1. SIDI™ ppt V2.0 1-01-08 1 Standardized Information on Dietary Ingredients (SIDI™) A joint trade association initiative to standardize ingredient information exchange

2. SIDI™ ppt V2.0 1-01-08 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. SIDI™ ppt V2.0 1-01-08 3 Members of the Standardized Information on Dietary Ingredients (SIDI) Working Group

4. SIDI™ ppt V2.0 1-01-08 4 Current Industry Practice Manufacturers use individualized product questionnaires because they: must qualify vendors/suppliers cannot audit every vendor

5. SIDI™ ppt V2.0 1-01-08 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. SIDI™ ppt V2.0 1-01-08 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. SIDI™ ppt V2.0 1-01-08 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. SIDI™ ppt V2.0 1-01-08 8 The Proposed Solution SIIP working group’s 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 Based on the Excipient Information Protocol (EIP) developed by IPEC

9. SIDI™ ppt V2.0 1-01-08 9 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

10. Optimizing information exchange between ingredient suppliers and manufactures, benefiting industry and consumers Ingredient suppliers Manufacturers

11. SIDI™ ppt V2.0 1-01-08 11 Advantages of Using SIDI™ Protocol Benefits of standardized ingredient information is INDUSTRY-WIDE:  Dietary supplement manufacturers  Ingredient suppliers  Consumers

12. SIDI™ ppt V2.0 1-01-08 12 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!

13. SIDI™ ppt V2.0 1-01-08 13 Advantages of using SIDI™ Protocol For manufacturers: Consistent information from multiple suppliers and across product lines Reduction/reallocation of costs/resources Change control

14. SIDI™ ppt V2.0 1-01-08 14 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 Advantages of using SIDI™ Protocol

15. SIDI™ ppt V2.0 1-01-08 15 For ingredient suppliers: Complete data in standardized format Reduced completion time Increased accuracy of information Advantages of using SIDI™ Protocol

16. SIDI™ ppt V2.0 1-01-08 16 For ingredient suppliers: Change control/notification Liability risk potentially reduced Potential for Electronic Data Interchange (EDI) Forms can be made available for download Advantages of using SIDI™ Protocol

17. SIDI™ ppt V2.0 1-01-08 17 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 Advantages of using SIDI™ Protocol

18. SIDI™ ppt V2.0 1-01-08 18 SIDI™ Protocol Contents  Scope and purpose of the SIDI™ Protocol  Formatting information  Section-by-section evaluation of the SIDI™ document  Dietary ingredient data sheets (DIDS)  Interactive definitions and glossary

19. SIDI™ ppt V2.0 1-01-08 19 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 Has been provided to FDA for comment

20. SIDI™ ppt V2.0 1-01-08 20 SIDI™ Format 2 separate main sections + glossary Defines the minimum type and scope of information that should be covered Information package vs. questionnaire Format of DIDS is ingredient supplier’s choice Similar to MSDSs Minimum topics Revision history/contact information Potential for broader usage

21. SIDI™ ppt V2.0 1-01-08 21 SIDI™ User Guide SIDI  User Guide Description of SIDI How to obtain the document Tips on use and application

22. SIDI™ ppt V2.0 1-01-08 22 SIDI™ Protocol

23. SIDI™ ppt V2.0 1-01-08 23 Part I Product Information 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. SIDI™ ppt V2.0 1-01-08 24 Product Information 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 Section 7 – Revisions Section 8 – Contact Information

25. SIDI™ ppt V2.0 1-01-08 25 Product Information B. Botanical Dietary Ingredients Section 2 – Botanical Manufacturing Information Section 3 – Physical/Chemical Information Section 4 – Labeling Information Section 1 – Botanical Product Information Section 5 – Regulatory Information Section 6 – Miscellaneous Product Information Section 7 – Revisions Section 8 – Contact Information

26. SIDI™ ppt V2.0 1-01-08 26 Part II 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. SIDI™ ppt V2.0 1-01-08 27 Site Quality Overview Section 1 – Site Overview Section 2 – Evidence of Compliance Section 3 – cGMP Compliance Details Section 4 – Additional Information Section 5 – Revisions Section 6 – Contact Information

28. SIDI™ ppt V2.0 1-01-08 28 Glossary 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. SIDI™ ppt V2.0 1-01-08 29 Uses of SIDI  Point of differentiation for quality focused ingredient suppliers Serves as “pre-audit” assisting manufacturers with vendor qualification and GMP compliance NDI notification International product registration

30. SIDI™ ppt V2.0 1-01-08 30 Future Developments Periodic surveys of SIDI™ users Continued emphasis at industry trade shows and in trade publications Globalization

31. SIDI™ ppt V2.0 1-01-08 31 Accessing the SIDI™ Accessible free of charge at: www.ahpa.org; www.ahpa.org www.chpa-info.orgwww.chpa-info.org; www.crnusa.org; www.naturalproductsassoc.orgwww.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

32. SIDI™ ppt V2.0 1-01-08 32 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

33. SIDI™ ppt V2.0 1-01-08 33 Summary Current industry challenges Goal of SIDI™ - To optimize information exchange between ingredient suppliers and manufacturers, benefiting industry and consumer

34. SIDI™ ppt V2.0 1-01-08 34 Special Acknowledgements Paul Bolar, Pharmavite Dave Schoneker & Alexa Smith, Colorcon, IPEC Steven Dentali, AHPA Marcia Howard, CHPA Dan Fabricant, NPA Andrew Shao, CRN

35. SIDI™ ppt V2.0 1-01-08 35 Questions???