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Jessica O'Connell

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.

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 guidance, and as a result

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 redesign “transformative” and believes the