Amazon FDA Registration Proof

Amazon FDA Registration Proof

Amazon FDA registration proof can be a moving target. Is it a certificate, a screen shot, something else!? The answer varies from week to week and from seller support agent to seller support agent. Amazon FDA registration proof is something this blog has tackled on numerous occasions.

Over the past six months I’ve been working with numerous clients attempting to ungate Amazon. As discussed in previous blog posts Amazon required a registration certificate that the FDA did not issue or set any parameters on. This lead to a flurry of refusals and confusion from Seller Support agents. Those previous posts are here and here. It now appears the solution created by Amazon is to require registration screenshots – what I am calling FDA Amazon registration screenshot. Amazon determined that a registration screenshot from the registration account would provide definitive proof that a company was properly registered. The trouble is that Seller Support agents have never registered a company or experienced the registration systems. The registration screenshot will vary from VCRP (cosmetic) to LACF (low acid) to food facility, medical device (both use FURLS) or drug (CDER Direct). Naturally the result has been a number of clients reporting that registration screenshots were deemed invalid.

Seller Support will continue to only request a FURLS account with a link to access.fda.gov. I;ve spoken with the corporate attorney at Amazon that manages Seller Support to highlight that this will not always be an option – say for cosmetic or OTC Drug. More changes are likely, but for now I am continuing to register clients and issue registration certificates. I am supplementing that with annotated screen shots using Snagit. Snagit is a useful tool for FDA label reviews and where I most frequently use the tool to annotate labels. In the case of registration screenshots it is used to identify the hallmarks of a valid registration – simple things like the URL, the date and time among others.

This is a learning curve both Amazon corporate and Seller Support. It typically isn’t recommended to share the registration account, but if selling on Amazon is important than this information appears required to ungate the e-commerce site.

Continue to share your Amazon registration certificate frustrations by commenting below or sending an inquiry to our Washington D.C. or Charlotte NC offices. The more we learn the more pressure we can place for constructive change.

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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

6 Comments

  1. Darla Douglas on November 7, 2019 at 9:19 pm

    I have been struggling for 2 days trying to find this registration proof on fda.gov. I can’t believe I can’t just search the manufacturer and get this info? What am I missing and where do i go?

    • Marc Sanchez on November 8, 2019 at 11:57 am

      Thank you, for your comment. Only medical device and drug registrations are public. Food, dietary supplements, and cosmetic registrations are not public only available if provided by the manufacturing registering.

  2. Evgeny on April 8, 2019 at 3:35 pm

    Hi Mark,
    I’ve tried to list a cosmetics product from Japan.
    Amazon asked me to get same topical approve with same options.
    I’ve asked Japanese manufacture to register in FDA in order to get the screenshot…but they (and me as well) do not understand how to do that.
    Is it Voluntary Qualified Importer Program from https://www.access.fda.gov/oaa/createNewAccountflow.htm?execution=e1s1 ???

    Or
    Voluntary Cosmetic Registration Program from https://www.fda.gov/Cosmetics/RegistrationProgram/default.htm ???

    • Marc Sanchez on April 8, 2019 at 4:56 pm

      Thank you for your comment, I’ll follow-up by e-mail to clarify the Voluntary Cosmetic Registration Program.

  3. Addy I. Zilberman on April 17, 2018 at 11:12 pm

    Hello Marc,
    I’ve applied to get ungated for groceries and got approved almost immediately. No FDA registration certificate was requested. Now I’ve tried to get ungated on topicals and they keep on asking me for one of the three:
    A Certification of Compliance with Good Manufacturing Practices (GMP)
    Proof of FDA registration
    A 510(K) Premarket Notification
    or a A Certificate of Analysis (COA),

    Have you done this? What is your process for this and how long does it take? What is the cost for this from your company?
    thanks,
    Addy I. Zilberman, MBA
    Aloshas
    (702)374-2121M
    (702)617-2845F

    • Marc Sanchez on April 18, 2018 at 9:07 am

      Hello Addy,

      Topicals is an odd creation made solely by Amazon. It doesn’t exist in the FDA regulations. I have worked with clients on ungating this category, typically by completing a FDA registration. A 510(K) would only apply to specific, Class II or III, medical devices. I’m happy to discuss further by e-mail (msanchez@fdaatty.com).

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