Hello Amazon Team & Fellow Sellers,
I am reaching out for clarification and assistance regarding the recent suspension of our lidocaine-based product listing, despite being within FDA-approved OTC limits (4% Lidocaine).
We have submitted multiple supporting documents, including:
- Screenshot of Amazon’s Policy
- FDA Registration Screenshot of the Supplier showing NDC code same as on product packaging
- Supply Agreement from China
- Supplier Invoice
- Authorization Letter from the Brand Owner
- Distribution Agreement
- Product packaging images all sides
However, we keep receiving a generic rejection stating:
“This product has been identified as containing lidocaine, which may be a prescription-only active ingredient. Amazon policy prohibits the sale or listing of products that require a prescription or a medical professional’s supervision or direction for their use on Amazon.com. If your product is an OTC drug and you believe that this determination has been made in error, please appeal with the Drug Facts for your product showing the ingredients and concentration information. If your product is a lab product, please appeal with the SDS showing ingredients and concentration information.”
The confusion is there are other sellers with similar or higher concentration (5%) of lidocaine who remain active. (When asked, Amazon support says these listings “will be removed soon”, but they have been active for years.). We get contradictory responses from Account Health Support. (Some reps say Amazon does not allow Lidocaine at all, which contradicts existing live listings. Others claim FDA OTC approval does not apply to Amazon policies, suggesting Amazon has separate restrictions.) Also, there's no Specific Policy Violation Cited. (We were told the listing was removed due to policy violation but were not provided with an exact reference or missing compliance requirement.)
We really need help with what should be done to fix the issue and looking for guidance from other sellers who are selling Lidocaine containing products. Also, we really want Amazon associates to help us identify the issue correctly so we can address it and get our listings activated we are losing sale as our product ranked among top Amazon choice products.
Thanks!
@Seller_pAPBCLhysbW5T
@Seller_rl7kltrMnkHFJ
@Seller_SBIjJooGeXSQ6