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Jessica P. O'Connell

Partner

Washington +1 202 662 5180

English
  • About
  • Representative Matters
  • Credentials
  • About

    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 foods, dietary supplements, cosmetics, OTC drugs, and animal products, 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. Chambers USA reports that Jessica "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."

    Jessica 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. She has engaged with Congress on cosmetic and drug legislative efforts and alternative meat and other food labeling requirements and has represented clients in both FDA and FTC investigations, including negotiating consent decrees, and in matters before the NAD. Jessica has specific expertise regarding the federal and state legal landscapes surrounding the development and marketing of products containing cannabidiol (CBD), the regulatory framework for alternative protein ingredients and products, Proposition 65, organic labeling, and claim substantiation requirements, as well as newly implemented manufacturing and supply chain requirements under FSMA.

    Previously, Jessica served as an Associate Chief Counsel in FDA’s Office of Chief Counsel, until 2014. While at FDA, Jessica counseled various components of FDA and HHS on a broad range of legal issues, and including FDA’s implementation of FSMA and agency actions regarding product marketing claims and intended use, food additives and GRAS status, cosmetics and color additives, medical foods, and 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.

    Areas of Expertise

  • Practices and Industries
  • Representative Matters
    • 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.

    Areas of Expertise

  • Credentials
    Education
    • Georgetown University Law Center, J.D., 2006
        • cum laude
    • Johns Hopkins School of Public Health, M.P.H., 2006
    • University of Virginia, B.A., 2000
        • Biology & Physics
    Bar Admissions
    • District of Columbia
    • Maryland
    Government Experience
    • U.S. Department of Health and Human Services – Food and Drug Administration
    Judicial Clerkship
    • Hon. Nancy B. Firestone, U.S. Court of Federal Claims, 2006 - 2008
    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.
    Accolades
    • Chambers USA - America's Leading Business Lawyers, Food & Beverages: Regulatory & Litigation (2018-2021) 
    • The Best Lawyers in America, FDA Law (2021-2022)
    • Law360, Food & Beverage MVP (2016)
    Memberships and Affiliations
    • Food & Drug Law Institute, Cannabis-Derived Products Committee, Member
    Previous Experience
    • U.S. Food and Drug Administration, Associate Chief Counsel

    Areas of Expertise

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