We provide counsel on USDA compliance issues including:
– Identifying whether a FDA-regulated product requires a USDA permit
– Filing, renewing, and amending a USDA permit (see USDA Permit Compliance)
– Advising on research permits for regulated materials
– Advising on USDA regulation of plant and seed materials
– Assisting in response to Emergency Action Notifications (EANs)
– Advising on USDA compliance requirements related to pests and/or violative materials in FDA-regulated goods
Our experience includes representing domestic and international businesses, and import and export matters regulated by FDA, CBP, USDA, and EPA.
Representative USDA Regulatory Experience
- Advised FDA-regulated milk powder manufacturer with animal-derived vitamins on USDA permit requirements
- Advised food manufacturer containing animal-origin materials on USDA permitting and compliance requirements
- Obtained USDA VS Permits for animal-origin containing materials of FDA-regulated products
- Assisted soybean manufacturer with response to EAN regarding federal noxious weeds contamination
- Advised seed research company on USDA plant research permitting
- Advised FDA-regulated food manufacturer on USDA treatment protocols for pests found on food products
- Counseled on phytosanitary certificates
- Advised manufacturer on USDA APHIS and FSIS regulations
Why Work With Us?
- Experienced and committed: While it helps that many of the products we advise on are ones we would use or recommend to friends and family, we are invested and care about you and the issues you are facing. We dedicate our resources to resolve your questions, and to help you reach the next peak.
- Responsive: We recognize that business happens quickly. We pride ourselves on being responsive to clients, and available when you need us, whether this means accommodating international time zones or strategizing for an unannounced FDA inspection.
- Client-focused: We focus on identifying the best legal and business solutions with your products and risk tolerance in mind.
- Partnership: We like to view our partnership as a long-term relationship, growing with you as an extension of your regulatory team.
- Specialized: Our practice is niche and our expertise is specialized. Chances are we have experience and the resources to address the regulatory questions keeping you up at night.
USDA compliance clients include:
· Importers · Exporters · Manufacturers · Contract manufacturers · Distributors · Trade organizations