Good Recordkeeping Practices Under FSMA

Guest Speaker: Joe Levitt, Partner, Hogan Lovells is a 25-year veteran of the U.S. Food and Drug Administration (FDA); he served as Director of FDA’s Center for Food Safety and Applied Nutrition (CFSAN) for six years, from February 1998 through December 2003. Joe counsels numerous food companies and trade associations in food safety, labeling and compliance matters and how to work effectively with the FDA. He is a recognized expert in the Food Safety Modernization Act (FSMA), including all phases of its development and implementation.

While serving as FDA/CFSAN Director, Joe led successful efforts to modernize food safety regulation and enhance the security of the U.S. food supply. He also initiated a revitalization of FDA's nutrition program. During his earlier FDA tenure, while in the Office of the Commissioner, Joe helped streamline the new drug review process and launch the agency's food labeling initiative. Additionally, he served as Deputy Director for Regulations and Policy at the FDA's Center for Devices and Radiological Health. He began his FDA career in the Office of Chief Counsel.

Joe has been consistently ranked in Chamber
s most recently being ranked in the Top Tier of food and beverage lawyers since joining Hogan Lovells. While at FDA, he received numerous honors and awards, including three Presidential Executive Rank Awards. More recently, Joe received the FDA Distinguished Alumni Award. Joe received his bachelor’s degree, magna cum laude, from Cornell University in 1975 and his J.D.. degree, cum laude, from Boston University School of Law in 1978.

Guest Speaker: Elizabeth Fawell, Associate, Hogan Lovells practices in the area of food and agriculture law. She represents food companies, including manufacturers, distributors, retailers, as well as restaurants and foodservice operators, and their trade associations. Her clients are regulated by the Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), Federal Trade Commission (FTC), Consumer Product Safety Commission (CPSC), and other health and safety regulatory agencies at both the federal and state levels.

Elizabeth counsels clients on the development, interpretation, and enforcement of laws and regulations governing food production, processing, distribution, and marketing. She analyzes legislation introduced in Congress and state legislatures, as well regulations proposed by FDA and USDA. Elizabeth provides assistance to trade associations and food companies with preparing comments and developing strategies in response to legislative proposals, agency rulemakings, guidance documents, and other public policy issues. Her practice increasingly involves counseling companies and trade associations regarding implementation of the FDA Food Safety Modernization Act (FSMA), having been directly involved in the development of this landmark legislation on behalf of food industry clients. She also advises clients on the development of label claims, website and promotional campaigns for products, as well as the various requirements applicable to the labeling of foods. Elizabeth assists clients in advertising disputes and with responses to Federal Trade Commission, congressional, and state Attorney General investigations.

Elizabeth’s practice also includes advising food and consumer product companies subject to the jurisdiction of the Consumer Product Safety Commission (CSPC). She counsels clients on compliance with CPSC safety standards, as well as testing and certification requirements. In addition, Elizabeth assists companies in complying with CPSC reporting requirements.

Prior to joining Hogan & Hartson, Elizabeth was a legislative assistant with the Office of Congresswoman Anne M. Northup. Previously, she was an English teacher with Foshan Yi Zhong Xue.

Shannon Cole, Senior Director, Science Program Management, GMA is a globally recognized project manager, matching cutting edge science to food policy issues, and delivering expert scientific and technical assistance to the food and consumer product goods industry.  At GMA, Ms. Cole oversees all scientific program management activities, including managing implementation of the Food Safety Modernization Act (FSMA).  In addition, she is also an active project leader for the APEC-PTIN work, staff lead for two Codex Committees, the Allergen Committee, the Food Industry Analytical Chemists Committee and the Beverages Committee.   Prior to her role as Senior Director, she supervised all laboratory operations and co-managed over 20 scientists and professional technical staff in the disciplines of chemistry, biochemistry, microbiology, processing technologies, and packaging and product forensics.  

Ms. Cole holds Master of Science degree in Bio-Inorganic Chemistry from the University of New Mexico and a Bachelor of Arts in Chemistry and Biology from the University of Northern Colorado.  She is a certified Project Management Professional (PMP), holds top certification in Microsoft Project, and is a professional Lean Six Sigma leader (green belt).