We are writing this memo to bring to your attention that the Food and Drug Administration (FDA) recently published a new final guidance titled: “Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk” (FCN Guidance). The guidance contains recommendations regarding how the scientific information in food contact notifications (FCNs) for infant food use should demonstrate that the food contact substance (FCS) is safe for the specific intended use in contact with infant food. FDA has previously provided guidance for the safety assessment of FCSs. However, the earlier guidance document did not specifically address dietary exposure and safety assessment considerations related to the migration of chemical substances from packaging and other food contact articles as it pertains to infants. FDA meant to fill the gap with this new guidance and the FCSs that would be affected by this guidance document include infant formula packaging for liquid and powdered formula, baby bottles, bottle inserts, nipples, and any other materials that are in contact with infant food.

In this post, we highlight the FDA’s chemistry and toxicology recommendations. Click here to read more. 

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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 Xin Tao Xin Tao

Senior Associate, Washington, DC

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.