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Danny Rubenstein is a member of Keller and Heckman’s Food and Drug and Tobacco and E-Vapor Practice Groups. Leveraging his background and experience as an Industrial Engineer, Mr. Rubenstein appreciates both the technical and legal aspects of the challenges faced by industry in navigating the complex regulatory systems in place across the world.
Mr. Rubenstein assists companies, organizations and trade associations in establishing compliance with regulatory requirements for food packaging materials and food ingredients throughout the United States, European Union (EU), Asia and South America (MERCOSUR). In this regard, Mr. Rubenstein assists clients in establishing a suitable U.S. Food and Drug Administration (FDA) status, and exemption from premarket review, for a variety of food-contact materials, and has successfully filed numerous Food Contact Notifications (FCNs) with FDA for new and innovative polymers, additives, and processing aids used in the manufacture of food-contact articles. In addition, Mr. Rubenstein advises clients regarding the suitable status of food-contact materials under the EU Framework Regulation, and the Plastics Regulation (EU) No. 10/2011.
As a former supply chain analyst for a Pittsburgh, Pennsylvania-based medical device manufacturer, Mr. Rubenstein has experience in process optimization, inventory control, facility layout and good manufacturing practice (GMP) in FDA-regulated facilities. Mr. Rubenstein uses this experience to assist clients in developing strategies to prevent and, when necessary, respond to contamination and “accidental additive” situations that arise during the manufacturing and transportation of food-contact materials. Mr. Rubenstein also proactively advises clients regarding quality control and internal auditing strategies and conducts in-depth analyses of manufacturing processes and Standard Operating Procedures (SOPs) for FDA-compliance purposes.
Mr. Rubenstein is a principal member of Keller and Heckman’s Tobacco and E-Vapor Audit and Inspection Program (AIP), which is designed to provide companies that are involved in any aspect of the tobacco or vapor product supply chain with confidence that their facilities are operating in accordance with FDA requirements. In this regard, Mr. Rubenstein conducts on-site training and auditing to evaluate and recommend improvements to e-liquid manufacturers and retailers under the Tobacco Control Act.
Mr. Rubenstein has previously been featured in Industrial and Systems Engineering Magazine, the American Bar Association's The Health Lawyer, and the University of Maryland's Journal of Health Care Law and Policy. Mr. Rubenstein is a member of the Institute of Industrial and Systems Engineers (IISE) and the Maryland State Bar Association.
American Bar Association Maryland State Bar Association Inst. of Industrial and Systems Engineers
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