Pre-compliance

Act NOW to Preserve Potential Tariff Refunds

Tariff policy is changing overnight, and all indicators signal that the Trump Administration will continue to impose tariffs to achieve its trade agenda. There are several lawsuits pending that may eventually invalidate some of the Administration’s tariffs. However, importers should not sit around and wait for the dust to settle. Importers must act NOW and take proactive measures to protect their ability to seek refunds if tariffs are ultimately found to be unlawful. 

IEEPA Tariffs at the Supreme Court

The Supreme Court (SCOTUS) heard oral arguments in Learning Resources, Inc. v. Trump on November 5, 2025. The case challenges whether the President has the authority to impose tariffs under the International Emergency Economic Powers Act (IEEPA). The Administration relied heavily on IEEPA to impose new tariffs – including fentanyl tariffs on China, Canada, and Mexico, and global reciprocal tariffs. Many trade lawyers are predicting that the Court will rule in favor of importers and find that IEEPA does not grant the President the authority to impose sweeping tariffs. 

Potential Refunds & What Importers Should Do

Although it remains unclear how CBP will handle refunds (should SCOTUS agree with the lower courts), it is likely that once an entry is liquidated and the liquidation becomes final, CBP may not grant a refund of duties paid, regardless of SCOTUS’s outcome. It will likely be the position that CBP only has to grant refunds to those parties that have a Court […]

By |2025-11-17T09:01:16-05:00November 17, 2025|International Trade, Pre-compliance, tariffs|0 Comments

FDA Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic Products

On September 12, 2025, the U.S. Food and Drug Administration (FDA) announced the launch of the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products. The system is an interactive tool designed to facilitate the public’s ability to search and find real-time adverse event data on cosmetic products. Through the tool, users can search and view reports using search terms, including the product name. Users can also download data sets and report listings. The FDA will update the tool daily to ensure it includes the most recent submissions.

The dashboard includes serious adverse event reports submitted by responsible persons for cosmetic products under requirements established by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), as well as voluntary adverse event reports submitted to the FDA by healthcare professionals, consumers, salon professionals, cosmetologists, and others. 

This announcement follows a recent launch of real-time reporting of adverse event and medication errors data for drugs and therapeutic biologics. 

In the announcement, the FDA stated these real-time reporting tools are part of the agency’s commitment to transparency and providing greater insight into the safety and regulation of the products consumers use every day.

Note: Reports in this dashboard have not been verified by the FDA, and their publication does not indicate that the FDA has concluded the product caused the adverse event. 

ICYMI: FDA Launches Nationalized Entry Review Program (NER)

FDA recently implemented the Nationalized Entry Review Program (NER), which centralizes how the agency reviews imports nationwide. The program is effective as of August 4, 2025. Key changes include: 

  • Coordinated National Response: Rather than each port conducting manual reviews of certain entries on its own, specialized teams now coordinate their efforts across the country to more quickly identify and stop dangerous products.

  • Harmonized Real-Time Alert System: If the FDA detects a high-risk product at one port, such as contaminated infant formula or counterfeit drugs, alerts are immediately shared across all ports so they can watch for the same threats.

  • Improved Efficiency: Built on a successful 2022 pilot, the NER program has sped up processing by 70% and increased detection of high-risk products by 36%.

  • Expanded Reviewer Capacity: The program allows for more FDA reviewer availability and collaboration across the national network. 

The FDA’s current evaluative standards, regulatory requirements, and admissibility thresholds remain the same. 

The FDA has also published a communications guide that includes general contact protocols, hot shipments handling, email formatting requirements, and FAQs.

Diaz Trade Law provides assistance with FDA pre-compliance as well as assistance in successfully navigating FDA enforcement actions. For assistance with NER requirements or other FDA matters, contact us […]

Census Bureau Releases Final Rule Clarifying Filing Requirements for In-Transit Shipments 

On August 14, 2025, The Census Bureau issued a final rule to clarify its regulations governing in-transit shipments from foreign countries through the United States that are subsequently exported to a foreign destination. The rule takes effect September 15, 2025. 

Background

The Census Bureau is responsible for collecting, compiling, and publishing import and export trade statistics for the United States. As part of this responsibility, the Census collects Electronic Export Information (EEI) in concert with the export control and enforcement functions of U.S. Customs and Border Protection (CBP) of the Department of Homeland Security (DHS), the Bureau of Industry and Security (BIS), and the Directorate of Defense Trade Controls (DDTC).

Public Law 107-228 directed the Census to publish regulations requiring exporters to file Shippers’ Export Declarations. As a result, the bureau experienced an increase in the number of inquiries regarding in-transit movements. Accordingly, in October of 2024 the Census solicited comments on a proposed rule to clarify its regulations governing in-transit shipments. The bureau received 11 letters and emails commenting on the proposed rule.

Key Changes

In addition to making definitional, grammatical and style changes, the rule: (i) clarifies who is the USPPI; (ii) makes changes to mandatory filing requirements; (iii) makes changes to voluntary self-disclosures.  

Who is the USPPI

The U.S. Principal Party in Interest (USPPI) is the person or legal entity in the United States that receives the primary benefit, […]

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 […]

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