NEWS & BLOGS

The $800 Magic Is Gone: Why Compliance is Now the Top Priority for U.S. Market Entry.

Provision Consulting Group
Sep 10
2 min read

Updated: Sep 24

End of the De Minimis Rule: A New Barrier to U.S. Market Entry

With the recent abolition of the de minimis rule, there has been a fundamental change in how products are exported to the United States. In the past, low-value, direct-to-consumer (D2C) shipments under $800 could enter the market relatively easily without formal customs clearance.

However, that door has now been closed, and a new era has begun where all products must go through the strict, formal customs clearance process.

The Era of Direct-to-Consumer Is Over: The Era of Formal Clearance Has Begun

From now on, the moment a product passes through U.S. customs, it will be subject to a thorough FDA review. If basic regulations such as labeling, product registration, prohibited ingredients, and adverse event reporting are not properly prepared, the risk of the product being held or returned at customs has increased.

This is not simply a matter of logistics costs; it can lead to the serious situation where a product loses the opportunity to enter the market entirely.

3 Things Companies with FDA-Regulated Products Must Check Compliance

In this new regulatory environment, there are three key areas that companies must be prepared for:

Labeling and Ingredient Regulations: You must meet the mandatory requirements under MoCRA (Modernization of Cosmetics Regulation Act). All items, including ingredient labeling, warning statements, and U.S. Responsible Person information, must meet FDA standards.
Product and Facility Registration: The formal customs clearance process requires you to have a valid FDA facility registration and product listing. If this information is missing or contains errors, it will be a reason for customs holds.
Adverse Event Reporting and Responsible Person Designation: MoCRA mandates the establishment of an Adverse Event Reporting system. Additionally, a legal U.S. Responsible Person must be designated to handle all inquiries and regulatory matters related to the product.

Successful U.S. market entry is no longer guaranteed by a good product alone. Thorough regulatory compliance has become the first step to success.