The U.S. Food and Drug Administration (FDA) has enacted a major change that directly affects importers of five key product categories. As of July 9, 2025, the FDA has officially eliminated the “manifest-only clearance” exception, requiring that all applicable imports be submitted as Type ET86 entries.

This change impacts thousands of shipments daily and is already disrupting businesses that aren’t prepared. Whether you import cosmetics, dinnerware, electronics, biological samples, or packaged food, your process now requires formal FDA data filing, regardless of shipment value.

In this comprehensive guide, we’ll break down everything you need to know about ET86 FDA compliance, what changed, what’s required, and how to stay ahead of regulatory delays.

1. What Is Manifest-Only Clearance – and Why It Was Important

Before July 2025, low-risk shipments under $800 (de minimis) were often cleared without direct FDA review under “manifest-only clearance.” These shipments were flagged for review only if the FDA manually selected them.

This allowed small e-commerce businesses and sample importers to move goods quickly. But with the explosion of commercial e-commerce imports, the FDA now views this loophole as a public health risk.

2. What’s New: Manifest-Only Clearance Eliminated for 5 Key Product Categories

As of July 2025, the FDA has officially removed manifest-only clearance for certain types of products. This means that even if the shipment is valued under $800 and qualifies for de minimis treatment, it can no longer bypass FDA scrutiny based solely on the shipping manifest.

Instead, the FDA now requires a formal electronic submission — known as an ET86 entry filing — before the shipment arrives in the U.S.

This change applies to the following five product categories:

• Cosmetics – including skincare products, makeup, and other personal care items
• Dinnerware – such as plates, cups, and utensils made of glass, ceramic, or other materials that come into contact with food
• Radiation-emitting non-medical devices – like televisions, microwave ovens, and computer monitors
• Biological samples – including lab specimens and research/testing samples
• Packaged food products – shelf-stable items that do not require refrigeration

What this means:
Shipments containing these products must now go through the full FDA clearance process. Importers need to submit proper documentation electronically in advance — regardless of the shipment’s value. This marks the end of informal clearance for these categories and places new compliance responsibilities on importers and carriers alike.

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3. What Is an ET86 Filing?

An ET86 filing is a special type of customs entry used for low-value shipments — typically under $800 — that still require FDA review. Even though these shipments fall under the de minimis threshold, they cannot bypass FDA scrutiny if the products fall into regulated categories.

The ET86 entry is submitted electronically through ACE (Automated Commercial Environment) — the U.S. Customs and Border Protection’s (CBP) digital system for processing import data.

To comply with FDA regulations, each ET86 filing must include detailed product information, such as:

• FDA product codes – identifying the specific type of product being imported
• Manufacturer details – including the company name and location
• Facility registration numbers – if the manufacturing or packing facility is FDA-registered
• Intended use of the product – e.g., for retail sale, research, personal use
• Ingredient listings – for applicable products like food, cosmetics, and supplements

Why is ET86 important?
The purpose of the ET86 filing is to allow the FDA to review and assess small-value shipments just as thoroughly as high-value imports. This helps protect public health by ensuring that even low-cost, high-volume e-commerce items meet safety and compliance standards.

4. Why the FDA Made This Change Now

The main reason behind this policy change is the rapid growth of cross-border e-commerce and the widespread use of what’s often called “loophole shipping.”

Many overseas sellers and U.S.-based importers were taking advantage of the $800 de minimis exemption by shipping goods in small parcels that avoided full FDA review. These shipments were cleared under manifest-only rules, meaning they entered the country without detailed product information or safety checks.

As a result, the FDA had limited visibility into what was being imported — and no way to verify product safety, proper labeling, or facility compliance.

Over time, this loophole led to serious concerns, such as:

• Contaminated or mislabeled cosmetics
• Food packaging materials that could leach harmful substances
• Electronics emitting radiation without required certification

Given these risks to public health, the FDA decided it could no longer allow low-value shipments to bypass scrutiny. The new rules ensure that all regulated products — no matter the shipment value — are reviewed like formal commercial imports.

