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 Recently, the FDA released a Draft Guidance on Mandatory Cosmetics Recalls, outlining the

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.