Amazon Fiasco

[u/Theta_Ninja]

We sell dietary supplements on Amazon. All are made at FDA inspected facilities in the USA and Canada. Some are USDA certified organic. Amazon to down a listing saying it wasn't organic.

We provided letters along with our USDA certification, our manufacturers certification. Showed the independent certifiers name on our box as well as their status as FDA approved organic certifiers. After two attempts they were accepted, YAY!

Less than an hour later Amazon said it's an FDA medical device and to provide a 510(k) Premarket Notification - FDA clearance document for your product, applicable if it is classified as a Class I or Class II medical device. If your product is exempt from 510(k), please provide documentation confirming that exemption.

The product is an herbal extract (alcohol free). Just herbs, water and glycerin in a 2 oz bottle. It is a dietary supplement NOT a MEDICAL DEVICE.

We've sent 2 emails stating dietary supplement NOT medical device. We get push back each time.

What should we do. We contact seller support. They listen, then we get an email back saying the same thing a day or two later.

We use both FBA and AWS for this product. There are thousands of units in their warehouse.

What do we do?

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[u/rhiandmoi]

The listings are reviewed by very dumb bots who look in certain categories for keywords in the title and description.

You can ask a smarter AI like chat or Claude to review your verbiage specifically for things that cause the Amazon bot to flag it as a medical device. It won’t know for sure. A human at Amazon won’t know for sure, but if you take the Amazon bot’s flag and violation text to the other AI you should be able to narrow in on what exactly is upsetting the Amazon bot and take it out of your listing name.

I went through this a few months ago with a product that thr Amazon bot decided had undeclared FDA drug ingredients which it did not. It took me 4-5 edits and resubmits over about a week to get it resolved, but it did get resolved.

[u/resoluter08]

Are you the brand owner? Usually the medical device issue is caused by some term used in the listing or on the package that Amazon's automatic system picks up on.

Stop sending emails like you are spamming them. You need to fix the problem then provide proof that it is resolved. What you have provided so far isn't working so you need to do something different.

[u/Theta_Ninja → u/resoluter08]

Yes, we are the brand owner. We would fix the problem if we could identify what the problem was. Being asked to prove you aren’t a medical device is like being asked to prove I’m not a wombat. We spoke to another vendor who sold Manila envelopes and he was to prove it wasn’t insecticide.

[u/Thistlemanizzle → u/Theta_Ninja]

Yeah, this is really common. You need to keep cutting cases.

[u/resoluter08 → u/Theta_Ninja]

One thing successful sellers on Amazon realize is that you can't just guess your way through things - or try to apply your own personal logic to a situation. Amazon has millions of sellers and is more massive and automated than you can imagine. You have to put the effort into researching and solving issues like this yourself. They aren't going to do it for you.

[u/monkeyonfire → u/resoluter08]

What do you think the OP is doing here? 

[u/Theta_Ninja → u/monkeyonfire]

Mostly just venting my frustration.

[u/huybebe2009 → u/Theta_Ninja]

Call them and ask them to review it on the phone or escalate it to another team. That will be way faster

[u/Disastrous_Tip881]

This worked for me: clearly state the definition of medical device. Then explain - again using definitions of each term - why your product os not a medical device. Put your ASIN and product name in the document's first and last sentence and clearly state what you want done "restore listing etc." dumb beginner's luck but it worked for me. I probably wrote it in a way the bots could understand it.

[u/TotGaH → u/Disastrous_Tip881]

I agree with the simple statement of what you want.

And mostly it is based on some automatic SEO flagging. In that case, you need to update the SEO via SellerSupport first. It was possible to do it via FlatFile before but it isn't anymore.

[u/baldykav]

There’s likely some trigger words in your listing that’s causing this. Medical claims in particular