To standardize the product listing and use of certificates on the platform, and to ensure the compliance and seriousness of product listing, AliExpress will strengthen the management of illegal claims involving the U.S. Food and Drug Administration (FDA). Specific requirements are as follows:

    1. Prohibit the use of images with the FDA Logo
    The FDA has developed rigorous guidelines on the use of its logo (for detailed information, please visit: https://www.fda.gov/about-fda/website-policies/fda-logo-policy). It particularly expresses that the logo cannot be used by the private sector without authorization.

    2. Prohibit the display of certificates or descriptions showing the seller has been approved by the FDA
    It is prohibited to display at any information level (including but not limited to product titles, attributes, detailed descriptions, main images and SKU images) FDA certificates issued by third parties and statements such as “FDA Approved”, “FDA Cleared”, “FDA Certified”, “FDA Endorsed”, and “FDA Listed Product”.

    3. Delete “FDA” from product attributes (e.g. Certification: FDA)

    The transition period is from the date of issue of this announcement to July 31, 2021. From August 1, products that have not been rectified will be removed. Please rectify as soon as possible.
    ——————————-
    FAQ:
    1) Our company has completed registration with FDA. How can we obtain a registration certificate that is recognized by FDA?

    A: The FDA has expressly stated that it will not issue any certificates or supporting documents to any registered sellers (for details, please visit: https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing). Sellers do not need to engage any third parties (e.g. a registration intermediary, foreign trade chamber, or certification company) to issue registration certificates on FDA’s behalf. Such certificates will not be recognized by FDA and shall not be displayed on AliExpress.

    2) Why can’t I display the FDA registration certificate I have obtained in my store?

    A: The FDA does not authorize any third parties (e.g. a registration intermediary, foreign trade chamber, or certification company) to certify on FDA’s behalf the registration of any manufacturers or their products. Such certificates are not recognized by FDA and shall not be displayed in the store.

    3) Our company has completed registration with FDA. Does it mean our company and products have been certified by FDA? Why can’t we say “FDA Approved” or “FDA Certified” even if we have completed registration?

    A: Annual registration with FDA is the basic compliance requirement for all business operators and sellers who plan to produce and sell their products to the U.S. The completion of registration does not denote FDA’s certification or recognition of a seller or its products. To obtain an FDA certificate, a seller needs to have a Premarket Notification Approval or a 510(k) Clearance Letter, and pass a more stringent FDA test.

    4) If we have obtained a PMA number or a 510(k) number for our products, can we display it?

    A: Sellers who have obtained a PMA number or a 510(k) number can display the number on the product detail page.

    5) How can we inquire whether we have obtained a PMA number or a 510(k) number for our products?

    A: To check the validity and status of your PMA number or 510(k) number, access the FDA databases (for PMA numbers, please visit:
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm;
    for 510(k) numbers, please visit:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm).

    AliExpress
    July 15, 2021