Guam Series: FDA Presence and Impact in Pacific Islands, Pt. 5 of 5: Summarizing the agency’s current efforts and future initiatives

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Host John Zaccone: Welcome to a brand-new episode of On The Frontlines. I'm John Zaccone, your new host for this OII podcast, a forum where we share the experiences and viewpoints of FDA employees at all levels who work to protect your family's health. 

This episode is the last in our five-part series focusing on FDA's presence in the Pacific Islands. And my guest today to summarize the agency's efforts and offer a glimpse into what to expect in the future, is the Assistant Commissioner for the Office of Import Operations, Mr. Dan Solis. 

So, Dan, thank you for joining me today. How are you?

OIO Associate Commissioner Dan Solis: I'm doing great, and thanks for having me. It's a pleasure to be here.

Mr. Zaccone: Absolutely. So, let's dive right in. Please remind us of the Pacific Island territories project. For instance, if you could share the importance of our presence there and our relationships in Guam.

Mr. Solis: This is an important initiative, not only for the Office of Import Operations, but for FDA as well. And we're using a novel program and approach to address a significant gap in our regulatory oversight for imported products from that region. 

Guam and adjacent Pacific Islands are U.S. territories with American citizens living on them. It's estimated that 95% of FDA-regulated products in Guam are imported. This includes essential medical products and foods, cosmetics, dietary supplements, and tobacco products. It's our responsibility to protect the health of the U.S. citizens and military families who live on the island.

Mr. Zaccone: And that makes sense. FDA works to protect Americans all over the world. Why the focus, though, on Guam specifically? What is it about that island?

Mr. Solis: Guam has always been a long-standing strategic location for the United States in the Pacific Rim as a gateway for products coming from Asian countries to the U.S. and vice versa with significant historic product import knowledge combined with a time zone more aligned with FDA’s international offices in China and India. The U.S. Pacific territories are in strategic position to act as sentinels to gain intelligence of imported products for global product safety issues as they arise.

The government of Guam has requested FDA’s assistance to help stem the flow of adulterated and unapproved FDA-regulated products coming to the U.S. Pacific Island territories and transshipped to the U.S. mainland. Guam and neighboring Pacific Islands are all U.S. territories, but they don't have the same robust import screening procedures that we have at our own local ports of entry.

Mr. Zaccone: Now, you mentioned that the government of Guam has been asking for FDA support. So, how long have we been there?

Mr. Solis: Historically, the FDA has always provided assistance to Guam and the Pacific region. The local district office prior to the program alignment, provided assistance, but it was intermittent, as in food inspections or emergencies or outbreak situations. 

What's unique about our current approach since 2022, with the start of the Guam pilot, the FDA has maintained a physical, constant presence in Guam on a continual basis. That boots-on-the-ground approach has resulted in more efficient working relationships with our Guam strategic partners that include Guam Customs referred to as CQA, and the Federal Department of Environmental Health.

We have been able to share targeting techniques that aid the processing of imports, furthering the protection for U.S. citizens in Guam, while also developing valuable information about products that could potentially be transshipped through one of the U.S. territories. 

The partnership between FDA and the government of Guam was signed in October 2023, which allows FDA and our strategic partners in Guam to continue to target and block loopholes for violative products entering Guam and transshipment of those goods to the U.S. mainland. Enhancing our import-related engagement in this region will ensure that we continue to protect the public by keeping unsafe and unregulated products out of the supply chain before they enter any U.S. ports.

Mr. Zaccone: So, since the pilot started, have you noticed any reoccurring trends that surprised you?

Mr. Solis: Conducting collaborative joint operations with the Guam DEH and CQA have yielded meaningful and tangible results in safeguarding public health. We've been able to intercept fraudulent, misbranded, or adulterated drugs and medical products from entering Guam and U.S. commerce. DEH and CQA have acknowledged the heightened public health protection achieved through direct FDA participation in operations and training to the government of Guam. Those efforts have effectively prevented the release of similar shipments of violative products, such as tainted supplements. 

A big surprise to us when we first engaged was the use of a manual paper-based process to review import entries into Guam. This is significantly different than the electronic process and data collection system used by U.S. Customs and Border Protection through their automated commercial enterprise, also called “ACE.” The electronic process through ACE allows robust methods of reviewing, screening, and targeting products. That technology and system capability is not available in Guam, and the current Guam manual review process contain significant gaps where illicit products, such as unapproved and adulterated food and medical products, can be easily smuggled or transshipped in and through Guam.

Another surprise has been counterfeit and substandard medical products being sold on the island and being used to launch these counterfeit shipments from Guam into U.S. destinations, such as Hawaii and California. It's also well-documented that many mail parcels use the Guam to Hawaii or to California routes of entry into the U.S. to bypass import screening because they are misdeclared as products originating from Guam, rather than from foreign sources.

Mr. Zaccone: Now, with so much going on, can you expand on some of the major successes you've mentioned and also perhaps share more about these opportunities remaining?