This marks a significant shift in how the U.S. handles small e-commerce imports and puts greater responsibility on importers to ensure compliance.

5. How the New Rules Affect Each Product Category

Let’s break down how the FDA’s updated policy impacts each of the five affected product types:

a. Cosmetics

Typical Products: Face creams, serums, cleansers, lipsticks, makeup, personal care items

New FDA Requirements:

• • Facility registration (especially for foreign manufacturers)
  • Accurate and compliant labeling
  • Intended use must be clearly stated

Key Risk: Shipments from countries like South Korea or Japan — which previously entered easily — may now be detained or rejected if an ET86 entry is not filed in advance.

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b. Dinnerware (Food-Contact Articles)

Typical Products: Plates, bowls, mugs, glass containers, food storage items

FDA Focus: Ensuring that materials are safe for food contact and don’t leach harmful chemicals

New Requirements:

• • FDA product code
  • Description of material composition (e.g., ceramic, plastic, glass)
  • Importer’s declaration confirming compliance with food-contact safety standards

c. Radiation-Emitting Devices (Non-Medical)

Typical Products: Televisions, computer monitors, microwave ovens, laser pointers

Why Regulated: These devices can emit potentially harmful radiation if not properly manufactured or tested

FDA Now Requires:

• • Manufacturer registration
  • Summary of radiation emission testing and safety compliance

d. Biological Samples

Typical Products: Human or animal tissue, blood samples, DNA swabs for research, testing, or diagnostics

New Filing Requirements:

• • Full documentation, including purpose of import
  • Declaration of lab use or testing facility

Important Note: This category faces high scrutiny due to potential biohazard risks, and improperly documented samples may be seized or rejected.

e. Food Products (Packaged and Shelf-Stable)

Typical Products: Instant noodles, snack foods, canned goods, cookies, dried fruits

FDA Now Requires:

• • Prior Notice submission before the shipment arrives
  • ET86 electronic filing
  • Facility registration for the manufacturer or food processor

Exceptions: Some high-risk products like ackees, raw mollusks, or unpasteurized dairy may still be prohibited from import, regardless of ET86 filing.

6. What You Need to Submit for ET86 FDA Compliance

To file an ET86 entry correctly and ensure your shipment clears FDA review, importers must prepare and submit specific documentation through the ACE (Automated Commercial Environment) system. This applies even to low-value parcels under the de minimis threshold.

Here’s a breakdown of what is required:

a. FDA Product Code

A standardized code that identifies the product’s classification based on its type, use, and composition. This code tells the FDA what kind of item is being imported — whether it’s food, cosmetics, dinnerware, etc.

b. FDA Facility Registration Number

If the product comes from a facility that is required to be registered with the FDA (such as food or cosmetics manufacturers), you must include the facility’s official registration number.

c. Manufacturer and Shipper Information

You’ll need to provide full contact details for both the manufacturer and the shipper. This includes names, addresses, and phone numbers or emails. The FDA uses this information to trace the product’s origin.

d. Intended Use Code

This code explains why the product is being imported. Is it for personal use, retail sale, scientific research, or clinical testing? The intended use affects how the FDA evaluates the shipment.

e. Product Label Images (when required)

For some product categories — especially cosmetics and packaged food — the FDA may require you to upload clear images of the product label. Labels must meet FDA requirements for ingredients, claims, and contact info.

f. Ingredient List (for food and cosmetics)

If your product is a food item or cosmetic, you must submit a full list of ingredients. This helps the FDA check for banned substances, allergens, or incorrect formulations.

g. Prior Notice (for food shipments)

Any food shipment must include a Prior Notice — an electronic alert submitted to the FDA before the product arrives in the U.S. This tells the FDA what food is coming, from where, and when.

 Important:

If any of the required information is missing, incorrect, or inconsistent, your shipment may be:

• Delayed
• Placed on hold for further inspection
• Rejected or refused entry into the U.S.

To avoid these issues, importers should double-check all documents and work with qualified brokers or compliance experts.

