By working with clients to navigate the complex world of federal regulation by the U.S. Food and Drug Administration, Anne Spiggle helps clients focus on their business objectives. Anne believes she can best enable clients to achieve their goals by taking a multi-faceted, “think-out-of-the-box” approach that considers the client’s needs from regulatory and public policy angles. She has developed a broad range of regulatory experience, representing clients in connection with the development, promotion and sale of:

• Foods
• Dietary supplements
• Prescription and over-the-counter drugs
• Cosmetics
• Medical devices
• Animal feed
• Consumer products

Anne’s representation of clients includes significant experience on a wide range of regulatory and public policy matters involving the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the Consumer Product Safety Commission (CPSC) and other federal and state health and safety regulatory agencies. This experience includes:

• Counseling clients on regulatory requirements
• Assisting clients in responding to regulatory enforcement actions
• Helping clients engage in the regulatory process through preparation of regulatory submissions (such as Citizen Petitions, New Dietary Ingredient submissions and comments on agency rulemakings)
• Advising clients on product labeling, advertising, and promotion and claims substantiation, and helping clients respond to challenges to their labeling, advertising, and promotion

Anne also counsels clients on reporting adverse events and carrying out product recalls. She assists clients in conducting regulatory due diligence on corporate transactions and private equity investments. Drawing on her years of experience engaging with regulators, lawmakers, and industry, Anne can think creatively to provide clients with practical advice and fresh perspective.