Introduction
The regulatory environment for low-value imports into the United States has greatly changed. On July 9, 2025, the U.S. Customs and Border Protection (CBP), in collaboration with the Food and Drug Administration (FDA), enacted a policy change that removes the de minimis exemption of FDA-regulated products under Section 321 of the Tariff Act of 1930. In the past, importers were allowed to import eligible FDA-regulated products into the U.S. without any formal entry requirements as long as the value of the shipment was less than $800. This exemption facilitated cross-border trade, especially online businesses and the cross-border trade of consumer goods.
The withdrawal of previous guidance, however, including CSMS 94-001260 and CSMS 17-000388, is a turning point. The FDA currently requires complete regulatory examination of all FDA-regulated imports, irrespective of their value or volume of shipment. The reason behind this shift lies in the technological advancement of the agency and its mandate of promoting the health, safety, and integrity of the products and the population board.
These new requirements are a challenge in terms of operation, procedure, and compliance for brokers, importers, and logistics platforms. This article gives an in-depth description of the policy change, the nature of the products that will be subject to the change, the new data and filing requirements, and the practical implications of the policy change to the affected stakeholders as they navigate the new Section 321 regime. With knowledge, the players in the industry will be able to comply with the rules and avoid disruptions while transporting FDA-regulated products.
II. What Changed on July 9th 2025?
CBP, in conjunction with the FDA, released Cargo Systems Messaging Service (CSMS) Notification 65581188 on July 9, 2025. This notice officially revoked an earlier guidance that had permitted some of the products regulated by the FDA to be imported duty-free into the U.S. under Section 321, which is a provision that allows the importation of any goods into the U.S duty-free as long as the value of the goods is not more than $800.
In the past, products regulated by the FDA, which exceeded the value threshold, could be exempted from a complete FDA review. This comprised a lot of consumer items that were usually transported in small packages. This exemption is not applicable, however, as of the July 2025 directive. Any FDA-regulated shipments are required to be sent to the FDA to be reviewed, regardless of monetary value or quantity.
Such a transition was made possible by the better technological ability of the FDA, as well as the trade participants who can now handle data in real-time. The agencies stressed that low-value shipments, no matter how small, may be hazardous to health and safety. The FDA will thus establish a level playing field and a risk-based approach to oversight by removing the de minimis exception, which will treat all regulated imports equally.
Notably, the CSMS 65581188 also rescinded previous messages- CSMS 94-001260, CSMS 17-000388, CSMS 52257745, CSMS 53697179– which had granted exemptions. The current position is that all products that are regulated by the FDA and imported into the United States should meet the requirements of the FDA, period.
III. When Did the Change Take Effect?
The policy came into effect as soon as the CSMS notice was issued on July 9, 2025. It had no implementation grace window or transition period. Consequently, all imports of FDA-regulated products to the U.S. that arrive on or after the date will be required to enter formally and submit to the FDA.
This quick implementation caught a lot of importers by surprise, especially those in the e-commerce and small business sector that had used Section 321 to streamline their clearance. Logistics providers and brokers noticed the increased number of inquiries made by clients, especially those exporting goods out of Canada, asking how they can be compliant with the new rules.
Policy-wise, the immediacy of implementation of the change shows how seriously the FDA takes consumer safety and consistency in regulation. It also recognizes that it is now possible to have the current electronic systems efficiently process and analyze the risk in small shipments without causing excessive complications in the supply chain.
IV. Which FDA-Regulated Products Are Affected?
The policy change is widely applicable to all products regulated by the FDA, regardless of their value. This includes categories that had enjoyed de minimis exemptions and those that were never subject to exemptions. The most significant product segments that will be impacted are:
- Cosmetics: Creams, lotions, shampoos, make-up, and so on.
- Dinnerware: Plate, cups, and cutlery that will come in direct contact with food.
- Radiation-Emitting Non-Medical Devices: Tanning beds, microwave ovens, and laser products are included in this category.
- Biological Samples: Samples that are utilized in research or diagnosis.
- Food Products: All consumables, other than those that have already been considered high-risk and have been excluded earlier in the exemption. This includes:
- Foods that were formerly non-exempt (under the FDA, but not under the FSMA) include: ackees, puffer fish, raw clams, oysters, mussels, and shelf-stable foods that are packed in airtight containers.
The list of categories is only a fraction of the wide regulatory powers that the FDA has. The agency regulates over-the-counter drugs, dietary supplements, contact lenses, infant formula, and other products related to health. Any consignment that contains such goods is now supposed to be formally checked and documented.
