October 31, 2017
12:00pm-1:30pm ET

Listeria monocytogenes bacteria sickens an estimated 1,600 people each year and of those about 260 die. The dangers of Listeria foodborne illness impacting U.S. consumers are very real and the implications of an outbreak can be enormously costly to the food processing industry.

FDA is currently reviewing public comments to the “Draft Guidance to the Industry on Control of Listeria Monocytogenes” which was published in January 2017. The industry can expect final Guidance from FDA soon. The new Guidance coupled with the Preventive Controls for Human Food (PCHF) enforcement is already resulting in a much more targeted approach by FDA with focus on both industry and FDA environmental swabbing. Positive swabs for L. mono. or indicator organisms could trigger aggressive FDA enforcement action.

Join presenters representing FDA, attorneys from Hogan Lovells and an EAS Independent Consultant and internationally known research microbiologist for a webinar focusing on the challenges and new FDA regulatory requirements for the detection and elimination of L. mono. This will provide attendees with leading edge and cross-cutting information on regulatory expectations as well as control mechanisms for L. mono. With this information, the food processing industry can improve existing L. mono. control programs, ultimately benefiting the consuming public. This webinar shares the perspectives of the new FDA enforcement strategy (preventive) from FDA’s view, a microbiologist sharing the latest information about L. mono as well as food industry counsel’s view. It is a “must attend” event for anyone with responsibility for complying with FDA’s new enforcement approach.

What do we know today about the “new” dangers of Listeria? What key monitoring and corrective action measures should the industry pay attention to, adopt and implement and how can we turn today’s risk assessment results into a safer and proactive approach to Listeria control?

Click here for more information and to register. 

Tags: Enforcement, FDA, Listeria
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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 Elizabeth Fawell Elizabeth Fawell

Partner, Washington, DC

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.

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