Dear Valued Partners and Clients, As 2025 comes to a close, we look back on a year where the U.S. FDA regulatory landscape was more dynamic than ever—from the full-scale implementation of MoCRA to the restructuring of OTC regulations and the tightening of FSVP management. We would like to express our deepest gratitude to you for choosing Provision Consulting Group as your trusted partner during these rapidly changing times. Top 3 FDA Regulatory Updates of 2025 Here is a summa

In the United States, sunscreens are regulated as OTC (Over-the-Counter) drugs , not cosmetics. This means they are subject to strict regulatory frameworks governing everything from ingredients and SPF testing to labeling and safety standards. Recent FDA announcements do not necessarily mean an immediate overhaul of all existing rules. Instead, they signal a strategic update to OTC Monograph M020 , clarifying the standards and direction for future sunscreen regulations. How i

How has the FDA cosmetic recall system evolved since MoCRA? In the past, even when issues arose with cosmetics sold in the U.S., they were primarily managed through voluntary recalls by companies. However, with the enactment of MoCRA  (Modernization of Cosmetics Regulation Act) in late 2022, the FDA’s legal authority to intervene in the cosmetics sector has become significantly clearer. Recently, the FDA released a Draft Guidance on Mandatory Cosmetics Recalls, outlining the

The way we live today is intrinsically tied to data. From the prescriptions we receive at the hospital and the glucose meters we use at home to the ECG features on our smartwatches and the records in our health apps—we are constantly generating a stream of "real-world data." Crucially, this data is now moving beyond simple record-keeping. Recent news indicates that this real-world data can serve as compelling evidence to support new product approvals (or regulatory reviews).

"Can I ship this to the U.S. without any issues?" "My Amazon listing suddenly disappeared. Why is that?" "I heard U.S. Customs is cracking down again because of MoCRA..." The Modernization of Cosmetics Regulation Act (MoCRA) , which officially took effect in late 2023, has brought the biggest shake-up to the U.S. cosmetics market in decades. Korean brands, manufacturers, and even beauty sellers within the U.S. are directly experiencing the impacts of this new regulation. Whil

Gen Z is a generation that values the meaning conveyed  over the visual appearance . For them, the functionality of a product is as important as its packaging, labeling, and communication style aligning with their personal values. Eco-friendly packaging, refillable containers, understated text, and an unboxing experience worthy of sharing on social media—all these factors are becoming selection criteria for beauty products just as crucial as the product itself. Why Gen Z Emph

Major foreign news outlets, including CNN, are reporting that the US federal government shutdown is finally nearing its end. While an official termination announcement has not yet been made, the normalization of government operations is imminent. Once federal agency operations resume, medical device registration and renewal processes, which had been suspended, will fully restart. This period is historically the time when system delays and errors are most frequent, as companie

Gen Z: The New Core of the Global Beauty Market Gen Z (born 1997–2012) has firmly established itself as a pivotal consumer group in the global beauty market. Global consumer reports from BCG and McKinsey estimate their direct purchasing power at approximately $360 billion. Furthermore, they are recognized as an ‘Influential Consumer’ segment, significantly impacting the purchasing decisions of their peers and families. This generation maintains clear criteria for consumption.

Provision Consulting Group highlights K-Beauty's status and challenges as a speaker at the U.S. ACI Forum  "My daughter has watched K-Pop Demon Hunters five times already. She knows more about the K-Beauty products she sees on social media than I do." This comment from a regulatory expert at ACI’s Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products  in Santa Monica, California, on October 8, drew laughter from the audience. It solidified how deeply t

The FDA recently issued Warning Letters to two overseas medical device manufacturers, citing significant violations of the Quality System Regulation (QSR) . This action is not a mere administrative notification; it sends a powerful message that the FDA is actively stepping up scrutiny of overseas manufacturing operations and their capacity for effective quality system management. Both companies were found to have systemic failures in product testing and validation procedures,