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Seller_7MTQs5zLnXpYe

Ongoing Listing Flagged as “Unapproved Drug” Despite FDA OTC Compliance.

I’ve been dealing with ongoing issues related to two topical products I’ve sold successfully on Amazon for over a year. Both are legally sold in the U.S. under the FDA OTC monograph system and are properly labeled as external-use only. Each contains a well-known active ingredient that is compliant under CFR guidelines and falls within the FDA’s approved OTC concentration range.

Despite this, both ASINs were recently removed and flagged as “unapproved drugs” or “consumable products” that don’t meet Amazon’s standards. I’ve submitted MSDS documentation, FDA monograph references, updated Drug Facts panels, and a full compliance explanation. However, the appeals continue to get denied — often with vague or copy/paste responses.

In one case, the listing was wrongly flagged due to an old image that’s no longer in use (updated months ago). In the other, it appears the system may be incorrectly classifying the product as a consumable, despite clear “external use only” labeling.

I’ve asked for a manual review by the compliance team, but I haven’t been able to get it escalated.

Has anyone had success getting a situation like this resolved when a product is flagged incorrectly due to system issues or lingering image data?

Any advice or ways to trigger a true compliance-level review would be appreciated. I’ve already submitted extensive documentation, but I’m open to suggestions from sellers who’ve been through something similar.

Any help would be superrrr helpful!

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11 replies
Tags:Product compliance
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user profile
Seller_7MTQs5zLnXpYe

Ongoing Listing Flagged as “Unapproved Drug” Despite FDA OTC Compliance.

I’ve been dealing with ongoing issues related to two topical products I’ve sold successfully on Amazon for over a year. Both are legally sold in the U.S. under the FDA OTC monograph system and are properly labeled as external-use only. Each contains a well-known active ingredient that is compliant under CFR guidelines and falls within the FDA’s approved OTC concentration range.

Despite this, both ASINs were recently removed and flagged as “unapproved drugs” or “consumable products” that don’t meet Amazon’s standards. I’ve submitted MSDS documentation, FDA monograph references, updated Drug Facts panels, and a full compliance explanation. However, the appeals continue to get denied — often with vague or copy/paste responses.

In one case, the listing was wrongly flagged due to an old image that’s no longer in use (updated months ago). In the other, it appears the system may be incorrectly classifying the product as a consumable, despite clear “external use only” labeling.

I’ve asked for a manual review by the compliance team, but I haven’t been able to get it escalated.

Has anyone had success getting a situation like this resolved when a product is flagged incorrectly due to system issues or lingering image data?

Any advice or ways to trigger a true compliance-level review would be appreciated. I’ve already submitted extensive documentation, but I’m open to suggestions from sellers who’ve been through something similar.

Any help would be superrrr helpful!

Tags:Product compliance
10
32 views
11 replies
Reply
11 replies
user profile
Cooper_Amazon

Good Afternoon @Seller_7MTQs5zLnXpYe,

I wanted to reach out to you regarding the two ASINs you have been dealing with that are being flagged as OTC medication. I have gone ahead and escalated all the corresponding cases and documents you sent to support. While I cannot guarantee they will change their decisions that you have already been told on the previous cases, it doesn't hurt to get a fresh pair of eyes to review the situation again to see if anything is being left out. I will follow up with you as soon as I hear back from them. Until then, have a great rest of the week.

Sincerely, Cooper_Amazon

10
user profile
Cooper_Amazon

Good Morning @Seller_7MTQs5zLnXpYe,

I wanted to follow up with you to let you know that I have heard back from the partner team and they are unable to reinstate the 2 ASINs (ending in S6J4 and 1VPR) as they require National Drug Code (NDC) for US and/or a Drug Identification Number (DIN) for CA to validate that the product has been approved for OTC use.

I know this is not the news that you were hoping for but at least we were able to have a second pair of eyes review the case. Please let me know if you have any questions about the outcome of this case.

Sincerely, Cooper_Amazon

10
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Seller_7MTQs5zLnXpYe

Ongoing Listing Flagged as “Unapproved Drug” Despite FDA OTC Compliance.

I’ve been dealing with ongoing issues related to two topical products I’ve sold successfully on Amazon for over a year. Both are legally sold in the U.S. under the FDA OTC monograph system and are properly labeled as external-use only. Each contains a well-known active ingredient that is compliant under CFR guidelines and falls within the FDA’s approved OTC concentration range.

Despite this, both ASINs were recently removed and flagged as “unapproved drugs” or “consumable products” that don’t meet Amazon’s standards. I’ve submitted MSDS documentation, FDA monograph references, updated Drug Facts panels, and a full compliance explanation. However, the appeals continue to get denied — often with vague or copy/paste responses.

In one case, the listing was wrongly flagged due to an old image that’s no longer in use (updated months ago). In the other, it appears the system may be incorrectly classifying the product as a consumable, despite clear “external use only” labeling.

I’ve asked for a manual review by the compliance team, but I haven’t been able to get it escalated.

Has anyone had success getting a situation like this resolved when a product is flagged incorrectly due to system issues or lingering image data?

Any advice or ways to trigger a true compliance-level review would be appreciated. I’ve already submitted extensive documentation, but I’m open to suggestions from sellers who’ve been through something similar.

Any help would be superrrr helpful!

32 views
11 replies
Tags:Product compliance
10
Reply
user profile
Seller_7MTQs5zLnXpYe

Ongoing Listing Flagged as “Unapproved Drug” Despite FDA OTC Compliance.

I’ve been dealing with ongoing issues related to two topical products I’ve sold successfully on Amazon for over a year. Both are legally sold in the U.S. under the FDA OTC monograph system and are properly labeled as external-use only. Each contains a well-known active ingredient that is compliant under CFR guidelines and falls within the FDA’s approved OTC concentration range.

