CWAG Annual Conference Vice President, Regulatory Affairs 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 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 1989. 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

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

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 Drug GMPs - Specifications - Testing - Documentation Dietary Supplement GMPs

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