Another Q4 surprise from Amazon! If you sell topicals on Amazon.com, you’ll want to know more about how to respond and handle this new vetting requirement.

What is a “topical”? In a nutshell, it’s anything that goes on your skin: ointments, creams, serums, even cosmetics are considered topicals. If you’re currently selling topicals on Amazon.com right now, there’s a good chance this change is already on your radar.

What are sellers receiving from Amazon?

Recently, sellers have been receiving the following notice regarding their topicals listings on Amazon:

Dear Seller,

You are receiving this message because you are currently offering one or more Topical products for sale on Amazon, or you have offered the products for sale in the past.

The information described below affects your ability to sell these products on Amazon.com.

As part of our ongoing efforts to provide the best possible customer experience, we are implementing requirements to sell Topical products. Effective December 8, 2017, you will need approval to sell Topicals. If you do not obtain approval, your Topical products will be removed. There is no fee associated with this application.

Effective immediately, you can only update your listings for price and quantity. Re-activating inactive listings and adding new listings is restricted until an application is approved. If you use a Bulk Upload File or Inventory File to update your listings, please make provisions to prevent any changes other than price and quantity. Any update other than price and quantity will deactivate your listings until the application is approved.

To apply for approval submit an application for an ASIN within Topicals by following the steps below:
1. In Seller Central, go to Inventory > Add a Product.
2. Run a search for the item you wish to sell.
3. In the search results, click the ‘Listing limitations apply’ link for the item.
4. Click the ‘Request approval’ button to begin the application process.

To check the status of an application, return to the ‘Add a Product’ tool and click the ‘Selling application status’ link towards the top of the page.

We appreciate your cooperation, and thank you for selling on Amazon.

Sincerely,

Amazon Services
Amazon.com
https://www.amazon.com

Why we are happy about this development

For the time being, the requirements are the same as many other subcategories Amazon has already gated, so as expected, you’ll be providing invoices and compliance documents.

If you’re selling something that goes on someone’s skin, it’s a likely bet that you have ready access to the documents you need, if the product(s) you’re selling are legit.

This gating of the Topicals category is an effort to ferret out the non-legitimate products and sellers, and is a welcome change.

  • As a buyer, it means that they can confidently purchase topical products on Amazon, knowing that what they’re getting is approved and tested safe.
  • As a seller, it means that you are among other approved sellers. No more reviews showing up on your listings, for a product that some other seller sold, with cringe-inducing complaints of skin irritation and damage, and the emotional distress that goes along with it.

It’s a win/win.

So then, you’ve got to get ungated! And it’s not as rough as it sounds. We’re seeing a lot of chatter on this right now; really great questions that a lot of people probably have too, and we’re also seeing a bit of anxiety and confusion.

We wanted to address some of the questions that have been coming up from sellers, to better inform you, and also ease some of this concern.

Frequently Asked Questions

I have a lot of products I’m listing, but Amazon didn’t say which ASINs would be taken down.  Does anyone know the best way to identify items Amazon may have assigned to this “Topical” category?

Yes! As a company full of former Amazonians who worked in the Compliance departments at Amazon, we know what a topical is, and what the documentation is that Amazon is requesting.

Classifying your products based on claims, ingredients, and use is how Amazon decides whether your product is a topical in the first place, and they’re getting much better at reclassifying your product back into the correct category if you upload it into a different category than it belongs in.

If the product is GMP or has FDA approval, then why would each seller need to be applying? It seems redundant.

First, GMP stands for Good Manufacturing Practices and is a manufacturer level audit certification. This only has to do with their factory conditions. Items that go on or in your body should always be manufactured in a facility that has GMP certification.

Second, the FDA does not provide approval for much of anything sold on Amazon… approvals are usually limited to medical devices, new food additives, and drugs. What Amazon wants from you is the certificate from the manufacturer, or the Certificate of Analysis that shows compliance with FDA regulations.

As far as why each seller needs to apply, Amazon has to validate the provenance of the goods. That is to say, they need to know where it came from. You need to prove where your particular goods come from.

Because unfortunately, there are many sellers with less than pristine sourcing approaches, and, as mentioned Amazon wants to ferret them out. That’s what this is all about.

The logistical difficulty of validating that product A, for which the COA was submitted, also applies to these other products is difficult to standardize.

The manufacturers we work with do not have these documents. Of course they have MSDS, will that work?

No. An SDS is covering the safety of use, storage, and handling, which isn’t related to the potential contamination of the product with yeast growth, bacteria, or heavy metals, which is what a Certificate of Analysis is for.

Thus, if your supplier appears to be unaware of the need for a certificate of analysis, you are either in for a significant amount of oversight as a private label seller, or you need a new supplier.

You must, absolutely must, be able to demonstrate compliance.

It looks like to get FDA registration online is very expensive, in the thousands of dollars! Do I really need to register?

If you are reselling a product, it is not going to be necessary for you to register. All you need is the proof that the product meets FDA regulations. This would come from the manufacturer, who has already done their due diligence and obtained their FDA registration. You should be able to look this up on the FDA’s website, although we have to warn you that their website is one of the more annoying US government agency websites to navigate. It’s also one of the oldest agencies, so it’s understandable, but can be quite frustrating.  

They are the ones who pay those thousands each year, not you! Ain’t life sweet?

However, if you’re importing items yourself, you do need to register. There are limited situations in which a seller or repacker is also required to register.