U.S. FDA Registration Application Guide: Compliance Essentials for Taiwan Cross-Border Sellers
You would never guess that FDA registration is so important! As the world's largest importer of agricultural products, the U.S. has extremely strict food safety regulations. Any enterprise that wants to export food products 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 cross-border sellers to enter the U.S. market more smoothly, we will analyze the FDA registration process and key points to note. What is the key point? It is to let your products pass through the U.S. Customs smoothly and avoid the risk of goods detention caused by registration problems.
First, let's look at the regulatory basis for FDA registration:
- U.S. Food, Drug, and Cosmetic Act
- Food Safety Modernization Bill
- Bioterrorism Preparedness Response Act
What businesses need to register? All manufacturing, processing, packaging, and warehousing businesses that export human and animal food to the U.S. must register with the FDA. However, it is important to note that some businesses are exempt from registration, such as most farms, retail food establishments, and restaurants.
What's even more surprising is that there are strict time requirements for FDA registration! Initial registrations must be completed prior to the start of business-related activities; 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 actually not complicated, just go to the official FDA website (https://www.access.fda.gov/) and follow the steps to fill in the relevant information. What's the most important thing? Starting October 1, 2020, the FDA will make it mandatory to fill in the Unique Firm Identifier (UFI), also known as Dunn & Bradstreet number, which is the "identity card" of the company.
It is worth reminding that if your product is a low-acid canned or acidified food, in addition to the general food business registration, you must also register for FCE and SID, which should not be overlooked!
Want to get the latest FDA registration policy updates? Scan the green circle now and join our LINE friends:https://line.me/ti/p/g2Vc38nLnR
# Cross-border E-commerce # Amazon Sellers # Registration # Food Exports # Taiwan Manufacturers # Compliance Policy Guidelines # U.S. Market # Cross-border Brands
EN 
ZH_TW 
ZH