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 of risk alongside a webpage
September 2025
Senator Cruz Unveils AI Framework and Regulatory Sandbox Bill
On September 10, Senate Commerce, Science, and Transportation Committee Chair Ted Cruz (R-TX) released what he called a “light-touch” regulatory framework for federal AI legislation, outlining five pillars for advancing American AI leadership. In parallel, Senator Cruz introduced the Strengthening AI Normalization and Diffusion by Oversight and eXperimentation (“SANDBOX”) Act (S. 2750), which…
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…
Creation of the Cross-Agency Trade Fraud Task Force and the Future of Tariffs Enforcement
On August 29, 2025 the Department of Justice (“DOJ”) announced the launch of a cross-agency Trade Fraud Task Force (“TFTF”), a partnership between DOJ’s Civil and Criminal Divisions, as well as the Department of Homeland Security (“DHS”). On the same day, the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”) issued a 7-4…
U.S.-Colombia Relations Facing Key Decision Points with Implications for Businesses
The United States and Colombia have historically maintained a strong bilateral partnership that has been the envy of much of Latin America. However, the bilateral relationship today is facing a test as U.S. and Colombian approaches to shared problems increasingly diverge. The next several months present milestones that will have significant implications for bilateral trade,…
EU and Brazil Adopt Mutual Adequacy Decision
***Update (January 27, 2026): The EU and Brazil have now formally adopted mutual adequacy decisions, confirming that both jurisdictions ensure comparable levels of data protection and enabling the free and safe flow of personal data between the EU and Brazil without the need for additional transfer mechanisms.***
On September 5, 2025, the European Commission announced…
California Lawmakers Advance Suite of AI Bills
As the California Legislature’s 2025 session draws to a close, lawmakers have advanced over a dozen AI bills to the final stages of the legislative process, setting the stage for a potential showdown with Governor Gavin Newsom (D). The AI bills, some of which have already passed both chambers, reflect recent trends in state AI…
Cybersecurity Maturity Model Certification (CMMC) Program Procurement Final Rule Announced
This blog post discusses the Department of Defense’s (“DoD”) new cybersecurity rule that imposes certain cybersecurity requirements on relevant DoD contractors and subcontractors. The post will be of interest to all DoD contractors, subcontractors, and possibly affiliates of contractors that may be impacted by the new rule’s cybersecurity requirements.
On September 10, 2025, DoD published…
FTC Sues LA Fitness Operators for Unfair Gym Cancellation Policies
On August 20, 2025, the Federal Trade Commission (“FTC”) sued Fitness International, LLC and Fitness & Sports Club LLC – the parent companies of LA Fitness and other gym chains – for violations of Section 5 of the FTC Act and the Restore Online Shoppers’ Confidence Act (“ROSCA”) in connection with alleged practices that make it…
4chan and Kiwi Farms ask federal US court to declare unenforceability of the Online Safety Act
On August 27, 2025, the imageboard website 4chan Community Support LLC (“4chan”) and discussion forum Lolcow, LLC (dba “Kiwi Farms”) (together, the “Plaintiffs”) filed a claim in the U.S. District Court of the District of Columbia (“Court”) asking the Court to declare, in effect, that the UK’s Online Safety Act 2023 (“OSA”) is unenforceable against…