Standardized Information on Dietary Ingredients SIDI

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Standardized Information on Dietary
Ingredients(SIDI)

• A joint trade association initiative to
  standardize ingredient information exchange

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Presentation Outline

• Members of SIIP working group
• Current industry practice
• Industry challenges to overcome
• Goals/advantages of SIDI
• Planned process/format
• Next steps

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Members of the Joint Standardized Ingredient
Information Protocol (SIIP) Working Group
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Current Industry Practice

• Manufacturers use individualized product
  questionnaires because they
• must qualify vendors/suppliers
• cannot audit every vendor

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Questionnaire Challenges Industry Must Overcome

• Inconsistent and inefficient
• Every manufacturer has own individual format
• Difficult for vendor to complete
  quickly/accurately
• Questions may not apply to ingredient(s) of
  concern
• Require stamps/signatures what do these really
  mean?

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Questionnaire Challenges Industry Must Overcome

• Every manufacturer has own individual format
• Vendors receive too many questionnaires to
  complete
• Change control practically impossible
• Questionnaires often sent to distributors
• Most common response N/A!

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Questionnaire Challenges Industry Must Overcome

• Manufacturer sends out and receives back 100
  questionnaires of 50 pages each
• Who reviews all this information?
• How much actual information is provided?
• How is the information judged, stored, retrieved?
• What about change control?

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Primary Goals of the SIDI

• Enhance information management between dietary
  ingredient suppliers and dietary supplement
  manufacturers by providing standards for the
  exchange of data.
• Integrate information on raw dietary ingredient
  sourcing into a voluntary, standardized system -
  eliminating the need for a questionnaire

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Goal of SIDI To optimize information exchange
between ingredient suppliers and manufactures,
benefiting industry and consumers
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Advantages of Using SIDI Protocol

• Benefits of standardized ingredient information
  is INDUSTRY-WIDE
• Dietary supplement manufacturers
• Ingredient suppliers
• Consumers

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Advantages of using SIDI Protocol

• Practical and economic advantages
• Hidden costs of current industry practice
• Time/potential mistakes/corrections
• Significant costs and errors from this activity
  could be eliminated!

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Advantages of using SIDI Protocol

• For manufacturers
• Consistent information from multiple suppliers
  and across product lines
• Reduction/reallocation of costs/resources
• Change control

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Advantages of using SIDI Protocol

• For manufacturers
• Rapid retrieval/interpretation of information
• Information is more accessible to FDA
• Facilitates FDA audits (all information is
  already assembled)
• Facilitates merger/acquisition transitions

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Advantages of using SIDI Protocol

• For ingredient suppliers
• Complete data in standardized format
• Reduced completion time
• Increased accuracy of information

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Advantages of using SIDI Protocol

• For ingredient suppliers
• Change control/notification
• Liability risk potentially reduced
• Potential for Electronic Data Interchange (EDI)
• Forms can be made available for download

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Advantages of using SIDI Protocol

• For consumers
• Increased standardization of any process has
  potential to reduce risk of error
• More organized system of vendor qualification
  could increase safety/quality of products

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The Proposed Solution

• SIIP working groups Standardized Information on
  Dietary Ingredients (SIDI) Protocol
• Provides the basis for suppliers to develop their
  own dietary ingredient data sheets (DIDS) to be
  sent to manufactures in lieu of questionnaires

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The SIDI A Users Guide

• Primary purpose
• Provide voluntary standards for the exchange of
  ingredient information between ingredient
  suppliers and finished product manufacturers

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The SIDI A Users Guide

• Content
• Scope and purpose of the SIDI Protocol
• Formatting information
• Section-by-section evaluation of the SIDI
  documents
• Dietary ingredient data sheets (DIDS)
• Interactive definitions and glossary

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Highlights of the SIDI Protocol

• Standardized document with change control,
  planned updates, and reviews
• Broad Scope
• developed by members of four industry trade
  associations with the goal of obtaining
  industry-wide acceptance
• Use is entirely voluntary and is not enforceable
• Will be provided to FDA for comment

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SIDI Format

• 2 separate main documents glossary
• Information package vs. questionnaire
• Defines the minimum type and scope of information
  that should be covered
• Format of DIDS is ingredient suppliers choice
• Similar to MSDSs
• Minimum topics
• Revision history/contact information
• Potential for broader usage

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SIDI Protocol
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I. SIDI Protocol

• Product Information Data Sheet
• Intended for non-botanical botanical
  ingredients
• Important physical, manufacturing and regulatory
  information specific to the ingredient
• Intended to facilitate the use of the ingredient
  in finished products

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Product Information

• Part A. Non-Botanical Dietary Ingredients
• Section 1 Product Information
• Section 2 Manufacturing Information
• Section 3 Physical/Chemical Information
• Section 4 Labeling Information
• Section 5 Regulatory Information
• Section 6 Miscellaneous Product Information

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Product Information

• Part B. Botanical Dietary Ingredients
• Section 1 Botanical Ingredient Identity and
  Composition
• Section 2 Botanical Manufacturing Information
• Section 3 Physical/chemical information
• Section 4 Labeling Information
• Section 5 Regulatory Information
• Section 6 Miscellaneous Product
  Information

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II. SIDI Protocol

• Site Quality Overview
• Tool to assist in evaluating the manufacturing
  practices and quality systems of ingredient
  suppliers
• Intended to address the foundation of the
  requirements and not all of the details
• Site specific

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III. SIDI Sections

• Comprehensive glossary
• Contains a comprehensive list of terms,
  compendia, regulations, authoritative bodies
• Definitions, web site links
• Hyperlinked to terms in the body of the document

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Under Development

• Mock or example forms
• SIDI FAQs

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Accessing the SIDI

• Accessible free of charge at www.ahpa.org
• www.chpa-info.org www.crnusa.org
  www.naturalproductsassoc.org
• Questions can be submitted to AHPA, CHPA, CRN or
  Natural Products Association
• Will be used as the basis for updates to the
  Protocol

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Challenges to Implementation

• Industry acceptance
• Each manufacturer attached to their own system
• Ingredient suppliers must maintain sensitivity to
  customers special requests (customer service)
• Both suppliers and manufacturers must remain
  current on global requirements

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Summary

• Current industry challenges
• Goal of SIDI - To optimize information exchange
  between ingredient suppliers and manufacturers,
  benefiting industry and consumer
• Additional details to follow soon!

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Special Acknowledgements

• Paul Bolar, Pharmavite
• Dave Schoneker Alexa Smith, Colorcon
• Steven Dentali, AHPA
• Marcia Howard, CHPA
• Dan Fabricant, NPA
• Andrew Shao, CRN

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Questions???