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 StandardLife Sciences & Digital Health
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 FrameworkNew German Guidelines on GDPR Requirements for International Transfers of Health Data in Medical Research
On September 17, 2025, the German Supervisory Authorities (Konferenz der unabhängigen Datenschutzaufsichtsbehörden des Bundes und der Länder, DSK) published new guidelines and recommendations addressing the complex requirements for transferring personal data, particularly health data (including health data contained in biomaterials), to countries outside of the European Economic Area for scientific research purposes under the GDPR. These guidelines may be of particular relevance for pharmaceutical, medical device, and other life sciences companies that conduct clinical research.
Continue Reading New German Guidelines on GDPR Requirements for International Transfers of Health Data in Medical ResearchFDA Advertising and Promotion Enforcement Activities: Update
This alert merely summarizes the allegations contained in FDA’s letters. It does not contain any analyses, opinions, characterizations, or conclusions by or of Covington & Burling LLP. As a result, the information presented herein does not necessarily reflect the views of Covington & Burling LLP or any of its clients.…
Continue Reading FDA Advertising and Promotion Enforcement Activities: UpdateGermany enacts Standard Contractual Clauses for pharmaceutical clinical trial agreements – Changes for medical device studies also on the horizon
Germany has taken another step to improve the conditions for pharmaceutical research & development in Germany. Now, the Federal Government has adopted the “Standard Contractual Clauses” for pharmaceutical clinical trial agreements. In this blog, we discuss what the new standard clauses cover and how they will affect clinical trials in Germany.
Continue Reading Germany enacts Standard Contractual Clauses for pharmaceutical clinical trial agreements – Changes for medical device studies also on the horizonFDA to Convene Advisory Committee Meeting on GenAI Mental Health Devices
The Food and Drug Administration (FDA) has announced that its Digital Health Advisory Committee (DHAC) will meet on November 6, 2025, to discuss and make recommendations on the topic of genAI-enabled digital mental health medical devices. The DHAC will discuss potential “benefits, risks to health, and risk mitigations” for such devices, “including premarket evidence and postmarket monitoring considerations.”
Continue Reading FDA to Convene Advisory Committee Meeting on GenAI Mental Health DevicesFDA and HHS Announce New Measures to Curb Direct-to-Consumer Prescription Drug Advertising
On September 9, 2025, the Department of Health and Human Services (“HHS”) and Food and Drug Administration (“FDA”) announced a series of measures to address “misleading” direct-to-consumer prescription drug (“DTC”) advertisements. The measures include (1) rulemaking to rescind the “adequate provision” requirement, which permits manufacturers to include a general statement…
Continue Reading FDA and HHS Announce New Measures to Curb Direct-to-Consumer Prescription Drug AdvertisingThe 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 RegulationDOJ White Collar Enforcement Six Months into the Trump Administration
By Steve Fagell, Nancy Kestenbaum, Aaron Lewis, Stephen Anthony, Lanny Breuer, Eric Carlson, Christopher Denig, Matthew Dunn, Mark Finucane, Sarah Franklin, Jim Garland, Benjamin Haley, Robert Henrici, Geoffrey Hobart, Gerald Hodgkins, Helen Hwang, Robert Kelner, Peter Koski, Amanda Kramer, Kristin Mace, Ashley Nyquist, Matthew O'Connor, Mona Patel, Patrick M. Phelan, Dana Remus, Don Ridings, Krysten Rosen Moller, Eric Sandberg-Zakian, Jennifer Saperstein, Daniel Shallman, W. Douglas Sprague, Daniel Suleiman, Addison Thompson, Veronica Yepez, Bruce Baird, Frederic Levy, Jean Veta, Alan Vinegrad, Ping An, Matthew Benov, Sarah Bishop, Jason P. Criss, Barbara Hoffman, Noam Kutler, Teresa Park, Molly Doggett, Dan Grant, Ian Redfearn, Joshua Roselman & Leah Saris on
Now that the Trump Administration has cleared the six-month mark, its approach to white collar enforcement is starting to come into focus through multiple policy announcements and an emerging track record. After a flurry of policy announcements from Attorney General Pam Bondi in the early weeks of the new administration…
Continue Reading DOJ White Collar Enforcement Six Months into the Trump AdministrationRecent Developments in Pet Food and Animal Feed Law & Regulation
By Deepti Kulkarni, Jeannie Perron, Grant Dixon & Alicia Lee on
Posted in Food and Drug Law, Life Sciences & Digital Health
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 & Regulation