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Best Practices

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BIS FY2025 Annual Report Signals Major Increase in Export Enforcement 

The U.S. Department of Commerce’s Bureau of Industry and Security (BIS) released its Fiscal Year 2025 Annual Report to Congress, providing a detailed look at the agency’s export control, licensing, and enforcement activity.  

Key Takeaways 

  • BIS reports an 18-fold increase in penalties, from approximately $16 million in calendar year 2024 to approximately $324 million in 2025. 
  • BIS completed 53 administrative enforcement actions, resulting in more than $108 million in civil penalties during FY2025. 
  • BIS enforcement activity included 455 warning letters, 705 detentions, 232 seizures, and 29 denial orders. 
  • BIS investigations resulted in 65 criminal convictions of individuals and companies during FY2025. 
  • BIS completed 1,840 end-use checks across 73 countries, demonstrating the agency’s ability to scrutinize transactions even after goods leave the United States. 
  • BIS added 142 entities to the Entity List, including parties associated with advanced computing, quantum technology, hypersonic weapons programs, and Iranian drone procurement. 
  • Licensing for Entity List parties has become significantly more restrictive: BIS reports granting only 16 new licenses to Entity List companies during Q2–Q4 2025. 
  • Exporters should reassess restricted-party screening, end-user and end-use diligence, product classification, licensing procedures, recordkeeping, and escalation protocols in light of […]
By |2026-09-11T14:55:52-04:00September 11, 2026|Best Practices, EAR, Export, U.S. Bureau of Industry and Security (BIS)|0 Comments
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BIS End-Use Checks: What Happens When an Export Control Officer Calls Your Customer 

BIS has published a plain-language FAQ on its End-Use Check program, the on-site visits its Export Control Officers conduct at foreign consignees and end users of U.S.-origin items. This article explains what those visits are, what your foreign customer will be asked to produce, the statutory and regulatory authority behind the request, and the consequences when a check cannot be completed. It matters because the penalty for a failed check falls on the exporter’s ability to ship, not only on the foreign party being visited. 

Key Takeaways 

  • An End-Use Check (EUC) is BIS verifying, on site and overseas, that your foreign customer is who it says it is and used your items the way the license or the EAR required. 
  • A failed or incomplete check does not need a finding of wrongdoing to hurt you. The customer can land on the Unverified List, license exceptions disappear, and every shipment then requires a UVL statement. 
  • Since October 2022, a check that stays incomplete for 60 days after Unverified List placement, because a host government blocks it, triggers Entity List proceedings. 
  • The exporter’s exposure is set before the visit ever happens: by the accuracy of the license application, the quality of the paper trail, and whether the foreign party was told what to expect. 
  • Diaz Trade Law prepares exporters […]
By |2026-09-03T12:02:14-04:00September 3, 2026|Best Practices, EAR, Enforcement, Export, U.S. Bureau of Industry and Security (BIS), Uncategorized|0 Comments
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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 |2026-06-05T11:20:09-04:00June 5, 2026|Best Practices, Enforcement, Import, International Trade, Labeling, U.S. Federal Trade Commission (FTC)|0 Comments
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FDA Announces One-Day Inspection Pilot

The U.S. Food and Drug Administration (FDA) announced that it is piloting one-day inspectional assessments. These assessments will be shorter, more focused, and will complement existing standard FDA inspections.  

Shorter Inspections, More Coverage 

Launched in April 2026, the pilot is part of a broader initiative to make the agency’s inspectional resources more targeted and efficient. The new assessments will allow for broader coverage, enabling the agency to assess more facilities without compromising regulatory rigor. 

The pilot is being conducted across multiple FDA inspectorates, including human and animal foods, biologics, medical products, and clinical research programs. Facilities are selected using risk-based criteria such as:  

  • Product type 
  • Prior inspection outcomes 
  • Operational characteristics  

As of late April 2026, the FDA has completed approximately 46 one-day assessments.  

The agency made clear that one-day inspectional assessments are not intended to replace standard FDA inspections. Instead, they are meant to provide an additional tool to the agency’s enforcement approach. The ‘one-day’ framework is also flexible – investigators retain authority to expand the scope or duration of an assessment if warranted.  

The pilot will continue through fiscal year 2026. The FDA is currently developing evaluation metrics to assess effectiveness, including inspection duration, escalation rates, and the utility of findings in informing risk-based decision-making. 

What Facility Owners and Operators Should Do 

Facility owners and operators should remain ready […]

By |2026-05-26T12:37:26-04:00May 26, 2026|Best Practices, Cosmetics, Enforcement, Food, Import, Medical Devices, U.S. Food and Drug Administration (FDA)|0 Comments
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Importer End-of-Year Checklist: How to Strengthen Compliance and Prepare for the Year Ahead

For U.S. importers, the end of the year is a critical moment to evaluate compliance, correct issues, and prepare for the year ahead. With tariff changes, supply chain uncertainty, and an increased focus on enforcement, importers who take a proactive approach now will start the new year strong. Here’s a practical checklist for your year-end review.

1. Review Import Data for Accuracy

Begin with a thorough audit of your import data. Confirm that HTS classifications are correct and current, declared values accurately reflect your transactions, and country-of-origin determinations are well documented. Small mistakes can lead to large penalties.

2. Reassess Tariffs and Duty Exposure

Year-end is the ideal time to evaluate whether you are paying unnecessary duties and explore your options for tariff mitigation strategies. Consider what exclusions have changed, whether tariff engineering may reduce costs, or whether sourcing strategies should be updated. Many importers discover duty-saving opportunities simply by reassessing their tariff positions annually.

3. Strengthen Forced Labor Compliance

With UFLPA enforcement intensifying, importers must confirm that supplier information, ownership structures, and supply chain documentation are up to date. Now is the time to verify traceability records, refresh internal training, and assess whether high-risk suppliers require additional review.

4. Update Written Compliance Procedures

If your compliance manual or SOPs haven’t been updated this year, they’re likely outdated. Written processes should reflect current regulations, product updates, tariff changes, and internal workflow adjustments. CBP expects importers to document their […]

By |2025-12-22T09:00:19-05:00December 22, 2025|Best Practices, Import, International Trade, Pre-compliance, U.S. Customs and Border Protection (CBP)|0 Comments
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