compliance Archives | Customs & International Trade Law Blog

CBP eRecordation Program Update: What Rights Holders and Importers Should Watch After CBP’s August 2026 Briefing

CBP’s Intellectual Property Enforcement Branch briefed eRecordation holders on August 27, 2026 on changes to the recordation application, future expanded pre-seizure disclosure authority, pending legislation, and an enforcement posture that has to consequence delivery, especially collecting penalties for IP violations. This article updates our earlier overview of CBP’s recordation program and identifies the items that should prompt rights holders to revisit existing recordations and importers to tighten sourcing controls. If your recordation was filed more than a year ago, several of these changes affect you directly.

KEY TAKEAWAYS

CBP’s FY 2025 IPR seizures reached roughly 78 million items with an MSRP near $7.4 billion, up sharply from the FY 2024 figures.
The e-Recordation portal now validates against USPTO data. Supplemental Register marks, dead registrations, and classes not on the principal registration are rejected.
Renewals are $80 per class and ownership changes are $80. Up to three contact emails are now accepted; one should be a monitored general inbox.
CBP is piloting a Master Price List collection (national MSRP for every covered product), which will be an upload option on new applications and renewals.
The Counterfeit Notification Act, which would let CBP share shipping labels, invoices, and e-commerce platform information with rights holders and their representatives , has passed both the House and Senate but must still clear final congressional action before being […]

By Jennifer Diaz|2026-08-31T09:45:38-04:00August 31, 2026|Enforcement, International Law, International Trade|Comments Off

FTC Cracks Down on False “Made in the USA” Claims

The Federal Trade Commission (FTC) recently announced law enforcement actions involving three companies that falsely claimed that their products were made in the United States.

Made in the USA

The “Made in the USA” labeling rules were enacted to prevent deceptive advertising and ensure customers can make informed purchasing choices. The concept of labeling products with the correct country of origin dates all the way back to the McKinley Tariff Act in 1890, and Congress and federal agencies have updated “Made in the USA” rules over the years.

FTC Jurisdiction

The FTC is charged with preventing deception and unfairness in the marketplace. Under the FTC Act, the Commission may bring legal action against “false or misleading claims that a product is of U.S. origin”. The agency is authorized to issue a civil penalty of up to $40,654 per violation.

The FTC has issued guidance on complying with the “Made in the USA” standard, most recently in 2021. View the latest guidance here.

When Can I Say Made in the USA?

For a product to be considered as “Made in the USA” without qualification, that product must be “all or virtually all” made in the U.S. How the Commission determines whether a product is “all or virtually all” made in the U.S. is by looking at whether there was “a ‘reasonable basis’ to support the claim at the time it is made”. To prove […]

By Jennifer Diaz|2026-06-05T11:20:06-04:00June 5, 2026|Best Practices, Enforcement, Import, International Trade, Labeling, U.S. Federal Trade Commission (FTC)|Comments Off

FDA Finalizes New National Drug Code Format

On March 5, 2026, the Food and Drug Administration (FDA) published a Final Rule adopting a new format for the National Drug Code (NDC). The rule takes effect on March 7, 2033. On the effective date, the FDA will assign new 12-digit NDCs and convert all previously assigned 10-digit NDCs to the uniform 12-digit NDC format.

What is the NDC?

The NDC is an FDA standard for uniquely identifying drugs marketed in the U.S. Currently, the NDC assigned by the FDA for each listed drug marketed in the U.S. is a unique 10-digit number and can be in several different formats.

Current formats:

10-digit identifier

The FDA’s standard NDC is a 10-digit numerical identifier that includes a labeler code, product code, and package code.

There are 3 FDA-assigned formats for the standard NDC:

4-4-2
5-3-2
5-4-1

HIPAA Format

The Health Insurance Portability and Accountability Act (HIPAA) adopted a uniform 11-digit NDC format that must be used when a HIPAA-covered transaction includes an NDC. This 11-digit format is standardized into a 5-4-2 format and created by adding a leading zero to either the labeler, product, or package code.

