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 StandardFood 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 FrameworkFDA 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 horizon
FDA 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 Devices
FDA 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 RegulationRecent 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 & RegulationFDA Proposes Extension to Food Traceability Rule Compliance Date
Posted in Food and Drug Law
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 DateFDA Advertising and Promotion Enforcement Activities: Update
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
Click here to read the full alert on cov.com.
Continue Reading FDA Advertising and Promotion Enforcement Activities: Update