Attention Cross-Border Exporters! U.S. FDA Food Business Registration Frequently Asked Questions Answered at Once

Do you know what kind of food business can successfully enter the U.S. market? The answer is: businesses that have completed FDA registration! According to the U.S. Federal Food, Drug, and Cosmetic Act (FD&C Act), all enterprises engaged in food production, processing, packaging, and storage need to complete the U.S. Food and Drug Administration (FDA) food business registration.

The biggest problem is that many Taiwanese cross-border sellers are not familiar enough with these regulations, which leads to obstacles in the U.S. market. We've put together a list of the seven most frequently asked questions in the "Food Business Registration Q&A Industry Guide (7th Edition)".

There is no need to wait for a specific time to register in the first place; businesses must complete their registration before they start the relevant business. Far more flexible than waiting for October 1 in even years. And you don't get a new registration number during the renewal process, which is an area of confusion for many businesses.

For multi-facility owners, each business registration requires an FDA-recognized Unique Facility Identifier (UFI), which is currently recognized by the FDA as a Dun & Bradstreet code (D-U-N-S). Moreover, foreign companies belonging to the same parent company can designate different U.S. agents, which gives companies more options.

What's even more outrageous is that many businesses don't realize that a change in registration information must be submitted to the FDA within 60 days of the change, unless that 60 days falls within an even-numbered year of registration renewal. Warehouse facilities that frequently change their food categories can select all of the food categories that they normally operate when registering.

It is important to note that the FDA does not require or even encourage the listing of business registration numbers on food labels to prevent improper use by others. At the same time, the FDA does not publicize specific information about food business registrations, only registration statistics. As of March 2024, there were 91,225 domestic food business registrations in the U.S. and 128,886 foreign food business registrations, with China having the largest number of food business registrations (including Mainland China, Taiwan, Hong Kong, and Macau).

If you are engaged in the production, processing, packaging or storage of human or animal food for sale in the U.S., your business must be registered with the FDA as a food business, which is the basic threshold for entry into the U.S. market!

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# Cross Border Exporter # Registered with the D.A.A. # Taiwan Manufacturer # U.S. Food Market # Compliance # Cross Border E-Commerce # Global Store Opening # Amazon Seller # Food Compliance # International Trade