Food, Drug & Device Law
In 1906, Congress chartered the Food and Drug Administration with a mission to promote public health by ensuring that foods are safe, wholesome, sanitary, and properly labeled; drugs and devices are safe and effective, and cosmetics are safe and properly labeled. In the more than 100 years since its inception, the FDA has exploded into an agency with more than 15,000 employees. It encompasses more than 750 centers, divisions, and departments, 230 field offices, and 13 laboratories in 50 states and offices in six foreign countries. Today, the FDA oversees licensing, registration, product approval and clearance, facility and product inspections, and civil and criminal enforcement of all aspects of the manufacturing, distribution, marketing and sale of products ingested, applied or implanted into humans or animals. This regulatory landscape continues to grow with the introduction of new laws, regulations, and guidance, amounting to thousands of pages every month.
The Clark Hill team is equipped to match the complexity of these issues with a multidisciplinary approach. Our lawyers have broad experience handling FDA regulatory matters, transportation and import/export issues, civil and criminal enforcement, intellectual property, unfair competition, and product liability defense. Our practice area leaders are available to answer any questions about our capabilities.
Farm to Table - Concept to Label - Demand to Dismissal
Food Manufacturing and Distribution
We counsel clients regarding the implementation of the Food Safety Modernization Act (FSMA) and the rules implementing the law and related regulatory guidance concerning preventive controls, produce safety, foreign supplier verification, third-party auditors, sanitary transport, and Mitigation Strategies to Protect Food Against Intentional Adulteration. We further counsel clients regarding facility and product licensing, registration, supplier and supply chain compliance, supplier verification, track and trace, and establishing and revising policies and procedures. We handle issues concerning labeling, claims substantiation, new dietary ingredients (NDI), packaging and food contact substances, and the changing landscape of foods and additives generally regarded as safe (GRAS). Our team is adept at addressing and responding to emerging and emergent product adulteration and labeling issues giving rise to a product recall.
Promotion and Advertising
Our food and drug team provides counseling regarding traditional print, broadcast, and internet advertisements and promotional content, concerning regulatory compliance for conduct and promotional activities related to tradeshows, educational programs, and sales representatives. Our experience extends from matters before the FDA to those where the FDA and FTC share jurisdiction over FDA-regulated product advertising and promotion. While our focus is compliance, anticipating, and substantiating misbranding and potential false advertising claims, we bring our litigation experience to bear in defending governmental, competitor and consumer false and deceptive advertising, Lanham Act, and misbranding claims. We help clients address emerging new technology applications for product promotion, development, co-branding, and data privacy and security.
We represent clients in a broad range of matters in this area from advising clients on negotiating with state and federal agencies, including FDA, FTC, USDA, and CBP regarding inspections, product detention, and product recalls to matters involving enforcement and administrative proceedings (483s), warning letters, and injunctions.
We advise clients through the defense of companies and individuals facing criminal prosecution and complex cases involving white-collar crimes, including fraud, “Park Doctrine” prosecutions, healthcare fraud, insurance fraud, official corruption, financial institutions fraud, and intellectual property rights violations. We have litigated cases at the federal level with U.S. Attorneys’ offices, the U.S. Department of Justice, U.S. Customs and Border Protection, FTC and FDA as well as with state law enforcement.
New sanitary transportation and supply-chain regulations have required revising policies and procedures and operating procedures as well as supplier, vendor, and broker agreements to address issues raised in current regulations. We have the necessary transportation and FDA experience to counsel clients on how to manage these risks. Our experience in transportation/logistics law includes airlines, direct and indirect air cargo carriers, motor freight carriers (including the less than truckload, truckload, tank, dry bulk, drive-away, courier and private segments), air, ocean and inland freight forwarders, transportation brokers, customs brokers, railroads, warehouse operators, consolidators, third-party and fourth-party logistics providers, shippers, and insurers. We handle legal matters that are unique to the world of transportation and logistics, whether the problem involves surface, maritime, air, or intermodal operations.
We counsel clients on the FSMA requirements for foreign supplier registration and verification requirements as well as third-party auditors and prior notice requirements. We serve clients in Latin America, Europe, Canada, the Caribbean, Asia, and the Middle East—with a special focus on Latin America. We assist clients requiring all modes of transportation for the production, sales, and distribution of goods and services across borders. Our lawyers have extensive experience with the intricate laws and regulations associated with import and export regulation, maritime matters, border security, and cross-border transportation, including the special regulatory regimes that apply to international transportation of hazardous materials, export of dual-use goods (having both military and civilian applications), and trade in goods for which NAFTA duty reductions are claimed.
Litigation and Dispute Resolution
New theories of liability are emerging and supplanting the traditional strict product liability doctrine for manufacturing defects, design defects, and marketing defects (or failure to warn). State or federal enforcement often leads to “follow-on” litigation. Our experience is well suited to defending against sophisticated new approaches that often draw on state law-based claims paralleling federal requirements. Because we understand and participate in establishing the law for dealing with these theories, our lawyers are poised to counter new litigation threats intelligently and efficiently. Our team of litigators has appeared throughout the United States in state and federal courts and administrative agencies and has managed litigation for some of the world’s largest companies including convenience store operators, retail, and pharmaceutical and medical device manufacturers.
Over the last 10 years, our team has managed some of the largest litigation and governmental proceedings in the country and has handled complex litigation for clients on national and regional bases. Our team of litigation management has been sought out for its efficiency, thoroughness, and cost saving in formulating and implementing programs to manage litigation efficiently and cost-effectively using several project-focused strategies.
Brand Name Identification and Protection
Whether it involves trademark, copyright, or internet practice, we guard brand value by protecting clients’ intellectual property rights from infringement, misappropriation, dilution, and counterfeiting. We have experience with diverse products, including medical devices, packaging, patient monitoring systems, pharmaceuticals, and products of genetic engineering. We prepare and prosecute patent applications, obtain copyright and trademark registrations, negotiate license agreements, counsel on mergers and acquisitions, and enforce intellectual property rights against infringers. We work in domestic markets, as well as in Central and South America, Canada, Asia, and Europe.
Our corporate and securities attorneys represent clients in a broad range of matters, including merger, acquisition and divestiture transactions, private and public stock offerings, financial regulations, securities arbitration and defense, corporate reorganizations, and other business matters. Corporations, early-stage companies, investors, brokers, and even non-profits rely on us to advise on everything from day-to-day compliance and reporting requirements to long-term business objectives.