‘Public Health Standard’ in FDA Tobacco Law

Greenwold, Mark

Thursday, August 16, 2012: 3:30 PM

2503 AB (Kansas City Convention Center)

Mark Greenwold, JD , Campaign for Tobacco Free Kids, Washington, DC

Mitch Zeller, JD , Pinney Associates, Bethesda, MD

Dr. David Ashley, PhD , US Food and Drug Administration, Center for Tobacco Products, Rockville, MD

Learning Objectives

At the conclusion of this presentation attendees will be able to:

Describe the difference in standards under which the FDA regulates products.
Demonstrate an understanding of the role of the public in rulemaking.
Demonstrate an understanding of the evidence base required in meeting regulatory standards.

Cross Cutting Program Area(s): Tobacco Industry and Tobacco Control Policies

· Audience: Speakers will provide background information on general food, drug, device and cosmetic regulatory standards; will consider the different standard under which tobacco products are regulated; and will lead participatory discussion on developing and communicating standards to protect the public health under the Act and the criteria to be applied in establishing such standards. Speakers will also address public participation in the rulemaking process and how organizations and individuals can provide information to inform regulatory decisions. · Key Points: Topics to be addressed include: defining public health standards under the Act; evidence required to meet the standards, including population-level impact;application of the standards to the regulatory process; implementation and communication of standards to the public and regulated industry; legal implications, including relevant burdens of proof; and application of appropriate standards to reviews of new, substantially equivalent or modified risk products. · Educational Experience: This proposed session will add to general knowledge of the Family Smoking Prevention and Tobacco Control Act and the standard under which tobacco products are regulated by the U.S. Food and Drug Administration. · Benefits: Participants will benefit by hearing discussion related to the establishments of the Family Smoking PRevention and Tobacco Control Act.