On Jan. 14, 2026, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) jointly released the “Guiding Principles of Good AI Practice in Drug Development,” a set of 10 high-level principles intended to steer the safe and responsible use of AI across the product lifecycle. While not formal industry guidance, the document provides important insights into FDA and EMA thinking on the deployment of AI during drug and biologic product development and signals future regulatory guidance from both regulators. Read on for further details and takeaways for regulated industry.
California Bill Limiting Scope of Consumer Arbitration Agreements to Goods or Services at Issue Becomes Law
California SB 82 — a bill that seeks to end “infinite” arbitration clauses and limit the scope of consumer arbitration agreements to the “use, payment, or provision of the good, service, money, or credit provided by that consumer use agreement” — was signed into law by Gov. Gavin Newsom on Oct. 6, 2025. SB 82 slides into section 1670.15 of California’s civil code and takes effect on Jan. 1, 2026. Consumer-facing companies in California may now want to re-examine their consumer-use agreements.
New CCPA Rules Are Here: Is Your Business Ready for What’s Next?
In a significant step toward strengthening consumer privacy protections, the California Privacy Protection Agency (CPPA) board adopted a comprehensive set of updates to the California Consumer Privacy Act regulations. These long-anticipated regulations — covering cybersecurity audits, risk assessments and automated decision-making technology — mark a pivotal shift in the state’s data privacy enforcement landscape. CPPA staff also revealed that hundreds of active investigations are already underway — many involving businesses that have yet to realize they are under scrutiny.
Read on for a summary of the new and revised regulations and how businesses should prepare for more stringent privacy obligations and heightened enforcement risk.
FTC Signals Continued Enforcement of “Made in USA” Labeling Rule and Guidance
The Federal Trade Commission was quiet in its role as the Made in USA enforcement authority during the first few months of the Trump administration. But July left little doubt that the current FTC will continue the robust activity of its predecessor. The first indication was FTC Chairman Andrew Ferguson declaring July 2025 to be “Made in the USA” month. He reiterated that the FTC is charged with enforcing laws prohibiting false or unsubstantiated Made in USA claims. He further noted the importance of protecting American consumers from improper claims so they can have confidence that buying products marketed as Made in USA truly support American businesses and workers.
Continue Reading FTC Signals Continued Enforcement of “Made in USA” Labeling Rule and GuidanceFDA to Expand Unannounced Inspections of Foreign Facilities — Manufacturers, Research Firms Should Prepare
medical products intended for American consumers and patients. The FDA stated that this new inspection strategy will ensure that foreign manufacturers receive the same level of oversight and regulatory scrutiny as domestic companies. Key aspects of the FDA’s plan include:
- Increased Frequency: The FDA will increase the frequency of unannounced inspections at foreign facilities.
- Elimination of Double Standard: The FDA stated that the move ensures that foreign manufacturers are held to the same standards and oversight as domestic companies.
- Exposing Bad Actors and Ensuring Safe Prescription Drugs: The FDA explained that unannounced inspections will help expose bad actors (e.g., those who falsify records or conceal violations) and ensure that every product entering the U.S. is safe, legitimate and honestly made.
- Increased Enforcement Activity: The FDA emphasized that it is authorized to take regulatory action against any company that attempts to delay, deny or limit an unannounced inspection.
Read on to learn more about the FDA’s new policy and key considerations for stakeholders.
Department of Justice Suggests “Aggressive” Enforcement of False Claims Act
In a speech to the Federal Bar Association’s annual qui tam conference on Feb. 20, 2025, Michael Granston, Deputy Assistant Attorney General for the Commercial Litigation Branch at the U.S. Department of Justice, discussed how the Trump administration plans to “aggressively” enforce the False Claims Act (FCA). His statements come on top of other comments from Trump administration officials stating that DEI, domestic sourcing/industry, pandemic relief and cost-related considerations will be among the administration’s key enforcement priorities. This raises compliance risks for numerous entities, including healthcare and government contracting industries, federal grant recipients, educational institutions, and cybersecurity, import/export, freight forwarding and infrastructure companies.
Granston’s remarks were made one day before the U.S. District Court for the District of Maryland preliminarily enjoined the provision concerning certifications under the FCA in Executive Order 14173, “Ending Illegal Discrimination and Restoring Merit-Based Opportunity.” The order would require a term in every procurement contract or grant award that compliance in all aspects with all applicable federal antidiscrimination laws is material to the government’s payment for purposes of the FCA.
Read on to learn more about Granston’s remarks and the FCA enforcement landscape.
State Attorneys General Poised to Crack Down On Price Gouging Amid Market Pressure
New York Attorney General Letitia James issued a warning to businesses against price gouging for eggs and poultry. The current bird flu outbreak began in March 2024 but has become a topic of increasing concern for consumers and businesses in the new year after more than 13 million hens — necessary to the success of the egg and poultry industry — died or were slaughtered within the last two months. The result? Mass egg shortages for consumers and soaring cost increases that have jumped more than 50% in the past year and accelerated in recent weeks.
Read on to learn what the crackdown could mean for businesses in the egg and poultry industry and for price gouging investigations in the agricultural space and other industries.
Delayed One-to-One Consent Rule Gives Companies Reprieve, Plus Other TCPA Updates
The Federal Communications Commission (FCC) announced on Jan. 24, 2025, that its highly anticipated one-to-one consent rule was postponed by at least one year. This is big news for companies that were gearing up for the implementation of the rule, which would have significantly altered the requirements for obtaining consent to place calls or text messages under the Telephone Consumer Protection Act (TCPA).
Companies should keep an eye on another FCC rule that will change the requirements regarding consumers’ ability to revoke consent, scheduled to take effect on April 11, 2025. Meanwhile the U.S. Supreme Court will decide to what extent courts must defer to the FCC’s interpretation of the TCPA.
Read on to learn how ongoing changes in the regulatory landscape for the TCPA stress the importance of reviewing and prioritizing TCPA compliance in 2025.
Insurance Recovery Resources After Disasters
Following the recent catastrophic wildfires that have affected California, businesses need assistance navigating the ins and outs of insurance coverage and the claims process and ultimately protecting their interests if litigation ensues. Whether it’s wildfires in California, hurricanes along the Atlantic and Gulf coasts, tornadoes in the Midwest, or infrastructure failures in major population centers, how can you maximize recoveries under insurance programs and policies? And how can corporate policyholders manage claims, coverage disputes, business interruption insurance and more — no matter the cause of the crisis or the industry involved?
Click below for resources that support those who have experienced loss, especially in the wake of the Los Angeles wildfires.
Food and Consumer Product Litigation and Regulatory Update: Webinar Replay
McGuireWoods’ Oct. 30 webinar covered recent regulatory and litigation developments facing the product manufacturing, food and beverage, and retail industries.
For more details, visit our website event page.