Jessica O’Connell provides strategic advice to a broad range of companies and trade associations in engaging with food and drug regulatory bodies and Congress. She assists clients in complying with U.S. regulatory requirements for the manufacture and sale of foods, dietary supplements, cosmetics, OTC drugs, and animal products, and the import and export of FDA-regulated products. In addition, she counsels clients regarding potential crises, such as recalls and unanticipated regulatory attention.
Ms. O’Connell joined the firm from FDA, where she served as an Associate Chief Counsel in FDA’s Office of Chief Counsel from 2008 to 2014. While at FDA, Ms. O’Connell counseled various components of FDA and HHS on legal issues related to conventional foods, dietary supplements, and cosmetics. Specifically, Ms. O’Connell worked closely on implementing various provisions of the FDA Food Safety Modernization Act of 2011, including the sanitary food transportation requirements and food safety-related fees, and provided legal advice on agency actions regarding food additives and GRAS status, cosmetics and color additives, food and dietary supplement labeling claims, medical foods, and foodborne illness outbreaks and related actions, including recalls and other enforcement activities. In addition, Ms. O’Connell provided legal counsel to the agency regarding FDA’s import and export activities for all FDA-regulated products.