As of July 9, 2025, the FDA has rescinded the “manifest-only” clearance exception for five previously exempt product categories under Section 801(a) of the Federal Food, Drug, and Cosmetic Act. These items—when shipped under the de minimis value threshold (currently $800 or less)—previously did not require direct FDA notification for entry admissibility. That’s now changed.
This update affects a wide range of industries, especially those relying on express and e-commerce-driven imports. If your supply chain includes cosmetics, electronics, dinnerware, or food products, this change is for you.
What’s Changed?
The following product categories must now be filed as Type ET86 entries and require full FDA data submission, regardless of shipment value:
- Cosmetics
- Dinnerware (ceramic/glass intended for food use)
- Radiation-emitting non-medical devices (e.g., televisions, microwaves)
- Biological samples for testing
- Food (with exceptions):
- Now included: packaged foods, shelf-stable goods
- Still requiring special attention: ackees, pufferfish, raw mollusks (clams, oysters, mussels), and air-tight canned goods
- Now included: packaged foods, shelf-stable goods
Why Were These Exempt Before?
Previously, under manifest-only clearance, the FDA viewed these five categories as low-risk or low-priority when shipped under de minimis value thresholds, particularly through express couriers or informal entry channels. These shipments were:
- Considered low volume or personal use
- Often pre-cleared based on past compliance
- Seen as low probability for public health risk (especially cosmetics and consumer electronics)
Under this system, CBP (Customs and Border Protection) could release goods without full FDA screening, assuming the value and use posed minimal risk.
Why the Change?
The FDA’s updated enforcement reflects:
- Growth in e-commerce volumes of FDA-regulated items
- Increase in commercial use of de minimis shipments to bypass regulation
- Rising concerns about quality, safety, and labeling in cosmetics, food, and radiation-emitting devices
- Better integration of entry data systems, allowing the FDA to screen more shipments efficiently
This change ensures greater visibility and control over goods that could impact consumer health, even in low-dollar volumes.
What to Do Now?
Importers, brokers, and carriers should:
- Update system logic to require ET86 filing for these five categories
- Ensure FDA product codes, manufacturer info, and intended use are submitted correctly
- Train staff and clients to no longer assume de minimis = FDA-free
Compliance delays can lead to holds, refusals, or enforcement action, especially for repeat offenders.
Have questions or need help adapting your workflow? We’re here to support you with practical solutions and up-to-date compliance guidance. Need support aligning your import strategy with these FDA changes? Coppersmith’s team is ready to help you navigate documentation, entry classifications, and new system requirements with clarity and confidence. We’ll help you stay compliant—without missing a beat.
Read our guide here.
