On October 31, 2025, the Ninth Circuit struck down certain parts of USDA’s National Bioengineered Food Disclosure Standard, including the exemption for highly refined foods in which modified genetic material is undetectable. The decision remands the invalidated portions of the regulations to USDA for revision and could result in a
Continue Reading Ninth Circuit Invalidates USDA’s Exemption for Highly Refined Foods Under the National Bioengineered Food Disclosure Standard
Jessica O'Connell
Jessica O’Connell co-chairs Covington’s market-leading global Food, Drug, and Device Practice Group. Drawing from nearly twenty years of experience working at FDA and in private practice, Jessica 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. 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’s practice focuses on food and beverages, dietary supplements, cosmetics, and OTC drugs. She has engaged with Congress and state legislators on cosmetic and drug legislative efforts and alternative protein and other food labeling requirements, and has represented clients in both FDA and FTC investigations, including negotiating consent decrees and responding to civil investigative demands, and actively practices 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, nutrition initiatives, cosmetic oversight, 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.
Senator Marshall Proposes an Overhaul of the GRAS Framework
On November 6, U.S. Senator Roger Marshall (R-KS), a member of the Senate Health, Education, Labor, and Pensions (HELP) Committee and MAHA Caucus, introduced the highly anticipated “Better Food Disclosure Act” (the “Better FDA Act”). The bill aims to close the so-called “GRAS loophole.” Although the bill, which was developed…
Continue Reading Senator Marshall Proposes an Overhaul of the GRAS FrameworkThe Make Our Children Healthy Again Strategy Report: What it Says and Doesn’t Say about U.S. Food Regulation
On September 9, President Trump’s Make America Healthy Again (MAHA) Commission, chaired by HHS Secretary Kennedy, released its “Make Our Children Healthy Again Strategy Report” (Strategy Report) as directed by Executive Order 14212 (EO), which established the MAHA Commission. A draft of this report was leaked to the public about…
Continue Reading The Make Our Children Healthy Again Strategy Report: What it Says and Doesn’t Say about U.S. Food RegulationFDA Proposes Extension to Food Traceability Rule Compliance Date
Earlier today, FDA issued a proposed rule that would extend the compliance date of the Food Traceability Rule by 30 months, i.e., until July 20, 2028. The Food Traceability Rule, which is one of the core rules FDA was required to issue under the Food Safety Modernization Act (FSMA)…
Continue Reading FDA Proposes Extension to Food Traceability Rule Compliance DateU.S. Food Agencies Issue Joint Request for Information on Ultra-Processed Foods
On July 25, 2025, the Food and Drug Administration (FDA), the Department of Health and Human Services (HHS), and the United States Department of Agriculture (USDA) issued a joint Request for Information (RFI) seeking “data and information to help develop a uniform definition of ultra-processed foods (UPF or UPFs) for…
Continue Reading U.S. Food Agencies Issue Joint Request for Information on Ultra-Processed FoodsSenators Introduce Bill that would Fundamentally Reshape FDA’s GRAS Framework
On July 17, 2025, Senators Ed Markey (D-MA) and Cory Booker (D-NJ) introduced the “Ensuring Safe and Toxic-Free Foods Act of 2025.” If enacted, this bill would fundamentally reshape FDA’s generally recognized as safe (GRAS) framework by, among other things, requiring that companies submit GRAS notifications for all ingredients currently…
Continue Reading Senators Introduce Bill that would Fundamentally Reshape FDA’s GRAS FrameworkIn Case You Missed It: Recent Food-Related Developments from the Trump Administration and Congress
Over the last week or so there have been several developments from the Trump Administration and Congress affecting the food industry. We outline several of those developments below and identify key ways industry stakeholders can engage.
Click here to read the full alert on cov.com.
Continue Reading In Case You Missed It: Recent Food-Related Developments from the Trump Administration and CongressTexas Also Enacts Bans on Certain Ingredients in School Meals; Similar Louisiana Bill Progresses
Yesterday, Texas governor Greg Abbott signed into law S.B. 25, which requires food products containing any of 40+ specified ingredients to bear a warning label. This follows Texas’s enactment of S.B. 314 in late May, which prohibits Texas school districts and open-enrollment charter schools from providing free or reduced-price meals that contain any of 17+ specified ingredients. As of the date of this writing, Louisiana S.B. 14, which would impose (1) disclosure requirements for any food product sold in the state that contains specified ingredients, and (2) a ban on the use of certain ingredients in school meals, is sitting on the governor’s desk. It will become law if he signs it or takes no action by June 25. These actions are part of a larger trend of increased scrutiny of food and color additives, as we previously reported and which is a significant feature of the Make America Healthy Again (“MAHA”) Commission’s Assessment released on May 22, 2025.
