Alerts
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Earlier this month, the US Department of Health and Human Services (HHS) and US Food and Drug Administration (FDA) announced a nationwide crackdown on direct-to-consumer (DTC) drug advertisements.
More than two years after the Integrity, Notification, and Fairness in Online Retail Marketplaces (INFORM) for Consumers Act took effect on June 27, 2023, the United States, on behalf of the Federal Trade Commission (FTC), brought the first enforcement action under the Act.
Headlines that Matter for Companies and Executives in Regulated Industries
The plaintiff, John Snyder, worked for a life insurance company from December 2006 to August 2016.
As the federal funding deadline of September 30, 2025, approaches, this alert highlights four possible scenarios and their potential implications.
Last month, the US Food and Drug Administration (FDA) announced that it would begin daily publication of adverse event data for drugs and biologics via the FDA Adverse Event Reporting System (FAERS).
On September 8, the US Department of Justice (DOJ) announced the withdrawal of dozens of pending rulemaking actions, including two related to the cannabis industry.
Prop 65 Counsel: What To Know
Following nearly two years of litigation, Cigna Health and Life Insurance Company and the named plaintiffs in Hecht v. Cigna Health and Life Insurance Co., Case No. 1:24-cv-05926 (N.D. Ill.) have announced a class action settlement in principle.
On September 15, US Customs and Border Protection (CBP) updated its guidance to implement President Trump’s September 4 Executive Order (EO) laying out terms of the US-Japan trade agreement and the phased reduction of selected US tariffs on Japanese goods.
On September 12, the US Food and Drug Administration (FDA) released guidance detailing its approach to using alternative tools, such as remote regulatory assessments (RRAs), information sharing with foreign regulators, and virtual inspections, to evaluate drug manufacturing facilities identified in pending marketing applications.
Headlines that Matter for Companies and Executives in Regulated Industries
In episode three of “Tax Stuff You Should Know,” hosts Bob Pluth and Gene Magidenko delve into the intricate world of S corporations, tracing their historical development, examining the qualifications for electing S status, and identifying the missteps that can inadvertently revoke that designation.
A proposed settlement in a Pennsylvania case and a citizen suit letter in South Carolina signal that discharging plastic into rivers and streams may trigger liability under the Clean Water Act (CWA) and Resource Conservation and Recovery Act (RCRA). Manufacturers who use plastics in their products or processes should evaluate if any plastic releases exceed their current permit conditions.
In this episode of Baker Tilly’s “Up to Speed” podcast, our partner Mike McMahan shares his insight on the legal considerations dealerships must address as they integrate AI solutions into their operations.
On August 22, the California Office of Environmental Health Hazard Assessment (OEHHA) issued a proposed rule establishing a new Proposition 65 no-significant-risk level (NSRL) for diethanolamine (DEA), first listed for cancer in 2012.
On August 28, President Trump directed federal agencies to investigate the use of federal grant funds where taxpayer funds are being spent on “grants with highly political overtones,” noting that “possible use of Federal grants as slush funds for political and legislative advocacy raises serious legal concerns.”
Anthropic PBC entered into a proposed class-wide settlement that would resolve Bartz et al. v. Anthropic PBC, No. 3:24-cv-05417 (N.D. Cal.), a high-profile copyright infringement action challenging the company’s use of millions of books to train its Claude large language models.
The Federal Circuit’s decision in PowerBlock Holdings, Inc. v. iFit, Inc., No. 24-1177 (Fed. Cir. Aug. 11, 2025) offers new subject matter eligibility guidance under 35 U.S.C. § 101 for mechanical-automation patents reciting physical components as opposed to purely software-based automation patents.
The US Environmental Protection Agency (EPA) has submitted a proposed revision to the Toxic Substances Control Act (TSCA) reporting rule for per- and polyfluoroalkyl substances (PFAS) to the White House Office of Management and Budget (OMB) for review.
Welcome to the September 2025 issue of “As the (Customs and Trade) World Turns,” our monthly newsletter where we compile essential updates from the customs and trade world over the past month. We bring you the most recent and significant insights in an accessible format, concluding with our main takeaways — aka “And the Fox Says…” — on what you need to know.
Federal enforcement of information blocking rules has entered a new era.
Headlines that Matter for Companies and Executives in Regulated Industries
The affected facilities, which are owned by companies based in South Korea and Taiwan, will have to contend with licensing requirements in order to receive exports, re-exports, and transfers of controlled items from their parent companies and suppliers.
On July 22, President Trump announced that the United States and Japan had reached a bilateral trade agreement.