We help clients in the food and beverage industry - or whose products subject them to food regulation - understand and comply with FDA and other regulations; chemical, pesticide, and biotechnology statutes; environmental, health, and safety issues; and voluntary product stewardship measures.
We help companies meet the challenge of bringing highly-regulated products to market and keeping them there.
Many food and beverage products, as well as their components and packaging, are regulated by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FFDCA) and its amendments, such as the Food and Safety Modernization Act (FSMA). State and international laws also regulate foods and beverages. In addition, the facilities that manufacture these products are subject to a wide range of environmental regulations.
B&D counsels clients on the expanse of environmental compliance and health and safety regulations affecting the food and beverage industry. Our practice combines specialized, cross-disciplinary legal expertise with the practical perspective of a company’s business objectives, whether it's importing, making, selling, or marketing products; ensuring product approval and ongoing compliance; defending enforcement actions and investigations; achieving appropriate levels of regulation; or dealing with recalls. Our extensive work in chemical, pesticide, and biotechnology law, uniquely positions us to help food and beverage industry clients with these issues.
We assist U.S. and multinational companies with product regulatory matters, including:
- Bringing new FDA-regulated products to market.
- Resolving compliance issues and FDA enforcement actions.
- Handling FDA inspections.
- Counseling on product recalls.
- Advocating for changes in FDA regulatory requirements and adoption of new rules.
- Advising on foreign counterparts to FDA requirements.
- Preparing Generally Recognized as Safe (GRAS) notifications.
- Working with food companies and industry trade groups on biotech crop regulation.
- Advising on regulatory requirements of pesticide residues under the Food Quality Protection Act (FQPA) and chemicals in food packaging.
We also assist with facility matters, including:
- Food processing plant regulatory requirements.
- Compliance and enforcement matters related to the transportation of food products and hazardous materials.
- Environmental Health and Safety (EHS) audits and audit disclosures.
- Air, water, and wastewater permitting.
- Stormwater management.
- Due diligence for corporate and real estate transactions.
- Environmental indemnity and related transaction agreements.
- Enforcement action defense.
- EHS counseling.
- Global product stewardship.