As previously reported, the Food and Drug Administration (FDA) and the U.S Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) are operating under significantly reduced functions since funding for the agency lapsed on December 22, 2018. Recently, there have been a number of media reports with updated information from FDA Commissioner Gottlieb regarding the scope of FDA food facility inspections during the government shutdown, which is summarized in this memorandum. We will continue to monitor major developments related to the scope of FDA’s food safety activities during the government shutdown; food companies may also wish to follow Commissioner Gottlieb’s Twitter account for the most recent developments on this issue. In a related update, we understand that FSIS is now in the process of reviewing label submissions in a limited capacity.

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Photo of Joe Levitt Joe Levitt

Partner, Washington, DC

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 Samantha Dietle Samantha Dietle

Associate, Washington, DC

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.