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
Deepti Kulkarni
Drawing from over 15 years of experience working in FDA’s Office of Chief Counsel and private practice, Deepti Kulkarni provides strategic advice to clients on a wide range of matters involving FDA and USDA regulatory oversight of foods, dietary supplements, and animal health products. She works closely with clients to develop and execute strategies to satisfy regulatory requirements and mitigate enforcement and litigation risk while also meeting key commercial goals.
Deepti also counsels clients on potential crises, such as product recalls, import refusals, and responding to agency warning or noncompliance letters, adverse inspection findings and other regulatory actions.
Chambers USA reports that Deepti is “a very strategic lawyer with deep expertise and strong business acumen,” “a food law and regulation expert,” who “has an incredibly thorough grasp of the regulatory process,” finds “creative solutions to novel and complex issues,” and “is also very responsive and gives sound and practical advice.”
Deepti previously served as an Associate Chief Counsel in FDA’s Office of Chief Counsel. While at FDA, she counseled various components of FDA and HHS on a broad scope of issues related to foods, dietary supplements, cosmetics, and animal health products as well as cross-product matters involving imports and exports, advisory committees, and constitutional issues. She also played a key role in the development and implementation of regulatory frameworks for foods and other products developed using biotechnology, gene editing, and other new and emerging technologies. Deepti received several awards during her time at the FDA, including the FDA Award of Merit (FDA’s highest award), Commissioner’s Special Recognition Award, and the CFSAN Director’s Special Citation Award.
Deepti also serves as an Adjunct Professor of Law at Georgetown Law School where she teaches Food and Drug Law.
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 RegulationRecent Developments in Pet Food and Animal Feed Law & Regulation
The current Congressional session has seen the introduction of bipartisan legislation that, if enacted, would dramatically change the regulatory landscape for pet food and animal feed products. The reintroduced Pet Food Uniform Regulatory Reform Act (PURR Act) would make sweeping changes to the regulatory framework for dog and cat food…
Continue Reading Recent Developments in Pet Food and Animal Feed Law & 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 Ingredients