Insights

In an effort to update and modernize the FDA’s regulation of sunscreen, Representative John Joyce (R-Ohio) and a group of bipartisan members of Congress introduced in June the Supporting Accessible, Flexible, and Effective Sunscreen (SAFE) Standards Act.  If enacted, the bill would establish a more flexible regulatory scheme at the FDA, decrease the cost in the approval process and expand the array of sunscreen available for purchase.

On July 23, 2025, the Internal Revenue Service (“IRS”) issued interim guidance for Large Business & International Division (“LB&I”) audit procedure. The IRS announced three major changes: (1) the Acknowledgement of Facts Information Document Request (“AOF IDR”) will be eliminated; (2) Accelerated Issue Resolution (“AIR”) applies to Large Corporate Compliance (“LCC”) cases; and (3) the IRS must conduct additional review before denying a taxpayer’s request to participate in the Fast Track Settlement (“FTS”). These changes reflect the IRS’s continued push to make its examinations “more efficient and current.”

On July 28, 2025, Cadence Design Systems Inc. (“Cadence” or “the Company”), a global electronic design automation (“EDA”) technology company based in San Jose, California, agreed to plead guilty in a settlement with the U.S. Department of Justice’s National Security Division (“NSD”) and the U.S. Attorney’s Office for the Northern District of California. Through its guilty plea, Cadence agreed to resolve charges that it committed criminal violations of export controls by selling EDA hardware, software, and semiconductor design intellectual property (“IP”) technology to the National University of Defense Technology (“NUDT”), a Chinese military university on the U.S. Entity List since 2015 due to its involvement in military and nuclear simulation activities. In addition, Cadence simultaneously resolved a civil enforcement action brought by the U.S. Department of Commerce, Bureau of Industry and Security (“BIS”) related to the same underlying conduct.

On August 7, 2025, the FAR Council issued a final rule amending FAR 52.204-7 to clarify that, effective immediately, an offeror’s failure to maintain continuous System for Award Management (SAM) registration between proposal submission and contract award does not render the offeror ineligible for award, so long as the offeror was registered in SAM at the time of proposal submission and is registered at the time of contract award. The final rule should address situations like TLS Joint Venture, LLC, B-422275, Apr. 1, 2024, 2024 CPD ¶ 74, where an offeror’s SAM registration lapsed for a single day between the proposal submission and award dates, and GAO found the offeror ineligible for award.

On July 24, 2025, President Trump signed an Executive Order titled “Saving College Sports” (the “Order”). The White House also released an accompanying Fact Sheet regarding the Order.

Historically, SEC-registered investment advisers have not been subject to comprehensive AML regulation under the Bank Secrecy Act (“BSA”) unless they also qualify as a broker-dealer or other BSA-regulated financial institution. Notwithstanding the absence of a formal requirement to date, many SEC-registered investment advisers have voluntarily adopted AML programs in line with industry expectations and investor demands. However, on August 28, 2024, FinCEN issued its Final Rule, establishing anti-money laundering/countering the financing of terrorism (“AML/CFT”) requirements for Covered Advisers similar to those that apply to broker-dealers. The Final Rule, which was scheduled to take effect on January 1, 2026, required Covered Advisers to maintain written AML programs, perform customer due diligence, file Suspicious Activity Reports (“SARs”) and other reports required of BSA-regulated financial institutions, and retain standard AML records.  

Threat actors have targeted insurance companies in a recent string of cyber-attacks, exposing patients’ personal information, including Social Security numbers, claims information, and health reports.

Over the past several months, Missouri and Florida have gone on the offensive against the nation’s largest proxy advisors related to what they deemed “radical” agendas in providing proxy advice. In Texas, two of the largest proxy advisors, Institutional Shareholder Services Inc. (ISS) and Glass, Lewis & Co., LLC (“Glass Lewis”), punched first, filing separate complaints in federal court against Texas Attorney General Ken Paxton in his official capacity, challenging the facial and as applied constitutionality of Senate Bill 2337 (“S.B. 2337” or “the Act”). The Act would require all proxy advisory services to disclose advice or recommendations that are “not provided solely in the financial interest of the shareholders of a company.” Advice and/or a recommendation is defined as being “for nonfinancial reasons” when it “is wholly or partly based on, or otherwise takes into account, one or more nonfinancial factors” including “an environmental, social, or governance (ESG) goal,” “diversity, equity, or inclusion (DEI)”, or “a social credit or sustainability factor or score.” Both Glass Lewis and ISS seek declaratory and injunctive relief enjoining the enforcement of S.B. 2337 as unconstitutional under the First and Fourteenth Amendments. Specifically, they allege the Act violates the First Amendment’s prohibition against viewpoint discrimination, infringes upon their freedom of association, and is unconstitutionally vague. Glass Lewis also argues that the Act violates the Dormant Commerce Clause, and that it is preempted by the Employment Retirement Income Security Act of 1974 (“ERISA”).

