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This article provides a comprehensive overview of recent changes in US trade policy. It highlights key developments such as new global tariffs and bilateral trade agreements, sector- and country-specific investigations, North American trade developments, geopolitical trade measures, and US-China trade relations so that members of the US dietary supplement industry can better understand trade policy issues affecting the US market.

AbstractThis article examines the issue of influencer-driven advertising in the German food supplement market from the perspective of German consumer protection organizations. It highlights regulatory gaps in consumer health protection related to misleading health claims, inadequate dosage controls, and unregulated online marketing practices. The article also demonstrates the need for strengthened consumer health protection through coordinated regulatory action at the European level.

Regulatory project managers (RPMs) in the pharmaceutical, biotechnology, and medical device sectors play a pivotal role that extends beyond traditional project management. RPMs have specialized expertise in drug development, clinical trial phases, and multidisciplinary team dynamics and are uniquely positioned to anticipate and mitigate risks that could jeopardize regulatory programs. This article explores the value of RPMs with advanced skills and deep industry knowledge by examining three cross-sectional projects, demonstrating how their strategic approach and broad understanding enhance regulatory submissions and overall project success.

In January 2026, RAPS will launch the Journal of Regulatory Affairs, a bimonthly (i.e., six times a year) publication building on the success of its predecessor, RF Quarterly. This independent, peer-reviewed journal will deliver original, research-based content on emerging issues in the global regulatory landscape. The new journal will also publish Online Only articles, which may or may not be included in a subsequent bimonthly issue. It will reach an audience of 30,000 regulatory professionals globally.

This article discusses the regulatory classification of novel foods, providing guidance for companies on the procedures that apply to novel foods and ingredients in the EU and internationally. It addresses how to navigate current regulatory complexity to realize commercial opportunities, as well as the challenges and opportunities for bringing food and food supplement products containing innovative ingredients or production techniques to markets worldwide.

The dietary supplement industry in the US faces increasing class action risk driven by labeling, testing, and compliance claims. Courts continue to apply the reasonable consumer standard when assessing plausibility, and recent decisions emphasizing that context, qualifiers, and disclaimers matter have strengthened that defense. This article examines current trends in class action lawsuits, including challenges to FDA disclaimers for structure/function claims, inaccurate protein %DV declarations, and discrepancies in labeled ingredient amounts. It also addresses lawsuits targeting 'greenwashing,” slack-fill, and synthetic ingredient claims and underscoring the importance of substantiated, contextual labeling and proactive compliance strategies.

This article discusses the impact of US state laws banning food ingredients. It examines two recently enacted state laws that require a warning or disclosure statement on the label, but do not outright ban ingredients. The article also examines federal developments that may, in part, be the result of, or a response to, the state initiatives.

This article explores how the analytic hierarchy process (AHP) can be used as a tool for selecting an optimal global regulatory strategy, using the New Zealand dietary supplement industry as an example. The AHP framework provides a structured and systematic approach that allows businesses to evaluate and prioritize various factors effectively. By quantifying and weighing these factors, AHP can facilitate informed and rational decision making, leading to improved performance, resource optimization, and strategic alignment with organizational goals. In the case study, AHP ranked the US and Canada as the top export markets, though sensitivity testing demonstrated that these rankings could shift under alternative assumptions.

Regulatory science applies scientific knowledge and methodologies to guide regulatory policies and practices. As opportunities to better understand contamination risks and implement risk mitigations arise, regulatory science can help guide contamination controls and sterility assurance for sterile products, supporting patient safety and product innovation. This article discusses how collaboration between manufacturers, regulatory agencies, researchers, and healthcare providers is critical to developing future requirements that will support innovation and international harmonization.

The Office of Therapeutic Products (OTP) within the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA) initiated a six-month pilot in July 2023 to reduce the number of original investigational new drug (IND) applications that are placed on clinical hold during the initial 30-day review. This article examines changes in OTP's processing of INDs, pilot results, and future steps for the FDA and sponsors of advanced therapies.

In October 2023, the US Food and Drug Administration (FDA) announced a new pilot program called Support for Clinical Trials Advancing Rare Disease Therapeutics (START). The program's purpose is to accelerate the pace of development for novel drug and biological products intended to treat rare diseases for which there is an unmet medical need through enhanced communication with the FDA. This article provides an overview of the program and the current status of development for each drug product selected for participation in the pilot program. Information about sponsor challenges and patient impact is unavailable, given that the program is still in its early stages. Future assessments will be valuable as more data emerge.

