On May 22, 2017, the Center for Food Safety (CFS), Breast Cancer Prevention Partners (BCPP), Center for Science in the Public Interest (CSPI), and Environmental Defense Fund (EDF), filed a complaint for declaratory and injunctive relief against the U.S. Food and Drug Administration (FDA) for the agency’s final rule regarding substances that are Generally Recognized as Safe (GRAS) for use in human and animal foods (the Final Rule). The Plaintiffs take issue with the voluntary nature of the GRAS notice program and allege the Final Rule is an “unlawful[ ] sub-delegation of authority,” an arbitrary and capricious agency action, and an abdication of statutory duty that violates the Administrative Procedure Act (APA) and the Federal Food, Drug, and Cosmetic Act (FFDCA).

By way of brief background, on August 17, 2016, FDA published the Final Rule to comply with a consent decree with CFS from another lawsuit that claimed the agency violated the APA by “indefinitely operating under a proposed rule in lieu of promulgating a final rule.”  The Final Rule clarified the criteria for when the use of a substance is GRAS and exempt from premarket approval requirements of the FFDCA for food additives. It also finalized the administrative procedure for any person to voluntarily notify FDA the basis of a conclusion that a substance is GRAS.

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Photo of Martin Hahn Martin Hahn

Partner, Washington, DC

Martin Hahn uses his background in food technology and his comprehensive understanding of the laws governing the food industry to navigate clients through the myriad regulatory and business issues impacting the industry from farm to table. He recognizes the demands placed on his clients and finds innovative and creative solutions, particularly when responding to observations raised by regulators  during inspections. Whether the issue involves obtaining the authorization of a new food or dietary ingredient, complying with manufacturing requirements, labeling or advertising, product recalls, or enforcement, Martin serves as an effective advisor and advocate.

Martin’s career has touched on almost every issue impacting the food industry. He has a comprehensive understanding of the laws affecting the labeling and advertising of foods, dietary supplements, infant formulas, medical foods, and foods for special dietary use. He helps clients anticipate new trends and develop the data that is needed to distinguish their products from others on the market. With his understanding of science and technology in the food industry, Martin provides assistance in obtaining regulatory authorizations to market new food ingredients, food packaging materials, and dietary ingredients. He also assists clients in responding to proposed regulations and draft guidance, as well as, tracks and keeps his clients apprised of the latest trends in class action law suits and helps clients anticipate new regulatory initiatives.

Martin grew up on a farm and worked in food processing plants before going to law school. His hands-on experience in the field and degree in food technology allow him to better understand the challenges his clients face in complying with the laws impacting food manufacturing. He understands Hazard Analysis Critical Control Point (HACCP) and the regulations under the Food Safety Modernization Act (FSMA).

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 Xin Tao Xin Tao

Senior Associate, Washington, DC

With a working knowledge of regulatory requirements and a strong understanding of life science, Xin Tao works closely with clients in the food and drug industry to navigate the evolving federal and state regulatory environments and develop innovative regulatory strategies to commercialize products made with emerging technologies.  Xin’s background in life science (biochemistry and biophysics) assists him in his science-based food and drug law practices. Xin advises clients on food and drug law with a particular focus on novel food and dietary ingredients, biotechnology, FDA cGMP compliance, ingredient labeling, and California’s Proposition 65.  Xin’s unique ability in understanding and interpreting the complex scientific issues as they relate to the governing regulatory requirements helps clients with all phases of the product development, manufacturing, and marketing.  He is also increasingly expanding his expertise of USDA’s organic regulatory regime as it pertains to his clients.

Xin has helped numerous food, dietary supplement, and pharmaceutical companies evaluate the need for marketing approval from the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA). He also pursues clearance or pre-market approval (e.g., food additive petition, GRAS notice, NDI notification) when necessary and responds to FDA enforcement activities including Warning Letters and Import Alerts. Xin has advised numerous companies on issues relating to the advertising and promoting of products including the Federal Trade Commission (FTC)’s claim substantiation standards . Xin also has vast experience with FDA and USDA due diligence investigations for companies subject to takeover or merger activity.

Xin is very actively involved in a number of organizations that serve Chinese legal and life science professionals in the Washington region, including the Sino-American Pharmaceutical Professionals Association and Washington DC Chinese Legal Association.  Xin is a frequent speaker and contributor to industry publications both in the U.S. and China.  He is adept at assisting both Chinese food and drug companies doing business in the U.S. and U.S. clients doing business in China.

During law school, Xin worked as a regulatory food scientist and also served as an executive editor of the Georgetown Environmental Law Review.