What to Know about COAs, GMP, and Dietary Supplements Ungating on Amazon

Imagine your situation – you have been selling in dietary supplements for the past few years. It’s one of the few strong and viable US-based private label businesses out there.

And now, you’ve received a notice from Amazon saying you need to submit your GMP certificate or a COA to be permitted to sell the products that you HAVE BEEN selling for two years. WHAT GIVES??

What Amazon is doing is cleaning up the “Grandfathered In” brands that were already in Dietary Supplements when they closed the subcategory last year. It’s now thousands of dollars to apply, and anyone new has to apply to be ungated with exactly these documents.

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So, you ask your supplier – can you give me a COA and a GMP certificate? And they say, great! yes! Here you go. You happily submit to Amazon, assuming that you’ll be able to go on your merry way.

Instead, you’re blindsided again:

Greetings from Amazon, Thank you for your interest in selling in the Dietary Supplements category. Unfortunately, you do not meet the criteria to list products in this category. For more information on about what products you can sell on Amazon, search “Categories and Products Requiring Approval” in Seller Central Help. Due to the proprietary nature of our business we are unable to disclose specific information about our reasoning for decline as it could compromise the application process. You are welcome to reapply at any time with new documentation. This doesn’t necessarily reflect poorly on you or your seller account. We evaluated the information you provided and it did not pass our approval process. We appreciate your understanding; be aware that our decision regarding this matter is final. Please let us know how we did. Were you satisfied with the support provided?

Struggling to get approval in Dietary Supplements?

Unfortunately, we’re seeing a lot of this lately, and have been working with companies struggling to get approved in dietary supplements ever since the subcategory was gated.

A COA is a Certificate of Analysis. It’s essentially a way for Amazon to see at a glance that the factory that you source from is testing regularly, under the conditions specified in standards and regulations appropriate to that product.

A GMP certificate stands for Good Manufacturing Process certificate. These are the guidelines that control authorization and licensing for the production and distribution of food, drugs, and dietary supplements in the US. 

Quite frankly, if your supplier can’t provide these correctly – RUN AWAY!! That’s a lawsuit waiting to happen.

As far as what to do now – you need to work with someone who can help you understand what’s needed on Amazon’s side and get back to selling. We specialize in policy and compliance on Amazon, and know exactly what Amazon is looking for. We regularly review documents for our clients and give them feedback on what is missing, or whether we think the documentation is so bad, they should ditch their supplier entirely.

We’d love to help you get back up and running, selling your dietary supplements on Amazon. Would you like our help?

Get your products back on to Dietary Supplements!
About the Author
Rachel Johnson Greer is a global business strategist who specializes in helping entrepreneurs increase their internet product sales, curate their brand image online and avoid catastrophic legal threats. After getting her MBA in international business at Seattle University, she spent nearly a decade at Amazon working in product development. Since then, Rachel has founded companies that reached both multi-six figure and multi-seven figure growth in under three years.

As a business coach, she supports clients in everything from international product expansion to 4x-ing their sales through online retailers. Rachel is frequently sought out by the media and has appeared on the Today Show, CNBC, Business Insider, The Wall Street Journal and Bloomberg. When she’s not working with clients, she’s scaring friends at parties with stories about the most problematic online products she’s found in their homes. She lives in Seattle, Washington.

7 thoughts on “What to Know about COAs, GMP, and Dietary Supplements Ungating on Amazon”

  1. Actually, I think it’s a good thing that Amazon is cracking down on a lot of supplements as there are dozens if not hundreds of unscrupulous companies with poor or mediocre products making exaggerated and illegal claims on Amazon. It gives the industry a black eye.

    Reply
    • I couldn’t agree more! When I first started consulting in this space, I was so surprised at how easy it was to sell products with no proof they were safe or even legal to sell. The marketplace will change significantly over the coming year, in my opinion, as Amazon continues to clamp down on unscrupulous or ignorant sellers. Thanks for your comment!

      Reply
  2. It’s crazy for re seller of known brand to even try and get COA / GMP / FDA Orange Book #. All company will say no to giving out their COA / GMP to a reseller, and FDA orange book covers only active ingredients usually. And Amazon will not accept that either.

    Reply
    • Hi Lam! This is certainly true. However, it can be issued by another entity other than the manufacturer. According to FDA’s Guidance for Industry, Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients:

      “Certificates should be dated and signed by authorized personnel of the quality unit(s) and should show the name, address, and telephone number of the original manufacturer. Where the analysis has been carried out by a repacker or reprocessor, the certificate of analysis should show the name, address, and telephone number of the repacker/reprocessor and reference the name of the original manufacturer.

      “If new certificates are issued by or on behalf of repackers/reprocessors, agents or brokers, these certificates should show the name, address and telephone number of the laboratory that performed the analysis. They should also contain a reference to the name and address of the original manufacturer and to the original batch certificate, a copy of which should be attached.”

      Please note that if you’re repackaging, bundling, or changing the product in any way, you’re considered a repacker/reprocessor for this purpose and can issue a COA if you follow the correct procedures on your own behalf.

      Reply
    • Hi Altis, you can usually receive these from the manufacturer upon request. If you don’t have one, you can work with an accredited laboratory to perform the required product testing. Hope this helps!

      Reply
  3. I am a brand owner/manufacturer and want to sell on Amazon.
    My company sells Personal Care Products (Shampoo/Conditioner/Face Serum/Face Scrub and a few others). We have caught wind that all products now sold on Amazon need to be produced in a GMP facility. Is this correct as of today, or are they going to be implementing this at a later date with the previous products grandfathered in.

    Other people on Amazon have said that you need the following as a reseller and as a primary seller where they are not the manufacturer. As the manufacturer do we need the follow to be sold in Amazon?
    #1 Certificate of Analysis (COA),
    #2 Proof of FDA registration / FDA Orange Book Application Number,
    #3 Certification of Compliance with Good Manufacturing Practices,
    #4 510 (K) Premarket Notification.

    Keep in mind that we are a Canadian company who controls 100% of our manufacturing.
    We sell personal care products.

    Our products are currently not manufactured in a GMP facility.
    We do not have a FDA registration or Orange book application #.

    Please see the #1-4 above and let me know what you think.

    The website below is not for our specific products, as we haven’t launched them yet.

    We only have our research website launched, as of now.

    Reply

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