• FDA Certification & Labels When Importing from China: A Complete Guide

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    Planning to import kitchen utensils, food products or medical devices from China, and sell in the United States? Then you need to ensure compliance with all mandatory FDA administered regulations.

    In this comprehensive guide to FDA regulations and requirements for importers, you will learn what you must know about FDA labeling requirements, premarket approvals, documentation and lab testing.

    In addition, you will also learn how Amazon.com is enforcing FDA regulations, such as 21 CFR, and why you should not rely on your manufacturer in China to manage the process for you.

    Which products are regulated by the FDA?

    FDA, standing for the Food and Drug Administration, is a government agency, not a standard or regulation in itself. The FDA administers regulations that affect various product categories.

    a. Food Contact Materials / Kitchen Utensils

    The FDA administers 21 CFR, which regulates all types of materials made to be in contact with food and beverages.

    21 CFR covers plastics, ceramics, coatings, glass and metal used in both food packaging and all types of kitchen utensils.

    For example, food packaging and kitchen utensils may not contain toxic or harmful chemicals and heavy metals – or affect the taste and smell of the food or beverage.

    21 CFR mainly concerns the substances used in kitchen utensils (both electrical and non-electrical) and food packaging.

    b. Medical Devices

    Most types of medical devices, imported to the United States, are regulated by the FDA. As a US importer, you must either provide a Premarket notification 510 (k), or obtain a Premarket Approval.

    As hinted, you must submit the paperwork before you import the medical devices.

    There are, however, some devices that are exempt from both. A full list can be found here.

    FDA regulations for medical devices cover technical specifications, documentation, lab testing and labeling requirements.

    For example, the mandatory labels include the following information:

    • User instructions
    • Manufacturer / Importer
    • Address
    • Batch ID
    • Unique device ID

    FDA compliance in China

    c. Food & Beverage

    The FDA regulates most types of food products and beverages, imported and sold in the US. Some types of food require a pre-market approval, before imported to the United States.

    In addition, the FDA also regulates how food product packaging must be labelled:

    • Product name
    • Net weight
    • Ingredients list
    • Serving size

    The FDA also regulates health benefit claims, and other claims made on the food packaging.

    Do I need to get my products tested by the FDA?

    FDA generally don’t test products, but there are testing companies that do.

    So do you need to get your FDA regulated products tested?

    That depends. For some products, third party compliance testing is mandatory, but that is not the case for most categories regulated by the FDA.

    Just keep in mind that the US customs, CPSC or FDA can request test reports, or other documents, that prove that your products are compliant – even if lab testing is not required by law.

    If they have reason to believe that your imported food packaging or medical device is non-compliant, they have the power to force you to provide test reports and other documents – or issue a forced recall.

    That is the last thing you want to happen.

    To be on the safe side, always book a third party lab test, before importing FDA regulated products from China.

    All of the large laboratory testing companies can help with ‘FDA testing’, including, but not limited to;

    • Asiainspection
    • SGS
    • Intertek
    • Bureau Veritas
    • TÜV

    When contacting these labs, you should not refer to ‘FDA testing’. At a very minimum, you should provide product information, and explain that they should do all testing required for the certain product category, in the United States.

    Or, even better, refer directly to the regulation, such as 21 CFR.

    Do I need a premarket approval from the FDA?

    Yes, when importing certain types of medical devices, or even food products, you need to obtain a premarket approval. Without such an approval, you cannot legally import and sell the product in the United States.

    Keep in mind that only a US entity can obtain a premarket approval, so don’t rely on your supplier to do it for you.

    The pre-marketing approval requirement is also applicable to certain substances used in food packaging and kitchen utensils.

    The problem, when importing from Asia, is that most suppliers don’t have detailed documentation of the materials – that covers chemicals and heavy metals.

    Hence, importers can only rely on third party lab testing to assess if a premarket notification is necessary or not.

    Do I need to make sure that my products are FDA compliant to sell on Amazon.com?

    Yes, like in all marketplaces, sellers on Amazon.com must comply with all applicable product regulations in the United States.

    That said, FDA only regulates products sold in the United States. If you, for example, plan to sell products on Amazon.de or Amazon.co.uk – you must ensure compliance with European Union product regulations.

    For example, the Medical Devices Directive, LFGB or the EU Food Contact Materials Framework regulation.

    In addition, the EU has its own documentation, labeling and lab testing requirements. A premarket notification submitted to the FDA in the US, cannot be used to sell the same product in Europe.

    Further, Amazon is increasingly strict when it comes to enforce product compliance. Many product categories, some of which are within the scope of FDA regulations, are restricted – and must be ‘unlocked’ by the seller.

    Part of this process involves the submission of compliance documents.

    They are also actively reviewing products and sellers, and can reject any product that is listed without the sufficient compliance documents.

    Before you import products to sell on Amazon.com, check their compliance requirements for your product.

    While they currently reflect the legal minimums set in each country, it’s possible that Amazon will go beyond this – and set product standards that are even higher than what is required by the FDA.

    How do I find ‘FDA certified’ suppliers in China?

    First of all, a supplier cannot be FDA certified. It comes down to the product, not the company.

    That said, a product can be ‘FDA compliant’.

    As mentioned, the FDA is not a standard – but a federal government agency that administers regulations for many different product categories.

    Yet, many Chinese suppliers refer to FDA as a standard. When browsing manufacturers of kitchen utensils on Alibaba.com or Globalsources.com, it’s common to see suppliers stating ‘FDA compliance’.

