On August 17, 2016, the U.S. Food and Drug Administration (FDA) issued its final rule regarding substances that are Generally Recognized as Safe (GRAS) for use in human and animal foods.  This long-awaited final rule, published nearly twenty years after the 1997 proposed rule, clarifies the criteria for when the use of a substance is not subject to the premarket approval requirements of the
Federal Food, Drug, and Cosmetic Act (FFDCA) because the substance is GRAS. It also establishes a new administrative procedure for any person to voluntarily notify FDA the basis of a conclusion that a substance is GRAS. We commend the agency for upholding its statutory authority of the FFDCA and retaining the voluntary nature of the GRAS program. We also support FDA’s efforts in providing more clarification of the basis of a GRAS decision and more flexibility with the voluntary GRAS notification program. The preamble of the final rule contains important comments related to FDA’s recent actions against substances with safety concerns and with the agency’s view on the GRAS criteria. Companies considering the addition of a substance to any food on the basis of a GRAS conclusion should carefully review the final rule and reevaluate the substance’s compliance with the FFDCA in light of the new regulations. The final rule becomes effective October 17, 2016.

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Photo of Martin Hahn Martin Hahn

Partner, Washington, D.C.

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…

Partner, Washington, D.C.

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 Xin Tao Xin Tao

Senior Associate, Washington, D.C.

With a strong understanding of life sciences, Xin Tao works closely with clients in the food and drug industries to navigate the evolving regulatory environments and develop innovative strategies to commercialize products made with emerging technologies both in the…

Senior Associate, Washington, D.C.

With a strong understanding of life sciences, Xin Tao works closely with clients in the food and drug industries to navigate the evolving regulatory environments and develop innovative strategies to commercialize products made with emerging technologies both in the U.S. and China.

Xin’s previous work experience as a research biochemist informs his science-based food and drug law practices. His unique ability in understanding and interpreting the complex scientific issues as they relate to the governing legal and regulatory requirements helps clients with all phases of product development, manufacturing, and marketing. His practice focuses on novel food and drug applications that require U.S. Food and Drug Administration (FDA) review and FDA current good manufacturing practice (cGMP) compliance for foods, dietary supplements, and pharmaceuticals.  Born and raised in China, Xin is well-equipped to assist global companies to adapt to China’s National Medical Products Administration’s (NMPA, formerly known as China Food and Drug Administration or CFDA) ever-changing regulatory regime.  Xin is increasingly expanding his knowledge of California’s Proposition 65 (Prop 65) as it pertains to his clients.

Xin is actively involved in a number of organizations that serve Chinese legal and life sciences professionals in the Washington, D.C. region, including the Sino-American Pharmaceutical Professionals Association and the Washington, D.C. Chinese Legal Association. Xin is a frequent speaker and contributor to industry publications in both the United States and China.

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

Photo of Samantha Dietle Samantha Dietle

Senior Associate, Washington, D.C.

Sam Dietle provides practical legal solutions and regulatory guidance to all segments of the food industry, including manufacturers, restaurants, retailers, animal producers and processors, and their trade associations.

She advises clients on federal and state regulatory issues that arise…

Senior Associate, Washington, D.C.

Sam Dietle provides practical legal solutions and regulatory guidance to all segments of the food industry, including manufacturers, restaurants, retailers, animal producers and processors, and their trade associations.

She advises clients on federal and state regulatory issues that arise throughout the entire food supply chain, including labeling and advertising compliance and claim substantiation issues, enforcement actions by the Food and Drug Administration (FDA) and United States Department of Agriculture (USDA), litigation support, and drafting comments on proposed regulations and agency guidance. Sam also counsels clients in consumer products industries on compliance with Consumer Product Safety Commission (CSPC) requirements.

Prior to joining Hogan Lovells, Sam advised food packaging companies on FDA premarket requirements and regulatory compliance matters. Sam also worked with electronic cigarette companies as FDA began to regulate this industry. While in law school, she served as a judicial intern in the U.S. Court of Federal Claims, working on vaccine injury claims cases.