If you are an importer of low-value food and cosmetic shipments into the United States, you must read this blog. Effective August 29, 2025, the De Minimis exception, which has been in place by the Food and Drug Administration (FDA) for these products for 30 years, has ended.
This means that every shipment, whether one with a few bars of chocolate or a single bottle of supplements, is no longer exempt from checks or duties. The same holds even if it contains a single lipstick. In short, every shipment, regardless of its value, must now undergo the customs clearance process with full FDA reporting.
These changes will undoubtedly place a significant burden on sellers and customs agents alike. The good news is that with the right process and a few best practices, you can maintain your volumes without a hitch. This blog will walk you through how to do just that.
What's Changed And Why?
For over three decades, some shipments valued under $800 could bypass security checks and were exempt from duties. The goal of this provision was to boost cross-border trade. As we entered the e-commerce boom, this allowed millions of small products to continue being FDA-regulated.
The latest administration’s stance is that bad actors are exploiting this exemption to bring in fentanyl and other illicit drugs into the United States, and hence the change. As a result, every shipment will now be treated as a standard import.
This also means that duties now apply to every shipment, even if it’s a $10 sample of a cosmetic. Additionally, CBP has implemented new directives to scrutinize shipments and imposed heavy civil penalties for violations of the One Big Beautiful Bill Act of 2025.
Here is a side-by-side comparison of how the process for low-value food and cosmetic shipments has changed post the end of de minimis.
Step/Requirement | Old Process | Post End of De Minimus |
FDA Prior Notice | Was required for all FDA-regulated products | Still required |
Details for cosmetic imports | It was only needed for formal entries. It was not required for a majority of low-value shipments. | Mandatory for all shipments regardless of their value |
Facility Registration (in case of cosmetics) | It was not required for most low-value shipments. | Mandatory for all, as per the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) |
Section 321 benefits | Entry was allowed without full PGA (FDA) data for many products. | Full FDA data is mandatory for all shipments. |
Type 86 filing | Was only required for PGA-regulated goods | Mandatory for all FDA-regulated shipments. |
Customs Duties/Tariffs | Nil for shipments under $800 | Duties and tariffs apply to all shipments. |
Penalties | Rare and not high for low-value parcels. | $5000 for the first violation and up to $10,000 for each subsequent violation. |
Chance of inspection | Very low | Very high |
Holds | Most low-value shipments were released with minimal delay | Shipments will be held or rejected for missing data or due to unpaid duties |
How to Handle Low-Value Food Shipments Under the New Rules?
The new process to handle low-value food shipments is as follows:
Step 1: File the FDA Prior Notice
As always, every food shipment regulated by the FDA will require you to file an FDA prior notice. There is no change in this part of the process, and the timelines remain the same. If the shipment is coming in via:
- Road: At least 2 hours before arrival.
- Air or Rail: At least 4 hours before arrival.
- Ocean: At least 8 hours before arrival.
Mail: Before the food is sent
Step 2: Classify and Value the Shipment and File the Appropriate Customs Entry Type
Since Entry Type 86 and Section 321 filings are no longer accepted, file either Type 01 (formal entry) or a Type 11 (informal entry) in the Automated Commercial Environment (ACE) system.
You will now have to file Full Partner Government Agency (PGA) Data that will include:
- The FDA product codes.
- The Manufacturer’s and facility details.
- The Intended use codes.
- The Affirmation of Compliance (AofC) codes.
- Detailed product descriptions and country of origin.
These are in addition to all the data points that you normally would for an FDA prior notice or Type 86 entry.
Step 3: Pay Any Applicable Duties or Fees
All shipments, even those valued under $800, are now subject to duty. This rate depends on the product’s tariff classification and the product’s country of origin, which you must calculate accurately and pay in advance to avoid delays.
Step 4: Respond Promptly to Queries from the FDA or Customs Officials
Be prepared and respond to any additional documentation or information requests from the customs officials or the FDA. Your shipments will be released once all the requirements are met.
How to Handle Low-Value Cosmetic Shipments Under the New Rules?
If you deal specifically in the import of low-value cosmetic products, this is what the new process looks like:
Step 1: List All the Products You Plan to Import
Under the Modernization of Cosmetics Regulation Act (MoCRA), you are now required to file a detailed list of products you plan on importing every year. This listing must include detailed information on the full ingredient list of each product.
If you are a facility that manufactures, packs, or distributes cosmetic products, you need to register with the FDA. This registration has to be renewed every two years. As an importer, you must now ensure that all products you import are registered and compliant with FDA regulations. You can find the listing here.
Step 2: Verify if All the Ingredients and Labelling are Compliant
The FDA is now enforcing strict labeling and packaging requirements as per the Fair Packaging and Labeling Act. All labels must include relevant contact information. Additionally, you have to ensure that all the ingredients listed on a product match your annual import product list submitted to the FDA.
Step 3: Classify the Shipment and File the Entry
As was the case with low-value food shipments, you have to file either a Type 01 or Type 11 entry. Here as well, you are now required to submit complete FDA Partner Government Agency (PGA) data that includes:
- The FDA product codes for each cosmetic item.
- The complete details of the product’s manufacturer.
- Affirmation of Compliance (AoC) codes (double check if the labels and ingredients are compliant).
- Detailed product descriptions and country of origin.
Steps 4 and 5: Same as Above
Once you file the entry type, provide all additional information if required by the relevant authorities promptly, and your shipment should clear customs with ease.
The Leading Causes for Rejections Post the New Changes
With all the rules, there’s definitely a lot of confusion. That said, most of the rejects are caused by completely avoidable mistakes. Here are a few of the leading causes that you should pay special attention to:
- Failure to file the FDA prior notice: The FDA prior notice was and is still mandatory and must be filed within the stipulated timelines.
- Still using the Type 86 entry: The old Section 321: Type 86 entry is no longer valid. Attempting to use this entry will lead to instant rejections.
- Missing FDA data: As per the current rules, you are required to submit every single PGA data point that has been asked for. Missing any will lead to delays.
- Data mismatches between agencies: Any discrepancies in data between the FDA and the Customs filings will be automatically flagged.
Non-payment of duties and tariffs: Duties and tariffs are now applicable to all incoming shipments. Failing to pay them on time will result in your shipment being withheld.
Streamline Your Imports With Customs City
The regulatory landscape for low-value food and cosmetic shipments has shifted dramatically this year. What was once a streamlined process is now riddled with regulatory requirements and hurdles. Based on current trends, they may remain in a state of flux in the near future.
As an importer, it can be overwhelming to stay on top of these changes on your own. In such situations, a dedicated software provider like CustomsCity can be a great asset to help ensure that your shipments continue to sail through with minimal disruptions.
Book a quick demo, see how CustomsCity can simplify your import process and safeguard your business against costly mistakes.
FAQs
An FDA prior notice can be filed either by you or your customs broker. However, to self-file file you will need to set up an ACE account.
In this scenario, you must create separate entry lines for each product and provide the complete PGA data for each product. Duties will also need to be calculated per line.
Treat each return or replacement as a new import. Confirm that the labeling still matches the product contents. For food, verify shelf life and storage conditions.
