Amazon Fiasco

Posted by 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?