Standardized Information on Dietary Ingredients SIDI

1. SIDI™ ppt V1.2 7-11-07 1 Standardized Information on Dietary Ingredients(SIDI™) A joint trade association initiative to standardize ingredient information exchange

2. SIDI™ ppt V1.2 7-11-07 2 Proposed solution: Advantages Format Challenges NG – Overview Current Industry Practice Situation Industry Challenges to Overcome Advantages to SIIP Process/Format Next Steps Proposed solution: Advantages Format Challenges NG – Overview Current Industry Practice Situation Industry Challenges to Overcome Advantages to SIIP Process/Format Next Steps

3. SIDI™ ppt V1.2 7-11-07 3 Members of the Joint Standardized Ingredient Information Protocol (SIIP) Working Group More companies to be added????? –More companies to be added????? –

4. SIDI™ ppt V1.2 7-11-07 4 Current Industry Practice Manufacturers use individualized product questionnaires because they: must qualify vendors/suppliers cannot audit every vendor must qualify vendors/suppliers Manufacturing practices Quality systems Nature of raw ingredient cannot audit every vendor Questionnaires cannot replace audits, but provide vital supplemental information to assist in must qualify vendors/suppliers Manufacturing practices Quality systems Nature of raw ingredient cannot audit every vendor Questionnaires cannot replace audits, but provide vital supplemental information to assist in

5. SIDI™ ppt V1.2 7-11-07 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 V1.2 7-11-07 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 V1.2 7-11-07 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? Answers to these questions will help create the solution Answers to these questions will help create the solution

8. SIDI™ ppt V1.2 7-11-07 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. SIDI™ ppt V1.2 7-11-07 10 Advantages of Using SIDI™ Protocol Benefits of standardized ingredient information is INDUSTRY-WIDE: Dietary supplement manufacturers Ingredient suppliers Consumers

11. SIDI™ ppt V1.2 7-11-07 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! Time it takes to send these out, follow up, receive back Possible mistakes made in providing the information Corrections, if mistakes are detected at all Time it takes to send these out, follow up, receive back Possible mistakes made in providing the information Corrections, if mistakes are detected at all

12. SIDI™ ppt V1.2 7-11-07 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. SIDI™ ppt V1.2 7-11-07 13 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. SIDI™ ppt V1.2 7-11-07 14 For ingredient suppliers: Complete data in standardized format Reduced completion time Increased accuracy of information

15. SIDI™ ppt V1.2 7-11-07 15 For ingredient suppliers: Change control/notification Liability risk potentially reduced Potential for Electronic Data Interchange (EDI) Forms can be made available for download

16. SIDI™ ppt V1.2 7-11-07 16 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. SIDI™ ppt V1.2 7-11-07 17 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 IPEC’s Standardized Excipient Information Protocol, EIP (www.ipecamericas.org) Based on IPEC’s Standardized Excipient Information Protocol, EIP (www.ipecamericas.org)

18. SIDI™ ppt V1.2 7-11-07 18 The SIDI™: A User’s Guide Primary purpose Provide voluntary standards for the exchange of ingredient information between ingredient suppliers and finished product manufacturers

19. SIDI™ ppt V1.2 7-11-07 19 The SIDI™: A User’s 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. SIDI™ ppt V1.2 7-11-07 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™ ppt V1.2 7-11-07 21 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 supplier’s choice Similar to MSDSs Minimum topics Revision history/contact information Potential for broader usage SIDI™ is an information package as opposed to a questionnaire Similar to MSDS (do not require signatures) Q & A format is not necessary or preferred Short, bulleted formats are encouraged Specific phrasing also not specified Must be in official company format and/or on letterhead Potential for broader usage - food, personal care, and dietary supplement industry, including botanicals SIDI™ is an information package as opposed to a questionnaire Similar to MSDS (do not require signatures) Q & A format is not necessary or preferred Short, bulleted formats are encouraged Specific phrasing also not specified Must be in official company format and/or on letterhead Potential for broader usage - food, personal care, and dietary supplement industry, including botanicals

22. SIDI™ ppt V1.2 7-11-07 22 SIDI™ Protocol

23. SIDI™ ppt V1.2 7-11-07 23 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 Explain part a and part b sections. Explain part a and part b sections.

