Food and Drug
Keller and Heckman’s world-renowned Food and Drug practice, provides clients with comprehensive legal and regulatory advice for a vast range of food and drug products, including foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, cosmetics, and cannabis products, as well as the packaging for these products. Our international team of attorneys, in collaboration with our in-house scientists, help clients bring their products to market and remain on the market.
We advise clients in promoting, protecting, and defending their products that are regulated by a variety of agencies and regulatory bodies, including the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture, the Federal Trade Commission (FTC), the Codex Alimentarius Commission (including the Committee on Food Labeling, Committee on Food Additives and Contaminants, the Committee on Nutrition and Foods for Special Dietary Use, and the Committee on General Principles), the European Commission and Member States authorities in the European Union (EU), the World Trade Organization (WTO), and similar authorities and regulators throughout the world.
Keller and Heckman counsels clients on issues relating to product composition suitability; inspection of manufacturing facilities; labeling and advertising; recall procedures, including adequate insurance coverage ; quality assurance programs; and appropriate responses to consumer complaints and tampering incidents. In collaboration with our litigation practice, Keller and Heckman vigorously defends clients when threatened by unwarranted action by competitors or regulatory authorities.
In the packaging arena, we counsel clients on the full range of global legal and regulatory issues, including ones in the United States, the European Union, China, Japan, and South America. We assist clients with the preparation and submission of food contact notifications, food additive petitions, technical dossiers, and other filings to obtain regulatory clearances for substances (including recycled materials) used in the production of packaging for food, drugs, and other products. Our attorneys also assist clients with drug master files (DMFs) and device master files (MAFs) submissions.
- Obtained a favorable no objection letter from the FDA in response to a generally recognized as safe (GRAS) Notice submission to FDA.
- Achieved an appropriate regulatory status for food contact materials through the submission of a food contact notification to FDA.
- Determined regulatory pathways available for a dietary ingredient used in dietary supplements and helped the client to understand the benefits and detriments of the different approaches.
- Assisted client in understanding labeling and claims that can be made on their label in compliance with FDA laws and regulations including a litigation risk assessment on various claims.
- Worked with client to understand food safety requirements such as Hazard Analysis and Risk-Based Preventive Control (HARPC) requirements.
- Helped review foreign facility food safety plans and draft Foreign Supplier Verification Program (FSVP) records for imports to comply with FDA’s FSVP requirements.
- Advised client on whether a food safety incident creates a health or safety risk that requires a recall, determine recall classification, and counsel on communication with FDA and press releases.
- Advised client on new bioengineered labeling requirements including exemptions and labeling options.