Chapter 1: What recent changes are affecting women's health products on Amazon?
If you sell any form of women's health products, you might be in for a rude awakening. My name is Noah Wickham. I'm VP of sales and marketing here at my Amazon guy.
And we have recently been seeing a swarm of different women's health products being taken off and completely removed from Amazon. So what exactly is going on here? This initially started just last week when we started getting these where it showed a restricted product's policy violation. When you dig into this product's policy violation, it actually comes up as it being a medical device.
And so what is Amazon consider a medical device and accessory and what are you supposed to do about this? Couple of different things. So essentially they have a whole entire policy about this.
I will link this exact article from Amazon support into the description down below if you do want to read more into it. but they consider it even things sold as over the counter to general consumers. So sometimes they consider supplements in that same range. So the product that got dinged over here is a women's health supplement.
And so this is obviously a really, really big deal, especially because normally in the past, anything that was over the counter never had to follow a form of exemption status or had to be considered a medical product at all. But now for any form of women's health or even vaginal health or anything like that, they are saying that this counts now for the general consumer.
So how do you get around this?
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Chapter 2: How are women's health supplements classified as medical devices?
Well, the unfortunate part is it's not going to be easy. So the FDA has a process for doing this called a five 10 K is a very specific type of exemption process or a labeling process. More likely I should say around specifically registering your product for this. I'll link this as well, which is the submission process through the actual FDA website for going through and getting a 510 K number.
It's usually going to be a seven digit code. Now, once you have your 510 K certification and number, you can take that and submit a review approval for your actual product. Now, this is also one of those freak situations where Amazon a couple of months ago had thrown out an evaluation where you could basically say, raise your hand, say, Hey, this is not right.
Well, they're not allowing it with this because anything that goes through the FDA has to actually meet a compliance guideline. And so it's one of the major reasons that Amazon has this. So you can even look as well under the compliance checklist for medical devices that essentially they are registered with the FDA.
So if you're selling even a women's health supplement and you're not registered, I would.
you either have a class one or class two non exempt medical device cleared by the FDA, you have to have again that 510 K clearance for your product class three, you actually have to go for a pre market approval, which most people shouldn't have to do is if it's just like a supplement or something like that, you also have to have very specific labeling.
So this is the part that's a little scary, because if you haven't had to have this in the past, and your product is getting flagged for this, you are going to have to update how you do your labeling. So This is a great example of essentially everything you have to include directly on all of the labeling.
You can see here the brand name, your global medical device, nomenclature, your device count, product identification, expiration date. So all of these, I think a lot of these are fairly normal when it comes to supplements, but there's some of them that you will want to be looking at. It will also affect your marketing because medical devices must not make false or misleading claims.
You also must use the claim of FDA cleared or FDA approved appropriately. One caveat there is a lot of times I wouldn't encourage you to put that into your SEO because Amazon will also ding you for that, even if you have already submitted your documentation.
so if you are somebody who currently has some form of women's health device or supplement or anything along those lines and your listing has recently been taken down i really encourage you to reach out to us here at my amazon guy we have so far successfully gotten up already five different women's health products where they have reached out to us with this exact issue and we've also coached them through how to get things like that 510k documentation and nomenclature so hopefully this isn't happening to you but if it is feel free to reach out to us here and we are more than happy
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