It must contain
 Name and address of manufacturer, packer, or distributor
 Ingredient list
 “Nutrition Facts” panel
 Information Pane should be placed to the immediate
right of PDP and if not, then next panel to right.
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Vedic Corporate Profile
Vedic has so far supported over 36 clinical studies (Phase II/ III) and
more than 400 preclinical across multiple therapeutic areas.
Core offerings entail Preclinical Studies, Consultancy, Project
Management (Phase I to IV), Clinical Data Management, BioStatistics, Medical Writing, Regulatory Consulting and
Pharmacovigilance Services
Founded in 2001, Vedic is a contract research organization that provides
broad-based yet highly tailored drug development & support
services to global Pharma, biotech and Lifesciences players.
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Vedic Services
Me
Clinic
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Dat
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Clinic
Con
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s
Tri
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ta
Mana
n
(Phas
Servic
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c
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me
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IV)  Data
 Preclinical
 GAP analysis  Study
nt
Consultancy
Validation
Feasibility
Analysis
 Feasibility
 Feasibility
 Investigator /  Database
Evaluation
Design
Site Selection
 Market
 Regulatory
Survey
Submission &  Data Entry &
 Study
analysis &
Tracking
Approval
Protocol
 CMC
(IRB/EC &
DCGI)
 Data Coding
 Study Set –  Analytical
 Site Initiation
up & Audits
Development
& Validation  Assessment  Database
Visits
Access
 Experimental
Management
 Site
& Project
 Formulation
Management
Management
Development
& Monitoring  Data
Management
 Investigational
Reporting
Product
Management
 Risk & Query
 Closeouts
management
 Query
Resolution
Pre
Cli
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Bio
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Regul
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Ser
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Wri
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 Clinical Trial  Study Design/i  Strategic cy  SAE
e
n regulatory
Design
Outline
collection, s
g planning for
evaluation,
specific
classification
countries
& reporting
 Sample Size  Protocol & its
Calculation
Amendments
Statist
ics
 Statistical
Analysis
Plans
 Informed
Consent
Document
 Pre – IND
meetings
 Medical case
reviews
 INDs
 Adverse event
narration &
coding
 Planning &
 Patient Diary
Execution of
and Subject  NDA and
interim
Emergency
ADNA
analysis
Card
 Final
Statistical
Analysis
 Clinical /
Statistical
study Report
 Statistical
Report
 Publication
Support
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 Applications
for marketing
license
 Complete
Pharmacovigil
ance
 BA/BE studies
 Biochemical
Assays
Thank You
Kindly visit us
at
www.vediclifesciences.com
Contact Us
at
[email protected]
Phone: +91-(0)22-42172300/10
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