Question about FDA registration?


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Question about FDA registration?

Not sure where to ask this, so I apologize if this is the wrong place for it.

1.I’m kind of confused as to what kind of company has to register under the FDA? Like if you decide to make a company that imports tooth paste or masks to sell in the US for example, would the company have to register as an importer? If so, how long does it generally take to get registered and what are the costs?

2. If a company sells items from Aliexpress on Amazon or Ebay, would they have to register on the FDA website as well? From what I know, most items go directly from Aliexpress to the customer through these websites, so would FDA registration be needed? Or does this depend on what kind of item you are selling?

Question about FDA registration?

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3 Replies to “Question about FDA registration?”

  1. This really depends. I would suggest contacting CDER small business office. They can be reached at You will need a list of the specific brands/types of toothpaste and/or other cosmetic items that might be classified as both a drug and cosmetic you plan to sell. After that, all applicable information you need is on the website. The ombudsman office is really for disputes in biological, medical devices and/drugs.

    Strictly speaking, cosmetic registration regarding importing and distribution are voluntary. You should still do so to be up to date on any recalls, etc.

    Where it gets tricky is if what you plan to import and/or distribute is also classified as a drug. This completely depends on if there is an active ingredient or not. If no – it’s not a drug. If yes – it is considered a drug.

    Once a product is classified as a drug you will need to evaluate any applicable GMP regulations – again very dependent on what exactly your new business will do. If you are just a middle man, it’s really straight forward. If you directly distribute to consumers you have some added responsibility. Ultimately, the manufacturers are responsible for their product quality and integrity. What you would need to ensure is that instructions provided by manufacturers are followed (labeling, tampering, etc.).

    In theory as an importer you would buy from a manufacturer. Manufacturers of drugs overseas must be registered with the FDA prior to the importation of any drug. Also, that drug must be approved by the FDA prior to distribution. Let’s look at fluoride as the drug in the case of toothpaste. If you are only an importer it is up to the manufacturer to ensure you are registered as an importer for their drug. You should also verify that you are listed so that you do not face any customs issues and that labeling is adequate. To be clear there are FDA officers within customs for all imports.

    In the case of already approved OTC drugs your involvement is very minimal and there is not much you should have to worry about once you square away the details of what is and is not applicable to your business based off what you plan to distribute.

    Source – former regulatory scientist

  2. I sell medical supplies online (mostly Amazon, other sites including my own as well). There’s a yearly medical device fee (around 5 grand) I have to pay, and the company that manufactures for me has to be registered with the FDA as well. If not paid then the product will be denied release at port once it reaches the USA (someone from the FDA will reach out to you if denied and you could technically just register really quickly from that point)

    Process takes about a week (you make payment then wait a few days for the registration info which you enter onto a different FDA website)

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