FDAImports, consultants and affiliated attorneys have been thinking about and praying for all of our friends, colleagues and clients affected by the massive earthquake and tsunami which struck Japan on March 11th. We wanted to provide an update on the affect of these events upon those importing FDA-regulated products to the United States from Japan. Certainly the earthquake in Japan will exact personal, social, and economic consequences that will be with us for many years. More particularly, this will have long-term consequences for Japan’s exportation of FDA-regulated products to the United States, especially as it relates to food safey. Importers of FDA-regulated products can still import into the United States from Japan, but new obstacles have emerged.
Even after Japan recovers the immediate effects of this earthquake, importers of drugs, medical devices, foods and beverages, dietary supplements, and cosmetics manufactured in Japan should expect extensive delays at U.S. ports of entry. FDA will especially scrutinize these products, which may have food safety-related concerns, due to their being affected by the earthquake and subsequent tsunami, with its extensive flooding.
This means that FDA will likely subject these products to extensive administrative review, field examination, potential detention, laboratory testing, and / or refusal, and import alert. Drugs, medical devices, foods and beverages, and dietary supplements subject to various current Good Manufacturing Practices (“cGMP”) standards will encounter obstacles upon entry into the United States because FDA will assume that the cGMP commitments of manufacturers and distributors located disaster-affected areas will have significantly compromised. Still, importers–even more than processors–of foods and beverages (including dietary supplements)–will likely feel the regulatory brunt of this enforcement because ‘delays at the ports of entry’ will account for the lion’s share of the problems.
Still, the earthquake in Japan also means FDA-registered facility inspections will increase over the coming years. Indeed, importing drugs and medical devices will be adversely affected due to FDA recordkeeping requirements as well, inasmuch as electronic and paper records may have been compromised.
The tragic effects of the Japanese earthquake’s impact on Japan’s nuclear infrastructure will also have long-term effects. After the Chernobyl disaster in 1986, FDA worked with the Food Safety Inspection Service to develop analytical standards to prevent the accidental consumption of food contaminated with radioactive materials, which lasted for several years. FDA could even issue country-wide Import Alerts for FDA-regulated products from Japan upon which the radiation-leaks may have a residual impact. Depending on the extent of exposure, these administrative actions may extend to areas of Korea as well.
The mammoth scope of the catastrophe likely means that Japan will need whatever food it produces for domestic consumption. Additionally, if the Bank of Japan’s recent, massive infusion of Yen into the Japanese economy has its desired effect–to stabilize, or even increase the value of, the Yen against other hard currencies–the price of Japanese exports to the United States will undoubtedly increase. And whatever FDA-regulated products make it to the United States from Japan, the pace of regulatory clearance at the U.S. ports of entry just got a lot slower.
– Benjamin L. England, Founder
