Repeated ASIN Delisting for FDA Claims Despite Prior Amazon Approval – Need Help
Hi Sellers & Amazon Team,
I’m reaching out in hopes of gaining visibility and support from anyone who’s faced a similar issue—or from an Amazon rep who can help escalate this internally.
Our listing for ASIN: B0D47W3PGH (Somnofit-S Anti-Snore Mouth Guard+) has now been delisted twice within two months for the same reason: supposed violations related to FDA claims.
Here’s the situation:
- Our product is FDA Cleared under 510(k) K231138, which is accurate and compliant for OTC Class II medical devices.
- We have never used the phrase “FDA Approved”, nor have we ever used the FDA logo in any of our listing images, copy, or A+ content.
- On May 14, 2025, our listing was reinstated by Amazon’s internal compliance team under Case ID: 17711369971.
- This reinstatement followed an escalation by Agent Rakesh, with final approval from Agent Mehmood, who explicitly confirmed that our FDA documentation was more than sufficient and that our listing was fully compliant.
Despite this, our listing was taken down again just one week later under Case ID: 17784019701—for the exact same issue—even though no changes were made to the listing since the prior internal approval.
In response to this new takedown, we:
Re-submitted all documentation that had already been approved, including our 510(k) letter, FDA registration, invoice, product packaging, and instructions.
Removed a “FDA Cleared” emblem from one image out of an abundance of caution (even though it was previously cleared).
Clearly referenced the prior case ID and internal approval in our appeal.
Yet, we received another generic takedown response citing “FDA Approved” claims or logo use—which are not present on our listing and had not been considered non-compliant in any prior reviews, including Amazon’s own internal compliance evaluation that led to reinstatement.
We’re now stuck in a frustrating and circular loop.
We’re a small U.S.-based brand working in good faith to follow every Amazon policy to the letter. We’ve already been through a formal internal review, received explicit confirmation of compliance, and made additional good-faith adjustments—yet the listing remains deactivated for the same already-resolved issue.
Has anyone else gone through this?
How were you able to break the loop and get Seller Performance to acknowledge a prior ruling?
Is there any way to truly escalate when an internal compliance review is being overlooked?
I’d be grateful for any guidance, support—or visibility this post might get with the right Amazon team.
Thanks so much,
Chris Garvey
Co-Founder, SnoreLessNow
Repeated ASIN Delisting for FDA Claims Despite Prior Amazon Approval – Need Help
Hi Sellers & Amazon Team,
I’m reaching out in hopes of gaining visibility and support from anyone who’s faced a similar issue—or from an Amazon rep who can help escalate this internally.
Our listing for ASIN: B0D47W3PGH (Somnofit-S Anti-Snore Mouth Guard+) has now been delisted twice within two months for the same reason: supposed violations related to FDA claims.
Here’s the situation:
- Our product is FDA Cleared under 510(k) K231138, which is accurate and compliant for OTC Class II medical devices.
- We have never used the phrase “FDA Approved”, nor have we ever used the FDA logo in any of our listing images, copy, or A+ content.
- On May 14, 2025, our listing was reinstated by Amazon’s internal compliance team under Case ID: 17711369971.
- This reinstatement followed an escalation by Agent Rakesh, with final approval from Agent Mehmood, who explicitly confirmed that our FDA documentation was more than sufficient and that our listing was fully compliant.
Despite this, our listing was taken down again just one week later under Case ID: 17784019701—for the exact same issue—even though no changes were made to the listing since the prior internal approval.
In response to this new takedown, we:
Re-submitted all documentation that had already been approved, including our 510(k) letter, FDA registration, invoice, product packaging, and instructions.
Removed a “FDA Cleared” emblem from one image out of an abundance of caution (even though it was previously cleared).
Clearly referenced the prior case ID and internal approval in our appeal.
Yet, we received another generic takedown response citing “FDA Approved” claims or logo use—which are not present on our listing and had not been considered non-compliant in any prior reviews, including Amazon’s own internal compliance evaluation that led to reinstatement.
We’re now stuck in a frustrating and circular loop.
We’re a small U.S.-based brand working in good faith to follow every Amazon policy to the letter. We’ve already been through a formal internal review, received explicit confirmation of compliance, and made additional good-faith adjustments—yet the listing remains deactivated for the same already-resolved issue.
Has anyone else gone through this?
How were you able to break the loop and get Seller Performance to acknowledge a prior ruling?
Is there any way to truly escalate when an internal compliance review is being overlooked?
I’d be grateful for any guidance, support—or visibility this post might get with the right Amazon team.
Thanks so much,
Chris Garvey
Co-Founder, SnoreLessNow
0 replies
Levi_Dylan_Amazon
Hello @Seller_9LxuNuqpYvt3l,
Thank you for posting about the repeated restrictions received for one of your ASINs.
I see that after successfully resolving the previous violation, you received another for the exact same ASIN and you are seeking assistance with getting this resolved. I understand that this is causing you significant frustration, so I would like to take a look and offer assistance in any way I can.
I was able to collaborate with our partner teams to learn more details. They confirmed that this has been raised up to the appropriate team for a review to be conducted. There are no updates on the review as of yet to share. I would like to keep an eye on this review for you. Once I hear back from that team, I will reach out here to let you know.
If you have any other concerns or questions in the meantime, please let me know. The forums community and I are here to support you.
Wishing you the best,
LeviDylan