Speaker

Ms. Jackson's practice is focused on regulatory counseling concerning the development, formulation, manufacture, distribution, and promotion of foods, dietary supplements, drugs, medical devices, and cosmetics. She handles matters involving regulation and enforcement by federal and state agencies, including the U.S. Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the United States Department of Agriculture (USDA), and the Consumer Product Safety Commission (CPSC). She also regularly handles matters involving self-regulatory bodies such as the National Advertising Division of the Council of Better Business Bureaus (NAD) and the National Advertising Review Council’s Electronic Retailing Self-Regulation Program (ERSP). In addition, Ms. Jackson provides valuable assistance to clients in litigation and settlement negotiations. Ms. Jackson represents numerous clients, helping them to navigate the complex regulations governing foods, food contact substances, dietary supplements, animal supplements, medical foods, over-the-counter (OTC) drugs, homeopathic drugs, medical devices, cosmetics, and consumer products in various stages of the product lifecycle. Ms. Jackson assists clients from the beginning stages of product development, advising on product formulation and design. She also assists clients in obtaining product clearance, approval, or permits, such as 510(k) clearance for medical devices or USDA import permits for animal-derived products. She likewise assists clients in submitting required notifications, such as new dietary ingredient (NDI) or GRAS notifications. With regard to product manufacture and distribution, Ms. Jackson advises clients on FDA’s good manufacturing practice (GMP) requirements and the CPSC’s requirements with regard to child-resistant packaging and certification for consumer products. She also assists with product and facility registration and listing.