Presentation to Life Sciences Research Office Expert Panel

Presentation to Life Sciences Research Office Expert Panel January 30, 2003

Overview of Metabolife • History – Founded in 1995 – Based in San Diego – Metabolife Is a Fast Growing Company, and It Is Rapidly Expanding Its Product Base

Overview of Metabolife (cont. ) • Flagship Product - Metabolife 356® Is the Nation’s Leading Weight Loss Supplement. – Popular for Supporting Weight Loss • Many Satisfied Consumers – Over the Last Five Years, Over 4. 5 Billion Caplets (Approximately 50 Million Bottles) Sold

Overview of Metabolife (cont. ) • Sampling of Other Metabolife Products for Weight and Nutrition Management – Metabolife Bars (in Six Flavors) – Various Vitamin and Mineral Products (e. g. , Adult Multi-Vitamin & Mineral, Chewable Calcium, and Omega-3 Fish Oil) – Various Herbal Products (e. g. , Women’s Hormonal Balance Formula and Men’s Saw Palmetto with Lycopene) – Various Sports Nutrition Products (e. g. , Whey Protein Powder, Chewable Soy Protein Powerballs, Buffered Creatine Powder) – Metabolife Ephedra-Free – Metabolife for Men

Metabolife As Industry Leader • Absence of Specific Federal Regulations for Ephedra Dietary Supplements – No Ephedra-Specific Federal Regulation – but Subject to FDA Dietary Supplement Regulation – A Number of States Have Restrictions – e. g. , • Science-Based Serving Limit Restrictions of Up to 25 mg/Serving and 100 mg/Day (Adopted by a Number of States, such as Hawaii, Michigan, Nebraska, Ohio, and Washington) • Prohibition on Use by Minors (Adopted by a Number of States, such as Ohio, Michigan, Nebraska, and Texas) – No Requirement that Health-Related Consumer Complaints for Any Dietary Supplement Be Collected by Companies or Reported to FDA

Metabolife As Industry Leader (cont. ) • Since 1996, Metabolife Has Been at Forefront of Pursuing Ephedra Regulation at the State and Federal Level, Advocating: – Appropriate Science-Based Serving Size and Frequency Limits (Such as Those Adopted by the States) – A Strict Warning Label – Prohibition on Sale to Minors – Prohibition on Use of Synthetic Ephedrine in Dietary Supplements – Prohibition on Sale of Ephedra-Containing Supplements as “Street Drug Alternatives” – Stringent Dietary Supplement Good Manufacturing Practices – Mandatory Reporting to FDA of Serious or Significant Anecdotal Health. Related Consumer Complaints (and an Improved FDA Reporting System) • Reporting Standard/System Tailored to Dietary Supplements

Metabolife As Industry Leader (cont. ) • Metabolife’s Practices Lead the Industry – Metabolife Has a Strict Warning Label

Metabolife As Industry Leader (cont. ) – Good Manufacturing Practices – As a Leader in the Industry, Metabolife Has Already Implemented Extensive Quality Assurance Programs, Including Batch-Testing for Each Batch of Metabolife 356® Produced, with Third. Party Validation of In-House Tests – Metabolife Health Information Line (MHIL) • Metabolife One of Few, If Not Only, Dietary Supplement Companies to Provide Free Nurse Consultation to Consumers • Despite Controversy, To Our Knowledge Metabolife is the Only Company to Voluntarily Give Its Consumer Complaints to FDA • MHIL was a Responsible Approach to Assist Consumers with Their Health and Weight Control Goals

Metabolife Health Information Line (MHIL) - Background Q: What is the MHIL? – Voluntary Toll-Free Customer Service Line (Number on Label as of October 1998) Q: Why Was the MHIL Established? – To Answer Weight Control Questions – To Provide Information About Appropriate Use of Metabolife 356®. – Not Designed or Intended to Collect Consumer Complaints or Health Complaints – Not Designed or Intended to be a Adverse Event Reporting System – Not Designed or Intended to Assess Causation or Risk

MHIL – Background (cont. ) Q: How Has the MHIL Operated? – MHIL Has Been Staffed Primarily by Registered Nurses (Currently 3 Nurses) – MHIL Staff Advised to Become Familiar With. . . • Recommended Use of Products • Product’s Label Instructions • Scientific Literature and Studies Associated with Ephedra – Notes Originally Kept on Calendars, Sticky-Pads, and Loose Paper, and Later Forms Were Developed to Record Calls

