In a sweeping regulatory shift that’s already sending shockwaves through the global supply chain, the U.S. Food and Drug Administration (FDA) has officially revoked the longstanding exemption for low-value imports. As of July 9, every shipment of FDA-regulated products—regardless of its dollar value or size—must now undergo full FDA review. This marks the end of a decades-old policy that allowed products valued at $800 or less to bypass FDA scrutiny, a loophole that many in the gray market had exploited to bring in unvetted goods.
The change stems from a recent Customs and Border Protection (CBP) update, signaling a new era of enforcement that closes a major gap in FDA oversight. Previously, low-value packages, particularly those entering under Section 321 of the Tariff Act, could slip through the cracks. But the FDA is no longer willing to take that risk. With advances in data systems and electronic transmission, the agency says it now has the tools to examine every incoming parcel, including those ordered online, sent through express carriers, or labeled “for research use.”
What’s affected? Pretty much everything under FDA’s umbrella: pharmaceuticals, medical devices, dietary supplements, cosmetics, food, beverages, and even biological samples. Smaller shipments, which were once treated with leniency, will now face the same scrutiny as bulk commercial imports. The FDA believes this is essential to prevent entry of non-compliant, unsafe, or counterfeit goods—and to identify repeat offenders trying to exploit loopholes.
This policy shift is particularly relevant in light of recent findings about the “gray market” for obesity drugs and other active ingredients sourced from unregistered Chinese suppliers. A June 2025 Reuters report revealed a surge in imports of cheap, research-labeled compounds, often used by individuals and companies to self-compound medications. These imports flew under the radar largely because they qualified for the $800 de minimis exemption. The FDA’s new rules effectively shut that door.
Importers now face several new responsibilities:
- Ensure all shipments, even low-value ones, include full FDA data at the time of entry.
- Continue to meet Prior Notice requirements for food and feed, which remain unchanged.
- Coordinate with suppliers and logistics providers to avoid shipment delays due to non-compliance.
- Consult FDA resources like the Supplemental Guide for ACE and de minimis FAQs to stay ahead of regulatory changes.
This policy would also impact personal imports by US-based patients. This move is not just regulatory housekeeping—it’s a targeted strategy to close known vulnerabilities in the supply chain. With FDA and CBP now working in tighter coordination, the U.S. aims to build a stronger, safer import system that doesn’t leave room for risk, fraud, or health hazards, no matter how small the package.
Bottom line? If you’re in the business of importing anything FDA-regulated, size no longer matters. Your shipment needs to play by the same rules as everyone else. The era of “small parcel, no problem” is officially over.
