# Presentation: 393240

## FDA Obesity Working Group

- Alan Rulis, Ph.D.
- FDA Public Meeting on Obesity
- October 23, 2003

## Obesity Working Group

- Charge to Form Working Group – August 11, 2003
- Action Plan to Commissioner - February 2004
- OWG Membership –
- Dr Lester Crawford, Deputy FDA Commissioner – Chair
- Mr Joseph Levitt, Director, CFSAN – Vice Chair

## OWG Members

- Pat Kuntze, Sr. Advisor for Consumer Affairs, OER/OC -Exec. Asst.
- Pete Salsbury, Acting Director, Executive Operations Staff, OCD/CFSAN - Exec. Sec.
- Alan Rulis, Senior Advisor for Applied Nutrition, OCD/CFSAN
- Susan Bond, Special Assistant to the Deputy Commissioner/OC
- Donna Robie Howard, Special Assistant to Senior Advisor for Applied Nutrition, CFSAN
- Christine Taylor, Director, Office of Nutritional Products, Labeling, and Dietary Supplements/CFSAN

## OWG Members

- Elizabeth Yetley, Lead Scientist for Nutrition/CFSAN
- Kathy Ellwood, Director, Div. of Nutrition Programs and Labeling, ONPLDS/CFSAN
- David Acheson, Chief Medical Officer, CFSAN
- Richard Williams, Director, Div. of Market Studies, OSAS/CFSAN
- David Orloff, Director, Div. of Metabolic and Endocrinologic Drugs, CDER
- Jonca Bull, Director, Office of Drug Evaluation V, CDER

## OWG Members

- Peter Pitts, Associate Commissioner for External Relations, OC
- Mike Landa, Deputy General Counsel, Office of the Chief Counsel
- Tomas Philipson, Senior Economic Advisor to the Commissioner, OC
- Serina Vandegrift, Senior Advisor for Policy and Operations, OC
- Mary-Lacey Reuther, Special Asst. to the Commissioner, OC

## OWG Adjunct Members

- Virginia Wilkening, Deputy Director, ONPLDS/CFSAN
- Steven Bradbard, Supervisory Psychologist, Div. of Market Studies, OSAS/CFSAN
- Lisa Lubin, Consumer Safety Office, OFAS/CFSAN
- Rick Canady, Senior Science Policy Analyst, OSCC/OC
- Jeff Shuren, Assistant Commissioner for Policy, OPPL/OC
- Susan Bernard, Policy Analyst, OPPL/OC
- Susan Wood, Director, Office of Women’s Health, OSCC/OC
- Joanne Lupton, Visiting Scholar, CFSAN

## Obesity Working Group

- Clear, Effective Message
- Education Program (to deliver the message)
- Support of the Message
- Food Labels
- Restaurants
- Therapeutic Treatments
- Research Needs
- Stakeholder Investment to Ensure Results

## Obesity Work GroupSubgroups

- Knowledge Base
- Message
- Public Meeting
- Food Labels
- Restaurants/Industry
- Education Program
- Therapeutic Treatment
- Research
- Report Writing

## Knowledge Base Subgroup

- Conduct Interviews and Collect Information on Existing and Planned Obesity Related Activities Occurring in the United States (Excluding Research)
- Assemble a Centralized Repository of the Information Gathered
- Report Out to the Full OWG on the Scope/Contents of the Repository

## Message Subgroup

- Identify Existing Messages in the Public and Private Sector
- Review these Messages for Appropriateness and Effectiveness
- Present Options for Consideration of the Full OWG

## Public Meeting Subgroup

- Satisfy All Procedural Elements for Conducting a Public Meeting
- Receive Input from Subgroup Leads and Chair/Vice Chair of OWG for Questions/Issues to be Addressed at Public Meeting
- Plan Outreach for the Public Meeting, Including the Media
- Provide a Report(s) to the Full OWG on the Public Meeting

## Food Labels Subgroup

- Examine Existing Statutory Framework for Labeling *vis a vis* Reducing Obesity and Preventing Weight Gain
- Consider Outcome of November 20 DHHS/FDA Workshop on Food Labels/Weight Loss
- Provide Recommendations to the Full OWG on Approaches for Using Food Labels to Convey Obesity Reduction Messages

## Restaurant/Industry Subgroup

- Pursue Dialogue with Restaurant Industry/Trade Associations on Current, Planned, and Potential Obesity/Nutrition Initiatives
- Provide Input to the Obesity Knowledge Subgroup and OWG at Large on Findings from such Dialogue
- Develop Recommendations on Approaches to Encourage the Restaurant Industry to take Appropriate Steps to Address the Obesity Epidemic

## Consider Outcome of November 20 HHS/FDA Workshop on Food Labels/Weight Loss
Focus on Packaging and Labeling
Funded by DHHS/ASPE

Report to the Full OWG on the Subgroup Recommendations

- Focus on Packaging and Labeling
- Funded by DHHS/ASPE
- Report to the Full OWG on the Subgroup Recommendations

- Restaurant/Industry Subgroup

## Education Program Subgroup

- Explore and Develop Answers to the Following Questions Concerning an Education/Outreach Program to Deliver FDA’s Message(s) on Obesity:
- What are the Target Populations for the Education Program?
- What are the most effective modes for delivering the program?
- How do we know the message(s) will be received?
- How would we evaluate whether the education program/message will be effective?

## Work with DHHS to Determine how FDA’s Obesity Outreach/Education Efforts Fit in the Larger Context of DHHS Efforts

Provide Recommendations to the Full OWG for Creating/Constructing a Program(s) to Deliver FDA’s Obesity Message(s) 

- Provide Recommendations to the Full OWG for Creating/Constructing a Program(s) to Deliver FDA’s Obesity Message(s)

- Education Program Subgroup

## Therapeutic Treatment Subgroup

- Gather Information on Existing Therapeutics for Obesity Treatment (Including Drugs, Devices, and other Medical Interventions) and Real or Perceived Barriers to Development of New, or Enhanced Therapeutics
- Make Recommendations to the Full OWG on Therapeutic Needs and Ways to Encourage Development of New or Enhanced Therapeutics

## Research Subgroup

- Identify Existing Research as Well as Research Gaps on Obesity (Including, but not Limited to, the Development of Healthier Foods and a better Understanding of Consumer Behavior and Motivation)
- Present Recommendations to the Full OWG on Areas for Expanded and/or New Research Pertinent to the Charge of the OWG and how to Facilitate that Research

## Report Writing Subgroup

- Solicit Input from OWG, Subgroups, Stakeholders and through Public Meetings as Material for the Final Report
- Prepare the Final Report of the OWG