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Jessica O'Connell

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.

Contact:Read more about Jessica O'ConnellEmail

August 21, 2024, Covington Alert

On August 15, 2024, the Food and Drug Administration’s (FDA’s) Center for Food Safety and Nutrition (CFSAN) took another important step in its sodium reduction efforts by issuing a Draft Guidance that contains new voluntary targets for sodium reduction in foods. The Draft Guidance builds on FDA’s October 2021 Final Guidance on Voluntary Sodium Reduction Goals, which established short-term voluntary targets for reducing sodium in commercially processed, packaged and prepared food. The Draft Guidance proposes new three-year sodium reduction targets for 16 overarching food categories and 163 subcategories that are commercially processed and packaged, or prepared in food service establishments such as restaurants. 

Background

Average sodium intake in the United States is currently almost 50% more than the recommended limit.[1]  To help reduce sodium across the food supply, FDA has taken an iterative, step-wise approach that includes establishing voluntary sodium targets for industry, monitoring and evaluating progress, and engaging with stakeholders.

FDA’s sodium reduction efforts began in 2016, when it released draft guidance on the agency’s short-term and long-term goals for sodium reduction in a variety of commercially processed, packaged, or prepared foods. FDA issued final guidance on this topic in October 2021 (Final Guidance), in which it set a goal of reducing average sodium intake from over 3,400 mg/day to 3,000 mg/day. As of 2022, about 40% of the targets set for foods in the Final Guidance had been reached.[2]  FDA has deemed the Final Guidance “Phase I” of its sodium reduction efforts.Continue Reading FDA Issues Draft Guidance on New Voluntary Targets for Sodium Reduction in Foods

On October 13, 2023, the Food and Drug Administration (FDA) announced that the guidance entitled “Prior Notice of Imported Food Questions and Answers (Edition 4): Guidance for Industry,” originally released as draft guidance on September 13, 2022, has been made final. FDA received no comments on the draft…

Continue Reading FDA Announces Availability of Final Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 4)

On May 16, 2023, FDA released a draft compliance policy guide (“draft CPG”) for major food allergen labeling and cross-contact, which updates the 2005 CPG Sec 555.250 Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens. CPGs are intended to advise FDA staff, including investigators, of the agency’s strategy for assessing and enforcing industry compliance. The draft CPG contains FDA’s current policies on major food allergen labeling requirements, allergen cross-contact, voluntary allergen information (e.g., advisory label statements), thresholds, and regulatory actions. The draft CPG is more comprehensive than the 2005 CPG and is intended to create a uniform standard and minimize the possibility that individual FDA staff will follow differing regulatory approaches.    

The draft CPG details the allergen labeling requirements of the Federal Food, Drug, and Cosmetic Act. We do not discuss those requirements here, but instead focus on the policies the draft CPG discusses that are not addressed, in detail, in other FDA allergen documents, such as the recent draft guidance, Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act.

I. Allergen Cross-Contact

Allergen cross-contact is the unintentional incorporation of a food allergen into a food that does not contain that allergen as an ingredient. The draft CPG notes that the likelihood an allergen will be present due to cross-contact can be impacted by factors such as the characteristics of the food, the distribution of the allergen within a food (homogeneous versus particulate), the type of manufacturing process, the equipment used, and the cleaning procedures applied (e.g., dry cleaning versus wet cleaning). While FDA acknowledges these factors, the agency states that cross-contact may occur due to practices such as the failure to clean shared equipment adequately or segregate allergens properly, improper rework addition, or improper production scheduling. The draft CPG does not explicitly acknowledge that even with adequate CGMPs, sanitation, and preventive controls, cross-contact can still occur.

The draft CPG also confirms FDA’s position that “[m]ajor food allergens unintentionally incorporated into a food are not to be declared in the ingredient list or the ‘Contains’ statement.”Continue Reading FDA Issues Draft Compliance Policy Guide for Major Food Allergen Labeling and Cross-Contact

On January 31, 2023, FDA Commissioner Robert M. Califf announced a proposed redesign of the human foods program at FDA. The proposal follows the findings and recommendations of a Reagan-Udall Foundation expert panel that Dr. Califf had charged with evaluating the agency’s existing human foods program. Commissioner Califf called the…

Continue Reading FDA Plans to Redesign the Human Foods Program