2. CWAG Annual Conference Vice President, Regulatory Affairs
Dietary Supplements
CWAG Annual Conference
July 18, 2016
Paul Bolar
Vice President, Regulatory Affairs
Pharmavite LLC

3. 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
Pharmavite was founded in 1971 by Barry Pressman, a pharmacist, and Henry Burdick, a sales representative. Their goal was to offer the highest quality vitamins, minerals, and supplements that delivered on their promises. Over 40 years later, Pharmavite remains committed to high standards and science behind products that work.
Pharmavite was purchased by Otsuka Pharmaceutical Company, Ltd. In With its international network, Otsuka brings to Pharmavite worldwide resources coupled with a shared vision to enhance the quality of human life.
Mission, Vision, and Values
We share our parent company’s mission: People creating products for better health worldwide.
Our vision: Inspiring the healthiest you through more complete nutrition, wherever you are in life
Pharmavite’s ~1350 employees pursue our mission and vision guided by Pharmavite’s values: Integrity, Diversity & Inclusion, Passion, Courage, and Teamwork
Pharmavite is based in Southern California. In addition to our headquarters in Northridge, we produce all our product in the U.S.. We have three production facilities in Southern California and one in Opelika, Alabama, as well as a DC in Valencia, CA and a 3PL DC in Indiana. We recently opened our first office outside the U.S., in Shanghai China. 3

4. Dietary Supplements Regulatory Environment
FDA
- DSHEA
- SAERs
- FSMA
FTC
Self-Regulation
- NAD
- Third-party verification
- Other Industry Initiatives
State Laws

5. 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)

6. Dietary Supplement GMPs
Food GMPs
- Sanitation,
- Housekeeping
- Pest control
Drug GMPs
- Specifications
- Testing
- Documentation
Dietary Supplement GMPs

7. 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

8. 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

9. Dietary Supplement GMPs Overview
Personnel
Receiving
Plant & Grounds
Equipment

10. Dietary Supplement GMPs Overview
Master Manufacturing Records
Batch Production Records
Quality Control and Laboratory Operations
Process Controls

11. Dietary Supplement GMPs Overview (cont.)
Manufacturing
Packaging & Labeling
Holding & Distribution
Returned Products

12. Dietary Supplement GMPs Overview (cont.)
Product Complaints
Recordkeeping

13. 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