Upcoming 6-Digit Format

The FDA will run out of 5-digit labeler codes in 10-15 years. Per FDA regulations (21 CFR 207.33), once the FDA runs out of 5-digit labeler codes, it will start assigning 6-digit labeler codes. Without this proposed change, there would be five NDC formats, 3 in 10- […]

By Jennifer Diaz|2026-03-05T10:07:19-05:00March 5, 2026|Enforcement, Food, Import, Medical Devices, U.S. Customs and Border Protection (CBP), U.S. Food and Drug Administration (FDA)|Comments Off

IEEPA May Be on the Chopping Block, But Your Duty Exposure Isn’t

On November 5, 2025, the Supreme Court of the United States (SCOTUS) held oral arguments for Trump v. V.O.S. Selections, Inc., regarding the legality of the International Emergency Economic Powers Act (IEEPA). The case will ultimately decide whether the Trump Administration has the authority to impose tariffs under IEEPA. Importers and trade professionals are watching the case closely, but even if the IEEPA tariffs are thrown out, the new administration has made clear that it will pivot and use other legal avenues to impose tariffs. Since oral argument, multiple discussions have been held with the Department of Justice and the plaintiffs regarding any refund possibilities. Based on these discussions, it appears that the United States is anticipating losing this matter at the Supreme Court but wants to put barriers to recovery. The United States has also clearly stated that they intend to find other ways to impose similar duties.

The message is clear: even if the Supreme Court strikes down IEEPA tariffs, tariff exposure is here to stay. NOW is the time for importers to revisit their valuation practices, explore duty minimization strategies, and ensure they are taking every lawful step to minimize duty impact going forward.

Why Tariffs Will Stay Even if IEEPA Dies

Since the earliest days of the Trump Administration, the White House has made tariffs a cornerstone of their trade and “America First” policy. The President and Administration officials have repeatedly touted tariffs as one of the best tools available to level the international trade playing field, […]

By Jennifer Diaz|2026-01-09T17:05:29-05:00January 9, 2026|Import, Tariffs|Comments Off

Five Tips for SMEs Looking to Scale Wellness Brands in the US

DTL President Jennifer Diaz was featured in Santander Navigator! Read below or on Santander here.

Pre-planning and investing in regulatory compliance measures are key to success

The US is the most lucrative wellness market in the world – and for some small and medium-sized enterprises (SMEs) that produce supplements, the potential for growth and a bigger bottom line is difficult to ignore.

And who would blame them? The US wellness sector is valued at US$2tn and is poised to continue growing, recording an average annual growth rate of 8.3% between 2019 and 2023, according to research by the Global Wellness Institute.

In contrast, China’s market, ranked the second-largest in the world, trails at a more modest US$870bn, followed by Germany at $310bn.

However, rushing in without being fully compliant could result in products being blacklisted or seized at the border, says Jennifer Diaz, an attorney and founding partner at Miami-based Diaz Trade Law, which specializes in customs and US Food and Drug Administration (FDA) laws and compliance.

Here, Diaz offers her top five tips for new brands to stay compliant and off the FDA’s blacklist.

1. Know the regulators

One of the first steps for SMEs planning to import supplements into the US is to register with the FDA, as they are considered a food product, Diaz says.

Companies also need to designate […]

By Jennifer Diaz|2025-06-17T08:40:04-04:00June 17, 2025|Best Practices, Import, Import Alert, International Business, International Trade, Labeling, Pre-compliance|Comments Off

The False Claims Act: Get Paid to Expose Fraud & Unfair Competition, Protect Yourself from an Investigation

____________________________________________________________________

!! UPCOMING False Claims Act Webinar !!

Learn how to expose fraud, blow the whistle on unfair competition, and avoid being the target of an FCA investigation

May 9, 2024 | 12:00 PM ET

Speakers: Jennifer Diaz, President &Dana Watts, Of Counsel, Diaz Trade Law and Jonathan Tycko, Partner, Tycko & Zavareei LLP

Register HERE.

____________________________________________________________________

The False Claims Act (FCA) is a powerful federal anti-fraud law that incentivizes average people to expose fraud. The law attempts to reward whistleblowers and disincentivize committing fraud and can be used to expose customs fraud.

What is the False Claims Act?

The FCA, 31 U.S.C. §§ 3729 – 3733, is a federal statute enacted in 1863 in response to defense contractor fraud during the Civil War.

The FCA provides that any person who knowingly submits, or causes to submit, false claims to the government is liable for three times the government’s damages plus a penalty. Conspiring to commit these acts also is a violation of the FCA.

The FCA allows the U.S. government to investigate perpetrators of fraud directly, but it also provides an avenue for private citizens to become whistleblowers and expose fraud.

The Department of Justice (DOJ) obtained more than $2.68 billion in settlements and judgments involving fraud and false claims in the fiscal year ending Sept. 30, 2023.

