Enviro News Asia, Washington – The United States market is highly alluring. Each year, Uncle Sam imports food and beverages worth around US$216 billion. This figure stands in stark contrast to Indonesia’s footprint there: exports of Indonesian food products to the U.S. amount to only about US$518 million, dominated by dairy products, beef, processed vegetables, and fresh fruit—just a small fraction of the vast opportunities available.
A similar gap is evident in other sectors. In cosmetics, U.S. imports reach US$7.79 billion annually, while Indonesia’s contribution is only about US$4 million. In the pharmaceutical sector, the U.S. market in 2024 was valued at up to US$234 billion, yet Indonesian pharmaceutical exports to the country have not even reached US$1 million. Medical devices tell the same story: of total U.S. imports worth US$41.5 billion, Indonesia’s exports in 2023 amounted to just US$79 million.
These figures are more than mere statistics. They signal how enormous the untapped opportunities are—and how tightly guarded the entry gate remains. In the United States, that gate is called the U.S. Food and Drug Administration (US-FDA).
This realization prompted the Embassy of the Republic of Indonesia (KBRI) in Washington, D.C. to host a webinar titled “Review of U.S. Food and Drug Administration (US-FDA) Regulations to Enhance Market Access for Indonesian Products to the United States” on December 11, 2025. Around 250 Indonesian business players from various sectors joined the online forum, hoping to find the key to unlocking the world’s largest market.
The Director for Export Information Product Development at the Directorate General of National Export Development, Ministry of Trade, emphasized that Indonesian products inherently possess competitiveness. However, that competitiveness will hit a ceiling if it is not supported by readiness to comply with international standards and regulations. The global market—especially the United States—is no longer driven solely by price and taste, but by compliance.
A similar message was delivered by Indonesia’s Ambassador to the United States, Indroyono Soesilo. According to him, compliance with US-FDA standards and regulations is not merely a formality, but a fundamental prerequisite for Indonesian products to enter—and survive—in the U.S. market, particularly in food and beverages, cosmetics, and health-related products.
The Trade Attaché of the Indonesian Embassy in Washington, D.C., Ranitya Kusumadewi, added an important note: more than 90 percent of Indonesia’s exports to the U.S. fall under US-FDA regulatory and certification requirements. At the same time, Indonesia–U.S. trade trends in 2025 show an upward trajectory, in line with U.S. efforts to expand its trade partnerships. This momentum, she said, should not be missed without strong regulatory preparedness.
The technical session of the webinar was delivered by Agus Setiawan, Regulatory Advisor for USA FDA Compliance at Registrar Corp., who provided an in-depth explanation of US-FDA regulations—from technical requirements and labeling to product safety and production facility standards—that often become stumbling blocks for businesses. The discussion was moderated by the Agricultural Attaché of the Indonesian Embassy in Washington, D.C., Danang Budi Santoso, who underscored the importance of access to accurate information as well as selecting the right and supportive agents and partners.
In the U.S. market, quality alone is not enough. Compliance is the primary language. And for Indonesian products, understanding US-FDA regulations appears to be no longer an option, but the only path to breaking into this giant market. (*)
