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  1. Regulatory News, Stories, and Features

Partnership in Action: Creating Safeguards for Imported Products Entering the United States in the Pacific Islands

By Dan Solis, Assistant Commissioner for Import Operations

You may not realize it, but the Pacific Rim is a strategically significant location when it comes to ensuring the safety of products bound for consumers in the United States. A little more than a third of global products coming into our country originate in the Asia-Pacific Region, making it an ideal location for us to act as sentinels and gather intelligence regarding imported products, ensuring they will be safe for American consumers.

Dan Solis Thumbnail Image (141 x 211 px)

The U.S. Food and Drug Administration’s (FDA’s) Pacific Island Program, initiated in April 2022 on the U.S. Island territory of Guam, focuses on ensuring the safety and security of the supply chain for FDA-regulated products entering the Pacific Islands. The Guam government asked for the FDA’s assistance, given our regulatory expertise, and the agency enthusiastically agreed. We are eager to pursue any strategy that will help stem the flow of transshipment points of adulterated and unapproved products coming on and off the island.

A pilot program in 2022 helped us evaluate the impact of the FDA’s presence in Guam to gain understanding of regulatory, laboratory, and criminal investigations capability and evaluate the current systems. We were also able to determine the design, feasibility, and organization of a long-term FDA presence in Guam and, more broadly, the Pacific Islands to include other U.S. territories, such as the Northern Mariana Islands.

These reconnaissance efforts led to the October 2023 signing of a Partnership Agreement with the Guam Department of Public Health and Social Services and the Guam Customs and Quarantine Agency to protect U.S. residents from foodborne illnesses and misbranded, adulterated, and fraudulent consumer commodities, including drugs and medical products, and to target and close loopholes for violative FDA products entering the U.S. mainland and elsewhere.

Over the past six months, our OII On the Frontlines Podcast has highlighted several of these accomplishments and provided a first-hand account of the impact of this partnership. The five-part series provides a range of perspectives as told directly by leadership and frontline specialists working in imports, criminal investigations, scientific analysis, and other areas under the regulatory oversight and enforcement in OII.

The FDA’s OII sustained presence in Guam, supported by HHS healthcare fraud prevention funding, has created opportunities to strengthen surveillance, compliance, and enforcement, resulting in tangible public health benefits. The program also emphasizes enhanced inspection and enforcement, capacity building, digital transformation, and community engagement.

Significant accomplishments and impact include the following:  

  1. Regulatory Oversight and Enforcement:
  • Operation Mombo Combo led to over 466 inspections across maritime, air passenger, and air cargo import channels, resulting in the seizure of counterfeit drugs, unapproved medical devices, and products on import alerts.
  • FDA and Guam authorities increased their capacity to identify non-compliant products, initiating over 240 joint import examinations and 186 collaborative operations targeting illegal imports.
  1. Training and Capacity Building:
  • The FDA provided extensive training for over 74 stakeholders on regulatory frameworks, import review processes, drug compliance, recalls, and public health risk management.
  • FDA-supported training in utilizing screening tools, such as the portable x-ray machine and Progeny device, enhanced Guam authorities' ability to intercept fraudulent and harmful goods.
  1. Community Engagement:
  • FDA engaged local communities through outreach programs and joint operations to raise awareness of public health risks, regulations, and enforcement actions. This included direct engagement with regulated industries and local public health task forces.
  • FDA co-hosted Guam Food Safety Week in September 2024, conducting training sessions for stakeholders on FDA regulations, safety standards, and consumer protection measures.
  1. Digital Transformation:
  • The collaboration identified gaps in Guam’s paper-based import review system. The FDA worked with partners to modernize data management and streamline communication channels, improving the effectiveness of inspections and risk assessment capabilities.
  1. Lab Operations and Surveillance:
  • The FDA established an analytical satellite lab in Guam in June 2023, allowing real-time testing and analysis of high-risk products. Out of 136 samples analyzed at the satellite lab, 97 were identified as containing illicit or misbranded substances, leading to swift regulatory actions.
  • FDA’s market surveillance efforts resulted in 187 product samples being collected, with 120 identified as violative per the Food Drug and Cosmetic Act.
  1. Joint Operations and Strategic Partnerships:
  • Collaboration with U.S. Customs and Border Protection (CBP) and with the Guam government led to the development of valuable intelligence on fraudulent supply chains originating from Asia. This intelligence was used to interdict counterfeit products and issue public warnings.
  • A historic partnership arrangement with the Pacific Island Health Officers’ Association (PIHOA) is nearing completion to enhance communication and shared responsibilities in the region.

Pacific Islands in the Future

As the FDA’s Office of Import Operations moves into 2025, the Agency plans to expand and refine its Pacific Island Program through:

  1. Enhancing Inspection and Enforcement with key performance indicators to increase the frequency and effectiveness of inspections.
  2. Strengthening Capacity Building and Training through proposed courses on regulatory processes, compliance, and health fraud prevention.
  3. Continuing Collaboration with Local Authorities to foster information-sharing and harmonized regulatory frameworks.
  4. Embracing Digital Transformation to modernize regulatory processes and streamline risk-based targeting efforts.
  5. Engaging the Community by developing outreach programs to educate and collaborate with stakeholders.

The FDA’s Pacific Island Program demonstrates a commitment to establishing a robust regulatory presence in Guam and safeguarding U.S. public health across the Pacific Rim and beyond. Through collaboration, enhanced surveillance, and capacity building, the FDA has fortified the safety and integrity of imported goods, creating a model for regulatory oversight in other remote U.S. territories. 
 

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