Genuine documents get rejected here every day, because they answer a question the notice did not ask.
For cases we accept: the product and its intended use, the exact requirement in the notice, the official record that matches it, and every claim surface reconciled.
A real person reads your case and replies within about an hour.
ASA Compliance Group operates Amazon Sellers Appeal. On FDA files we reconcile product, claims and official record, then either correct the catalog or evidence the status that already supports it. We are not regulatory counsel.
Include what the product is and what it is for, photographs of the label and packaging, and any regulatory documents already sent. Four short steps. Or Shamosh reads every intake.
Or Shamosh · Founder and lead strategist
5,500+ enforcement cases since 2016. Every intake is personally assessed before acceptance.
Send what you have, including prior DIY or agency appeals. We say what is viable in writing before you commit.
Questionnaire
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* Across ASA’s accepted and fully managed enforcement cases (all notice types we take on), not FDA matters alone. Details under Proof.
There is no single FDA document problem. Amazon may be testing whether the product is a drug, a medical device, a cosmetic, a food, a supplement or something else; whether the registration, listing, clearance, approval, labelling or documentation that category requires exists; whether an approval claim is accurate; or whether the listing itself moved the product into a regulated category.
So the first job is narrow and unglamorous: read what the notice actually asked for. A response that supplies a genuine document answering a different question is the commonest way these cases stall, and it can repeat for months.
The vocabulary, because these six are routinely used as if they meant the same thing:
For medical devices, an establishment registers with FDA and a device is listed. Both say a facility or product is on record. Neither says anything was reviewed. Other FDA-regulated categories use different registration, listing, application or authorisation systems, so read which one your notice names.
Different review pathways with different evidence behind them. Both are decisions about a specific product, not a company.
An exemption removes one requirement under stated conditions. Compliance is meeting whatever still applies, which is usually more than nothing.
Common Amazon notices refer to 510(k) clearance or exemption for a medical device, an NDC or drug listing, or a New Drug Application. These records are not interchangeable, and an NDC listing does not mean FDA approval - the directory says so itself, stating that inclusion does not indicate the products are FDA-approved.
FDA states the first distinction itself, in its own guidance on registered versus approved, and describes what registration and listing are. Amazon's side sits in restricted products and its document requirements. Where the finding is eligibility rather than classification it belongs with restricted products, and where it is testing or an incident it belongs with product safety compliance. This page is diagnostic: regulatory conclusions depend on product facts and jurisdiction, and belong with qualified review.
Most of these are not sellers offering unlawful products. They are ordinary goods whose paperwork or wording placed them somewhere unintended.
The product genuinely falls in a regulated category and the record that category requires is missing, belongs to someone else, or was never obtained. This is the branch where the answer may be that the product cannot be offered until something real changes.
Establish the category first from the product and its intended use. Working backwards from the document you happen to hold is how a case acquires a second problem.
The listing says approved, cleared or certified when the record does not support that word. Sometimes the seller believed it; registration certificates are often presented by suppliers in ways that invite exactly this reading.
The most common branch, and the most fixable. An ordinary product acquires a regulated intended use because of what the listing says it does. The physical item never changed; its described purpose did.
Intended use can be communicated in the title, bullets, images, enhanced content, video, backend terms, packaging, inserts, instructions or linked marketing. Which is why editing the title alone leaves the classification exactly where it was: see medical claims compliance for that analysis in full.
The record is genuine and belongs to a different legal manufacturer, model, product code, intended use, applicant or address. Suppliers share documents freely and the coverage rarely travels with them.
Where you rely on another entity's record, the file needs the authorisation and the model-to-listing mapping as well as the record itself.
Language describing diagnosis, treatment, mitigation or prevention of disease is the wording that most often moves a product, and it does not require the word medical to appear anywhere. A structure or function statement may or may not have that effect: it depends on the product category, the intended use and the exact wording, so read the three together rather than treating any such phrase as decisive.
Where the same language is printed on the unit, its packaging or its instructions, a catalog edit leaves the underlying position untouched. The physical and the digital both have to reach a compliant state, and they are corrected by different means.
Reviewers are matching a specific requirement against a specific product. Genuine documents fail that match constantly.
An establishment registration or database listing sent to answer a request for clearance or approval. They are different records.
A record belonging to a different manufacturer, model, applicant or intended use, with no authorisation and no mapping to the product sold.
The obvious phrase removed while the same intended use remains in bullets, images, enhanced content, video, backend terms, packaging or inserts.
The product called a cosmetic or a wellness item while its own claims describe diagnosis, treatment or prevention.
Screenshots, partial records or documents with anything altered. Originals are checkable; edits end the conversation.
The catalog corrected while the unit, its packaging and its instructions still carry the claim that created the classification.
What the product is, what the notice asked for, and the record that connects them. In that order, because the third depends on the first two.
Record the exact request and any rejection reasons, the listing, the product type, the category and the marketplace. Then describe the product physically: what it is made of, how it works, whether it has a powered function, a delivery mechanism, a measurement or an active ingredient. Regulatory category follows from function and intended use, and both are established from the object.
Photograph the whole label and packaging, the instructions, the warnings, the ingredients or materials, the model numbers and the manufacturer or importer identity. What the unit says about itself is often decisive and is frequently the part nobody has looked at.
Capture every surface that could carry intended use, current and historical, because the classification may have been driven by content that is no longer visible:
Mark each as compliant, to be corrected, or defensible. A claim that is accurate and permitted for a genuinely regulated product should not be deleted in a panic; removing legitimate content can weaken a correct classification argument.
Then the official evidence appropriate to the category: the registration or listing, the clearance, the approval, the monograph status, the drug listing context, or the exemption basis, mapped to the exact manufacturer, model and intended use. Where you rely on another entity's record, add the authorisation and the mapping.
Say plainly what each record establishes and what it does not. A file that claims less and proves it reads far better than one that overstates and gets checked, and the checking here is against public databases.
Catalog corrections run through prepared, uploaded, processed and live-verified. Physical corrections have their own states, and inventory already produced does not change because a page did. Report each honestly, and see incorrect detail page for the catalog half.
Where the requirement is documentation rather than correction, Amazon's compliance submission route is the path, and the document requirements in its product-document rules decide whether what you send is usable at all.
If you are relying on a supplier's document, say whose it is. That single fact changes what the file needs, and discovering it late has cost cases weeks.
Scoped historical outcomes on cases we accepted and fully managed. One seller voice below; deeper galleries live on account reinstatement.
Population: historical cases ASA accepted and fully managed (we prepared the compliance response and ran follow-ups in Seller Central). The figure combines reinstatement and restoration work across notice types in that managed population, not FDA matters alone. Declined intakes and self-serve template buyers are not in the rate.
Success: reinstatement or restoration of the privileges Amazon had restricted for that file (account, listing, verification, funds, or related, depending on the case). Amazon decides every outcome; the rate is not a guarantee for future cases.
Review: the underlying records were independently reviewed. Verified as of .
More methodology context and galleries: account reinstatement proof.
“In less than 24 hours after the appeal, my account was reactivated with all products available for sale.”
More outcomes and video proof: account reinstatement proof.
For sellers who already have the Performance Notification. Broader questions: full FAQ library.
If Amazon requested FDA documents or reclassified your product, start with the questionnaire.
Listing removed rather than mis-described: listing reinstatement. Other notice names: all suspension types.
