May 15, 2017, was the “stand up” day for the Food and Drug Administration’s (FDA) Office of Regulatory Affairs (ORA) new organizational structure under its Program Alignment initiative. The Program Alignment initiative began in 2013 as an effort to modernize and strengthen the agency’s workforce and to improve public health response. A key aspect of the Program Alignment initiative is a shift from the current geography-based district offices to program-specific “division” offices where staff are aligned by FDA-regulated product – i.e., there will now be distinct food-based offices, inspectors and labs and distinct medical products-based offices, inspectors and labs. This means that, over time, food companies will be inspected by individuals trained in food inspections, not drug or device inspections. This increase in specialization is intended to create a more proficient workforce and increase the efficiency of FDA operations.

With the change to program-specific division offices, some of the former district offices have been merged together. Practically speaking, this means that for some food companies, the contacts in their respective division offices may have changed. Other key changes under the Program Alignment initiative include a reorganization of the import program, state cooperative programs, and FDA’s field laboratories, and the creation of a Produce Safety Network. We have provided an overview of the key organizational changes at ORA that impact the food industry.

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Photo of Joe Levitt Joe Levitt

Partner, Washington, D.C.

As the FDA’s former top food regulator, Joe Levitt brings a true insider’s knowledge to helping food industry clients deal effectively with the FDA. Whether influencing policy making or confronting a threatened compliance action, Joe’s 25 years of FDA experience…

Partner, Washington, D.C.

As the FDA’s former top food regulator, Joe Levitt brings a true insider’s knowledge to helping food industry clients deal effectively with the FDA. Whether influencing policy making or confronting a threatened compliance action, Joe’s 25 years of FDA experience puts clients in the best position to succeed.  In the private sector, Joe was on the ground floor when Congress developed the landmark FDA Food Safety Modernization Act (FSMA). Joe was also a leading voice for the food industry when the FDA developed regulations that all food companies must now follow. No one can help navigate the labyrinth of FDA’s FSMA regulations better than Joe and his team, and no one can better put your company in the driver’s seat when the FDA inspector knocks on your door for your first FSMA inspection.

Joe adeptly handles high visibility recalls and compliance actions. If a company finds itself in trouble with the FDA, they need someone with a deep insider’s understanding of what works and what doesn’t. Joe knows what the agency expects in the compliance arena, and the bar clients will be expected to meet. He can communicate his client’s position calmly and effectively to the FDA so the matter gets put behind them. His record of “helping startups and multinational companies… survive Food and Drug Administration investigations and avoid import bans that could shutter the companies,” led to Joe being named a Law360 Food & Beverage MVP (2016).

Joe is among the most decorated officials in FDA history, with his achievements being recognized by multiple U.S. presidents, cabinet secretaries, and FDA Commissioners. He maintains close working relationships with senior FDA officials and has served as the Board Chair of the FDA Alumni Association.

Photo of Maile Hermida Maile Hermida

Partner, Washington, D.C.

Maile Gradison Hermida represents all segments of the food industry and their trade associations. She has a keen understanding of the issues affecting the industry, from product development through production, distribution, and retail sale. Her core practice involves helping companies…

Partner, Washington, D.C.

Maile Gradison Hermida represents all segments of the food industry and their trade associations. She has a keen understanding of the issues affecting the industry, from product development through production, distribution, and retail sale. Her core practice involves helping companies ensure they are in compliance with regulations from federal agencies such as the Food and Drug Administration (FDA) and U.S. Department of Agriculture. Maile also provides strategic advice on public policy issues, frequently involving agency rulemakings.

Maile has considerable experience with the FDA Food Safety Modernization Act (FSMA), having worked with numerous companies and trade associations on all aspects of the law since the day it was signed. She translates her in-depth knowledge of FSMA into practical solutions for companies working on implementation strategies. She also is a Preventive Controls Qualified Individual (PCQI), as well as a Food Safety Preventive Controls Alliance Lead Instructor for the PCQI training.

Additionally, Maile assists companies with matters involving regulatory enforcement. She helps clients navigate product recalls; government inspections; and other enforcement actions, such as Warning Letters and import detentions. Maile also advises clients on the development of label and advertising claims, as well as labeling requirements for foods and dietary supplements.

Maile is a frequent speaker and contributor to industry publications. Prior to joining Hogan Lovells, 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.

Photo of Elizabeth Fawell Elizabeth Fawell

Partner, Washington, D.C.

Elizabeth Fawell navigates the detailed, and often complex, regulatory issues confronting food companies and helps them understand both the rules and various risks involved so that they can make informed business decisions. Elizabeth works with every segment of the food…

Partner, Washington, D.C.

Elizabeth Fawell navigates the detailed, and often complex, regulatory issues confronting food companies and helps them understand both the rules and various risks involved so that they can make informed business decisions. Elizabeth works with every segment of the food industry, including manufacturers, distributors, retailers, restaurants, and food service operators; and their trade associations.  Elizabeth’s work on behalf of food industry clients with the Food Safety Modernization Act (FSMA) since its inception and her understanding of Hazard Analysis Critical Control Point (HACCP) systems provides her with the experience and perspective needed as she counsels clients on how to comply with new requirements under the law. Elizabeth is a Preventive Controls Qualified Individual (PCQI) and has completed the FSPCA PCQI training.

Elizabeth knows how laws, regulations, and guidance documents are developed, interpreted, and enforced. Her extensive knowledge enables clients to prevent and respond to enforcement actions such as Warning Letters, Import Alerts, and agency investigations. She helps clients in determining whether an RFR is necessary and whether a recall is warranted. If so, she helps manage the recall to minimize business impacts. Elizabeth provides real-time advice during factory inspections, helps clients prepare 483 responses, and drafts inspection manuals. She also assists clients in lawfully and creatively promoting their products; such as the development of labels, claims, and website and promotional campaigns. Elizabeth also supports clients in advertising disputes and with responses to FTC and Attorney General investigations.

Elizabeth helps clients stay informed of and ahead of public policy issues and develops strategies for effective advocacy before regulators. She also counsels clients on compliance with Consumer Product Safety Commission (CPSC) safety standards, testing and certification requirements, and reporting obligations.

Elizabeth is a member of the Food and Dietary Supplements Committee of the Food and Drug Law Institute.

Photo of Samantha Dietle Samantha Dietle

Senior Associate, Washington, D.C.

Sam Dietle provides practical legal solutions and regulatory guidance to all segments of the food industry, including manufacturers, restaurants, retailers, animal producers and processors, and their trade associations.

She advises clients on federal and state regulatory issues that arise…

Senior Associate, Washington, D.C.

Sam Dietle provides practical legal solutions and regulatory guidance to all segments of the food industry, including manufacturers, restaurants, retailers, animal producers and processors, and their trade associations.

She advises clients on federal and state regulatory issues that arise throughout the entire food supply chain, including labeling and advertising compliance and claim substantiation issues, enforcement actions by the Food and Drug Administration (FDA) and United States Department of Agriculture (USDA), litigation support, and drafting comments on proposed regulations and agency guidance. Sam also counsels clients in consumer products industries on compliance with Consumer Product Safety Commission (CSPC) requirements.

Prior to joining Hogan Lovells, Sam advised food packaging companies on FDA premarket requirements and regulatory compliance matters. Sam also worked with electronic cigarette companies as FDA began to regulate this industry. While in law school, she served as a judicial intern in the U.S. Court of Federal Claims, working on vaccine injury claims cases.