MHIL – Background (cont. ) – No Consistent System to Record Information Relevant to Assessing Risk or Causation (e. g. , Serving Size, Frequency of Use, Pre-Existing Conditions) – If a Health Complaint Raised, Metabolife Representative Generally Advises Caller to See a Health Care Practitioner – If Caller Has Seen a Physician. . . • Approximately 40 -50 Cases of Medical Records Have Been Received • Generally, Records Received Are Reviewed by a Nurse and/or a Physician

MHIL – Call Records Q: How Many Caplets of Metabolife 356® Have Been Sold Over the Last 5 Years? – Over 4. 5 Billion Caplets (Approximately 50 Million Bottles) Q: How Many Calls Have Been Made to the MHIL Over the Last 5 Years? – Over 400, 000 Calls Q: Of Those, How Many Are Potentially Health-Related? – Approximately 16, 500 (4%)

MHIL – Call Records Q: What Was In the Other 96% of the Call Records? – – – – Success Stories Testimonials - Weight Loss/ Weight Gain Testimonials - Increase/ Decrease in Energy Questions About the Product and Its Usage Complaints About the Price Complaints About the Design of the Bottle Refund Requests, Etc.

MHIL – Expert Reviews Q: Has Metabolife Attempted to Assess the Health-Related Data Collected in the Call Records? – Yes -- Metabolife Retained Three Experts Q: Why? – To Prepare for Voluntary Public Disclosure of the Call Records (Prior to Senator Durbin’s Involvement) – To Help Craft a Mandatory National Reporting System Proposal

MHIL – Expert Reviews (cont. ) Q: Were the Experts Able to Use the Call Records to Directly Assess Risk or Causation? – No – They Determined that This Was Not Possible Because the MHIL Was Not Designed or Intended to Collect Consumer Complaints or Health-Related Incidents. . • Call Records Are Incomplete and Inconsistent • Call Records Lack Information Required to Assess Risk and Causation (e. g. , Serving Size, Frequency of Use, Pre-Existing Medical Conditions)

MHIL – Expert Reviews (cont. ) Q: Were the Experts Able to Use the Records to Compare the Incidence of Heart Attack, Stroke, and Seizure In Metabolife Users vs. the Background Population? – Yes – Experts Made Conservative Assumptions About. . . • Veracity of the Reports • Overall Number of Metabolife Consumers • Reporting Rates – Unanimous Conclusion – For Heart Attack/Stroke/Seizure • Incidence in Metabolife Consumers Consistent With, Below, or Significantly Below the Expected Background Rate of Events in the General Population.

Objective of LSRO Review Q: Why Did Metabolife Commission LSRO? – Mechanism for “Lessons Learned” from MHIL Experience – To Play a Constructive Role by Fostering Expert Debate on Best Approach to Supplement Reporting

Objective of LSRO Review (cont. ) Q: What is the Objective of the LSRO Review? – To Review Metabolife’s Health-Related Call Records and Identify Lessons Learned – To Review Existing Models for Adverse Event Reporting – To Pool the Collective Knowledge of Experts To Recommend a Feasible and Meaningful Reporting System for Dietary Supplements

Objective of LSRO Review (cont. ) Q: Within the Scope of the Effort, Has Metabolife Placed Any Conditions on LSRO in Terms of LSRO’s Findings? – Absolutely Not – Metabolife Provided Funding, But No Conditions or Restrictions – Independent Process • This is a Contribution to the Supplement Reporting Debate Overall, and We May or May Not Agree With Your Findings – No Metabolife Admissions of Fact or Law – Metabolife is Under No Obligation to Accept or Endorse the LSRO Panel Recommendations

Objective of LSRO Review (cont. ) Q: What Does Metabolife Plan To Do with the LSRO Recommendations? – Metabolife Has Long Advocated a Mandatory Reporting System for Dietary Supplements – Metabolife Is One of Few Companies to Support Mandatory Reporting – If LSRO’s Proposal Is Feasible/Reasonable, Metabolife Would Advocate the Recommendations Before Congress, FDA, States, and Industry.