Not defining a product as an FDA-regulated product can lead to detention and refusals, and even penalties. The importers will have to review the lines of their products and the shipping procedures in order to comply with the new policy.
V. What Information Must Be Transmitted to the FDA?
To meet the new requirements, importers (or their brokers) are obliged to send the detailed product and shipment information to the FDA via the Automated Broker Interface (ABI). This entails a set of required data fields in the messaging specifications of the Partner Government Agency (PGA) of the FDA. The fields required include:
- Intended Use Code
- FDA Product Code
- Source Type
- Country of Origin
- Base Unit of Measure
- Parties
- Manufacturer
- Shipper
- FDA Importer
- Deliver-To Party
Certain product categories may need an Affirmation of Compliance (AOC), which shows that the product is in compliance with the applicable FDA standards or has the requisite pre-approvals or registrations. These are data points specific to each product type, and they are needed to complete entry processing.
The Prior Notice (PN) requirements are also applicable to importers of food items, and the longstanding rules remain unchanged. PN should be provided prior to the arrival of the food shipments in the U.S. port of entry, irrespective of the value.
The absence of the aforementioned data may result in delays in the shipment or automatic rejection of the shipment at the border. As such, businesses are advised to go through the FDA Supplemental Guide to ACE to make sure that all the necessary fields are filled out correctly.
VI. How to File Through the CustomsCity Platform
CustomsCity provides an easy and regulatory-compliant process of filing the necessary FDA data. The platform is compatible with the filing of Entry Type 11 shipments and has the functionality of FDA entries as per the requirements of PGA messaging. The procedure usually varies slightly depending on the type of user.
- Customs Brokers: Brokers have the ability to work with CustomsCity’s proprietary FDA+T11 Template. Once a broker fills it, the template enables them to upload all the necessary data into the system to be sent to CBP and FDA. This is a process that is similar to other available filing options in CustomsCity and, therefore, easy to integrate.
- Standalone Prior Notice Filers (of Food): Importers who only need to file Prior Notice will be able to continue to upload their products into their existing product catalogs and submit to the FDA using existing processes. The new policy does not change these preexisting functionalities.
Importers are recommended to check with their account managers or the CustomsCity support team to determine that they are using appropriate filing methods and formats, particularly when moving to formal FDA entry procedures.
VII. Who Is Authorized to File Entry Type 11?
The most important part of the policy is that only U.S. Customs Brokers can file the entries of Entry Type 11, which contain products that are regulated by the FDA. Entry Type 11 is the entry type of the CBP specifically created to deal with low-value shipments up to a value of $2500. Since the de minimis exemption is no longer in use, a higher level of regulatory knowledge and documentation is needed in this type of entry.
Using the services of an experienced customs broker can ensure that the submissions are made accurately and on time, reducing the chances of penalties, cargo delays, or rejections due to non-compliance.
VIII. Why This Matters to Importers and Brokers
The removal of the FDA de minimis exemption for products is not a mere procedural change, as it changes the costs, paperwork, and timing of cross-border shipments. Companies that have been accustomed to using simplified clearance of consumer goods now have to submit to an increased level of compliance.
The direct effect on importers is that they will have to collect and report much more detailed information on each and every shipment, whether it is of low value or not. This could involve the reconfiguration of the supply chain systems, training of staff, and the introduction of new partnerships with customs brokers.
The change is a challenge and an opportunity for customs brokers. With increasing numbers of importers turning to professional help in filing, brokers can broaden their service offerings and become a major compliance partner in cross-border e-commerce activity.
Policy-wise, the initiative is a further manifestation of the FDA’s desire to uphold the well-being and safety of the populace. Using uniform scrutiny to all imports regulated by the FDA, the agency wants to reduce the importation of unsafe, counterfeit, or mislabeled products, no matter how small the shipment seems.
IX. Final Thoughts and Resources
Withdrawal of the de minimis exception on FDA-regulated products is a major change in trade compliance in the U.S. Since July 9, 2025, the simplified Section 321 route to import FDA-regulated products is no longer available to importers. There is a greater demand for full documentation and formal review, and this has given greater importance to proper classification, data transmission, and regulatory readiness.
To stay in compliance and not get hit with expensive delays, importers and brokers ought to:
- Check product portfolios of FDA-regulated products
- Make sure that precise data can be captured and submitted using ABI
- Entry Type 11 filings should be done in partnership with a licensed customs broker
- Make use of platforms such as CustomsCity to ensure compliant and efficient submissions
To learn more, the following sources should be consulted:
For direct inquiries, stakeholders may also contact the FDA at Imports@fda.hhs.gov
