U.S. Food Market Access: A Practical Guide to FDA Registration for Taiwan Cross-Border Sellers
Do you know what kind of Taiwan cross-border sellers can smoothly enter the U.S. food market? The answer is: FDA-registered sellers! As the world's largest importer of agricultural products, the U.S. food imports are strictly regulated by the Food and Drug Administration (FDA). According to U.S. federal regulations, all food-related companies exporting to the U.S. must complete registration on the FDA website, otherwise the products will be detained at the port of entry or refused entry.
In order to help Taiwan manufacturers expand into the U.S. market more smoothly, we have compiled this guide to the FDA registration process and key points to note, so that you can avoid the risk of goods detention caused by registration problems.
First, the regulatory basis for FDA registration consists of three main items: the U.S. Food, Drug, and Cosmetic Act, the Food Safety Modernization Act, and the Bioterrorism Preparedness Act. Together, these laws and regulations form the regulatory basis for food safety in the United States.
What businesses need to register? All manufacturing, processing, packaging, and warehousing businesses that export human and animal food products to the U.S. must be registered. However, it is important to note that most farms, retail food establishments, restaurants, non-profit food businesses, etc. are exempt from registration. For specific exemptions, please download and refer to the Guidance for Industry published by the U.S. FDA.
This is outrageous, and many sellers don't realize that FDA registration has such strict time requirements: initial registration must be completed before the start of business activity; re-registrations should be submitted between October 1 and December 31 of every even-numbered year; changes in information must be updated within 60 days; and cancellations must be completed within 60 days.
The registration process is relatively simple and can be completed step-by-step through the official FDA website (https://www.access.fda.gov/). However, the biggest challenge is that starting October 1, 2020, the FDA will make it mandatory to fill in the company's Unique Firm Identification (UFI), also known as Dunn & Bradstreet (D&B) code. This is a 9-digit global code that is the equivalent of a corporate ID card.
For example, during the Greek economic crisis, many food exporters suffered significant losses because they did not understand the FDA registration requirements. What's more, if your product is a low-acid canned or acidified food, you must register for FCE and SID in addition to your regular registration. This detail should not be overlooked!
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# Cross-border E-commerce #DA Registration # Taiwan Sellers # Food Export # Compliance # Risk Prevention # U.S. Market # Cross-border Brands
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