Regulatory and enforcement actions can present significant challenges for a company’s day-to-day business operations and strategic planning efforts. Shook, Hardy & Bacon counsels prescription and nonprescription drug, cosmetic, food and beverage, dietary supplement, medical device, and animal feed and drug manufacturers and retailers on matters governed by the U.S. Consumer Product Safety Commission (CPSC), Environmental Protection Agency (EPA), Food and Drug Administration (FDA), Federal Trade Commission (FTC), Occupational Safety and Health Administration (OSHA), and Department of Agriculture (USDA) as well as various UK regulatory agencies.
We provide regulatory, compliance and risk management advice to a broad range of clients from emerging companies to some of the largest companies in the world. Our attorneys handle various enforcement and rulemaking proceedings, in addition to assisting clients with regulatory matters. Shook attorneys advise on compliance in connection with the manufacture, sale and promotion of products; clinical trials; approval pathways; labeling; safety; facility and product registration; facility inspections; custom holds; and product withdrawals and recalls.
We support clients on crisis management issues that arise from inspections, quality failures and recalls—including evaluating reporting obligations, responding to Form 483 findings and enforcement letters, and preparing media statements. We also assess litigation risks and product liability considerations as part of the audit program we offer to our clients.