On November 16, 2017, the Food and Drug Administration (FDA or the agency) issued a federal register notice soliciting comments on its Draft Guidance for Industry, “Best Practices for Convening a GRAS Panel.”

The Draft Guidance is intended for persons responsible for a conclusion that a substance may be used in food on the basis of the generally recognized as safe (GRAS) provision of the Federal Food, Drug, and Cosmetic Act (FFDCA) when that person convenes a panel of experts (GRAS panel) to independently evaluate whether the available scientific data, information, and methods establish that the substance is safe under the conditions of its intended use in human or animal food.

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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 Christine Forgues Christine Forgues

Associate, Washington, DC

Chris Forgues provides business-oriented legal and scientific solutions to food and agriculture companies and trade associations.
She advises clients on state and federal regulatory issues that arise throughout the entire food supply chain and production line, ranging from USDA and FDA enforcement actions and federal investigations to regulatory compliance, import and export issues, litigation support, comment preparation, advertising disputes, and labeling issues.

Chris’s background in life science (chemistry and pharmacology) assists her in her science-based food law practice. Chris’s unique educational background and regulatory scientist experience provides valuable context to complex scientific issues as they relate to the governing regulatory requirements.

When she joined Hogan Lovells, Chris brought with her more than nine years of regulatory consulting experience. A part-time student by night and a regulatory scientist by day, Chris worked throughout law school at a firm in Washington, D.C., focusing on product review, development, and post-marketing in the life sciences sphere, with experience handling matters under the Food and Drug Administration (FDA), the Department of Agriculture (USDA), and the Environmental Protection Agency (EPA), the Federal Trade Commission (FTC), the National Advertising Division (NAD), the Consumer Product Safety Commission (CPSC), as well as state regulatory bodies.