The Food and Drug Administration (FDA) recently issued revised draft guidance regarding the control of Listeria monocytogenes (Lm) in ready-to-eat (RTE) foods. The 2017 draft guidance expands on the version initially issued by FDA in 2008. Along with added details on many topics, the 2017 draft guidance also changes several key recommendations, particularly with respect to the recommended corrective actions that should be taken following environmental and product testing. In general, the draft guidance encourages a “seek and destroy approach,” similar to that used by the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA).

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Photo of Gary Kushner Gary Kushner

Partner, Washington, D.C.

Gary Jay Kushner knows the food industry inside and out as he has been a part of it for almost 40 years. His clients are some of the largest food corporations in the world as well as their trade associations.

Partner, Washington, D.C.

Gary Jay Kushner knows the food industry inside and out as he has been a part of it for almost 40 years. His clients are some of the largest food corporations in the world as well as their trade associations. Because of his extensive exposure to the industry at all levels, Gary approaches his clients’ challenges from the perspective of a food industry executive.
Gary has participated in the development of virtually every law and regulation affecting the food industry in the last four decades. Gary analyzes legislation considered by the U.S. Congress and state legislatures and regulations proposed by the U.S. Department of Agriculture, Food and Drug Administration, and other federal and state government agencies, and evaluates their impact on the food industry from farm to table. His insight allows him to anticipate how these initiatives might change the way his clients do business so they can plan most effectively.

Gary also helps companies address regulatory compliance issues, advising them on labeling, advertising, inspection, and representing them in enforcement proceedings before government agencies and the courts.

Previously, Gary served as vice president and general counsel for the American Meat Institute where he directed the organization’s legal, regulatory, and legislative activities. He began his food industry career as staff counsel for Scientific Affairs for the Grocery Manufacturers of America, and began his legal career as law clerk to the Honorable John R. Hess in the Superior Court for the District of Columbia.

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 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.