FSMA Inspections Webinar: Get Ready Now or Get Cited Later

FACULTY

 


Joseph A. Levitt
Partner
Hogan Lovells US LLP
Washington, DC


Joseph Levitt 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, as well as on regulatory aspects of Federal, state and private litigation.  He is particularly accomplished in helping companies who face significant compliance challenges with the FDA.  He is a recognized expert in the FDA Food Safety Modernization Act (FSMA), including all phases of its development and implementation.

Joe’s deep knowledge of the FDA is reflected in the many roles he held at the agency.  While serving as FDA/CFSAN Director, Joe was involved in virtually all aspects of food regulation.  In particular, he 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. Earlier in his FDA tenure, Joe functioned as the executive assistant to the commissioner, director of executive operations, chief of staff and acting deputy commissioner in the Office of the Commissioner, where he 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 where he led efforts to implement safe medical device and mammography quality standards programs. He began his FDA career in the Office of Chief Counsel as a litigating attorney.

In the private sector, Joe has served on the Boards of Directors for the:  Food and Drug Law Institute (FDLI); Food Allergy & Anaphylaxis Network (FAAN) (recently rebranded as Food Allergy Research & Education, Inc. (FARE) (Board Chair, 2007); and FDA Alumni Association (Board Chair, 2012-14).

Joe has received numerous honors and awards in both the public and private sectors.


Elizabeth B. Fawell
Counsel
Hogan Lovells US LLP
Washington, DC

 

Elizabeth Fawell 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.


Maile Hermida
Associate
Hogan Lovells US LLP
Washington, DC

 



Maile Gradison Hermida practices with Hogan Lovells in the area of food and agriculture law. She represents food companies, including manufacturers, distributors, retailers, and their trade associations. Her clients are regulated by the Food and Drug Administration, Department of Agriculture, Federal Trade Commission, and other health and safety regulatory agencies at both the federal and state levels.

Maile 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. She also provides assistance to trade associations and food companies with fashioning comments and developing strategies in response to agency rulemaking and other public policy issues. Her practice is increasingly focused on counseling companies and trade associations as to the implementation of the FDA Food Safety Modernization Act. Maile also assists clients with responses to Federal Trade Commission, Congressional, and state Attorney General investigations and counsels clients on the development, interpretation, and enforcement of laws and regulations governing food production, processing, and distribution.

Prior to joining Hogan & Hartson, she served as a judicial clerk to the Honorable Charles F. Lettow of the U.S. Court of Federal Claims. Maile graduated with high honors from The George Washington University Law School, where she served as executive editor of The George Washington Law Review.