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NEWS & BLOGS
Blog: Blog2


"Wellness or Medical Device? The FDA Guide for K-Beauty Device Success in the U.S."
The Next Frontier for K-Beauty: The Rise of "K-Beauty Devices" The global phenomenon of K-Beauty is no longer confined to skincare and cosmetics. By combining innovative ingredients and fast-paced trends with advanced technology, a new wave of "K-Beauty Devices" (or K-Devices) is rapidly gaining traction in the U.S. This category spans from at-home skin management devices and LED masks to MedSpa-inspired home-care tools that treat the face, scalp, and body simultaneously. U.S
Provision Consulting Group
Jan 123 min read


Grateful for 2025 | Supporting Your 2026 FDA Regulatory Success with a Special Credit
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
Provision Consulting Group
Dec 31, 20252 min read


FDA’s New Guidance on Mandatory Cosmetic Recalls: What Brands Need to Know
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 Recently, the FDA released a Draft Guidance on Mandatory Cosmetics Recalls, outlining the
Provision Consulting Group
Dec 19, 20253 min read


K-Beauty's Next Chapter in the U.S.: Proving Reliability Over Simply Controlling Quality
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
Provision Consulting Group
Nov 4, 20253 min read
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