How do you prepare for U.S. FDA requirements? The FDA does not issue certificates: five things dietary-supplement exports to the United States actually need to do

Short answer: The U.S. FDA does not issue certificates ¹⁹. What you need to do is confirm the classification, register the facility and appoint a U.S. agent, submit an NDI notification, use the required label format, and give notice for every shipment.

Scenario: a dietary-supplement owner receives one sentence from a U.S. distributor

You make lutein and have sold it in Taiwan pharmacies for eight years. A distributor of Asian foods in Los Angeles sees your samples and sends a very short email: "The product looks good. Sort out the FDA first, then we can talk."

You ask three people and get three answers: one says to "apply for FDA registration," another says that "the FDA does not approve dietary supplements," and another says that "finding a U.S. agent is enough." All three sound right, yet they seem to contradict one another. You worry most about spending half a year and a significant sum on a document, only for the distributor to say, "This is not it." You worry even more that the first shipment will reach the Port of Los Angeles and be held there because one document you have never heard of is missing.

The problem lies in the four words, "sort out the FDA." They actually cover five different tasks, each assigned to a different party. Here they are, one by one.

How do you prepare for U.S. FDA requirements? First: the FDA does not issue certificates

First, clarify the most common misunderstanding: the FDA does not 'approve' dietary supplements. Under the 1994 DSHEA, dietary supplements are classified as food. The FDA has no authority to review a product's safety, efficacy, or labeling before it goes on the market; the company itself is responsible for product safety and truthful labeling ¹. So the phrase "obtaining FDA approval" does not exist for dietary supplements. When a distributor says to "sort it out," they mean completing the five tasks below and being able to produce the documents.

The FDA does not issue a registration certificate. It does not recognize "proof of registration" issued by private providers ⁹. A registration number only means that you registered; it does not mean the FDA approved or endorsed you ². For food and dietary supplements, the tasks are facility registration, premarket notification for a new dietary ingredient (NDI), and compliant labeling ²³⁴. Cosmetics follow MoCRA: facility registration is renewed every two years and product listings are updated annually; the FDA likewise issues no proof document, and a registration number does not mean approval ¹⁰. Documents sold as FDA registration are usually issued by an intermediary or are laboratory test reports. Neither is issued by the FDA.

Five steps, in order

Back to the scenario: what the distributor usually wants is the registration number from step 2, the compliant label from step 4, and clarity about who will be the importer in step 5. You need to confirm steps 1 and 3 yourself; no one else will check them for you.

Five pitfalls Taiwan brands most often encounter

1. Promoting a dietary supplement as a drug. Disease claims such as "improves eyesight" or "prevents macular degeneration" cannot be used for dietary supplements. You can make only structure/function claims, such as "helps support eye health," and must include the disclaimer that the statement has not been evaluated by the FDA ⁶. If you use a structure/function claim, the manufacturer, packer, or distributor must notify the FDA within 30 days after first marketing ¹². This is where directly translating Taiwan copy most often causes trouble.

2. Ignoring state-level rules. Clearing federal requirements does not mean that you clear every state. For example, California Proposition 65 requires a warning on products sold in California, including online, when people are exposed to a listed chemical above its safe-harbor level; businesses with fewer than 10 employees are exempt ⁷¹³. Check this before entering California channels.

3. A label translation that is not compliant. Supplement Facts is not simply an English translation of a nutrition label. Its fields, units, and order are all prescribed ⁴.

4. No product-liability insurance. U.S. channels and distributors often require it. This is a commercial convention, not a regulation; without it, many channels will not discuss business with you.

5. Underestimating customs-clearance time. Prior notice, the importer's FSVP, and customs documents all need to be ready. Do not arrange for the first shipment to arrive only a week before the listing date.

When we do not recommend doing these FDA tasks yet

• The product classification is not confirmed. If the formula contains an ingredient the United States treats as a drug, completing the next four steps will not help.
• The contract manufacturer will not cooperate with registration. Facility registration is the factory's responsibility. If the factory will not register, you cannot replace that step.
• You have not decided who will be the importer. The importer is responsible for FSVP and prior notice ⁸. Without an importer, no one handles step 5.
• You only want to 'try' the United States first. All five tasks have fixed costs that small volume cannot spread out. Before selling on Amazon U.S., first work through these three decisions.

Frequently asked questions

Do dietary supplements need FDA approval before they can be sold in the United States? No. You do not need it, and you cannot obtain it. The FDA does not 'approve' dietary supplements ¹ and does not issue registration certificates ⁹. Companies are responsible for safety and labeling; the FDA's role begins after products enter the market.

What does a Taiwan factory need to do? Register the facility with the FDA and update it every two years. Foreign facilities must appoint a U.S. agent ².

What is an NDI notification? For a new dietary ingredient that was not sold in the United States before October 15, 1994, the manufacturer or distributor must submit a safety notification to the FDA at least 75 days before marketing ³.

One small next step

Before replying to the distributor, write one line for each of the five steps: "who is responsible, and where are we now?" For the lines you cannot complete, message us (LINE or email). For North America, our model is a low upfront service fee plus a share of completed business; we will give clear figures in the first discussion.

Based on practical experience; not legal advice. Last verified: October 1, 2026. Follow the current version of official FDA pages for FDA requirements.