FDA Certification & Labels When Importing from China: Video Tutorial

hey my name is Frederick and in this video tutorial I will explain what you must know about FDA compliance when importing products ok and with the FDA I'm referring to the US Food and Drug Administration you have different FTAs around the world like K FDA in Korea the CFDA in China this is about American FDA okay so what is the FDA the FDA is not a certificate it's not a standard it's a government agency that administer some regulations that affect certain products and we'll get to that in a bit but just wanna make clear that there is no FDA approval so the cover is actually inaccurate because nobody will stamp and say this FDA approved well at least not unless you develop cutting-edge medical devices okay so with that clear we can look into products what products are regulated by the FDA and as I said there's no such thing as an FDA standard but instead they administer regulations that cover certain products and one of those one categories of food contact materials or while kitchen utensils anything that is in contact with food its regulated by the FDA I think it's my I think it's through 21 CFR okay so if you import any kitchen utensil a grater or or food packaging you need to comply with FDA administered regulations B we have medical devices that's not really covered in this this video because I don't work with companies behind medical devices at least not more than very very basic medical devices and see food and beverage okay so anything that can come in contact with human tissue or be digested is covered by well it's regulated one above the other by the FDA so that's what they do okay now do you need to get your product tested by the FDA now FDA don't really do product testing unless it comes if unless unless we discussing medical devices or former products but I'm not so if you're importing kitchen utensil if they will not test your product however you can get your product tested according to regulations administered by the FDA such as 21 CFR which covers food contact materials okay so that's how it works and you should in that case be working with testing company that is accredited by the FDA they have lists of accredited compliance testing companies okay do you need to get an approval before you place a product on the market or a pre-market approval yes it depends if you are placing a new product on the market or a new substance on the market or a substance that has not been used for a certain certain application you may need to get a pre-market approval and this is mainly the way works but you might have heard that a drug gets an FDA approval because that's that's required but if you plan to start selling wine glasses for example you don't need a pre-market approval it doesn't work like that unless you soak it in a chemical or a coating that is it's not supposed to be there in which case you may need to get one okay but for most products you know you don't have to bother with this but lab testing is still recommended even if it may not be mandatory but pre-market approval is different okay enough about that do you need to ensure FDA compliance before selling on Amazon Amazon accom is only reflecting the regulations in the u.s. okay so both on state and federal level they don't have their own regulations at least on yeah they may actually have in the future I'm not I'm not joking they may actually have their own product regulations in the future what is the price being and the future as in later this year next year we'll see in a way if you plan to sell any product that is regulated by the FDA or regulated through an FDA administered regulations such as 21 CFR that applies to food contact materials and Amazon will come may require test reports another documentation as required by that specific regulation so yes you will need to ensure compliance with all regulations that apply to your product FDA or not and keep in mind that you have other regulations administered by other government agencies such as CPSC for example so it's not only FDA you need to keep track of okay now how do you find FDA compliant suppliers I said there's no such thing as an FDA standard so technically apply can't even be FDA compliant but they can comply they can make a product that complies FDA administered regulations I keep saying that but it's a huge difference so it has to be said whenever you import any product in China dye is covered by a substance regulation such as 21 CFR you should ask for test reports okay and that could be chemical test report I have a metal support migration of elements test reports and so on some supplies even refer to the product as FDA compliant so even if that is not correct you can still ask them to provide a well FDA test report or lfg be corresponding regulation in Germany and you have different regulations on the world but in a way when you before you import anything from a supplier you should do a background check and check if they have some sort of existing tests report now you can't use those test reports for your products but you can at least make an assessment if they can make a compliant product or not because many suppliers they can't make products that comply with American European product regulations and you should of course stay away from that category of suppliers and they are really rare there the vast majority it's only a fraction of suppliers that can actually make compliant products okay do you need an FDA label no you don't need an FDA label because this knows the FDA is not in the business of approving products I've actually seen the FDA label printed on many products in China for some reason so it seems that a lot of a lot of importers they assume that this is some sort of like labeling requirement like FCC or C but that's not the case honestly I'm not aware of any case where you should use an FDA label that said though they do have labeling requirements they have requirements that for for how you package food how the contents should be presented weight and so on serving and so on expiry dates but you shouldn't print a big FDA label anywhere or state that is approved by the FDA or something like that at least of a consumer products okay maybe different products for drugs and for for high-end medical devices but that's not really what we do here China and portal is it okay if you want to learn more go here and get this free 20 page PDF case study that will guide you from spec sheet to delivered products a to set and everything in between so sign up now is free you can go to shine and portal calm former star sign up and get your copy right now or you can just subscribe to our YouTube channel and stay up to date with our uploads we upload videos every week


  1. hello i currently have soap bars under fda review just shipped from china how long is that process take do you have any idea?

  2. Your video doesn’t resolve the problem of “how to find FDA compliant suppliers” !!

  3. Hello. Do I need FDA approval to import toys that are made out of pvc and pp plastic? I have SGS lab test certificates, but not sure what else is required

  4. Hey if i want to sell this

    And the Chinese manufacture says its fda approved should i be ok to sell it?

  5. First off, great video. Super informative!

    5:33 – 5:49, you mentioned asking for test reports and gave a few examples. Just to clarify, these test reports are not PRODUCT-specific? Say a kitchen utensil manufacturer makes a metal whisk with a rubber handle. Would you want to see a report showing compliance with the metal & chemicals they use in general to make ALL their utensils? Or would you want to see a report for that specific whisk?

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