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Regulatory Requirements for Dietary Supplements in USA
Mansi Ahuja
Vedic Lifesciences Pvt LtdVedic Lifesciences Pvt Ltd
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Health Regulators Worldwide
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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
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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
Pre Market NotificationMarketing
Success OF
Marketing
Claims
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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
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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
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.
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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
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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)
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
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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.
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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.
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.
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Vedic Services
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(Phase I-IV)(Phase I-IV)
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