24. SIDI™ ppt V1.2 7-11-07 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 Section 1 - Product Information This section provides general information about the product. Full product description Product name and code (if applicable) "Common or usual name" of product Scope of document General product information, e.g., generally intended uses, form, etc. (optional) Section 2 – Manufacturing Information This section provides general information about how the product is manufactured. Name and address of site where this product is manufactured Indicate whether this product is self-manufactured, contract manufactured (including any toll processes) or brokered Description of manufacturing process (blend, reaction, etc.) and/or flowchart GMP compliance statement (e.g., food GMPs, USP dietary manufacturing practices, etc.) Identify any method of sterilization and/or fumigation used (if applicable). Brief description of known or potential impurities Identify any organic solvents and solvent mixtures (including composition) used in product manufacturing and address potential for residual solvent levels in finished commercial product Include the known and suspected impurities listed below in section 3 Section 3 – Physical/Chemical Information This section provides general physical, chemical and related information about the product. List all ingredients (including excipients) in descending order of predominance and indicate the weight percentage, “common or usual name,” other synonyms, and CAS number of each ingredient, with the exception that weight percentages need not be given for proprietary blends of dietary ingredients. Origin information for each ingredient contained in the product (synthetic, animal, vegetable, mineral, product of fermentation, botanical, etc…) Section 3 – Physical/Chemical Information, con’t Product specifications - Attach current product specification sheet including method of analysis and limit of detection for each test. Specifications should include, as applicable, the following: Appearance/physical description Method(s) of determining ingredient identity Physical parameters (e.g. pH, mesh size, moisture, bulk density) Microbiology (total aerobic plate count, yeast and mold, coliforms, E. coli, Salmonella spp., other) Disclose known or suspected impurities; include specifications (if known): e.g. polycyclic aromatic hydrocarbons (PAH), dioxins, acrylamides, heavy metals, pesticides, organic volatile impurities (OVI), aflatoxins and other mycotoxins, preservatives, latex, silicones, other CA Proposition 65 chemicals, etc… Quantitative analysis of active compounds and/or marker compounds Description of how impurities and lot-to-lot variation are controlled Bioassay method, if applicable. Section 4 - Labeling Information This section provides general information related to product labeling. Required finished product label statements (e.g., patent attribution, logo usage, etc…, if applicable) Recommended restrictions of use – see section 5 for possible specifics Information related to Nutritional Facts/Supplement Facts statements (e.g., fat, protein, carbohydrate and other nutritional content information, if applicable) Section 5 - Regulatory Information This section includes information related to the regulatory status of the product and addresses pertinent product specific topics of general regulatory concern as applicable. Information about patent coverage Compendial grade (e.g., USP/NF, ANSI, FCC, PhEur, BP, JP, JSFA) Regulatory status and supporting information New Dietary Ingredient (NDI) status Generally Recognized as Safe (GRAS) status Food additive status Other (e.g., 21 CFR, CA Proposition 65, European legislation, JECFA) Product Master File (NHPMF) availability BSE/TSE Information (both related to the product and the potential for cross-contamination) Vegan or vegetarian status Allergens/Hypersensitivities Information (both related to the product and the potential for cross-contamination) – Reference the regulation or specific allergens evaluated Provide lists and references for specific allergens cited in the regulations: FALCPA, EU Directive, Japan, etc… Kosher/Halal and/or Organic status, including certifying agency(s) GMO status of all ingredients (non-GMO, GMO-free by testing, identity preserved, etc…). Tariff code for importation/exportation of product(s) Section 6 - Miscellaneous Product Information This section should be used by the supplier to provide any additional information that may be pertinent to the product but is not covered elsewhere in this document or in the other SIDI™ documents. Explanation of the batch/lot numbering system Description of batch definition Expiration dating and/or recommended reevaluation interval Recommended storage conditions Other optional information Package size offerings and/or types Use of recycled packaging materials Suggested product claims, including supporting documentation MSDS Other product safety information Section 1 - Product Information This section provides general information about the product. Full product description Product name and code (if applicable) "Common or usual name" of product Scope of document General product information, e.g., generally intended uses, form, etc. (optional) Section 2 – Manufacturing Information This section provides general information about how the product is manufactured. Name and address of site where this product is manufactured Indicate whether this product is self-manufactured, contract manufactured (including any toll processes) or brokered Description of manufacturing process (blend, reaction, etc.) and/or flowchart GMP compliance statement (e.g., food GMPs, USP dietary manufacturing practices, etc.) Identify any method of sterilization and/or fumigation used (if applicable). Brief description of known or potential impurities Identify any organic solvents and solvent mixtures (including composition) used in product manufacturing and address potential for residual solvent levels in finished commercial product Include the known and suspected impurities listed below in section 3 Section 3 – Physical/Chemical Information This section provides general physical, chemical and related information about the product. List all ingredients (including excipients) in descending order of predominance and indicate the weight percentage, “common or usual name,” other synonyms, and CAS number of each ingredient, with the exception that weight percentages need not be given for proprietary blends of dietary ingredients. Origin information for each ingredient contained in the product (synthetic, animal, vegetable, mineral, product of fermentation, botanical, etc…) Section 3 – Physical/Chemical Information, con’t Product specifications - Attach current product specification sheet including method of analysis and limit of detection for each test. Specifications should include, as applicable, the following: Appearance/physical description Method(s) of determining ingredient identity Physical parameters (e.g. pH, mesh size, moisture, bulk density) Microbiology (total aerobic plate count, yeast and mold, coliforms, E. coli, Salmonella spp., other) Disclose known or suspected impurities; include specifications (if known): e.g. polycyclic aromatic hydrocarbons (PAH), dioxins, acrylamides, heavy metals, pesticides, organic volatile impurities (OVI), aflatoxins and other mycotoxins, preservatives, latex, silicones, other CA Proposition 65 chemicals, etc… Quantitative analysis of active compounds and/or marker compounds Description of how impurities and lot-to-lot variation are controlled Bioassay method, if applicable. Section 4 - Labeling Information This section provides general information related to product labeling. Required finished product label statements (e.g., patent attribution, logo usage, etc…, if applicable) Recommended restrictions of use – see section 5 for possible specifics Information related to Nutritional Facts/Supplement Facts statements (e.g., fat, protein, carbohydrate and other nutritional content information, if applicable) Section 5 - Regulatory Information This section includes information related to the regulatory status of the product and addresses pertinent product specific topics of general regulatory concern as applicable. Information about patent coverage Compendial grade (e.g., USP/NF, ANSI, FCC, PhEur, BP, JP, JSFA) Regulatory status and supporting information New Dietary Ingredient (NDI) status Generally Recognized as Safe (GRAS) status Food additive status Other (e.g., 21 CFR, CA Proposition 65, European legislation, JECFA) Product Master File (NHPMF) availability BSE/TSE Information (both related to the product and the potential for cross-contamination) Vegan or vegetarian status Allergens/Hypersensitivities Information (both related to the product and the potential for cross-contamination) – Reference the regulation or specific allergens evaluated Provide lists and references for specific allergens cited in the regulations: FALCPA, EU Directive, Japan, etc… Kosher/Halal and/or Organic status, including certifying agency(s) GMO status of all ingredients (non-GMO, GMO-free by testing, identity preserved, etc…). Tariff code for importation/exportation of product(s) Section 6 - Miscellaneous Product Information This section should be used by the supplier to provide any additional information that may be pertinent to the product but is not covered elsewhere in this document or in the other SIDI™ documents. Explanation of the batch/lot numbering system Description of batch definition Expiration dating and/or recommended reevaluation interval Recommended storage conditions Other optional information Package size offerings and/or types Use of recycled packaging materials Suggested product claims, including supporting documentation MSDS Other product safety information

