FDA Legal, Regulatory & Compliance Issues, Part 2: Customs Regulation & International Trade

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In this second part of our series in collaboration with Arnall Golden Gregory LLP, Wayne chats with Luis Arandia Jr., Partner and Co-chair of International Trade at AGG, and Allison Raley, Partner in AGG’s Corporate & Finance practice and Chair of the firm’s International Compliance & Risk team. Together, they discuss how pharmaceutical and biologics companies should rethink global supply chains in light of the Section 232 tariffs affecting patented pharmaceutical products; common customs and trade compliance issues with imported FDA-regulated goods; legal risk-mapping to avoid detentions, refusals, and unexpected duty exposure; potential tariff actions impacting medical devices; how shifting U.S. trade policies are changing global supply chains for pharmaceuticals, biologics, and medical devices; the impact of heightened enforcement on forced labor in global supply chains; how industry should manage sanctions and export control exposure; and much more.

This episode and the rest of our series do not include the usual Headlines and Resources Links segments.

About Our Guests

Luis Arandia Jr.

Luis Arandia Jr. is a partner and co-chair of the International Trade team and a member of the Corporate & Finance practice, where he focuses on international trade law, including customs and import laws, trade remedy and policy, export controls and economic sanctions, and enforcement matters tied to the movement of goods and global supply chains.

Companies turn to Luis for guidance on complex regulatory requirements that affect cross-border operations, specifically as U.S. tariff regimes, export controls, and national security restrictions continue to expand. He works with U.S. and multinational clients in many industries, including manufacturers, consumer products, advanced technology companies, logistics providers, and aerospace and defense firms. His work spans the U.S. and international markets, including the Americas, Europe, and Asia, where he supports clients in addressing trade controls that impact sourcing, logistics, and market access.

Luis is actively advising importers on potential refund opportunities arising from International Emergency Economic Powers Act tariff actions, including eligibility assessments and recovery strategies. He has deep experience in a wide range of substantive customs and tariff issues, including tariff classification, country of origin, valuation, free trade agreements, and duty preference programs. He regularly advises on the evolving trade remedy landscape, including Section 301, Section 232, Section 122, the Uyghur Forced Labor Prevention Act, and antidumping and countervailing duties. His experience also includes representing clients before the U.S. Trade Representative and U.S. International Trade Commission. This work often involves assessing duty exposure, structuring import strategies, and responding to government scrutiny before issues escalate.

Luis is frequently called upon when companies face enforcement actions, audits, or trade disputes. He represents clients in proceedings before U.S. Customs and Border Protection and handles matters before the U.S. Court of International Trade and the U.S. Court of Appeals for the Federal Circuit. He guides companies through investigations, penalty actions, and disputes with regulators, helping resolve issues and protect ongoing operations. He also assists clients in developing and implementing effective compliance programs to help ensure that reasonable care is exercised over import matters.

Luis also advises on export controls and sanctions under the Export Administration Regulations, International Traffic in Arms Regulations, and regulations administered by the Office of Foreign Assets Control. In this context, he conducts internal investigations, prepares voluntary disclosures, obtains required government authorizations, and proactively implements compliance procedures to mitigate the risk of enforcement and penalties.

He has experience advising in large-scale, government-supervised compliance matters, providing insight into how regulators evaluate risk, oversee remediation, and enforce trade and export control laws in practice. He works closely with C-suite executives, compliance teams, and supply chain leaders to address enterprise-wide risk, particularly where trade controls affect operations, hiring, and technology access. His industry experience includes aerospace, electronics, oil and gas, and medical devices.

Clients value Luis’ ability to translate complex trade requirements into clear strategies that mitigate risk, withstand regulatory scrutiny, and keep business moving forward. He is known for helping companies resolve high-stakes customs and export control issues under government scrutiny while maintaining business continuity.

A recognized thought leader, he is frequently quoted in Bloomberg Law, Law360, Texas Bar Journal, CBS News, and regularly publishes on tariffs, trade policy, and export controls.

Allison Raley

Allison Raley is a partner in the Corporate & Finance practice, chair of International Compliance & Risk, and a member of the firm’s International practice. A former global general counsel and chief compliance officer for a financial services company, she brings a rare combination of executive judgment, regulatory sophistication, and commercial acuity to complex domestic and international matters.

Allison advises financial institutions, multinational businesses, emerging technology companies, and sovereign entities on high-stakes regulatory, investigative, and strategic risk matters spanning the United States and key global markets. Her practice focuses on financial services regulation, global trade, sanctions, payments, emerging technologies, and enterprise risk, with significant experience across the United States, Europe, South America, and Southern Africa. Clients turn to her for counsel on market entry, licensing, enforcement exposure, operational risk, and the legal and regulatory demands of doing business in complex jurisdictions.

Her work includes advising international sovereign nations and globally active enterprises on regulatory architecture, financial integrity, market access, and jurisdiction-spanning compliance strategy. She has also led and advised on sensitive international investigations and high-consequence internal matters requiring rigorous fact development, discretion, and careful coordination across legal, compliance, audit, cybersecurity, and executive leadership functions.

Allison has a sophisticated command of the regulatory frameworks governing financial flows, product movement, sanctions risk, and enterprise compliance. Her practice encompasses matters involving CBP, OFAC, AML and BSA obligations, anti-corruption controls, sanctions regimes, import and export regulation, and related U.S. and international enforcement authorities. She counsels clients on navigating the movement of funds, goods, services, and technology through complex and highly scrutinized regulatory environments, with particular experience in compliance architecture, investigations, licensing, enforcement defense, and strategic risk mitigation. She is especially valued in matters where trade, payments, sanctions, and financial crime risk converge.

Drawing on both in-house and private practice experience, Allison helps clients build, strengthen, and remediate legal, compliance, risk, audit, cybersecurity, and governance functions in a manner that supports growth while reducing regulatory and enterprise exposure. She also brings substantial experience in commercial disputes and enforcement defense, representing clients ranging from Fortune 5 companies to rapidly scaling and emerging businesses.

Additionally, Allison co-chairs the firm’s Emerging Technologies industry team and Women in Tech Law initiative. She holds multiple industry credentials, including Certified Anti-Money Laundering Specialist, Certified Global Sanctions Specialist, Certified Cryptocurrency Investigator, and Certified Regulatory Compliance Manager. A frequent speaker, she presents on financial regulation, sanctions, cybersecurity, digital assets, payments, and international risk.

Outside of her practice, Allison is active in access to justice and equal justice initiatives, supports the work of International Justice Mission in combating global slavery, and serves as an ornithological consultant for Crystal Bridges Museum of American Art.