Photo of 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 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.

The Office of Management and Budget (OMB) recently released the Spring 2020 Unified Agenda of Regulatory actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum summarizes the major actions that may be of particular interest to the food industry that are being planned by the U.S. Food and Drug

Dr. Stephen M. Hahn, the Commissioner of Food and Drugs for the Food and Drug Administration (FDA) issued a statement on July 10, 2020, describing the agency’s intentions and approach to resuming domestic inspections in light of the COVID-19 pandemic. After temporarily suspending inspections in March 2020, FDA is working toward restarting on-site inspections during

On May 1, 2020, Blue Bell Creameries L.P. (Blue Bell) and the U.S. Department of Justice (DOJ) entered into two separate agreements related to the 2015 listeriosis outbreak linked to Blue Bell ice cream. This memorandum provides an overview of the negotiated agreements, the facts giving rise to the agreements, and key takeaways for the

In March, the Food and Drug Administration (FDA) issued guidance documents, first revised on March 27, temporarily relaxing certain regulatory requirements for the production of alcohol-based hand sanitizers, to respond to the increased demand for hand sanitizer products during the novel coronavirus crisis. Yesterday, FDA issued additional minor updates to these documents. Notably, FDA provides

This post summarizes the U.S. Food and Drug Administration (FDA) Compliance Program Guidance Manual (CPGM) for food facilities subject to preventive controls and sanitary human food operation requirements. As an overview, FDA’s “Compliance Programs” provide instructions to FDA personnel for conducting activities to evaluate industry compliance with the Federal Food, Drug, and Cosmetic Act (FFDCA)

The Department of Homeland Security’s (DHS’s) Cybersecurity & Infrastructure Security Agency (CISA) has issued recommendations to address hand sanitizer shortages. CISA has identified that the problem of hand sanitizer shortages lies primarily in shortages in the supply chain of raw materials to make hand sanitizer to the necessary specifications. Accordingly, CISA is providing recommendations to

This post summarizes recent actions the U.S. Food and Drug Administration (FDA) has taken in response to the COVID-19 outbreak. First, FDA Deputy Commissioner for Food Policy and Response Frank Yiannas issued a food safety and supply public service announcement (PSA). The PSA states the U.S. food supply remains safe for both people and animals,

As the novel coronavirus crisis continues to escalate, the demand for hygienic products such as hand sanitizer has dramatically increased. In response, many businesses, such as food and industrial and beverage alcohol manufacturers, are seeking to produce alcohol-based hand sanitizers using certain food grade materials, or to produce alcohol to be used in production of