Enforcement Litigation and Compliance Washington, DC December 9-10, 2015 Compliance Central with FDA Center Compliance Directors (Part I) Michael Roosevelt, Deputy Director, Office of Compliance, CFSAN Daniel McChesney, Director, Office of Surveillance and Compliance, CVM Ann Simoneau, Director, Office of Compliance and Enforcement, CTP Moderated by Martin Hahn, Partner, Hogan Lovells

Human Food Compliance and Enforcement Activities Center for Food Safety and Applied Nutrition 2015 Update Michael Roosevelt, Deputy Director Center for Food Safety and Applied Nutrition - Office of Compliance December 9, 2015

The View from the CVM’s Office of Surveillance and Compliance By Daniel G. McChesney, Ph.D. Director Office of Surveillance and Compliance Center for Veterinary Medicine To FDLI’s Enforcement Conference Compliance Central December 9, 2015

OSC Accomplishments 2015 Publishing FSMA Animal PC rule Publishing GFI 230 on Animal Drug Compounding FR notice on improved data collection for antimicrobials subject to Section 105 Identifying mechanism for moving GFI 213 drugs to VFD on Jan 1, 2017 Success in removing unapproved drugs from market

OSC: 2016 Priorities Implement labeling changes in response to guidance 213 Implement VFD regulations Review and respond to comments on requirement for species data under Section 105 Review, consider and revise Compounding CPG as appropriate Review and consider nominations for Appendix A of Compounding CPG

OSC: 2016 Priorities Address post-approval safety concerns and shortages Support drug approval process by addressing competing unapproved and/or compounded products Increase utilization and data mining of ADE database Review and modify Feed Manufacturing Compliance Program to address VFD and FSMA requirements

OSC 2016 Priorities Prepare to implement Animal Preventive Controls rule in the animal food industry Develop multiply guidance documents supporting implementation of Animal PC Finalized GRAS notification rule Finalized SFTA rule

Staffing FSMA resources vs. Drug resources –Separate funding stream for new hires 7 member team dedicated to compounding –Little overlap among current staff –Chokepoint point is OCC review because of volume of review work –FSMA inspections Oct 2016; 213/VFD inspections Jan 2017 Reviewing/revising compliance program for multi- purpose inspections during single visit

9 Thank you.

FDLI’s Enforcement, Compliance, and Litigation Conference Center for Tobacco Products Office of Compliance and Enforcement 2015 Update Ann Simoneau, Director Center for Tobacco Products - Office of Compliance and Enforcement December 9, 2015

Regulations and Guidances Guidance National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions – Small Entity Compliance Guide 10/26/15 Final Rule National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions 9/24/15 Proposed Rule Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" 9/24/15 Draft Guidance Use of Investigational Tobacco Products9/24/15 Guidance Enforcement Policy for Certain (Provisional) Tobacco Products that FDA Finds Not Substantially Equivalent 9/11/15 Guidance Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions 9/8/15 Guidance Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order8/28/15 Guidance Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers Responses to Frequently Asked Questions 5/13/15

Retailer Enforcement FY15 Results Contracts with 55 jurisdictions Contracts with tribes Over 162,000 inspections completed

Retailer Enforcement: Warning Letters Issued Over 16,500 Warning Letters Sale to minor violation rate for FY15 was 14.7%

Retailer Enforcement: CMPs Issued Over 3200 CMP’s

Retailer Enforcement: No Tobacco Sale Orders October Initiated the first No-Tobacco-Sale Order (NTSO) actions against eight retailers for repeat violations, including sales to minors NTSO actions posted to CTP website

Manufacturer Enforcement: Warning Letters for MRTP Violation Modified risk tobacco products are products that are sold or distributed for use to reduce harm or the risk of tobacco- related disease associated with commercially marketed tobacco products A manufacturer who seeks to implicitly or explicitly claim that a product poses fewer risks than other tobacco products must submit an MRTP application to the FDA with scientific evidence to support that claim and receive authorization prior to marketing August 2015 – Issued WLs to three tobacco manufacturers for making “additive-free” and/or “natural” claims on cigarette labeling without authorization by Office of Science

Internet Surveillance and Enforcement Warning Letter Violations: –Sale of tobacco products to minors –Modified risk tobacco products –Flavored cigarettes –Smokeless tobacco product warning statements –FDA Approved claims

Provisional Tobacco Products Found Not Substantially Equivalent (NSE) Products found NSE can no longer be sold, distributed, imported or marketed in interstate commerce Misbranded and adulterated NSE tobacco products webpage Ongoing surveillance and inspections Notifications to retailers

Compliance Webinars TitleDate Guidance for Industry: Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order 9/2/2015 Introducing the CTP Ombudsman5/2015 Guidance for Industry - Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions 3/24/2015 User Fees for Domestic Manufacturers and Importers of Tobacco Products 11/5/2014 Update on SE and GF10/29/14