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Drawing from more than a decade of experience both working at FDA and in private practice, 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 all FDA-regulated products. She also regularly counsels clients regarding potential crises, such as recalls, regulator investigations, and other unanticipated regulatory attention. Chambers USA reports that Ms. O’Connell has “fantastic regulatory insight and understanding.”

  • Counsels clients during crises such as outbreak investigations, consent decree negotiations, civil investigative demands, regulatory inspections with adverse findings, product recalls, and pathogen contamination incidents, including a significant FDA, CDC, and state investigation of a Hepatitis A outbreak linked to an imported food product.
  • Provides regulatory and policy guidance regarding the development of food, dietary supplement, medical food, OTC drug, cosmetic, and CBD containing 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 multiple clients in successfully responding to marketing claim challenges before the NAD and 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.
  • Provides advice regarding the federal and state legal landscape surrounding the development and marketing of CBD products, including engagement with FDA on critical regulatory and scientific issues.
  • Represented multiple clients – both corporations and individuals in their personal capacity – in consent decree negotiations with DOJ and FDA.
  • Advises clients on bioengineering labeling and related claims, including on potential approaches to compliance with new federal biotechnology labeling requirements.
  • Assists clients in complying with new FDA Food Safety Modernization Act and Nutrition Facts Label 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.
  • Drafted influential amicus brief in FTC contempt proceeding against a major dietary supplement marketer.
  • Conducts regulatory due diligence evaluations for mergers and acquisitions.

Pro Bono

  • Advises research institutions and advocacy groups on regulatory strategy for efforts to expand reproductive rights and access.
  • Serves as General Counsel to the Hemp and Cannabinoid Science Institute.
  • Advises standard setting organizations regarding the development of critical standards for sustainability in food manufacturing.

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) 
  • The Best Lawyers in America, FDA Law (2021)
  • Law360, Food & Beverage MVP (2016)