Texas S.B. 25
S.B. 25 requires human food products containing any of 40+ specified ingredients to bear the following warning label: “WARNING: This product contains an ingredient that is not recommended for human consumption by the appropriate authority in Australia, Canada, the European Union, or the United Kingdom.” Violators may be subject to a fine not to exceed $50,000 per day for each distinct food product in violation of the requirement.
The ingredients subject to the warning label requirement are the FD&C colors (i.e., Blue Dye No. 1, Red Dye No. 40, etc.) and numerous other ingredients including bleached flour, bromated flour, azodicarbonamide, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), potassium bromate, and propylparaben. Although the sweeteners aspartame, sucralose, acesulfame potassium (as well as high fructose corn syrup) were listed in earlier drafts of the bill, they are not included in the bill ultimately signed into law.
The warning requirement will apply only to food product labels “developed or copyrighted on or after January 1, 2027.” Thus, it appears that food labels in use or even just copyrighted before that date could continue to be used for extended periods of time beyond that date.Continue Reading Texas Also Enacts Bans on Certain Ingredients in School Meals; Similar Louisiana Bill Progresses
West Virginia Passes Law Prohibiting the Use of Seven Food Dye Ingredients
On March 24, 2025 Governor Patrick Morrisey of West Virginia signed into law H.B. 2354 which will impose a ban on the use of specified food additives, including seven food dyes, in food, drink, confectionery, or condiment products in the state. In passing this law, West Virginia became the first state…
Continue Reading West Virginia Passes Law Prohibiting the Use of Seven Food Dye IngredientsExecutive Order on Deregulatory Initiative: What it Means for Food, Cosmetic, Drug, and Device Stakeholders
On February 19, 2025, President Trump issued an Executive Order titled “Ensuring Lawful Governance and Implementing the President’s ‘Department of Government Efficiency’ Deregulatory Initiative” (the EO). The stated purpose of the EO is to advance the Administration’s policies of focusing executive enforcement actions on regulations “squarely authorized by federal statute” and deconstructing the administrative state in order to achieve the stated goal of “[e]nding Federal overreach and restoring the constitutional separation of powers.” The EO appears to present opportunities for FDA-regulated stakeholders to identify certain regulations, guidance, and enforcement actions for recission or termination. Likewise, certain stakeholders may face changes in the competitive balance with competitors if the EO causes FDA to stop enforcing regulations that currently prohibit the marketing of certain products.
Key Provisions of the EO
In order to effectuate the stated policy, the EO provides for 1) the rescission of existing regulations across federal agencies, 2) the de-prioritization and termination of certain ongoing enforcement actions, and 3) the review of new regulations by members of the Department of Government Efficiency (DOGE) and the Administrator of the Office of Information and Regulatory Affairs (OIRA):
- “Rescinding Unlawful Regulations and Regulations That Undermine the National Interest”: The EO directs agency heads, in coordination with their DOGE team lead and the Office of Management and Budget (OMB) Director, to, within the next 60 days, review all agency regulations and identify regulations deemed to be 1) unconstitutional, 2) unlawful, 3) based on “anything other than the best reading of the underlying statutory authority or prohibition,” 4) implicating “matters of social, political, or economic significance that are not authorized by clear statutory authority,” 5) excessively costly, 6) “harmful to the national interest,” or 7) overly burdensome for small businesses or entrepreneurs. Notably, and consistent with the Administration’s other recent deregulatory actions, the EO defines “regulations” to include guidance documents. The EO states that the Administrator of OIRA, in consultation with agency heads, will then develop a Unified Regulatory Agenda to rescind or modify the identified regulations. Pursuant to this mandate, FDA will likely be expected to conduct a broad review of its regulations and guidance documents over the next 60 days and identify items that may merit rescission.
- “Enforcement Discretion to Ensure Lawful Governance”: The EO grants agency heads discretion to “preserve their limited enforcement resources” by 1) de-prioritizing enforcement of regulations that are “based on anything other than the best reading of a statute” or “that go beyond the powers vested in the Federal Government by the Constitution”; and 2) to terminate ongoing regulatory enforcement proceedings which “do not comply with the Constitution, laws, or Administration policy.” This, in turn, could pose significant implications for both future and ongoing FDA enforcement actions. Under the EO, even long-standing precedents that provide the foundation for FDA’s enforcement activities could be scrutinized if the Administration considers them to be not based on the current “best” reading of a statute. In practical terms, this could lead to the truncation or effective deletion of certain long-standing regulatory requirements across all product areas regulated by FDA.
- “Promulgation of New Regulations”: The EO requires that agency heads consult with their DOGE Team Leads and the Administrator of OIRA on potential new regulations as soon as practicable and instructs DOGE Team Leads and OIRA to evaluate potential new regulations against certain criteria outlined in the EO.