How Amazon Misclassifies Consumer Products as Medical Devices

When Amazon flags your product (for instance, by labeling it as a medical device, stating it can only be used by professionals, or labeling it as an unapproved drug), this is typically due to an incorrect classification by Amazon. In many instances, an Amazon classification for your product classifies it incorrectly as being a “medical device” or as an “unapproved drug”. Generally, a product is not classified as a medical device and is therefore not a medical device (or unapproved drug) when the product in question is available for purchase by “everyday consumers.”

The primary problem occurs when Amazon’s automated classification system does not thoroughly or adequately evaluate individual products based on their respective classifications. This is so common that Amazon routinely misclassifies normal, everyday consumer products. As we have done since 2016, we have continuously assisted brands who currently experience issues with Amazon’s classification system as a result of misclassification of their products.

When Amazon Misclassifies Products as Success

Misclassification of Supplement Products as Pain Relievers

Two listings on Amazon for supplement products were flagged incorrectly for being classified as Over-The-Counter (OTC) Pain Reliever products.

We provided proof of a valid registration as well as safety & efficacy documents and Certificate of Analysis to demonstrate that the product is a legitimate supplement. Our response was promptly approved.

Misclassification of Cosmetics

The Amazon systems incorrectly placed a listed product in the category of cosmetics, even though the product does not meet the definition for cosmetics.

We changed the listing content by removing any references to being cosmetics and provided supporting documentation for the appeal. We received approval for our appeal.

Dietary Supplement Listed as Private Label Product

The private label product was incorrectly categorized by Amazon as being classified as a dietary supplement.

In addition, there was a technical failure that precluded the updating of images. A form was filled out to document the tech issue, proof of the actual detail page, trademark registration and a Certificate of Analysis (C of A) were provided. Appeal #1 was upheld.

Unapproved Drug Item on Non Drug Item?

Amazon flagged a branded product as being classified as an unapproved drug even though that brand or trademark does not exist in any manner as being a drug.

One completed form changed the classification of the item and reinstated the list of items.

Consumer Items Classified as Professional Use Only

Two standard consumer grade products were recategorized as being medical devices of a professional grade.

The regular appeals were not successful until a legal letter requesting review was presented showing that the items do not require a 510 ( k) from the FDA and are legally sold to consumers. Both items were restored to their original status.

Personal Use Test Strips Classified as Professional Use Only

Private label professional use only urine test strips were flagged by Amazon.

Standard appeals could not be obtained. A pre-arbitration letter notifying Amazon of their responsibility for a review was sent. All items were restored.

Products Without FDA Approval May be Listed by Amazon as “Not Approved”

Amazon sent a notification to us about a product that was flagged as “Not FDA Approved” by their system. However, we can confirm this product is FDA compliant.

We have implemented additional verification procedures to ensure the product is classified correctly and that appropriate labeling is applied, as well as temporarily halting the merchant fulfilled inventory for our appeal. The account is now cleared.

Lidocaine Content Indicated for Automatic Suspension

Amazon suspended our product for containing Lidocaine. FYI, our product conforms to all federal and state regulatory guidelines for good manufacturing practices. We provided testing results to demonstrate compliance and the product was allowed to return to the marketplace after submission of our appeal.

Amazon Flagged a Lidocaine-Free Listing as Containing Lidocaine

The product was flagged by Amazon as containing Lidocaine; in fact, the product does not contain Lidocaine.

Independent testing verified that Lidocaine was not present in the product, and we submitted verification from the manufacturer that the product conformed to all federal and state regulations. We were successful in getting this appeal approved.

The Reason for Constant Classifications Error

Every Amazon product is not manually checked by a human. Instead, the company uses algorithms to examine the content of all items up for sale, such as titles, bullet points, descriptions, ingredient lists, and backend attributes.

Some keywords trigger an automatic enforcement of restricted categories too.

Certain words (e.g. relief, treat/ment, therapeutic, professional, clinical, and even drug) can cause a miscalculation classification for products based on their proper context.

For example, if you list a stress relief supplement, it may be classified as a medicine. Likewise, if you list a product to be used at home that is described as having therapeutic affect, it would be classified as being used professionally only. Lastly, if you list an item which does not provide a medical application but has a single term that could be fo guessed as unapproved by the FDA, it can also be classified as an unapproved drug.

These decisions are made automatically, and not by human beings.

How To Get a Misclassification Changed

Don’t try to fight the system; rather, prove how your item/classification should be classified by having evidence (documentation) for human reviewers to reference.

Documentation is more powerful than automation when it comes to overriding classification decisions.

Submissions containing effective documentations may be:

– Certificate of analysis that shows true make-up of item.

– Safety data sheets confirming the proper classification.

– Testing/results showing compliance.

– Trademark registration verifying how you intend to use the product.

– Manufacturer’s statement of what a product is or how to use it.

Without documentation, an appeal will never be routed to a human reviewer, and no ruling/decision will be made outside of the automation of all classifications.

If you receive repeated denials (and you will), you will need to escalate. This can occur via sending letters via legal counsel that reach other teams/organizations to review. Or, you can advise them that if you cannot resolve this matter through automated means, you will move on to Pre arbitration; this escalates/forces a senior level of review to take place on automated classifications.

What Sellers Need to Know

Why Does Amazon Misclassify Products?

Amazon’s misclassification is based on keyword recognition. Certain restricted categories can be flagged by various keywords without having regard to their context.

Will a Typical Appeal Work?

In many instances, yes, given the appeal includes full documentation. If you have multiple denials, it is likely you are stuck in an auto-response review loop.

Can Professional Use Classifications Be Reversed?

Yes, in many cases, we can demonstrate that your product is not subject to FDA 510(k) requirements and will be classified for consumer use. However, in certain cases this will require a higher level of escalation to obtain a successful result.

How Are Unapproved Drug Labels Removed?

By proving that your product is not actually a drug and providing documentation to establish the proper regulatory classification.

What Should I Do if Amazon Prevents Me From Editing My Listing?

Document the technical restriction Amazon has provided and submit evidence that demonstrates your correct classification; we have previously resolved many cases through these means.

When Is Pre-Arbitration Required?

Pre-arbitration is required when your standard appeal process, including higher level escalation documentation, fails to break the auto-responded classification loop.

Who We Are

I am CJ Rosenbaum. I am the founder of Amazon Sellers Lawyer and have been practicing law since 1995. My firm has focused exclusively on helping Amazon sellers with legal issues since 2016.

I am the author of six books specifically addressing legal issues related to selling on Amazon. The major media outlets such as The Wall Street Journal, Forbes, Bloomberg, and FOX Business use my quotes as a source for Amazon sellers’ legal advice.

I also have spoken about Amazon enforcement systems at various industry conferences such as the Prosper Show, Global Sources Summit, and Retail Global. These conferences include training workshops to help people understand what to do when they receive a notice from Amazon that they are restricted from selling on their platform.

Our firm represents sellers doing business all over the world including but not limited to the United States, Canada, Mexico, the UK, countries in the EU, Japan and other countries that operate on an e-commerce basis.

Why We Are Successful In Misclassification Cases

Farha has worked with Amazon’s Restricted Products division first. She was responsible for the systems that classify and review drugs, medical products and professional use cases.

She knows how to trigger algorithmic enforcement and what type of evidence review teams need from human reviewers to override incorrect classifications.

This experience helps us resolve a large number of cases on first appeal because we know what human reviewers at Amazon will need to see in order to reverse automated errors.