PGA Filing Exemption Rescinded for FDA-Regulated De Minimis Shipments

With the PGA filing exemption no longer applicable, all FDA-regulated products, regardless of value or quantity, must now be submitted for review by the FDA at the time of entry.

The U.S. Customs and Border Protection (CBP) has announced the end of the previous PGA filing exemption that applied to low-value shipments of products regulated by the U.S. Food and Drug Administration (FDA). 

As of July 9, 2025, all shipments that include FDA-regulated products must be submitted for FDA review. This is “to facilitate legitimate trade and prevent the importation of violative products.”

The update affects Section 321 (de minimis) imports, which allow duty-free entry for goods valued at $800 or less.

It reflects the agency’s position that low-value imports may pose risks to health, safety, and security.

With this new guidance, all previous communications that exempted some FDA-regulated imports from Partner Government Agency (PGA) filing requirements under the de minimis provision no longer apply.

For importers using Entry Type 86 for their low-value shipments, they must now ensure all required FDA data elements are included.

Additionally, Prior Notice (PN) requirements will continue to apply to all food and feed shipments, regardless of their value or quantity, unless they are exempt under 21 CFR 1.277(b).

What guidance was rescinded?

The following CSMS messages, which outlined the now-invalid PGA filing exemption, have been officially rescinded:

• CSMS #94-001260
• CSMS #17-000388
• CSMS #52257745
• CSMS #53697179

Affected FDA-regulated products

Under the updated policy, FDA-regulated products must be filed with complete PGA data. These products include:

• Cosmetics
• Dinnerware (including eating and/or cooking utensils)
• Radiation-emitting, non-medical devices (e.g. microwaves, televisions, CD players, etc.)
• Biological samples for laboratory testing
• Food (excluding ackees, puffer fish, raw clams, raw oysters, raw mussels, and foods packed in air-tight containers intended to be stored at room temperature)

Next steps for U.S. importers

If your business previously benefited from the PGA filing exemption for low-value shipments, you must now:

• Identify the affected products in your shipments.
• Ensure that Entry Type 86 filings include all required FDA data elements.
• Submit a PN for all food and feed shipments, unless exempt.
• Consult a customs broker to avoid delays or fines and ensure compliance.

Please refer to the FDA Supplemental Guide for a full list of data elements that must be transmitted.

How Cole International can help

At Cole International, we constantly monitor changing trade regulations and offer customs and compliance consulting services to help businesses navigate these changes.

Additionally, we provide timely and efficient customs brokerage services to help U.S. importers streamline their customs clearance and other import processes.

If you import low-value, FDA-regulated goods, please reach out to one of our trade professionals to discuss the impact of this update on your business and how we can help simplify the entry of your goods.