Mr. Solis: We're really proud of what we accomplished, John, and definitely recognize that there are opportunities as well as challenges to face. The Guam Department of Environmental Health made available office space, including a wing in their building that includes a newly renovated lab screening station, enabling our investigators to establish a base of operations that they have not had previously. In utilizing this space, we were able to stand up FDA analytical satellite lab operations in Guam in quarter four of fiscal year 23. I know that you spoke with JaCinta Batson in our prior episode, and I'm sure she highlighted the great work accomplished with the satellite lab. 

Regular meetings with Guam Customs and the Department of Environmental Health to discuss procedures, regulations, limitations, and overall agency policy on an ongoing basis, has not only aided in capacity building and risk management, but also strategies to leverage each other’s strengths in keeping the public safe from adulterated goods. 

Working side-by-side with Guam Customs and the Department of Environmental Health has helped refine operational, investigational, and inspectional activities. Let me give you one example. FDA conducted over 240 joint import product examinations with DEH and CQA. As a result of FDA participation, CQA and DEH were able to address the following identified: violative drugs in devices that may pose a health risk to Guam and possibly the continental U.S.; unmanifested undeclared pharmaceuticals, including controlled drugs and opioids; dietary supplements with illegal health claims; dietary supplements containing undeclared active pharmaceutical ingredients; misbranded drugs bearing an FDA logo that provides the false appearance of FDA approval; and non-compliant food products with potential public health risk.

Mr. Zaccone: And what about challenges?

Mr. Solis: The government of Guam has recognized the importance of FDA’s assistance to stem the flow of transshipment points of adulterated and unapproved products. I know we have their support due to the governor of Guam signing of a partnership agreement with FDA in October of 2022. But with that, we recognize that the fact that Guam lies outside of the U.S. Customs territory and has no electronic import screening system like ACE, it provides a significant obstacle for our import operations to quickly screen and examine products entering the U.S. territory.

The lack of an electronic import database further hinders the ability to monitor vast numbers of shipments for trends or to incorporate the use of advanced artificial intelligence targeting techniques on supply chains. Without the ability to effectively use screening tools on all imports, FDA does not know the full extent and severity of fraudulent or unapproved products flowing through Guam. Through the Pacific Island program, we're helping to provide some visibility to this issue and efforts right now are being employed to develop an electronic database from the paper manifest, a first step towards incorporating electronic screening techniques that focus on identifying high-risk shipments. 

Another main challenge is working through the local government on both import and domestic enforcement issues. Usually, FDA would take the lead on import enforcement without having to engage local governments, such as when to sample, detentions, or refuse the entry. However, we have been able to pivot, share our expertise, and provide support to the local government on import shipments to further aid their decisions on whether to sample, detain, or refuse entries. Both DEH and CQA have felt this working relationship has been greatly successful. 

The challenge of not having a permanent staff in Guam and through the Pacific Islands has slowed our progress to thoroughly investigate the supply chain and transshipment issues and help interdict and stem violative and adulterated products from entering the U.S. and other U.S. territories.

Mr. Zaccone: Now as the project moves forward, what can we expect in the future in the Pacific Islands?

Mr. Solis: FDA’s Import Program, in conjunction with other FDA offices, designed the Guam pilot to be executed in different phases as part of a greater Pacific Island project that also includes American Samoa, the Commonwealth of Northern Mariana Islands, and other Pacific islands. The lessons learned from piloting operations in Guam will be the foundation for expanding operations to the other Pacific Island territories as time and resources allow. 

For fiscal year 2025, FDA’s Pacific Island program will continue to adapt operations as necessary, based on our evaluation of our strategic planning and return on investment. Fiscal year 25 will implement key performance indicators and objectives for inspection, capacity building, collaboration, digital transformation, and community engagement. These will be used for monitoring, assessment, and evaluation to make sure we're having an impact towards protecting this unrepresented population. This effort is intended to ensure product safety and supply chain security related to the importation of fraudulent, misbranded, or adulterated FDA-regulated products through the Pacific Islands.

The impact of FDA’s presence in Guam has provided valuable intelligence on supply chain security within the Pacific region and prevented harmful products from entering commerce within the United States.

Mr. Zaccone: Well, with that, Dan, we're coming to a close on this episode, and I want to thank you for the extraordinary work being done by FDA personnel, as well as our partners in the Pacific Islands. I also want to take a moment to thank all our guests throughout this series for talking with us about the agency’s on-the-ground initiatives in that region.

In this final episode, we wanted to highlight the agency's efforts and provide a sneak peek at what's to come from FDA's partnership with the government in Guam. Also, to reinforce the importance of relationships with our partner government agencies there. 

And if you'd like to hear more about FDA's impact on the Pacific Islands, you can visit our website at www.FDA.gov to access all five episodes in this series. Once there, you can also learn more about this podcast, you can access our featured profiles, and subscribe to OII News and Stories. 

Once again, I'm John Zaccone, your new host of On The Frontlines, An OII Podcast. 

Until next time, be well.