The FCA and International Trade

The FCA is commonly used to prosecute financial crime such as misuse of federal grants and healthcare related claims. However, in recent years the FCA has been increasingly used to allege customs duty […]

By Jennifer Diaz|2024-04-18T17:01:11-04:00April 18, 2024|Enforcement, U.S. Customs and Border Protection (CBP)|Comments Off

Building & Maintaining an Export Compliance Plan

Diaz Trade Law’s President, Jennifer Diaz, Associate Attorney Sharath Patil, are enthusiastic to announce Bloomberg Law published another one of our articles, “Building & Maintaining an Export Compliance Plan”! We also thank our law clerk, Gabi Perez, for her support with research for this article. Below is the article reproduced with permission for your reading pleasure. You can read the article here (where you’ll have the ability to access all of the great hyperlinks). Please note you cannot click on the hyperlinks below.

We’d love to hear your feedback!

[…]

By Jennifer Diaz|2022-11-10T15:44:12-05:00October 18, 2022|Bloomberg, Bloomberg Export, International Law, U.S. Bureau of Industry and Security (BIS), Uncategorized|Comments Off

Customs Undervaluation – It’s a Crime

Customs Valuation is a procedure to determine the customs value of imported goods. The customs value is essential to calculate the total duty to be paid on an imported good. As part of its agreement with the World Trade Organization (“WTO”), the U.S. is part of an internationally standardized system of valuing imports. This standardized system allows for CBP to protect revenue, ensure reasonable care from importers, and accurately calculate Census trade statistics. Accordingly, it is critical to declare the value of importations accurately and compliantly.

The U.S. Customs and Border Protection (CBP) valuation methodology (as well as a summary of relevant Customs rulings) are described in detail in the Valuation Encyclopedia (i.e., the best resource on valuation inquiries). CBP permits merchandise to be valued according to one of the six valuation methods listed below. The methods are applied sequentially from first to last until an applicable value is determined. If the first method does not apply, the importer must then evaluate the second, and so on, until an appropriate method applies. The only exception to this sequential evaluation requirement is when evaluating between deductive value and computed value – an importer may choose to use the computed value before the deductive value.

Methods of Valuation:

The transaction value of imported merchandise (the majority of imports use transaction value – i.e., the price paid or payable plus assists (see below))
The transaction value of identical merchandise
The transaction value of similar merchandise
Deductive value
Computed […]

By Jennifer Diaz|2022-09-29T11:30:35-04:00October 4, 2022|Best Practices, International Trade, Seizures, U.S. Census Bureau, U.S. Customs and Border Protection (CBP), U.S. Department of Homeland Security (DHS), U.S. Department of Justice (DOJ)|Comments Off

Customs and Trade Weekly Snapshot

Here is a recap of the latest customs and international trade law news:

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Uyghur Forced Labor Prevention Act (UFLPA): What You Need to Know

Uyghur Forced Labor Prevention Act (UFLPA) and What You Need to Know?

On June 16, 2022, CBP held a webinar on the Uyghur Forced Labor Prevention Act (UFLPA). The UFLPA goes into effect June 21, 2022 so it is critical that importers are proactive about forced labor compliance in preparation for this implementation. During the webinar CBP discussed their recently published operational guidance for importers. This blog article provides an overview of CBP’s current enforcement environment and how UFLPA will change CBP’s enforcement procedures for imports generally, and specifically from the Xinjiang region. For general guidance on preventing the importation of goods produced with forced labor and how importers should audit their supply chain to ensure non-use of forced labor, please refer to our Bloomberg Law article, “U.S. Customs Targets Use of Forced Labor”.

Background

Under Section 307 of the Tariff Act of 1930 (19 U.S.C. 1307), CBP derives the authority for preventing the entry into the U.S. market of products made with forced labor by investigating and acting upon allegations of forced labor in supply chains. CBP issues Withhold Release Orders (WROs) and findings to prevent merchandise produced in whole or in part in a foreign country using forced labor from being imported into the United States. CBP defines Forced labor as all work or service which is extracted from any person under the menace of any penalty for its nonperformance and for which the worker does not […]

By Jennifer Diaz|2022-06-17T18:05:17-04:00June 16, 2022|301 INVESTIGATIONS, Enforcement, Forced Labor, Import, International Trade, Pre-compliance, Reasonable Care, U.S. Customs and Border Protection (CBP), U.S. Trade Representative (USTR)|3 Comments