FDA Limits Availability of Covid Boosters for Young Children

## Overview The **U.S. Food and Drug Administration (FDA)** is a federal agency within the Department of Health and Human Services responsible for protecting public health by ensuring the safety, efficacy, and security of a wide range of products, including human and veterinary drugs, biologics, medical devices, food, cosmetics, and products that emit radiation[1][2][3]. Its mission is to advance public health by helping to speed innovations that make medical products safer, more effective, and more affordable, while providing the public with accurate, science-based information about these products[1]. ## Functions and Regulatory Scope The FDA’s regulatory authority is expansive. It oversees the approval, manufacturing, marketing, and distribution of prescription and over-the-counter drugs, vaccines, blood products, medical devices (from simple tongue depressors to complex pacemakers), dietary supplements, most foods (except some meat, poultry, and egg products regulated by the USDA), cosmetics, and tobacco products[1][2][5]. The agency also regulates electronic products that emit radiation, such as X-ray machines and microwave ovens[2][5]. Importantly, the FDA does not regulate the practice of medicine, medical services, product pricing, or health insurance reimbursement[2]. The FDA achieves its goals through a combination of **premarket reviews**, **post-market surveillance**, **facility inspections**, **enforcement actions**, and **public education**[3][4]. It maintains several adverse event reporting systems—such as MedWatch and VAERS—to monitor product safety after they reach the market[4]. The agency also plays a key role in the nation’s counterterrorism efforts by ensuring food supply security and fostering the development of medical countermeasures[1]. ## History and Key Achievements Established in 1906 with the passage of the Pure Food and Drugs Act, the FDA’s origins trace back to efforts to combat adulterated and misbranded food and drugs. Its regulatory powers expanded significantly with the

**STAT (statnews.com)** is a leading digital media company specializing in fast, in-depth journalism about health, medicine, life sciences, and biotechnology. Founded in 2015 by John Henry, owner of The Boston Globe, STAT was created to fill a gap in high-quality coverage of the life sciences sector, which was underserved in traditional media[1][2]. The name "STAT" derives from the Latin "statim," meaning "immediately," reflecting the organization’s commitment to delivering timely and essential news and analysis[2]. Starting as a small Boston-based operation with fewer than two dozen employees, STAT has expanded into a national and international brand with roughly 100 staffers across key scientific and political hubs in the U.S. such as New York, Washington D.C., California, and the Midwest, as well as an emerging presence in the U.K.[1][3]. The editorial leadership under co-founder and executive editor Rick Berke has emphasized authoritative, tough-minded reporting that covers both the scientific revolution and the complexities and challenges of the U.S. healthcare system[1][4]. STAT distinguishes itself through a subscription-driven business model, prioritizing revenue from dedicated readers rather than relying heavily on advertising. This approach has supported steady growth in paying subscribers, even amid advertising downturns during fluctuating healthcare market conditions. Subscriptions have grown robustly in recent years, with expected revenue growth over 10% in 2025, reflecting strong market demand for expert health and science journalism[5]. The organization’s content is notable for its multimedia storytelling, including data visualization and animations, to make complex scientific topics accessible and engaging. STAT regularly covers influential players from biotech startups to pharmaceutical giants, policy makers, and public health leaders. It also hosts in-person and virtual events, providing forums for discussion and networking within the health and science communities[4][7]. As part of Boston Globe Media but editorially independent, STAT benefits from the resources of a major news organization while maintaining agilit