Practice Areas: FDA Regulatory Compliance Representation & Defense

Benjamin L. England & Associates provides representation and counsel to domestic and foreign members of the Food and Drug Administration (FDA) regulated community, including food, drug, cosmetic, device, and tobacco companies. Whether assisting multinational corporations, small companies, or trade associations, we create an individualized approach to meet our clients’ needs.

We represent clients before FDA in a wide range of issues, including facility inspections, 483s and Warning Letters, import holds and detention, import alerts, and product recalls. Furthermore, we represent industry members and trade groups to influence the evolving regulatory climate as FDA changes it through new regulation or guidance.  By appreciating the legal and regulatory issues with the different forms of FDA involvement, we represent and work to protect our clients’ interests as they intersect with FDA.

We advise clients on all aspects of FDA compliance, including labeling and marketing, product clearances (510(k)) and formulation (color additives and OTC monographs), and registrations. By understanding our clients’ operations, we help them develop and implement procedures to comply with Quality Systems Regulation (QSRs), current Good Manufacturing Practices (cGMPs), Hazard Analysis and Critical Control Point (HACCP), and other FDA obligations. We help our clients build robust compliance programs to minimize the risk of FDA involvement and scrutiny.

A provision of the Food Safety Modernization Act is the Foreign Supplier Verification Program, or FSVP. Importers of food will be required to verify that their foreign suppliers are in compliance with U.S. law. As this provision moves from the proposed regulation stage to being an enforceable rule, our attorneys will keep abreast of the impact it may have on businesses and their supply chains.