Amazon FDA Registration Proof
Amazon FDA registration proof can be a moving target. Is it a certificate, a screenshot, or 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 has led to a flurry of refusals and confusion from Seller Support agents. It now appears the solution created by Amazon is to require registration screenshots – which I am calling FDA Amazon registration screenshots. Amazon determined that a registration screenshot from the registration account would provide definitive proof that the company was properly registered. The problem 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 drugs (CDER Direct). Naturally, the result has been a number of clients reporting that registration screenshots were deemed invalid.
Seller Support will only continue to request a FURLS account with a link to access.fda.gov. I’ve spoken with the corporate attorney at Amazon who manages Seller Support to highlight that this will not always be an option – say for cosmetics or OTC Drugs. More changes are likely, but for now, I am continuing to register clients and issue registration certificates. I am supplementing that with annotated screenshots using Snagit.
Snagit is a useful tool for FDA label reviews that I use frequently 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 for both Amazon corporate and Seller Support. It typically isn’t recommended to share a registered 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 on constructive change.
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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?
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.
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 ???
Thank you for your comment, I’ll follow-up by e-mail to clarify the Voluntary Cosmetic Registration Program.
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
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).