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Dietary Supplements Public Meeting November 15, 2004

Dietary Supplements Public Meeting November 15, 2004. George A. Burdock, Ph.D. Diplomate, American Board of Toxicology Fellow, American College of Nutrition. A Conservative Response by the Agency. Legitimate dietary supplements Out of reach of the consumer Underground/unregulated products

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Dietary Supplements Public Meeting November 15, 2004

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  1. Dietary SupplementsPublic MeetingNovember 15, 2004 George A. Burdock, Ph.D. Diplomate, American Board of Toxicology Fellow, American College of Nutrition www.burdockgroup.com

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

  3. 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 www.burdockgroup.com

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

  5. 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’ www.burdockgroup.com

  6. 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 www.burdockgroup.com

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

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

  9. 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 www.burdockgroup.com

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

  11. 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 www.burdockgroup.com

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

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

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

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

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

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

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

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

  20. Independent Expert Review & FDA Notification Confidential submission To Agency 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 www.burdockgroup.com

  21. Independent Expert Review & FDA Notification Confidential submission To Agency Decision By Agency 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 No Public Notice Returned to Submitter www.burdockgroup.com

  22. Independent Expert Review & FDA Notification Public Notice By Agency Confidential submission To Agency Decision By Agency 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 Inadequate No Public Notice Returned to Submitter www.burdockgroup.com

  23. Independent Expert Review & FDA Notification Public Notice By Agency Confidential submission To Agency Decision By Agency 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 Inadequate No Public Notice Returned to Submitter www.burdockgroup.com

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

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

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

  27. 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) www.burdockgroup.com

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

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