# Presentation: 226786

## 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
- Spurious claims
- Unsafe products

## 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

## Dietary SupplementsThe Players and the Tension

**FDA**

**Consumer**

**Industry**

- Greater Access

- Free Speech

- Consumer Demand

- Efficacy

- Safety

- Return on Investment

## 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’

## 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

##  The Players and the TensionFDA is the key player FDA the Engine for Resolution

## Three Steps Forward

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

## 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

## Notification Program

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

## 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

## Term of Exclusivity

- Consumer
- demand

- Manufact.

- R&D

- Safety testing

- Efficacy testing

- $?

## Term of Exclusivity

- Consumer
- demand

- Manufact.

- R&D

- Safety testing

- Efficacy testing

- $

- No objection

## Term of Exclusivity

- Consumer
- demand

- Manufact.

- R&D

- Safety testing

- Efficacy testing

- Manufacturing
- & Distribution

- Marketing

- $

- No objection

## Term of Exclusivity

- Consumer
- demand

- Manufact.

- R&D

- Safety testing

- Efficacy testing

- Manufacturing
- & Distribution

- Marketing

- $

- No objection

## Term of Exclusivity

- Consumer
- demand

- Manufact.

- R&D

- Safety testing

- Efficacy testing

- Manufacturing
- & Distribution

- Marketing

- $

- "Pirate"

- $?

- No objection

**X**

## Term of Exclusivity

- Consumer
- demand

- Manufact.

- R&D

- Safety testing

- Efficacy testing

- Manufacturing
- & Distribution

- Marketing

- $

- "Pirate"

- $?

- No objection

**X**

**X**

**No ROI**

## Three Steps Forward

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

## Independent Expert Review

- & FDA Notification

- Dossier Approved
-  by Independent
-     Experts
***(1) Safety &***
***      ******Proposed***
***      ******claim ***
***(2) Supporting ***
***     ******evidence***

## 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

## 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

## 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

## 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

## Term of Exclusivity

- Public Release
- _(immediate)_
- Safety information
- Claim
- Product name & manufacturer

- Sequestered Info.
- _(~5 years)_
- Supporting evidence for claim

## Independent Expert Review

- & FDA Notification

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

## Term of Exclusivity

- _Ensure ROI_
- Respond to consumer demands for a variety of products
- Ensure products are properly vetted
- Ensure competition in marketplace

## 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)

## 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**