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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.

  • Counsel clients during crises such as outbreak investigations, regulatory inspections with adverse findings, product recalls, and market withdrawals, including a significant FDA, CDC, and state investigation of a Hepatitis A outbreak linked to an imported food product, pathogen contamination incidents, and allergen-related recalls.
  • Provide regulatory and policy guidance regarding the development of a number of new food, dietary supplement, medical food, OTC drug, and cosmetic products, from formulation to labeling, marketing, and website design, including strategies for minimizing risk of consumer fraud or class action litigation and compliance with state requirements such as Proposition 65.
  • Assisted client in responding to a challenge of its food marketing claims submitted through the Advertising Self-Regulatory Council.
  • Advised client in engagement with FDA regarding warning letter about labeling claims that led to successful resolution of all issues; assisted in developing a related citizen petition requesting that FDA update its “healthy” food labeling regulations consistent with current nutrition science.
  • Advise clients on GMO labeling and related claims, including on potential approaches to compliance with new federal biotechnology labeling requirements.
  • Assist clients in complying with new FDA Food Safety Modernization Act (FSMA) and Nutrition Facts Label (NFL) requirements.
  • Successfully petitioned for removal of clients and clients’ suppliers from FDA Import Alerts, and assisted a number of clients in obtaining releases of imported products held by FDA.    
  • Provide regulatory support in commercial litigation matters relating to food safety and contamination issues and labeling and manufacturing requirements for FDA and FSIS regulated products.
  • Drafted influential amicus brief in FTC contempt proceeding against a major dietary supplement marketer.
  • Conduct regulatory due diligence evaluations for mergers and acquisitions.

Memberships and Affiliations

  • Food & Drug Law Institute, Cannabis-Derived Products Committee, Member

Previous Experience

  • U.S. Food and Drug Administration, Associate Chief Counsel
  • Chambers USA - America's Leading Business Lawyers, Food & Beverages: Regulatory & Litigation (2018-2020) 
  • Law360, Food & Beverage MVP (2016)