Chairman: Richard F. Mann, Partner & Chair, Management Committee
David J. Ettinger, Chief Representative Shanghai Office, [email protected]
Number of partners: 36
Number of lawyers: 75
Languages: Mandarin, English, French
In 2004, Keller and Heckman LLP opened an office in Shanghai to meet the rising demand for global regulatory advice from companies operating in Asia. From their Shanghai office they provide legislative and strategic analysis to clients on regulations throughout Asia in the areas of food, food packaging, drugs, dietary supplements, medical devices, pesticides, tobacco and e-vapor, and industrial and specialty chemicals. Keller and Heckman attorneys advise clients on the legal status of ingredients and finished products under all the Asian regulatory schemes and assist them in obtaining pre-market clearance, where necessary. They also counsel clients on advertising and labelling regulations, including those related to nutrition and health claims, hygiene and inspection matters, and import/export certification requirements. The office is highly experienced in dealing with product seizure and detention at port and when products are in the stream of commerce. The office handles all levels of crisis management. Their lawyers and scientists have built relationships over the years with government officials, industry associations, and other groups throughout Asia. Keller and Heckman is a member of the Chinese Food Additives and Ingredients Association, the American Chamber of Commerce in Shanghai, the American Chamber of Commerce South China, and the European Chamber of Commerce in China.
Main Areas of Practice:
Food & Drug:
Keller and Heckman offers global food and drug services to its clients. Their comprehensive and extensive food and drug practice is one of the largest in the world. They promote, protect, and defend products made by the spectrum of industries regulated by various regulatory agencies including, the Chinese National Health Commission, the Chinese State Administration for Market Regulation, the Chinese Ministry of Agriculture and Rural Affairs, the Chinese National Medical Products Administration, the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU), and similar authorities throughout the world. The products they help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, tobacco-related products and cosmetics.
Keller and Heckman has a comprehensive practice in the regulation of packaging materials for foods, drugs, cosmetics, and other regulated products. The firm counsels clients in all matters relating to these products, including the suitability of packaging components, inspection of manufacturing facilities, and quality assurance programs.
Keller and Heckman counsels clients on the full range of regulatory compliance issues affecting cosmetics. They review labelling and advertising for compliance requirements and advise on the classification of a product as a cosmetic or a drug based on the product claims. They also provide guidance on the safety testing of cosmetic ingredients, including toxicology, carcinogenicity, and sensitivity testing. In addition, Keller and Heckman assists in compliance issues, including good manufacturing practices, recordkeeping, product recalls, and governmental inspection practices.
Tobacco & E-Vapor:
Keller and Heckman counsels clients at every level of the tobacco, e-cigarette and vaping supply chain from manufacturers of components and additives, to manufacturers of finished products (both consumables and hardware) and their distribution and delivery to consumers.
Keller and Heckman counsels clients in all media (i.e., air, water, waste) and in the areas of chemical control and pesticides. Their attorneys and scientists help clients obtain needed approvals for new chemicals and pesticides by developing product approval programs and providing premarket notification and technical dossiers. They have extensive international environmental experience in regulatory and compliance counseling, analyzing legislative issues, and managing audits.
In today’s global marketplace, an understanding of international trade, foreign laws and regulations, and international standards is a must. Members of Keller and Heckman’s international regulatory affairs practice group have extensive experience in helping clients understand how foreign laws and regulations affect their interests. By combining a thorough understanding of trade and regulatory policymaking, with a technical knowledge of diverse laws and regulations, they successfully promote their clients’ interests in the global marketplace.