NEWS & BLOGS

MoCRA Shock: 7 Real-World Case Studies of Regulatory Impacts in the U.S. Cosmetics Market

Provision Consulting Group
3 days ago
3 min read

Updated: 2 days ago

"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.

While the industry has been buzzing with talk—"MoCRA is tough," "Customs clearance got harder"—concrete examples of actual regulatory consequences have not been widely publicized. In this post, we've compiled real-world case studies from the past year or two to clearly illustrate the changes taking place in the U.S. market.

Amazon Mass Deletes Cosmetic Listings Due to MoCRA Non-Compliance

Between June and December 2024, Amazon updated its internal MoCRA-related policies. As a result, hundreds to thousands of cosmetic listings were reported to have been deleted for reasons including missing Responsible Person information, lack of Facility Registration, and failure to submit Product Listing.

When MoCRA requirements are not met, Amazon's automated deletion algorithm can instantly remove a listing. Amazon's official policy already explicitly states: "Cosmetics require Manufacturing Facility Registration, a Responsible Person, and Product Listing."

Spike in Cases of Cosmetic Import Refusals and Returns After MoCRA

Following MoCRA's implementation, the CBP (Customs and Border Protection) has been aggressively checking cosmetics shipments for the Responsible Person (RP), manufacturing facility registration status, and labeling errors during customs clearance.

Products have been subject to Detention or Refusal if the label is missing RP information, contains ingredient mislabeling, or includes drug-like claims. In one real-world case, a skincare product was held by customs five times in a row, with return shipping costs alone reaching tens of thousands of dollars.

Reda More: FDA – Import Refusal Report Database

FDA Issues Warning Letters for the Use of Efficacy Claims (Drug-Like Expressions)

Since MoCRA, the FDA has been particularly strict about using efficacy claims (such as ‘anti-inflammatory’ or ‘eczema care’) on cosmetic products. In 2024, the FDA issued multiple warning letters to beauty companies using functional claims.

Phrases like ‘hypoallergenic tested,’ ‘improves skin troubles,’ or ‘relieves atopy’ can instantly classify a product as an OTC drug (Over-The-Counter), leading to warning letters and the risk of a recall.

Reda More: FDA – Warning Letters Related to Cosmetics

Recalls Due to Contamination Issues: What Happens Without Safety Substantiation

In April 2024, Kosette Beauty Market in the U.S. initiated a nationwide recall due to microbial contamination. Major retailers like Target and Walmart were notified, and immediate stop-sale orders were implemented. Beyond contamination, similar issues are likely to arise if safety documentation is inadequate or manufacturing records are not properly established.

Reda More: FDA – Recalls, Market Withdrawals & Safety Alerts

Recommended for Recall After Failing to Report Adverse Events

Under MoCRA, serious adverse events must be reported to the FDA within 15 days. If this reporting is not done correctly, or if consumer complaints accumulate, the FDA may initiate an investigation or recommend a product recall.

Reda More: FDA – Submitting Adverse Event Reports (Cosmetics)

Enhanced Inspections of U.S. Manufacturing Facilities

MoCRA has led the FDA to conduct more rigorous inspections of cosmetic manufacturing facilities. They check GMP (Good Manufacturing Practices) records, batch management, and potential contamination issues. If problems are found, the facility may receive an OAI (Official Action Indicated) classification, which requires immediate corrective action or could result in operational restrictions.

Reda More: FDA – Inspection Classification Database

Increased Customs Clearance Risk for Korean Companies

Both the Korea International Trade Association (KITA) and the Korea Cosmetic Industry Institute have reported that the customs clearance risk for Korean cosmetics has increased due to non-compliance with MoCRA regulations. While Korean cosmetics are popular in the U.S. market, the heightened regulatory requirements have genuinely raised the risk level at the import and verification stages.

The U.S. market offers great opportunity, but its regulations have also grown significantly. What is more important than the fact that regulations have strengthened is understanding the actual consequences of those changes in the market. With this understanding, companies can prepare and proactively mitigate unnecessary risk.

Provision Consulting Group offers the following services to help businesses safely navigate the U.S. market in compliance with MoCRA and FDA regulations: