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Amazon now requires all topical products to list manufacturer on the packaging!
Amazon has recently been adding more stringent requirements for sellers of all topical products, trying to weed out home-formulators and smaller players by requiring pre approval of the following:
1. A recent invoice with all details matching your Amazon acc (if you’re a distributor).
2. Packaging design with manufacturer name.
3. GMP certificates OR proof of FDA registration for each product.There’s also a $3000 ungating fee upon successful application, and rumor has it no overseas manufacturers are approved. Even people with all the paperwork in place are having problems, and old time sellers have their sales go to 0 as they spend months trying to get ungated for products they were already selling and now can’t restock.
I believe that this could be a positive change overall, although the lack of transparency and sudden enforcement isn’t super cosy, but the requirement to list manufacturer name strikes me as strange, given that the FDA only requires distributor OR manufacturer name listed. This means anyone using contract manufacturers will from now on be forced to disclose who their manufacturer is if they’re to sell on Amazon.
Isn’t that considered a bit of a trade secret?
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30 Replies
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Couldn’t you just list your own company as the manufacturer?
Do these changes apply when you are using the Amazon FBA system? I didn’t have to provide this stuff when I sent my pallets of product to them.
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If you’re not actually manufacturing the products, how will you get GMP certification? Alternatively if registering an OTC with the FDA you need to provide them with the actual OTC registered manufacturer to at all be able to register the product. I’m not sure how Amazon would react to you applying as a manufacturer and your FDA registration showing your manufacturer to be a different entity, I guess you could try.
The changes are gradually rolled out this year an apply to any seller selling topicals, not only FBA users AFAIK.
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If you are using a reputable manufacturer, they can provide a letter of cGMP compliance on letterhead. This is no big issue unless your manufacturer is very informal, in which case you would want to avoid them anyway. Personally, I have no issue with this. Rather than seeing it as being discriminatory to Home Crafters, you should see it as raising the bar and requiring the crafters to manufacture in a safe and credible manner. Amazon has been weeding out the non compliant products slowly. If that is a problem, there is always the entirely unregulated market in Etsy.
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Oh come on. Requiring a $3,000 dollar fee is not “raising the bar” it is outright predatory and disgraceful.
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@microformulation I’m not quite sure who you are replying to, I was asking Perry how he’d get a cGMP compliance letter if he’d states he’s the manufacturer without actually being the manufacturer..
For me this change will likely give me an advantage, the issue I raised in my post was having to disclose your CMO on the packaging, which I think is odd as it’s beyond what the FDA specifies. Personally I don’t have a problem with it as I like transparency, but it would mean having to reprint a lot of packaging to confirm with Amazon’s standard.
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I dealt with this last week for a manufacturer. They didn’t mention a $3000 fee (which I agree will be a barrier for some), but on my first draft of a cGMP Compliance Letter I drafted for them from a template, the documentation was accepted.
This is part of the increased documentation standards they came out with several weeks ago. They now also can require an MSDS.
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The exact requirements seems to be changing on a weekly basis, they may not have been required to pay a fee.
Yes MSDSs are also commonly requested if your product contains any volatile ingredient such as alcohol, I believe this is automatically searched for by some algorithm.
One thing I will say, the proficiency of evaluating these documents by Amazon seem quite variable; beyond having a the key elements they ask for there doesn’t seem to be any clear standards out there.
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Zink, I’m a little confused - as a manufacturer, we issue our own cGMP certificates. Hypothetically, if we were to choose to claim to be a manufacturer in a case where some or all of the components of our product were not manufactured in our facility (which we would never actually do, since it would be unethical), what would stop us from issuing cGMP certificates? There’s no third party issuing, approving, or otherwise certifying these things - they are just a statement that cGMP procedures have been followed. Anyone can “issue” one - the only question is how credible the issuer is.
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@Bobzchemist they require 3rd party certificates. I believe the specifics vary from state to state on how you get em. Not something I know a lot about, and I’m not sure Amazon does either.
