PGA Filing Exemption Ends for Some De Minimis FDA Products – Effective July 9
Trade Update • July 9, 2025
Key Points:
- FDA filing is now required for all FDA-regulated products—even low-value items under the $800 de minimis threshold.
- CBP has rescinded all prior exemptions for certain FDA-regulated products.
- Effective immediately, Entry Type 86 filings must include FDA data where applicable.
Prior Notice requirements for food and feed remain unchanged.
.S. Customs and Border Protection (CBP) announced on July 9 that certain low-value FDA-regulated imports previously exempt from filing with the Food and Drug Administration (FDA) must now be submitted for FDA review, effective immediately.
What’s Affected
This policy change affects a range of products—including cosmetics, dinnerware, radiation-emitting devices (non-medical), biological samples, and most foods—that were historically released under the Section 321 de minimis exemption without FDA oversight. These products were typically exempt from providing data through systems like Entry Type 86, a streamlined clearance option for goods valued under $800.
However, CBP and FDA jointly stated that advancements in technology now allow FDA to review all electronically transmitted entries, regardless of shipment value or quantity. Consequently, all prior guidance permitting exemptions for certain low-value shipments has been rescinded, including:
“Effective immediately, all FDA-regulated products must be submitted to the FDA for review,” the message stated. “All prior communications exempting certain low-value FDA-regulated products are rescinded.”
The agencies emphasized that even small shipments can pose health and safety risks. The updated approach is meant to enhance consumer protection, close potential regulatory gaps, and ensure consistent application of FDA standards across all imports.
What Importers Need to Know
Entry Type 86 remains available for low-value shipments, but FDA-regulated products must now include the appropriate PGA data.
Importers must ensure they continue to meet Prior Notice (PN) requirements for all food and feed shipments, unless exempt under 21 CFR 1.277(b).
Failure to comply may result in shipment delays, holds, or refusals at the border.
Resources for Compliance:
Contact:
For general import questions, reach out to: Imports@fda.hhs.gov
How GHY Can Help?
GHY specializes in helping businesses navigate and reduce the impacts of tariffs through strategic solutions tailored to their needs. Our experts can audit your supply chain to identify inefficiencies, uncover cost-saving opportunities, and ensure compliance with evolving trade regulations. We also employ tariff engineering techniques to optimize product classification and sourcing strategies, minimizing duty exposure and maximizing profitability.
By partnering with GHY, your business gains access to the tools and expertise needed to streamline operations and stay competitive in a challenging trade environment.
Contact Us Today! Booking a Meeting, email consult@ghy.com, or call +1 (800) 667-0771.
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