Standardized Information on Dietary Ingredients SIDI

1
Standardized Information on Dietary
Ingredients(SIDI)

• A joint trade association initiative to
  standardize ingredient information exchange

2
Presentation Outline

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

3
Members of the Joint Standardized Ingredient
Information Protocol (SIIP) Working Group
4
Current Industry Practice

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

5
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?

6
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!

7
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?

8
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

9
Goal of SIDI To optimize information exchange
between ingredient suppliers and manufactures,
benefiting industry and consumers
10
Advantages of Using SIDI Protocol

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

11
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!

12
Advantages of using SIDI Protocol

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

13
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

14
Advantages of using SIDI Protocol

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

15
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

16
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

17
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

18
The SIDI A Users Guide

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

19
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

20
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

21
SIDI Format

• 3 separate main sections 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

22
SIDI Protocol
23
I. SIDI Sections

• Section 1. 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

24
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

25
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

26
II. SIDI Sections

• Section 2. 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

27
III. SIDI Sections

• Section 3. Supply Chain Security Overview
• Designed to provide manufacturers with
  information concerning the ingredient suppliers
  plans to ensure the protection of the product and
  the continuity of supply
• Intended to provide an overall picture of the
  suppliers plans while preserving the integrity
  of the plans
• Site specific

28
IV. 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

29
Under Development

• Mock or example forms
• SIDI FAQs
• Completion of the remaining two sections
• Site Quality
• Supply Chain Security

30
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

31
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

32
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!

33
Special Acknowledgements

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

34
Questions???