Dietary Supplements Public Meeting November 15, 2004

1
Dietary SupplementsPublic MeetingNovember 15,
2004

• George A. Burdock, Ph.D.
• Diplomate, American Board of Toxicology
• Fellow, American College of Nutrition

2
A Conservative Response by the Agency

• Legitimate dietary supplements
• Out of reach of the consumer
• Underground/unregulated products
• Spurious claims
• Unsafe products

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

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

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

7
The Players and the TensionFDA is the key
player FDA the Engine for Resolution
8
Three Steps Forward

• Promote the use of Independent Experts
• Initiate a Notification program
• Permit a term of exclusivity

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

10
Notification Program

• Examples
• GRAS Notification
• NDIN
• Advantages
• Public information and safety
• Assured vendors

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

12
Term of Exclusivity
?
Manufact.
RD
Consumer demand
Safety testing
Efficacy testing
13
Term of Exclusivity

Manufact.
RD
Consumer demand
Safety testing
Efficacy testing
No objection
14
Term of Exclusivity

Manufact.
RD
Consumer demand
Safety testing
Manufacturing Distribution
Efficacy testing
Marketing
No objection
15
Term of Exclusivity

Manufact.
RD
Consumer demand
Safety testing
Manufacturing Distribution
Efficacy testing
Marketing
No objection
16
Term of Exclusivity

X
Manufact.
RD
Consumer demand
Safety testing
Manufacturing Distribution
?
Efficacy testing
"Pirate"
Marketing
No objection
17
Term of Exclusivity
No ROI

X
X
Manufact.
RD
Consumer demand
Safety testing
Manufacturing Distribution
?
Efficacy testing
"Pirate"
Marketing
No objection
18
Three Steps Forward

• Promote the use of Independent Experts
• Initiate a Notification program
• Permit a term of exclusivity

19
Independent Expert Review FDA Notification
Dossier Approved by Independent Experts (1)
Safety Proposed claim (2)
Supporting evidence
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
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
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
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
24
Term of Exclusivity

• Public Release
• (immediate)
• Safety information
• Claim
• Product name manufacturer

• Sequestered Info.
• (5 years)
• Supporting evidence for claim

25
Independent Expert Review FDA Notification

• Relieve the logjam of petitions
• Benefit from the knowledge of
• independent experts
• Respond to consumer demands
• for empowerment

26
Term of Exclusivity

• Ensure ROI
• Respond to consumer demands for a variety of
  products
• Ensure products are properly vetted
• Ensure competition in marketplace

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)

28
Dietary SupplementsPublic MeetingNovember 15,
2004

• George A. Burdock, Ph.D.
• Diplomate, American Board of Toxicology
• Fellow, American College of Nutrition
• Gburdock_at_burdockgroup.com