Dietary supplement contract manufacturers and their “own-label distributor” customers must navigate a host of issues in order to establish effective business partnerships that ensure quality and compliance with federal laws and regulations.
- An overview of issues purchasers and manufactures should consider:
- What information is needed to prepare a manufacturing quote?
- How should specifications be set?
- How are record keeping and quality control tasks assigned?
- Regulatory requirements for each party:
- What does FDA expect during inspections?
- How do the inspection obligations of the contract manufacturer differ from those of the own label distributor?
- What manufacturing records should a distributor retain?
- Who has responsibility for customer complaints and adverse events?
- Insights from veterans from both sides (manufacturers and distributors)
- Answers to participants' questions by an FDA official and legal and industry experts
Tony Young -- Partner at Kleinfeld, Kaplan and Becker, LLP, and AHPA General Counsel
Cara Welch -- Team Leader of the Dietary Supplements Regulations Implementation Team in the Division of Dietary Supplement Programs at the U.S. Food and Drug Administration (FDA)
David Morrison -- Vice President of Scientific and Regulatory Affairs at Vitamin Shoppe
Richard Kaufman -- Chief Operating Officer at Paragon Laboratories
Mitch Coven -- President of Vitality Works, Inc.
Michael McGuffin -- President of AHPA
- MP3 Audio file recording of the two-hour webinar
- White paper: The Relationship Between Dietary Supplement Contract Manufacturers and Packagers and their Customers -- DRAFT
- White paper: Records Requirements for Contract Manufacturers, Packagers and Distributors of Dietary Supplements -- DRAFT
- Checklist: Assigning responsibilities for contract manufacturers and their customers
- Sample distributor Request for Quote from a contract manufacturer
- Annotated Final Rule on Dietary Supplement cGMP
- Presenters’ slides