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7. Step-by-Step Guide to the ET86 Filing Process

To comply with the new FDA requirements for low-value shipments, importers should follow these four key steps to successfully complete an ET86 filing:

Step 1: Register the Manufacturing Facility with the FDA

If your product is manufactured or processed in a facility outside the United States — especially for food, cosmetics, or medical-related items — that facility must be registered with the FDA.

• You’ll receive a valid FDA registration number after completing the registration process.
• This number must be included in the ET86 filing.

Tip: Make sure your supplier provides a current and active registration number.

Step 2: Identify the Correct FDA Product Classification

Each product must be classified correctly using the FDA Product Code — a specific code that tells the FDA what the product is, how it’s used, and what it’s made of.

• Use the FDA Product Code Builder (an online tool) to find the correct code.
• Accuracy is essential: using the wrong code can lead to shipment delays or rejections.

Tip: Review product ingredients or materials to ensure the classification matches.

Step 3: Work with a Customs Broker Familiar with ET86

Not all brokers are equipped to file ET86 entries, so make sure your customs broker:

• Can file ET86 entries via ACE (Automated Commercial Environment)
• Understands the specific documentation and compliance rules for your product type
• Has experience with FDA-regulated imports

Tip: Share all product details with your broker early to avoid back-and-forth later.

Step 4: File the ET86 Entry Before Shipment Arrival

Timing is critical. The ET86 entry must be submitted electronically before the shipment arrives in the U.S.

• If the filing is late or incomplete, your shipment may be held or refused entry.
• This step also includes submitting Prior Notice if the shipment contains food.

Tip: Confirm with your broker that the ET86 has been successfully submitted and accepted.

8. How to Prevent Shipment Delays – Best Practices for Importers

With the FDA’s stricter rules now in place, it’s essential to take proactive steps to avoid having your low-value shipments held, delayed, or rejected. Here are some best practices importers should follow:

a. Don’t Rely on the De Minimis Exemption Anymore

In the past, many importers assumed that shipments under $800 would automatically clear without issue.
That’s no longer the case — especially for FDA-regulated products like cosmetics, food, and electronics.
Even low-value items are now treated like commercial imports and require full documentation under the ET86 process.

b. Educate Your Suppliers and Shipping Partners

If you work with overseas suppliers (especially in Asia), they may not be aware of the new FDA rules.
Make sure they understand the importance of:

• Providing accurate product descriptions and ingredient details
• Supplying facility registration numbers
• Ensuring labels meet FDA standards

Tip: Share a compliance checklist or guide with them.

c. Update Your Customs Broker’s Instructions

Immediately notify your customs broker that any shipments containing the 5 affected product categories (cosmetics, dinnerware, radiation devices, biological samples, packaged food) now require ET86 entry filings.

• Ask your broker to flag these categories in their system
• Confirm that they are prepared to file through ACE with full FDA data

Tip: Review a sample filing with your broker to ensure everything is correct.

d. Consider Using FDA Compliance Tools or Consultants

Managing FDA product codes, label reviews, ingredient lists, and documentation can be complex — especially when you’re dealing with many small shipments.

To simplify this process:

• Use FDA compliance software that helps automate product classification and label checks
• Or work with FDA consultants who specialize in import compliance for your product type

Tip: This is especially helpful for businesses scaling up e-commerce shipments or sourcing from multiple vendors.

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Don’t Wait Until Your Shipment Is Delayed

The FDA’s removal of manifest-only clearance is already in effect — and it’s changing how thousands of low-value shipments are processed each day. If you’re importing Korean cosmetics, Japanese snacks, Chinese electronics, or any of the five affected product categories, compliance with the new ET86 requirements is now mandatory.

Delays, detentions, and rejections are becoming more common for importers who haven’t updated their procedures.

Take action now.

Partner with a trusted FDA compliance expert to ensure your import process is ET86-ready.

Contact G.O.L for Support:

Phone: +65 8342 6900

Email: clients@golsolution.com

Office: 160 Robinson Road #14-04, Singapore 068914

Website: https://golsolution.com

Let G.O.L help you stay compliant, avoid shipment disruptions, and streamline your FDA filings — no matter your product category or shipment volume.