Transcript Nutritional Supplements

Dietary Supplements
CWAG Annual Conference
July 18, 2016
Paul Bolar
Vice President, Regulatory Affairs
Pharmavite LLC
Pharmavite Background
Founded in 1971
NatureMade® is the #1 U.S. national brand in the vitamin
category
Committed to high quality and scientific support behind
products that deliver on their promise
1400+ employees
Headquarters based in Northridge, California
Production facilities in Southern California and Opelika,
Alabama
Dietary Supplements
Regulatory Environment
FTC
State Laws
Self-Regulation
FDA
- DSHEA
- SAERs
- FSMA
Dietary
Supplements
- NAD
- Third-party
verification
- Other Industry
Initiatives
Dietary Supplement Health and
Education Act of 1994 (DSHEA)
Key Provisions
 Defines “Dietary Supplement”
 Specifies eligible types of Dietary Ingredients
 Provides process for introducing New Dietary
Ingredients
 Specifies allowable types of claims,
e.g. “structure/function” claims
 Good Manufacturing Procedures (GMPs)
Dietary Supplement GMPs
Food GMPs
- Sanitation,
- Housekeeping
- Pest control
Dietary
Supplement
GMPs
Drug GMPs
- Specifications
- Testing
- Documentation
Dietary Supplement GMPs
 The primary objective is to ensure that
Finished Products meet specifications for:
• Identity
• Strength
• Purity
• Composition
• Limits on Contaminants
 Raw Material and In-Process specifications
must also be established and tested for to help
ensure Finished Product specifications are met
Dietary Supplement GMPs
 Scientific compendia, such as USP, can provide
good source of product specifications and test
methods
 3rd party verification programs (e.g. USP, NSF)
can provide added assurance that specifications
are met and GMPs are followed
Dietary Supplement GMPs
Overview
Personnel
Receiving
Plant &
Grounds
Equipment
Dietary Supplement GMPs
Overview
Master
Manufacturing
Records
Batch
Production
Records
Quality Control
and
Laboratory
Operations
Process
Controls
Dietary Supplement GMPs
Overview (cont.)
Manufacturing
Packaging &
Labeling
Holding &
Distribution
Returned
Products
Dietary Supplement GMPs
Overview (cont.)
Product
Complaints
Recordkeeping
Dietary Supplements
Summary
 DSHEA is the key law that governs composition
and claims for dietary supplements
 Dietary Supplement GMPs provide a
comprehensive set of rules that govern the
quality of dietary supplements