Amazon Registration Certificates and Seller Support

Amazon Registration Certificate

A recent post on Amazon Registration Certificates generated a number of questions along with shared frustrations. In the previous post I talked about selling on Amazon in a FDA regulated category, like health and beauty, where Amazon requires among other hurdles to be listed a certificate from the FDA. The FDA does not issue certificates of registration. The FDA under the Food and Drug Act is even prohibited from releasing certain information about a company’s registration to the public. Yet, Amazon requires it.

What became clear in the questions and comments is the chaos, disarray, and at times outright nightmare Seller Support can be on what constitutes a valid certificate. The FDA not only does not issue registration certificates the Agency does not set requirements or regulations for registration certificates.

Neither does it appear that Amazon or Seller Support operate with a set of requirements for the certificates requested. This is a point I’ve raised with Amazon’s legal department. It is incredibly frustrating working with Seller Support where generic boiler plate responses are given when certificates are refused. I’ve worked on matters where Amazon Seller Support refuses a certificate because it lacked a bald eagle, or the eagle wasn’t big enough, or because the certificate lacked the word “valid.” Recently Seller Support stated only printed and scanned certificates were valid.

The question I raised with Amazon’s legal department was whether Amazon was effectively privatizing the regulatory role played by the FDA. In one case Amazon Seller Support refused a certificate on a Class I device because the initial registration number was not proof of registration. I sent an e-mail from the FDA’s Center for Devices confirming the initial registration number was sufficient to begin sales. Seller Support wouldn’t budge. Interactions like this raise serious questions.

In working with Seller Support the key is persistence. For my clients I continue to tweak the certificate to capture the information requested. There is also growing recognition of the certificates issued by my firm due to the repeated inquiries with Seller Support and the legal department. I also find that a cover letter explaining the legal basis for the certificate helpful.

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.

 

Share this:

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. Julie on November 10, 2017 at 1:23 pm

    Ive been selling my skin care line on Amazon for over 7 years with a sterling record. So imagine my dismay when I too received the request for invoices and GMP/COA/FDA registrations for my product line of skin care items. As was pointed out by a very annoyed supplier who is providing me with COA’s for over 13 products, this seems to be an underhanded way for Amazon to find our suppliers and start their own lines of skin care to shove us off of the site, as they have done in so many other categories. There should be a non-disclosure agreement, but its Amazon, and they genuinely dont give a crap about sellers. Im about to start the submission process…its going to take days. So much for trying to get ready for Black Friday and Cyber Monday.

    • Marc Sanchez on November 10, 2017 at 1:34 pm

      Julie,

      Thank you for sharing your comment and experience. It can be a struggle to meet the shifting demands of big retailers.

  2. Mai Huynh on January 26, 2017 at 3:05 pm

    What should I do to get approved on Topical products? I want to sell the nail polish which are listed as Topical Product under another seller

    • Marc Sanchez on January 26, 2017 at 3:45 pm

      To be ungated and able to sell with Amazon you will need to register with the FDA. Please feel free to contact me for more details (msanchez@fdaatty.com).

  3. Amazon FDA Registration Proof - What Works? on September 9, 2016 at 9:10 am

    […] 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 […]

  4. […] 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 […]

Leave a Comment

You must be logged in to post a comment.

Are you in trouble with the FDA?

Don’t panic — you’ve got backup. Download 5 Tips to Help You Navigate FDA Enforcement and learn how to resolve the situation right now.

Expert knowledge of FDA regulations that helps you strategically grow your business