Food and Drug Packaging
Keller and Heckman’s Food and Drug Practice is internationally recognized in the packaging world as the leader in providing comprehensive legal and regulatory advice and representation before government agencies on packaging for food, pharmaceuticals, cosmetics, and medical devices. Our expertise extends to materials used to produce, store, hold, prepare, and package this range of products.
We assist clients in addressing the full range of legal and regulatory issues with which they may be confronted including the compliance status of their products under laws in the United States, the European Union, China, Japan, South America, and throughout the world. We also assist on labeling and advertising issues, inspection of manufacturing facilities, product recalls, and quality assurance programs. We provide businesses—ranging from multi-national corporations to cutting-edge start-ups—with the legal and scientific support they need to bring their products to commercial success throughout the world and to resolve compliance issues should they arise.
We focus on finding the most efficient ways to establish suitable regulatory clearances for packaging materials. Our opinion letters on regulatory compliance of packaging materials—including plastics and resins, adhesives and coatings, paper and paperboard, printing inks, and additives used in the manufacture of such materials—are recognized globally by industry and government officials.
Keller and Heckman clients benefit from the in-depth expertise and extensive experience of our attorneys, many of whom have government experience and expertise in multiple areas of the law. In addition to our legal staff, we have more than 20 in-house scientists who work closely with the firm’s attorneys on matters of technical complexity. We use an interdisciplinary approach to problem-solving by collaborating with our in-house scientific staff who specialize in organic and inorganic chemistry, toxicology, genetic engineering, biochemistry, molecular biology, microbiology, bioengineering, chemical engineering, physical chemistry, analytical chemistry, and nanotechnology. Being an industry leader, Keller and Heckman’s Food & Drug Packaging Practice consistently receives the highest rankings globally by legal guides, including Chambers & Partners and Legal 500.
- Counseled numerous companies, both domestic and foreign, in establishing a suitable status for goods made from recycled materials (both paper and plastic), including obtaining FDA concurrence when needed
- Assisted multiple plastics manufacturers in conducting risk assessments of non-intentionally added substances/impurities in Europe and in the U.S., respectively
- Prepared and successfully completed several hundreds of Food Additive Petitions, Food Contact Notifications, and other regulatory requests through the clearance processes established by numerous authorities throughout the world, including the U.S. FDA, the EU Commission, China, Health Canada, and South America’s MERCOSUR (Mercado Común del Sur or Southern Common Market)
- Negotiated the successful resolution of numerous Notices of Violation regarding food and food packaging materials under California’s Proposition 65
- Provided guidance to clients on the evolving regulations and regulatory environment regarding food-contact materials in Asian countries
- Submitted industry comments on legislation concerning food and food-contact materials in China and elsewhere in Asia seeking common sense exemptions and revisions
- Counseled clients on good manufacturing practice (GMP) considerations, including conducting GMP audits of client facilities
Areas of Focus
- Providing clients legal opinions on the regulatory status of food packaging and other food contact materials in jurisdictions throughout the world
- Preparation and submission of food contact notifications, petitions, technical dossiers, and other filings to obtain regulatory clearances for substances (including recycled materials) used in the production and packaging of food, drugs, and other products
- Assist with good manufacturing practice requirements, Declarations of Compliance, product guarantees, and other warranty and customer assurance statements, product recalls, and responding to government inquiries, inspections, and warning letters
- Monitoring legislative and regulatory developments and providing targeted analysis of food packaging issues arising around the world
- Assist in the development and submission of comments on federal and state rulemaking proceedings
- Preparing and updating drug master files (DMFs) and device master files (MAFs)