On Friday, November 16, 2018, the U.S. Department of Agriculture (USDA) Secretary Perdue and U.S. Food and Drug Administration (FDA) Commissioner Gottlieb announced a joint regulatory framework to oversee cell cultured products. Under the proposed framework, FDA plans to oversee cell collection, cell banks, cell growth, and cell differentiation. USDA will oversee cell harvest, production, and labeling of food products derived from the cells of livestock and poultry. While the technical details of the framework remain undefined, the agencies have expressed their view that no legislation on the topic is necessary because the agencies have statutory authority to regulate cell cultured food products derived from livestock and poultry.

This announcement comes three weeks after USDA and FDA hosted a joint public meeting on the topic, and before comments on the meeting are due. The agencies also announced they continue to seek public comment on the issue and will extend the deadline to submit comments until December 26, 2018.

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Photo of Gary Kushner Gary Kushner

Partner, Washington, DC

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 Brian Eyink Brian Eyink

Counsel, Washington, DC

Drawing on experience throughout the supply chain — from animal production to food processing to distribution and retail sale — Brian Eyink brings vast and cross-cutting industry knowledge to help clients find practical solutions to regulatory problems. Brian is particularly sensitive to risk management issues as companies adapt to a regulatory and political environment increasingly focused on inspections, enforcement, and investigations.

Brian helps food and agriculture companies navigate increasingly complex and high-stakes federal and state regulatory issues. He draws on deep experience with the USDA, FDA, and FTC, as well as state, local, and self-regulatory bodies, litigation, and acquisitions to solve clients’ regulatory and business problems. Brian advises clients on the full scope of regulatory issues facing the food and agriculture sectors, ranging from USDA and FDA enforcement actions and federal investigations to regulatory compliance, import and export issues, litigation support, comment preparation, legislative drafting, policy development, trade association governance, advertising disputes, and labeling issues.

Brian also represents food and agriculture trade associations, advising on issues including general counseling and governance, influencing policy and public perspective, and implementation of industry initiatives.

Before joining Hogan Lovells, Brian served as a judicial law clerk to the Honorable Gerald Bard Tjoflat of the United States Court of Appeals for the Eleventh Circuit. While in law school, he served as an executive editor of the Duke Law Journal.

Mary Lancaster

Mary Lancaster provides practical guidance on complex regulatory issues to help food and beverage companies in all segments of the industry achieve their business goals.

Mary advises clients on Food and Drug Administration (FDA) and United States Department of Agriculture (USDA) compliance with current good manufacturing practice (cGMP), advertising and labeling compliance, and food safety issues that arise throughout the entire food supply chain. She also advises on enforcement actions and drafts comments on proposed regulations and agency guidance. Mary also has experience with matters in front of the Federal Trade Commission’s Bureau of Consumer Protection.

Prior to law school, Mary was a legal assistant at a Washington, D.C. law firm, where she assisted lawyers in white-collar investigations, pharmaceutical class action litigations, and federal habeas petitions for death row inmates.