25. SIDI™ ppt V1.2 7-11-07 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 Explain part a and part b sections. Explain part a and part b sections.

26. SIDI™ ppt V1.2 7-11-07 26 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

27. SIDI™ ppt V1.2 7-11-07 27 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

28. SIDI™ ppt V1.2 7-11-07 28 Under Development “Mock” or example forms SIDI™ FAQs To demonstrate an example of a complete dietary supplement ingredient data sheets (DSIDS) Imaginary product and company New questions can be submitted to AHPA, CHPA CRN, or NPA Will be used as the basis for updates to the Protocol Regulatory Reference Guide -- Purpose To provide links to regulatory information to assist in the preparation of DIIP documents Maintained by SIIP working group Valuable tool to all regulatory/quality professionals involved in the dietary supplement industry Available free of charge http://www.tobedetermined.org To demonstrate an example of a complete dietary supplement ingredient data sheets (DSIDS) Imaginary product and company New questions can be submitted to AHPA, CHPA CRN, or NPA Will be used as the basis for updates to the Protocol Regulatory Reference Guide -- Purpose To provide links to regulatory information to assist in the preparation of DIIP documents Maintained by SIIP working group Valuable tool to all regulatory/quality professionals involved in the dietary supplement industry Available free of charge http://www.tobedetermined.org

29. SIDI™ ppt V1.2 7-11-07 29 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 The SIDI™ will be made available electronically free of charge from the web site of any one of the four participating trade associations: The SIDI™ will be made available electronically free of charge from the web site of any one of the four participating trade associations:

30. SIDI™ ppt V1.2 7-11-07 30 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

31. SIDI™ ppt V1.2 7-11-07 31 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!

32. SIDI™ ppt V1.2 7-11-07 32 Special Acknowledgements Paul Bolar, Pharmavite Dave Schoneker & Alexa Smith, Colorcon Steven Dentali, AHPA Marcia Howard, CHPA Dan Fabricant, NPA Andrew Shao, CRN

33. SIDI™ ppt V1.2 7-11-07 33 Questions???