Despite this, both ASINs were recently removed and flagged as “unapproved drugs” or “consumable products” that don’t meet Amazon’s standards. I’ve submitted MSDS documentation, FDA monograph references, updated Drug Facts panels, and a full compliance explanation. However, the appeals continue to get denied — often with vague or copy/paste responses.

In one case, the listing was wrongly flagged due to an old image that’s no longer in use (updated months ago). In the other, it appears the system may be incorrectly classifying the product as a consumable, despite clear “external use only” labeling.

I’ve asked for a manual review by the compliance team, but I haven’t been able to get it escalated.

Has anyone had success getting a situation like this resolved when a product is flagged incorrectly due to system issues or lingering image data?

Any advice or ways to trigger a true compliance-level review would be appreciated. I’ve already submitted extensive documentation, but I’m open to suggestions from sellers who’ve been through something similar.

Any help would be superrrr helpful!

Tags:Product compliance
10
32 views
11 replies
Reply
user profile

Ongoing Listing Flagged as “Unapproved Drug” Despite FDA OTC Compliance.

by Seller_7MTQs5zLnXpYe

I’ve been dealing with ongoing issues related to two topical products I’ve sold successfully on Amazon for over a year. Both are legally sold in the U.S. under the FDA OTC monograph system and are properly labeled as external-use only. Each contains a well-known active ingredient that is compliant under CFR guidelines and falls within the FDA’s approved OTC concentration range.

Despite this, both ASINs were recently removed and flagged as “unapproved drugs” or “consumable products” that don’t meet Amazon’s standards. I’ve submitted MSDS documentation, FDA monograph references, updated Drug Facts panels, and a full compliance explanation. However, the appeals continue to get denied — often with vague or copy/paste responses.

In one case, the listing was wrongly flagged due to an old image that’s no longer in use (updated months ago). In the other, it appears the system may be incorrectly classifying the product as a consumable, despite clear “external use only” labeling.

I’ve asked for a manual review by the compliance team, but I haven’t been able to get it escalated.

Has anyone had success getting a situation like this resolved when a product is flagged incorrectly due to system issues or lingering image data?

Any advice or ways to trigger a true compliance-level review would be appreciated. I’ve already submitted extensive documentation, but I’m open to suggestions from sellers who’ve been through something similar.

Any help would be superrrr helpful!

Tags:Product compliance
10
32 views
11 replies
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Cooper_Amazon

Good Afternoon @Seller_7MTQs5zLnXpYe,

I wanted to reach out to you regarding the two ASINs you have been dealing with that are being flagged as OTC medication. I have gone ahead and escalated all the corresponding cases and documents you sent to support. While I cannot guarantee they will change their decisions that you have already been told on the previous cases, it doesn't hurt to get a fresh pair of eyes to review the situation again to see if anything is being left out. I will follow up with you as soon as I hear back from them. Until then, have a great rest of the week.

Sincerely, Cooper_Amazon

10
user profile
Cooper_Amazon

Good Morning @Seller_7MTQs5zLnXpYe,

I wanted to follow up with you to let you know that I have heard back from the partner team and they are unable to reinstate the 2 ASINs (ending in S6J4 and 1VPR) as they require National Drug Code (NDC) for US and/or a Drug Identification Number (DIN) for CA to validate that the product has been approved for OTC use.

I know this is not the news that you were hoping for but at least we were able to have a second pair of eyes review the case. Please let me know if you have any questions about the outcome of this case.

Sincerely, Cooper_Amazon

10
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user profile
Cooper_Amazon

Good Afternoon @Seller_7MTQs5zLnXpYe,

I wanted to reach out to you regarding the two ASINs you have been dealing with that are being flagged as OTC medication. I have gone ahead and escalated all the corresponding cases and documents you sent to support. While I cannot guarantee they will change their decisions that you have already been told on the previous cases, it doesn't hurt to get a fresh pair of eyes to review the situation again to see if anything is being left out. I will follow up with you as soon as I hear back from them. Until then, have a great rest of the week.

Sincerely, Cooper_Amazon

10
user profile
Cooper_Amazon

Good Afternoon @Seller_7MTQs5zLnXpYe,

I wanted to reach out to you regarding the two ASINs you have been dealing with that are being flagged as OTC medication. I have gone ahead and escalated all the corresponding cases and documents you sent to support. While I cannot guarantee they will change their decisions that you have already been told on the previous cases, it doesn't hurt to get a fresh pair of eyes to review the situation again to see if anything is being left out. I will follow up with you as soon as I hear back from them. Until then, have a great rest of the week.

Sincerely, Cooper_Amazon

10
Reply
user profile
Cooper_Amazon

Good Morning @Seller_7MTQs5zLnXpYe,

I wanted to follow up with you to let you know that I have heard back from the partner team and they are unable to reinstate the 2 ASINs (ending in S6J4 and 1VPR) as they require National Drug Code (NDC) for US and/or a Drug Identification Number (DIN) for CA to validate that the product has been approved for OTC use.

I know this is not the news that you were hoping for but at least we were able to have a second pair of eyes review the case. Please let me know if you have any questions about the outcome of this case.

Sincerely, Cooper_Amazon

10
user profile
Cooper_Amazon

Good Morning @Seller_7MTQs5zLnXpYe,

I wanted to follow up with you to let you know that I have heard back from the partner team and they are unable to reinstate the 2 ASINs (ending in S6J4 and 1VPR) as they require National Drug Code (NDC) for US and/or a Drug Identification Number (DIN) for CA to validate that the product has been approved for OTC use.

I know this is not the news that you were hoping for but at least we were able to have a second pair of eyes review the case. Please let me know if you have any questions about the outcome of this case.

Sincerely, Cooper_Amazon

10
Reply
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