Drawing from nearly twenty years of experience working at FDA and in private practice, Jessica O’Connell provides strategic advice to a broad range of companies…
Drawing from nearly twenty years of experience working at FDA and in private practice, Jessica O’Connell provides strategic advice to a broad range of companies and trade associations in navigating regulatory frameworks and engaging with food and drug regulatory bodies and Congress. She works closely with clients to develop product strategies that are low-risk from both a regulatory and litigation perspective while also meeting marketing goals and objectives.
Jessica is based in our Washington, DC office and is vice chair of the Food, Drug, and Device practice group. Chambers USA reports that she "is enthusiastic, exceptionally smart and a talented lawyer who brings tremendous insight from being a regulator" and that she "knows how best to interact with the FDA in a productive and efficient way."
She assists clients in complying with U.S. regulatory requirements for food, dietary supplements, cosmetics, and OTC drugs, and has specific expertise advising on FDA’s import and export requirements across all product categories. She also regularly counsels clients regarding potential crises, such as recalls, regulator investigations, and other unanticipated regulatory attention.
Jessica has engaged with Congress on cosmetic and drug legislative efforts and alternative protein and other food labeling requirements. She has represented clients in both FDA and FTC investigations, including negotiating consent decrees and responding to civil investigative demands, and in matters before the NAD. Jessica has specific expertise regarding the regulatory framework for new and emerging food technologies, including alternative protein ingredients and products and specialized nutrition products such as infant formula and medical foods, the marketing of cosmetics and OTC drugs, including sunscreens, Proposition 65, organic labeling, the federal and state legal landscapes surrounding the development and marketing of products containing CBD, and claim substantiation requirements, as well as manufacturing and supply chain requirements under FSMA and FDA’s implementation of MoCRA.
Jessica also has an active pro bono practice, with a particular focus on issues relating to reproductive rights and health care access.
Before joining Covington, Jessica served as Associate Chief Counsel in FDA’s Office of Chief Counsel. While at FDA, Jessica counseled various components of FDA and HHS on a broad range of food, cosmetic, and drug legal issues, including FDA’s implementation of FSMA and FDA’s work investigating foodborne illness outbreaks and related actions, including recalls and other enforcement activities. In addition, Jessica provided legal counsel to the agency and Department regarding FDA’s import and export activities for all FDA-regulated products.
Drawing from nearly twenty years of experience working at FDA and in private practice, Jessica O’Connell provides strategic advice to a broad range of companies…
Drawing from nearly twenty years of experience working at FDA and in private practice, Jessica O’Connell provides strategic advice to a broad range of companies and trade associations in navigating regulatory frameworks and engaging with food and drug regulatory bodies and Congress. She works closely with clients to develop product strategies that are low-risk from both a regulatory and litigation perspective while also meeting marketing goals and objectives.
Jessica is based in our Washington, DC office and is vice chair of the Food, Drug, and Device practice group. Chambers USA reports that she "is enthusiastic, exceptionally smart and a talented lawyer who brings tremendous insight from being a regulator" and that she "knows how best to interact with the FDA in a productive and efficient way."
She assists clients in complying with U.S. regulatory requirements for food, dietary supplements, cosmetics, and OTC drugs, and has specific expertise advising on FDA’s import and export requirements across all product categories. She also regularly counsels clients regarding potential crises, such as recalls, regulator investigations, and other unanticipated regulatory attention.
Jessica has engaged with Congress on cosmetic and drug legislative efforts and alternative protein and other food labeling requirements. She has represented clients in both FDA and FTC investigations, including negotiating consent decrees and responding to civil investigative demands, and in matters before the NAD. Jessica has specific expertise regarding the regulatory framework for new and emerging food technologies, including alternative protein ingredients and products and specialized nutrition products such as infant formula and medical foods, the marketing of cosmetics and OTC drugs, including sunscreens, Proposition 65, organic labeling, the federal and state legal landscapes surrounding the development and marketing of products containing CBD, and claim substantiation requirements, as well as manufacturing and supply chain requirements under FSMA and FDA’s implementation of MoCRA.
Jessica also has an active pro bono practice, with a particular focus on issues relating to reproductive rights and health care access.
Before joining Covington, Jessica served as Associate Chief Counsel in FDA’s Office of Chief Counsel. While at FDA, Jessica counseled various components of FDA and HHS on a broad range of food, cosmetic, and drug legal issues, including FDA’s implementation of FSMA and FDA’s work investigating foodborne illness outbreaks and related actions, including recalls and other enforcement activities. In addition, Jessica provided legal counsel to the agency and Department regarding FDA’s import and export activities for all FDA-regulated products.
