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. She also regularly counsels clients regarding potential crises, such as recalls and unanticipated regulatory attention.
Ms. O’Connell works closely with food, cosmetic, and OTC clients to develop labeling and advertising options that are low-risk from both a regulatory and litigation perspective while also meeting marketing goals and objectives, and has specific expertise regarding organic labeling, “healthy” claims, and claim substantiation requirements. Ms. O’Connell has engaged with Congress on cosmetic legislative efforts and food labeling requirements, and has prepared comments on behalf of individual companies and trade associations to FDA, USDA, and the NOSB. She also has significant expertise in issues relating the implementation of the FDA Food Safety Modernization Act (FSMA) and has advised clients both within the United States and abroad on compliance with the range of new requirements under that legislation.
Previously, Ms. O’Connell 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 FSMA and provided legal advice on agency actions regarding allergen labeling requirements, 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.