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MoCRA Shock: 7 Real-World Case Studies of Regulatory Impacts in the U.S. Cosmetics Market
"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
Provision Consulting Group
Dec 1, 20253 min read
![[Client Successful Story] Navigating Complex MoCRA Regulations: The Sincere Partnership of Global S and Provision.](https://static.wixstatic.com/media/7ffba2_f48d81b8c6de4ee3b6865c8ccf64b62b~mv2.jpg/v1/fill/w_375,h_250,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/7ffba2_f48d81b8c6de4ee3b6865c8ccf64b62b~mv2.webp)
![[Client Successful Story] Navigating Complex MoCRA Regulations: The Sincere Partnership of Global S and Provision.](https://static.wixstatic.com/media/7ffba2_f48d81b8c6de4ee3b6865c8ccf64b62b~mv2.jpg/v1/fill/w_454,h_303,fp_0.50_0.50,q_90,enc_avif,quality_auto/7ffba2_f48d81b8c6de4ee3b6865c8ccf64b62b~mv2.webp)
[Client Successful Story] Navigating Complex MoCRA Regulations: The Sincere Partnership of Global S and Provision.
Amidst the heightened scrutiny under the updated MoCRA FDA regulations, many companies are feeling the pressure. Here's the success story of global enterprise S, which partnered with Provision to establish a clear, strategic response and overcome the complex regulatory hurdle. This wasn't just about procedure; it was about a sincere partnership. The Challenge: A Global Company Confronts Unfamiliar Regulations Since the enforcement of the Modernization of Cosmetics Regulation
Provision Consulting Group
Oct 20, 20253 min read


FDA MoCRA Latest Update: Why Regulatory Delays Can Be Your Opportunity
Companies looking to enter the U.S. cosmetics market should pay close attention to the latest news from the FDA regarding MoCRA...
Provision Consulting Group
Oct 3, 20252 min read


FDA Labeling Errors: The Top Cause of U.S. Import Delays & Launch Failures
Have you ever had a seemingly perfect product unexpectedly delayed or detained at customs? One of the most common reasons for this is a...
Provision Consulting Group
Aug 4, 20252 min read


FDA, New Medical Device User Fees for FY 2026
On July 30, 2025, the U.S. FDA announced the Medical Device User Fees applicable for Fiscal Year 2026 (October 1, 2025 – September 30,...
Provision Consulting Group
Aug 1, 20252 min read


New FDA Import Rules Eliminate $800 De Minimis Exemption
What the End of the “De Minimis” Rule Means for FDA-Regulated Imports As of July 2025, the U.S. FDA has officially eliminated the...
Provision Consulting Group
Jul 28, 20252 min read


FDA's Return-to-Office Challenges: Navigating Potential Delays in Regulatory Processes
March 21, 2025 The U.S. Food and Drug Administration (FDA) has recently mandated a comprehensive return-to-office policy, requiring...
Provision Consulting Group
Mar 21, 20252 min read


Dexcom’s Growth Surge Amid Regulatory Scrutiny: A Lesson in MedTech Resilience
Monday, March 17, 2025 Introduction In the fast-paced world of medical technology, innovation often races ahead of regulation. Dexcom , a...
Provision Consulting Group
Mar 17, 20252 min read


MoCRA Compliance Crackdown: Is Your Cosmetic Business at Risk?
February 07, 2025 The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) has ushered in a new era of regulatory oversight for the...
Provision Consulting Group
Feb 7, 20253 min read


Common Mistakes to Avoid When Selecting an FDA Initial Importer
February 6, 2025 Common Mistakes to Avoid as an FDA Initial Importer When importing medical devices into the United States, manufacturers...
Provision Consulting Group
Feb 6, 20252 min read


Risks of Not Having an FDA Initial Importer
February 5, 2025 Risks of Not Having an FDA Initial Importer When importing medical devices into the United States, failing to designate...
Provision Consulting Group
Feb 5, 20252 min read


Responsibilities of an FDA Initial Importer
February 4, 2025 Responsibilities of an FDA Initial Importer When importing medical devices into the United States, manufacturers must...
Provision Consulting Group
Feb 4, 20252 min read


How to Select the Right FDA Initial Importer for Your Medical Device
February 3, 2025 Why Choosing the Right Initial Importer Matters Selecting the right FDA Initial Importer is a critical decision for...
Provision Consulting Group
Feb 3, 20252 min read


Who Can Act as an FDA Initial Importer for Medical Devices?
January 31, 2025 Understanding the Role of an FDA Initial Importer For foreign medical device manufacturers looking to enter the U.S....
Provision Consulting Group
Jan 31, 20252 min read


Who Needs an FDA Initial Importer? Understanding the Requirements
January 30, 2025 Keyword Phrase: FDA Initial Importer Requirements Understanding the Role of an FDA Initial Importer If you manufacture...
Provision Consulting Group
Jan 30, 20253 min read


FDA Proposes Bold Changes to Front-of-Package Nutrition Labeling
January 29, 2025 The FDA strives to take decisive steps to help consumers make healthier food choices by proposing a standardized...
Provision Consulting Group
Jan 29, 20252 min read


Navigating FDA Regulations: Importing Medical Devices into the U.S.
January 10, 2025 Importing medical devices into the United States is a complex process that requires strict adherence to regulations set...
Provision Consulting Group
Jan 10, 20253 min read


“Healthy” Redefined: The FDA’s New Rule for Food Labeling
January 10, 2025 The way we define “healthy” in the United States is undergoing a significant transformation, thanks to updated...
Provision Consulting Group
Jan 10, 20252 min read


Streamline Your Food Imports with FDA’s Voluntary Qualified Importer Program (VQIP)
December 17, 2024 In the fast-paced world of food importation, delays at the border can mean missed opportunities and wasted resources....
Provision Consulting Group
Dec 17, 20242 min read


FDA Releases New FAQ Updates for Cosmetic Facility Registration and Listing
December 12, 2024 The U.S. Food and Drug Administration (FDA) has released updated guidance for the cosmetics industry, focusing on the...
Provision Consulting Group
Dec 12, 20243 min read
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