1. www.burdockgroup.com Dietary Supplements Public Meeting November 15, 2004 George A. Burdock, Ph.D. Diplomate, American Board of Toxicology Fellow, American College of Nutrition

2. www.burdockgroup.com A Conservative Response by the Agency Legitimate dietary supplements Out of reach of the consumer Underground/unregulated products –Spurious claims –Unsafe products

3. www.burdockgroup.com Dietary Supplement Market Strong consumer market & driving forces –Quality of life issues –Lionizing of natural remedies –Reaction to high cost of drugs Strong consumer market –Encourages enterprise –Encourages competition

4. www.burdockgroup.com Dietary Supplements The Players and the Tension FDA Consumer Industry Greater Access Free Speech Consumer Demand Efficacy Safety Return on Investment

5. www.burdockgroup.com A Conservative Response by the Agency May affirm some strongly held beliefs Conspiracy theories about “big pharma” We ignore the wisdom of our elders We ignore the beneficence of ‘mother earth’

6. www.burdockgroup.com DSHEA as a Safety Valve DSHEA was a safety valve in response to a conservative posture by FDA Locking the valve –Consumers will lose faith in the Agency –Will give rise to Underground Uncontrolled Unsafe Wild, wild west

7. www.burdockgroup.com The Players and the Tension FDA is the key player FDA the Engine for Resolution

8. www.burdockgroup.com Three Steps Forward 1.Promote the use of Independent Experts 2.Initiate a Notification program 3.Permit a term of exclusivity

9. www.burdockgroup.com Independent Experts Precedent –GRAS for food ingredients –GRASE (…safe and effective) for drugs –FDA Advisory Committees Fact Sheet – Strategy for Dietary Supp. –Third party review Future? –Health Independence Information Act - HR 4004

10. www.burdockgroup.com Notification Program Examples –GRAS Notification –NDIN Advantages –Public information and safety –Assured vendors

11. www.burdockgroup.com Term of Exclusive Marketing Rights Precedent –Food additive master files –Drug master files Will drive investment –Fund safety studies –Fund efficacy studies Return on investment required

12. www.burdockgroup.com Term of Exclusivity Consumer demand Manufact. R&D Safety testing Efficacy testing $?

13. www.burdockgroup.com Term of Exclusivity Consumer demand Manufact. R&D Safety testing Efficacy testing $ No objection

14. www.burdockgroup.com Term of Exclusivity Consumer demand Manufact. R&D Safety testing Efficacy testing Manufacturing & Distribution Marketing $ No objection

15. www.burdockgroup.com Term of Exclusivity Consumer demand Manufact. R&D Safety testing Efficacy testing Manufacturing & Distribution Marketing $ No objection

16. www.burdockgroup.com Term of Exclusivity Consumer demand Manufact. R&D Safety testing Efficacy testing Manufacturing & Distribution Marketing $ "Pirate" $? No objection X

17. www.burdockgroup.com Term of Exclusivity Consumer demand Manufact. R&D Safety testing Efficacy testing Manufacturing & Distribution Marketing $ "Pirate" $? No objection XX No ROI

18. www.burdockgroup.com Three Steps Forward 1.Promote the use of Independent Experts 2.Initiate a Notification program 3.Permit a term of exclusivity

19. www.burdockgroup.com Independent Expert Review & FDA Notification Dossier Approved by Independent Experts (1) Safety & Proposed claim (2) Supporting evidence

20. www.burdockgroup.com Independent Expert Review & FDA Notification Dossier Approved by Independent Experts (1) Safety & Proposed claim (2) Supporting evidence Criteria Reviewed by Agency Claim & sup- porting evidence (Limited Review Criteria) Experts qualified “…by training and experience… Rationale sup- porting claim Credibility of sup- porting data Confidential submission To Agency

21. www.burdockgroup.com Independent Expert Review & FDA Notification Dossier Approved by Independent Experts (1) Safety & Proposed claim (2) Supporting evidence Criteria Reviewed by Agency Claim & sup- porting evidence (Limited Review Criteria) Experts qualified “…by training and experience… Rationale sup- porting claim Credibility of sup- porting data Inadequate Confidential submission To Agency Decision By Agency No Public Notice Returned to Submitter

22. www.burdockgroup.com Independent Expert Review & FDA Notification Dossier Approved by Independent Experts (1) Safety & Proposed claim (2) Supporting evidence Criteria Reviewed by Agency Claim & sup- porting evidence (Limited Review Criteria) Experts qualified “…by training and experience… Rationale sup- porting claim Credibility of sup- porting data No objection Public Notice By Agency Inadequate Confidential submission To Agency Decision By Agency No Public Notice Returned to Submitter

23. www.burdockgroup.com Independent Expert Review & FDA Notification Dossier Approved by Independent Experts (1) Safety & Proposed claim (2) Supporting evidence Criteria Reviewed by Agency Claim & sup- porting evidence (Limited Review Criteria) Experts qualified “…by training and experience… Rationale sup- porting claim Credibility of sup- porting data No objection FDA Website “Truthful Statement” (the claim) Product identity Manufacturer Safety data Public Notice By Agency Inadequate Confidential submission To Agency Decision By Agency No Public Notice Returned to Submitter

24. www.burdockgroup.com Term of Exclusivity Public Release (immediate) Safety information Claim Product name & manufacturer Sequestered Info. (~5 years) Supporting evidence for claim

25. www.burdockgroup.com Independent Expert Review & FDA Notification Relieve the logjam of petitions Benefit from the knowledge of independent experts Respond to consumer demands for empowerment

26. www.burdockgroup.com Term of Exclusivity Ensure ROI Respond to consumer demands for a variety of products Ensure products are properly vetted Ensure competition in marketplace

27. www.burdockgroup.com Resolution Consumers –Empowerment - greater access to new discoveries/enhancement of QoL –Drug cost savings Industry –Free speech assured –Return on investment FDA –Ensure consumer safety –Ensure efficacy (no mis-labeling)

28. www.burdockgroup.com Dietary Supplements Public Meeting November 15, 2004 George A. Burdock, Ph.D. Diplomate, American Board of Toxicology Fellow, American College of Nutrition Gburdock@burdockgroup.com