At OFW Law, our lawyers form attorney-client relationships with members of the conventional food and cosmetic industries to further the client's legal, regulatory, competitive, and other business objectives by employing a variety of available means - both conventional and creative. Our attorneys and Senior Policy Advisors lobby Congress and administrative agencies; write comments and muster coalitions of related interests in rulemakings; counsel on regulatory compliance, enforcement risk and corrective action; draft notifications, petitions, and other voluntary or mandatory submissions; file complaints against competitors; and otherwise advance and defend client interests before courts, before federal and state enforcement officials, and in the marketplace. The experience and knowledge our lawyers offer are unique. We render timely, effective, and cost-efficient legal advice and services.
At OFW Law, we help shape the laws that govern the marketing of FDA-regulated products, including:
Our professionals were instrumental in the enactment of the Nutrition Labeling and Education Act (NLEA), the FDA Modernization Act (FDAMA), the Public Health Security and Bioterrorism Preparedness and Response Act (Bioterrorism Act), the Food Allergen Labeling and Consumer Protection Act (FALCPA), the FDA Amendments Act, and the FDA Food Safety Modernization Act.. We also have been actively involved in rulemakings to establish regulations implementing these statutes. As a result, we are intimately familiar with the explicit requirements of these laws, as well as the policy nuances underlying them.
We believe that, when feasible, anticipating and circumnavigating issues before they become real problems (e.g., enforcement action, business disruption, adverse publicity) is the most prudent approach to addressing regulatory challenges. At OFW Law, our professionals encourage and facilitate positive interactions between clients, lawmakers, and regulatory officials on a broad array of compliance matters. We also prepare clients for handling FDA inspections and conduct due diligence reviews relative to the sale of food and cosmetic businesses.
Our professionals represent clients across the country and throughout the world. We understand what it is like when clients face deadlines or unforeseen difficulties. Consequently, we are positioned and ready to immediately act on behalf of a client — no matter the distance that separates us, whether by phone, fax, e-mail, or onsite travel — when compliance or enforcement issues arise.
OFW Law attorneys have authored a number of publications for The Food Institute on compliance and enforcement matters. We also collaborate on seminars addressing regulatory matters.