Food & Agriculture
For more than four decades, OFW has been a premier resource for FDA and USDA-regulated clients in the food and agriculture sector. We are steadfastly committed to assisting clients bringing products from farm to table, offering comprehensive counsel on regulatory matters involving food and fiber production.
An exciting new enhancement to our capabilities comes with the integration of the accomplished attorneys from Benjamin L. England & Associates. This strategic collaboration significantly bolsters OFW’s expertise, particularly in addressing a wide spectrum of matters pertinent to imports, exports, Customs & Trade compliance, as well as robust defense strategies for both consumer and commercial litigation within the food and agriculture industry.
Key Regulations & Laws We Navigate
Our attorneys have deep expertise in the Federal Food, Drug, and Cosmetic Act (FFDCA), the Food Safety Modernization Act (FSMA), the Federal Meat Inspection Act (FMIA), the Poultry Products Inspection Act (PPIA), and the Agricultural Marketing Act.
We regularly work with FDA’s preventive controls regulations, USDA-FSIS inspection requirements, Country of Origin Labeling (COOL) rules, organic certification standards (NOP), and bioengineered food disclosure requirements.
We also counsel clients on state-level regulations including California Prop 65, allergen laws, and hemp/CBD food provisions.
Agencies & Processes We Handle
We represent clients before the Food and Drug Administration (FDA), including CFSAN and ORA; USDA’s Food Safety and Inspection Service (FSIS), Agricultural Marketing Service (AMS), and Food and Nutrition Service (FNS); U.S. Customs and Border Protection (CBP); the Federal Trade Commission (FTC); and state departments of agriculture.
Our work includes FDA 483 responses, Warning Letter remediation, import refusals and admissibility issues, FSIS NOINs and NOSIs, HACCP and HARPC plan development, facility registration and re-inspection requests, and regulatory comments on proposed rules.
Compliance & Enforcement Matters
We assist clients with FDA facility inspections (domestic and foreign), USDA establishment audits, import detention and refusal responses, voluntary and mandatory recalls, 483 observation responses, consent decrees and injunctions, debarment proceedings, administrative hearings, and civil money penalty negotiations.
Our team handles FSMA Foreign Supplier Verification Program (FSVP) compliance, Preventive Controls Qualified Individual (PCQI) matters, Sanitary Transportation Rule requirements, and Intentional Adulteration (IA) rule implementation.
Product Authorization & Market Entry
Our attorneys guide clients through FDA food additive petitions, Generally
Recognized as Safe (GRAS) notifications and self-determinations, color additive approvals, New Dietary Ingredient (NDI) notifications for food uses, USDA grant of inspection applications, organic certification appeals, bioengineered food disclosure compliance, and state-level product registrations.
We also handle qualified health claims, structure/function claims substantiation, and nutrient content claim compliance.
Food Manufacturing, Processing, and Marketing
OFW provides trusted regulatory counsel
and representation to large and small food manufacturers, packers and processors, feed mills, restaurants and retailers.
Food Distribution & International Trade
OFW advises clients on compliance and policy aspects of food distribution, including international trade regulations.
Government Relations
OFW’s government relations group provides strategic advice to assist our agriculture and food clients in influencing federal agencies, Congress, and the White House.
Agriculture & Agribusiness
OFW’s professionals work with farmers, ranchers, and agribusinesses on a broad array of legal and regulatory matters.
SNAP/WIC
The USDA’s Food and Nutrition Service (FNS) is the federal agency with primary responsibility for administering the Supplemental Nutrition Assistance Program (SNAP) and the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).
Litigation
OFW Law’s Litigation group represents agricultural businesses, associations, farmers, food and beverage, drug, and medical device manufacturers, processors, retailers, grocers, convenience stores, and other related entities across the food and agriculture spectrum.