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 long-standing “De Minimis” exemption, which previously allowed low-value shipments (under $800) to bypass formal FDA requirements. Now, all FDA-regulated products—regardless of declared value—must comply with full import procedures, including Prior Notice filing and detailed entry documentation.

This regulatory change affects cosmetics, dietary supplements, foods, and medical devices alike—regardless of whether they’re shipped via bulk import or direct-to-consumer platforms like Amazon or Shopify.

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

What’s Changing?

Under the old rule, low-value shipments under $800 (based on HS Code) were generally exempt from FDA review. Now, all FDA-regulated products must:

• Submit Prior Notice to the FDA before arrival

• Provide detailed importer information, product codes, and country of origin at customs

• Follow the same documentation and screening process as higher-value imports

Even low-cost items shipped via direct-to-consumer channels (e.g., K-beauty products, supplements) must now go through formal import procedures. Non-compliance increases the risk of detention, seizure, return, or monetary penalties.

Why Did This Change Happen?

The FDA cited a sharp rise in misuse of the De Minimis exemption in recent years, including:

• Illegal drugs, counterfeit supplements, and unregistered cosmetics entering the U.S. market

• A 44% increase in low-value pharmaceutical shipments from China in 2024 alone

In response, the FDA and U.S. Customs and Border Protection (CBP) are tightening oversight. Some e-commerce platforms have already begun requiring sellers to submit FDA registration numbers, product classification codes, and Prior Notice IDs to avoid shipping disruptions.

How Should Companies Respond?

With the removal of the De Minimis exemption, all shipments are now subject to full FDA scrutiny. This means brands must proactively address regulatory compliance to ensure smooth entry into the U.S. market.

Here’s how to prepare:

• Prior Notice & PGA FilingPrepare FDA + CBP integrated documentation in line with updated import requirements.

• Product Registration & Label ReviewEnsure proper registration numbers, accurate ingredient disclosure, and category-specific compliance for foods, cosmetics, and dietary supplements.

• E-commerce-Specific StrategiesCustomize your regulatory approach for platforms like Amazon, Shopify, and others.

• Prevention of Import Delays or SeizuresEstablish forward-looking compliance systems to avoid costly detentions or returns.

The end of the De Minimis exemption marks more than just a procedural shift—it signals a new regulatory era for exporters to the U.S. No longer is product value a shield against inspection. Brands must now treat regulatory readiness as a core part of their go-to-market strategy, not an afterthought.

In this new landscape, compliance is not optional—it’s strategic. Preparing robust documentation and minimizing import risks will be key to securing and sustaining success in the U.S. market.

Provision Consulting Group is a specialized consulting firm focused on FDA regulatory approvals and FDA inspection readiness. We are committed to supporting and partnering with

Korean companies to ensure successful entry into the U.S. market.

If you have any questions or need assistance, please feel free to contact us.

>>>>> Start Your Consultation

CONTACT US

Office: 1-909-493-3276

Email: ask@provisionfda.com