    What they actually mean, is that their product is 21 CFR compliant.

    In the end, what matters is that they can make a compliant product. This can, however, not be taken for granted when sourcing suppliers in China.

    Many suppliers don’t have a clue if their products contain chemicals or heavy metals that are restricted by the FDA.

    At best, they can provide a Chinese language substance list from a subcontractor, but that is far from enough.

    Yet, it’s also about as good as it gets.

    When sourcing suppliers, you should always limit your selection to those that can provide verifiable test reports and chemical documentation.

    But, you cannot expect to find suppliers that have test reports for their entire product catalog. At best, you will get a two or three test reports, that may not even be valid in the US.

    But that’s acceptable.

    How do I know if my supplier can make an FDA compliant product?

    The only way to be sure, is to send a pre-production sample for laboratory testing. As mentioned, there are plenty of compliance testing companies that can verify if your product is compliant with all relevant FDA regulations.

    Just keep in mind that compliance testing can be costly. Labs charge at least US$500 for one product sample.

    Do I need to get my products FDA labeled?

    Yes, there are various FDA administered labeling regulations, applicable to food packaging, electrical kitchen appliances, kitchen utensils, Class I and Class II medical devices.

    There is, however, no FDA mark in use. That said, some Chinese companies use the FDA logo on their products, or packaging, as some sort of seal of approval from the FDA.

    This is not permitted, and you should not use the FDA logo on the product or packaging.

    Further, the labeling requirements depend on the product. Also notice that additional, non-FDA administered labeling requirements may apply.

    For example, all products sold in the United States must carry a country of origin label, and some electronics products must carry the FCC mark.

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  • 16 Responses to “FDA Certification & Labels When Importing from China: A Complete Guide

    1. David Chen at 3:48 pm

      Hi Fredrik,

      I plan to sell food contact products in EU and US, and I am going to apply outside lab test per EC/1935/2004 and LFGB, can I use these reports instead of FDA test certificate in US?

      1. Fredrik Gronkvist at 12:13 pm

        Hello David,

        No, you need to get it tested according to FDA standards/rules for the US. Not sure, but maybe your lab can use some of the test results for both test reports (EU and US) if you do it at the same time? It’s worth asking.

        1. david chen at 1:34 pm

          Noted, really appreciated!

        2. david chen at 5:33 pm

          Hi Fredrik,

          FDA mentioned food contact material shall not cover some materials: such as GRAS (generally recognized as safe) substances. Our product material is silicon dioxides which is within GRAS list, so can I exempt FDA test?

          1. Fredrik Gronkvist at 11:58 am

            Hi David,

            I think what they mean is that only certain types of materials are accepted as FCMs. That does not mean that all “accepted” materials are exempt from testing.

            You should still consult a lab though.

    2. Ignacio Vallin at 2:08 am

      Hi Fredrik,

      Can you advise what certifications are needed to sell China manufactured Shawarma and Hot Dog Machines in the U.S?

      I see different information out there. Some say no official certifications are needed, others say that UL and NSF certifications are required.

      1. Fredrik Gronkvist at 12:15 pm

        Hi Ignacio,

        In this case, you must consider food contact materials regulations (FDA), machinery safety (OSHA maybe) and finally electrical safety (that’s where UL standards come in).

    3. Scott McPherson at 3:58 pm

      Hi,
      Looking for some FDA advice please.
      We are in the middle of registering for FDA approval on class I medical devices, drapes / gowns.
      We use a sub-contractor in China, 95% of goods will be shipped to the UK for completion,then shipped to the US, however on occasion I would like to ship direct to the USA from China, what are the rules around this ?

      1. Fredrik Gronkvist at 10:35 pm

        Hi Scott,

        I don’t think FDA regulations have any impact on whether you ship directly to the US or via the UK.

    4. Gloaria at 12:27 am

      I plan to sell a product with FDA approved silicone material in it. It is not a medical device, but this product is in contact with the body. My company is located in France, but I plan to sell in the US market. Do I need the premarket approval ? Thanks for your answer!

    5. Margaret at 6:24 am

      You’ve said that premarket approval is only given to a US entity. And it is required for food, utensils, medical devices, and food packaging. So am I understanding correctly that a non-US citizen cannot import any of those items into the US to sell on Amazon.com? Thanks for your insight.

      1. Fredrik Gronkvist at 7:20 pm

        Hi Margaret,

        You must set up a US company. You don’t need to be in the US for that.

    6. Reya at 8:18 am

      Hi Fredrik, very helpful article.
      I am trying to import Bamboo Utensil sets from China, most of my supplier said that they do not have manufacturer’s FDA registration number and said that their customers test for the product themselves. How do I go about having it FDA cleared when it reaches US Customs?

      1. Ivan Malloci at 7:38 am

        Hello Reya,

        yes, it’s quite common that Chinese manufacturers can’t provide an FDA certificate, also because a certifica / test report is only valid for a specific product. It’s also common that importers test their production batch themselves (with the help of a testing lab).

        I suggest you to start by watching our free webinar on ensuring compliance in US and EU. You can signup for the webinar here: https://chinaimportal.easywebinar.live/webinar-c

    7. Natalie at 1:43 pm

      When I pay for a FDA certificate from my supplier do they send it to me via email or directly to me using FEDX or UPS??

      1. Fredrik Gronkvist at 11:59 am

        Hi Natalie,

        First, you shall NEVER pay a supplier for a lab test. You can book it directly with a company such as Asiainspection.com.

        They will send a test report (PDF) after the test is done. That is all you need.

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