Alibaba FDA registration application standard requirements

FDA registration is for Amazon in the United States. Cosmetics FDA registration is a voluntary registration principle, not a mandatory requirement. Exports to the US customs will not require FDA certification. Of course, e-commerce platforms such as Amazon will require cosmetic sellers to provide FDA certification information. , otherwise it is not allowed to open a store or remove the product.

FDA registration has a different legal authority over cosmetics than other regulated products, such as pharmaceuticals, biologics, and medical devices. Under the FDA's Federal Food, Drug, and Cosmetic Act (FD&C Act), cosmetic products must not be "adulterated" or misbranded. For example, they must be safe for consumers when used as labeled or under the conditions of use, and must It is properly labelled and must not mislead consumers. Companies and individuals selling cosmetic products are legally responsible for the safety and labelling of their products.

Benefits of Participating in the Cosmetic Voluntary Registration Program (VCRP)

A manufacturer voluntarily registers and obtains a registration number does not mean FDA approval of the manufacturer or its products, and FDA does not allow manufacturers to use the registration number or listing number obtained by participating in VCRP for commercial promotion; however, manufacturers will directly benefit from VCRP:

1. Obtain important information on cosmetic ingredients. FDA enters all information from the VCRP into a computerized database. If a currently used cosmetic ingredient is deemed harmful and should be banned, FDA will notify the manufacturer or seller of the product through the address book in the VCRP database. If your product is not in the registration database, FDA will not be able to notify you.

2. Avoid products being recalled or detained when imported due to ingredient problems. If a cosmetic manufacturer records the product formula in the VCRP, as long as the FDA finds that the manufacturer has used unapproved color additives or other prohibited ingredients in the formula, it will remind the manufacturer to pay attention. In this way, manufacturers can modify product formulations before products are imported or sold, eliminating the risk of product recalls or withholding due to the use of inappropriate ingredients, and helping retailers identify risk-conscious manufacturers.

To sum up, although participating in the Cosmetic Voluntary Registration Program does not mean FDA's license or approval of the product, it shows that your product has been reviewed by the FDA and entered the US government database, which can improve the competitiveness of the product (retailers). Sometimes the FDA is asked if a cosmetic company is registered with the FDA to improve the competitiveness of the product), on the other hand, it also avoids some safety risks (because if you submit a product formula that is incomplete, or contains a certain banned Approved Color Additives, FDA will notify you)

Qualification requirements for selling to the United States (applicable to fully paid suppliers)

1. Production enterprises:

The company's FDA food registration number Registration Number + FDA Yanwang screenshot

2. Trade enterprises:

The company and its cooperative manufacturers FDA food registration number Registration Number + FDA official website screenshot

US FDA registration certification classification

1. Cosmetics FDA registration/VCRP registration (also called Cosmetics Voluntary Registration Program, not mandatory)

2. FDA registration of medical devices (class I, II, III medical devices, 510k, exempt from 510k (some class II medical products)) We can do most of the class I medical products + medical products exempted from 510k

3. Drug FDA registration / OTC registration of over-the-counter drugs

4. Food FDA registration/FDA food contact material testing

5. FDA registration of laser products

Why do you need to apply for FDA, and what is the purpose of applying for FDA?

U.S. regulations stipulate that products sold in the United States must be registered/tested by the FDA, and can be sold on the market only after the FDA inspection proves that they are safe. For example, when you go online on Amazon’s US site (for FDA-administered products sold in the United States, you must have relevant FDA testing or registration), and customs need to check when you go offline for customs clearance. In addition, when many domestic merchants sell some products, in order to package the authority of their products, they will apply for an FDA-related registration or testing to publicize them to increase sales.