This article discusses the current and future market for on-body delivery systems (OBDS), the current regulatory pathways for drug delivery systems, future connectivity trends, and the regulatory implications of 'connected OBDS” in the US.

This article explores the transition to the EU Clinical Trials Regulation (EU CTR), focusing on the operational challenges sponsors and applicants faced. Key topics include harmonizing country-specific documents prior to transition submissions, operational and functionality issues within the Clinical Trials Information System (CTIS), transparency requirements, and the need for regular updates on guidance and Q&A documents during the transition period. The article highlights the need for ongoing communication between stakeholders to address these challenges.

Postmarket clinical follow-up (PMCF) surveys are a proven method for collecting the data used for EU Medical Device Regulation (EU MDR) submissions, but there is limited guidance on survey procedure and use. This article explores the challenges in planning and executing high-quality Level 4 and general/usability Level 8 PMCF surveys, as outlined in Appendix III of the Medical Device Coordination Group (MDCG) 2020-6 guidance document. It addresses poor survey design, insufficient statistical justification, unmet endpoints, and recruitment issues. It will also suggest strategies for addressing these challenges and best practices for effectively implementing the survey.

This article highlights the similarities and differences in the acceptance of real-world evidence (RWE) as clinical data for medical devices in the US and the EU. It will explore the industry perspective on the use of RWE in the US and the notified body perspective on accepting RWE as clinical evidence. The article includes four anonymized case studies in which RWE collected by postmarket clinical follow-up (PMCF) activities was accepted by a notified body in support of CE marking.

Clinical immunogenicity studies have been required for biopharmaceuticals for more than 30 years to address unwanted immunogenicity by identifying and characterizing antidrug antibodies (ADA) and neutralizing antibodies (NAb). Bespoke ADA/NAb assays, which must be valid and meet regulatory requirements, are used to test serum samples from clinical trials and must demonstrate fit for purpose. Testing must be performed in a good clinical laboratory practice (GCLP) environment. This article describes the regulatory dynamics of unwanted immunogenicity testing over the last 15 years.

Artificial intelligence (AI) tools are becoming increasingly common across various regulatory functions. This article reviews the privacy policies and terms of service of a selection of AI tools to help regulatory professionals make informed decisions about data management and vendor qualification when using AI. The tool selection is based on a 2024 RAPS article by Meredith Brown-Tuttle and Jay Mashburn. This review will explore the qualitative ratings for each tool established by the community project Terms of Service;Didn't Read.

The US Food and Drug Administration's (FDA's) Office of Prescription Drug Promotion (OPDP) conducts several research studies each year focused on the advertising and promotion of prescription drugs. This article explores the intersection between OPDP research and recent enforcement actions, highlighting trends and providing insights for regulatory affairs advertising and promotion (ad promo) professionals. The article describes how OPDP research informs enforcement actions and offers guidance on staying current with the office's evolving requirements. Keywords – enforcement, OPDP, research, trends

Software can have different applications in healthcare, with many benefits for healthcare systems, physicians, and patients. Qualifying and classifying medical software and applying the appropriate regulatory requirements is important to ensure quality and safety. This article describes and compares the requirements for market entry of medical device software in the EU and US, based on the different applications and intended use that software can have in healthcare. The article examines the EU Medical Devices Regulation (EU MDR; 2017/745), the European regulation applicable to medical devices, and the Medical Device Coordination Group (MDCG) guidelines for medical device software in the EU. The Federal Food, Drug, and Cosmetic Act (FD&C Act), the US Code, Title 21, and the US Food and Drug Administration (FDA) guidelines applicable to medical device software are examined for the regulatory framework applicable in US.

While FDA experience is highly valued in the private industry, transitioning from the agency to private-sector employment requires new skills and a shift in mindset. This article provides resources for regulatory professionals with FDA experience seeking careers in the private sector. The article explores common career pathways in the medical device space, addresses key differences between the FDA and industry roles, and provides strategies for leveraging FDA experience outside the agency. The insights are based on the authors' experiences after departing from the FDA. The article is divided into two sections – the first outlining career pathways and the second offering advice on job hunting.