Flagged as an unapproved medical device
We are facing a very tricky situation. our listings was removed in May and was flagged as an unapproved medical device.
However, Amazon and the FDA allow these products to be sold, as long as they do not exceed a certain size and do not penetrate the skin or cause harm.
After appealing, the review team asked us to remove all possible medical claims. In fact, our product page did not contain any medical claims.
Although the FDA's regulatory documents explicitly allow marketing claims such as "exfoliation, smoother, luminous," we removed them anyway.
Then came a long wait, and they again replied, "Due to multiple attempts to add medical claims to the detail page after reinstatement, we will not be able to reinstate the ASIN. A new ASIN is required to avoid quality issues."
We contacted Seller Support and checked our optimization records for the past two years. We confirmed that there were no medical claims on the product page in each update, as FDA allowed marketing claims like "exfoliation, smoother, luminous look".
We also contacted the FDA agent and confirmed that the regulatory documents and previous ones are the same and there have been no other updates.
We created this listing has six years ago, has nearly 4600 reviews, and a 4.5 rating, we really put a lot of effort into it.
Can anyone tell us how to appeal our listing? id: 15333876061
@Dominic_Amazon@Dougal_Amazon @Stevie_Amazon@Sandy_Amazon@Ricardo_Amazon
Does anyone know if the jeff@amazon.com is still working?
Thanks!
Flagged as an unapproved medical device
We are facing a very tricky situation. our listings was removed in May and was flagged as an unapproved medical device.
However, Amazon and the FDA allow these products to be sold, as long as they do not exceed a certain size and do not penetrate the skin or cause harm.
After appealing, the review team asked us to remove all possible medical claims. In fact, our product page did not contain any medical claims.
Although the FDA's regulatory documents explicitly allow marketing claims such as "exfoliation, smoother, luminous," we removed them anyway.
Then came a long wait, and they again replied, "Due to multiple attempts to add medical claims to the detail page after reinstatement, we will not be able to reinstate the ASIN. A new ASIN is required to avoid quality issues."
We contacted Seller Support and checked our optimization records for the past two years. We confirmed that there were no medical claims on the product page in each update, as FDA allowed marketing claims like "exfoliation, smoother, luminous look".
We also contacted the FDA agent and confirmed that the regulatory documents and previous ones are the same and there have been no other updates.
We created this listing has six years ago, has nearly 4600 reviews, and a 4.5 rating, we really put a lot of effort into it.
Can anyone tell us how to appeal our listing? id: 15333876061
@Dominic_Amazon@Dougal_Amazon @Stevie_Amazon@Sandy_Amazon@Ricardo_Amazon
Does anyone know if the jeff@amazon.com is still working?
Thanks!
0 replies
Manny_Amazon
Hello @Seller_egSUnPBHJLlYL,
I'm sorry you're having trouble appealing your product. I have reviewed your issue and can confirm that the product has been identified as a microneedling skin roller or similar product that is considered a medical device due to either (1) the product’s technical characteristics, as the product’s needle length is greater than 0.3 mm, (2) the inclusion of medical marketing claims in the product details and/or images, or (3) a combination of both technical characteristics and marketing claims.
I would recommend reviewing Listings Lounge: There is no way THIS is a Medical Device! Appealing Your Product IS NOT a Medical Device. This includes specific steps you can take to appeal that your product is not a medical device. If you want to appeal the status of your product you will need to ensure the following:
- Ensure you know all the Laws, Regulations, and Policies that might apply to your type of product.
- Ensure that your product detail page, product packaging, and instructions do not include any Medical Claims. You can learn more about what these claims might look like on the Prohibited Product Claims help page. (Please note that if the claims are on the product packaging or instructions, the product will be ineligible to appeal it’s not a medical device)
In any appeal you will want to include photos of all sides of the product packaging, photos of each page of the instructions. Depending on the nature of the restriction you may need to provide additional details.
Thanks and have a great day.
- Manny
