Food & Beverage
Administrative Litigation
Our Firm has extensive litigation capabilities and has represented clients in administrative proceedings under:
- The Federal Insecticide, Fungicide and Rodenticide Act
- The Food, Drug and Cosmetic Act
- The Agriculture Marketing Agreement Act
- The Federal Meat Inspection Act
- The Poultry Product Inspection Act
- The Packers and Stockyards Act
- The Perishable Agriculture Commodities Act
Agricultural Chemicals & Biologics
Our experience includes:
- Obtaining the registration of synthetic chemicals, antimicrobials, biopesticides and biologics
- Defending the re-registration of products
- Obtaining experimental use permits
- Obtaining emergency exemption requests
- Handling data compensation issues
- Addressing food labeling issues
- Defending companies in suspension proceedings
- Representing Task Forces formed to respond to Data Call-Ins
- Handling agency enforcement proceedings, including seizure actions
Agricultural Cooperatives
Our experience includes representation of cooperatives engaged in marketing, wholesale distribution, manufacturing, transportation and providing credit, financial services, electricity, telephone services and housing. Our services and counsel to cooperatives include:
- Business and tax planning
- Employee benefits issues
- Mergers and acquisitions
- Corporate shareholder relationships
- Member guarantees
- Licensing issues
- Litigation
- Obtaining tax legislation for cooperatives
Food Labeling
Our Group has advised companies, individuals and associations on numerous food labeling issues including:
- Compliance with FDA and USDA requirements
- Standards
- Development and submission of comments on regulatory proposals
- Addressing false or misleading advertising claims including actions under the Lanham Act
Public and industry interest in these labeling issues dramatically increased in recent years with the passage of the Nutrition Labeling and Education Act (NLEA), the initiation of numerous regulatory proposals designed to implement NLEA, and related enforcement of efforts by both FDA and USDA. Virtually every food processor and the entire food growing and distribution chain are affected by these developments.
Food Safety
We have been active in a wide variety of food safety issues that have surfaced both in the United States and abroad. Our activities include representation and advice regarding:
- Microbiological and chemical contaminants
- Compliance with regulatory requirements
- Development of product sampling programs
- Development of quality control programs
- Food additives
- Assistance with voluntary recalls
- Resolution of issues regarding the seizure or detention of food products that are alleged to be either adulterated ormisbranded
- FDA, USDA and the National Marine Fisheries Service Inspection requirements
When serious food safety problems arise, the group is experienced in providing comprehensive crisis management assistance. We have served in such a role for clients involved in issues involving substances such as Alar, nitrosamines, e. coli, listeria, salmonella and genetically enhanced materials.
Legislative Representation
Our lawyers have extensive Capitol Hill experience and have developed an effective legislative component to our food and beverage practice. In representing clients on Capitol Hill, we:
- Create legislative strategies and assist clients in implementing those strategies
- Lobby on legislative issues
- Provide testimony at hearings
- Advance client interests by maintaining informal contacts with key Hill members and staffers
We consider the legislative process to be a critical component of our client service package. While Congressional and legislative activity is not necessarily a component of strategy on every food or beverage related issue, we utilize it frequently. We often find that carefully targeted Congressional involvement can make the difference between a problem languishing in the bureaucracy and receiving priority attention.
Business Planning
We advise companies, investors and inventors regarding the likely regulatory status of new products or product concepts. Such advice includes the type of application that would have to be filed, the data to be developed, the likelihood of complications during government review of the application, the time to approval and the costs associated with such an effort. We also discuss the claims and promotional statements that might be made in the marketplace.
Marketing the Approved Product
We have considerable experience in helping companies market products without disruption by the regulators. We can assist in developing the elements of a quality system, including procedures for compliance with Good Manufacturing Practice Regulations. Group members can provide SOPs and guidance in developing an effective complaint handling system, including provision for failure investigation.
Compliance and Enforcement Matters
We are actively engaged on a daily basis representing clients who are involved in compliance-related matters. Our group members advise companies during EPA and FDA inspections and help craft responses and corrective action programs needed because of inspectional observations or warning letters. We help companies decide on the scope of necessary recalls and implement recall strategies. The group deals with field corrections, retrofits and supplemental labeling.
We also represent clients in injunction actions and seizures, litigating them or negotiating consent decrees allowing the firms to resume or continue distribution. We are equally equipped to deal with the Agency headquarters compliance offices and the regional, district and resident offices in the field.
In addition to reacting to Agency compliance initiatives, we help clients avoid enforcement problems by conducting regulatory and data-integrity audits, either generally or in particular situations where a client is concerned about possible exposure.
Contacts
- Edward M. Ruckert
+1 202 756 8214
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