This news bulletin is provided by the International Trade Group of Crowell & Moring. If you have questions or need assistance on trade law matters, please contact Anand Sithian or Simeon Yerokun or any member of the International Trade Group.

On Monday, July 21, 2025, the Food and Drug Administration (FDA) issued draft guidance entitled “E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials” from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance is currently in Step 2 of the ICH process and open for public comment until September 19, 2025.

Following the February announcement of the Omnibus package, the European Commission, Council, and Parliament have made several decisions indicating ways in which EU ESG laws are likely to be streamlined. This alert provides a high-level summary of the most significant proposed changes to existing and draft ESG legislation.

On July 23, 2025, the Trump Administration issued an artificial intelligence (AI) action plan titled “Winning the Race: America’s AI Action Plan” (the Plan) to guide AI innovation in the U.S. The Plan includes 90 policy recommendations that will shape future AI guidance and policies impacting a range of entities and industry sectors, including health care/life sciences and entities involved in clinical research.

On July 23, 2025, the White House released Winning the Race: America’s AI Action Plan (“the Plan”) the Trump Administration’s most significant policy statement on artificial intelligence to date.

In April 2025, the IRS and the Department of Homeland Security (DHS) formalized a Memorandum of Understanding (MOU) enabling Immigration and Customs Enforcement (ICE) to create a system of information sharing between the agencies. Under the MOU, the IRS can share tax return information for non-tax criminal investigation purposes. More specifically, the MOU permits ICE to request sensitive tax information from the IRS for purposes of pursuing immigration related cases and deportations. Given the Trump administration’s focus on undocumented workers, the implications of the MOU likely will go even further as sharing this information will result in tax enforcement against employers of deported individuals.

The USPTO is actively implementing and seeking out technologies to enhance the speed, accuracy, and consistency of the examination of patent applications.

On July 4, 2025, President Trump signed into law the One Big Beautiful Bill Act (the “Act”), after it was passed by Congress on July 3, 2025. Notably, the Act made significant and welcome changes from the perspective of startup company stockholders and venture capital investors to the qualified small business stock (“QSBS”) rules set forth in Internal Revenue Code (“Code”) Section 1202. In a nutshell, the changes modernize (by adjusting for inflation) and expand the already favorable tax treatment for QSBS under Code Section 1202. The Act also permanently reinstates elective expensing for qualifying domestic research and experimental expenditures that will likely help more startups in research and capital intensive sectors qualify for favorable QSBS treatment.

Briefing. The Trump administration continues to raise the stakes for importers and other actors in the international trade space. Bloomberg Law reports that the Department of Justice has tasked its MIMF (Market Integrity and Major Frauds) Unit with investigating fraud schemes by companies dodging U.S. tariffs. The MIMF Unit is already well-versed in financial fraud investigations, is set to grow significantly with the addition of prosecutors previously assigned to consumer protection matters, and now is shifting resources to tariff evasion cases.

On July 8, 2025, the Department of Justice Antitrust Division announced a new program to provide rewards to individuals who report antitrust violations related to the Postal Service. This is the first program of its kind to provide a monetary reward to individuals who assist in the prosecutions of antitrust crimes. Under the new initiative, whistleblowers will have the opportunity to receive up to 30% of any criminal fines recovered for violations affecting the Postal Service, its revenues, or its property. 

In response to the recent U.S. strikes on Iranian nuclear facilities, the New York State Department of Health (“NYS DOH”) issued a cybersecurity advisory (the “Advisory”) that cautions healthcare providers, such as hospitals, treatment centers, and healthcare practitioners, of a high likelihood of increased cyberattacks and heightened cybersecurity threat activity.  The Advisory follows similar announcements and warnings from U.S. Department of Homeland Security (“DHS”), NYS Intelligence Center (NYSIC) and the Health-ISAC (Information Sharing and Analysis Center).

Twenty years ago, the Supreme Court held that “one who distributes a device with the object of promoting its use to infringe copyright, as shown by clear expression or other affirmative steps taken to foster infringement, is liable for the resulting acts of infringement by third parties.” MGM Studios, Inc. v. Grokster, Ltd., 545 U.S. 913, 919 (2005). In the Grokster case, the Supreme Court found that peer-to-peer file sharing companies could be liable for copyright infringement for their users’ deployment of file sharing software. There, the Court found that liability was warranted because the file sharing companies knew that its users were infringing, and the companies materially contributed to that infringement.