Www.vediclifesciences.com Regulatory Requirements for Dietary Supplements in USA Mansi Ahuja Vedic...

www.vediclifesciences.com

Regulatory Requirements for Dietary Supplements in USA

Mansi Ahuja

Vedic Lifesciences Pvt LtdVedic Lifesciences Pvt Ltd


Health Regulators Worldwide


Status of AYUSH Products in USA

In INDIA AYUSH Products

Traditional Indian

Medicine

Patent & Proprietary or

Shastrokta Drugs

Can claim disease cure /

treatment

Can be prescribed or

OTC

In USA Dietary Supplements

Herbal Supplements

Food Supplements

Cannot claim disease

cure, but only health

maintenance

Only OTC

Not reimbursed by

insurance


Types of Health Regulations

“How To Enter” Regulations(Pre-Market)

“What to Submit” Regulations(Guidelines)

“What To Do” Regulations(Marketing, Post-marketing)


“How To Enter” Regulations

Pre-Market


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


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


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.


Dietary Supplement

ODI NDI

Pre Market NotificationMarketing

Success OF

Marketing

Claims


Difference between Dietary Supplement, Foods & Drugs

Foods:Principal Item of a

Person’s Diet

Dietary Supplement:Supplements diet by increasing the total

dietary intake

Drugs:Diagnosis, Cure,

Mitigation, Treatment or prevention of a

disease


“What to Submit” Regulations

Guidelines


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.


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.


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.


Warning

Dietary Supplement with NDI can only reach the

market after 75 days of notification period.


“What to Do” Regulations

Marketing & Post Marketing rules


cGMP Requirements as per August 24, 2007

Regulations of cGMP ensure the quality through out 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.


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

cGMP Requirements as per August 24, 2007


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


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"


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


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.


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.


Tips for Good Clinical Trials

Follow Good Clinical Practices (ICH GCP)

Qualified, Trained and Professional Team

Scientifically Strong Protocol with a valid Statistical Plan

Maintain Audit trail

Third Party Monitoring by trained Professionals

Internal + External Audit, Quality Assurance

Central Lab for multi-centric trials

AE and SAE reporting

Compliant Data Management

High Quality Unbiased Medical Report and Manuscript Writing

Publication

Follow all available drug guidelines

Outsource / offshore the study to a CRO if required


Label Information

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.


Vedic Corporate Profile

Vedic has so far supported over 36 clinical studies (Phase II/ III) and more than 400 preclinical across multiple therapeutic areas.

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, Bio-Statistics, Medical Writing, Regulatory Consulting and Pharmacovigilance Services

Core offerings entail Preclinical Studies, Consultancy, Project Management (Phase I to IV), Clinical Data Management, Bio-Statistics, 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.

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.


Vedic Services

Pre Clinical Pre Clinical

ServicesServicesConsultancyConsultancy

Clinical TrialsClinical Trials

(Phase I-IV)(Phase I-IV)

Clinical DataClinical Data

ManagementManagement

BioBio

StatisticsStatistics

Medical Medical

WritingWriting

RegulatoryRegulatory

ConsultancyConsultancy

Other Other

ServicesServices

Preclinical Preclinical ConsultancyConsultancy

Feasibility Feasibility EvaluationEvaluation

Study Study analysis & analysis & ProtocolProtocol

Study Set – Study Set – up & Auditsup & Audits

Experimental Experimental & Project & Project ManagementManagement

GAP analysisGAP analysis

FeasibilityFeasibility

Market Market SurveySurvey

CMCCMC

Analytical Analytical Development Development & Validation& Validation

Formulation Formulation DevelopmentDevelopment

Study Study Feasibility Feasibility AnalysisAnalysis

Investigator / Investigator / Site SelectionSite Selection

Regulatory Regulatory Submission & Submission & Approval Approval (IRB/EC & (IRB/EC & DCGI)DCGI)

Site InitiationSite Initiation

Assessment Assessment VisitsVisits

Site Site Management Management & Monitoring& Monitoring

Investigational Investigational Product Product ManagementManagement

CloseoutsCloseouts

Query Query ResolutionResolution

Data Data ValidationValidation

Database Database DesignDesign

Data Entry & Data Entry & TrackingTracking

Data CodingData Coding

Database Database Access Access ManagementManagement

Data Data Management Management ReportingReporting

Risk & Query Risk & Query managementmanagement

Clinical Trial Clinical Trial DesignDesign

Sample Size Sample Size CalculationCalculation

Statistical Statistical Analysis Analysis PlansPlans

Planning & Planning & Execution of Execution of interim interim analysisanalysis

Final Final Statistical Statistical AnalysisAnalysis

Statistical Statistical Report Report

Study Design/ Study Design/ OutlineOutline

Protocol & its Protocol & its AmendmentsAmendments

Informed Informed Consent Consent DocumentDocument

Patient Diary Patient Diary and Subject and Subject Emergency Emergency CardCard

Clinical / Clinical / Statistical Statistical study Reportstudy Report

Publication Publication SupportSupport

Strategic Strategic regulatory regulatory planning for planning for specific specific countriescountries

Pre – IND Pre – IND meetingsmeetings

INDsINDs

NDA and NDA and ADNAADNA

Applications Applications for marketing for marketing license license

SAE SAE collection, collection, evaluation, evaluation, classification classification & reporting& reporting

Medical case Medical case reviewsreviews

Adverse event Adverse event narration & narration & coding coding

Complete Complete PharmacovigilPharmacovigilanceance

BA/BE studiesBA/BE studies

Biochemical Biochemical AssaysAssays


Thank You

Kindly visit usat


Contact Usat

[email protected]

Phone: +91-(0)22-42172300/10

http://www.vediclifesciences.com/

mailto:[email protected]

Www.vediclifesciences.com Regulatory Requirements for Dietary Supplements in USA Mansi Ahuja Vedic...

Documents

Transcript of Www.vediclifesciences.com Regulatory Requirements for Dietary Supplements in USA Mansi Ahuja Vedic...