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@Zink - I didn’t create any cGMP certificates. My contract manufacturer essentially handled all the interaction with Amazon, paperwork and shipping it to them.
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@Microformulation
you should see it as raising the bar and requiring the crafters to manufacture in a safe and credible manner.Totally agree with this. Is it really true that homecrafters could sell their home made concoctions on Amazon and Etsy without being GMP certified?
Why am I even surprised. I see a lot of crafters having their own company and they don’t even half know what they’re actually selling or making. I see it a lot in some Facebook discussions. I was astonished to see the utter lack in basic chemical knowledge and yet they had their own ‘brand’ and they were ‘CEO’ of some skincare company.
I thought regulations were very strict on cosmetic skincare, no matter the platform you’re selling from?
I’m a homecrafter myself, but I find it appalling to see that a large group just seems to think you just need a kitchen, some ingredients and not even the slightest bit of knowledge and caution and hope to see the money come pouring in. -
@Doreen81 I am in total agreement.
I have had potential clients call me several times in the last 3 years. The FDA pays a visit to their “manufacturing site” (in some cases their kitchen which is a no-no) in response to an over reaching claim posted online. (Crafters have a tendency to make these claims) The FDA shows up and as part of their inspection they have the FDA cGMP check list in hand. The Inspector hits them on numerous issues. Then they call me and ask about setting up a cGMP program which is something I don’t do. I do refer them to some sources to start with;
- https://www.fda.gov/Cosmetics/ResourcesForYou/Industry/ucm388736.htm
- https://www.fda.gov/Cosmetics/GuidanceRegulation/GuidanceDocuments/ucm2005190.htm
- https://www.amazon.com/Good-Manufacturing-Practices-Cosmetic-Handcrafters/dp/0979594545
Now, I would also like to stress that this is not limited to crafters. I have had some “manufacturers” (used loosely) call with the same issue.
Lastly, before Amazon started tightening things up I had my attention called to multiple non compliant products. One that stands out was a seller offering a 70% Glycolic Acid Solution for home use with little to no guidance. Etsy is much worse.
You can not under estimate the complexity of this market. It is not insurmountable, but one shouldn’t jump in, over estimate one’s skills, under estimate the complexity and feel that they are creating a safe product. I believe if you asked many of the Chemists on here they would honestly say that when they first started in a manufacturing environment, it was several years before they developed the skills and knowledge base needed to start their own facility. To do so with some Internet research and no practical experience can be a recipe for disaster.
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@Doreen81 - regulations are the same for big corporations or home crafters. I’m not sure I would qualify them as “very strict” but the overriding rule is that it is illegal to sell unsafe cosmetics.
Unfortunately, it seems home crafters are misinformed and ignore regulations all the time. Mostly, they suffer no consequences because the FDA has limited resources and cannot go after every violation.
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I learned something new. ICMAD issues GMP certificates.
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So, could you get a GMP certificate without actually manufacturing anything? In that case you could register as the manufacturer even if you use a CMO.
Alternatively a FDA cosmetics or OTC registration could suffice. Maybe something to try first if you don’t want to list your CMO on the packaging.
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It seems you can get a certificate through ICMAD in which list your manufacturer (“the company who does the filling”).
Then you MIGHT be able to register as the combined manufacturer/distributor on Amazon, letting you use your own company name instead of revealing your 3rd party contract manufacturer to the public.
One major caveat is that this would require both you and your manufacturer to become members, at least $500 for you, and for your manufacturer it could be several thousand depending on their sales.
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I’m in the process of adding our products into amazon FBA, we don’t have a GMP very. (Never bothered) but it does allow us to list products with a CoA. Also I don’t see any mention of $3,000 fee I’ll have to wait for approval to see.
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@sabahi how did you do with approval?
@Bobzchemist ICMAD GMP certificates are not valid, they need to reference a US or international GMP standard.
A COA or FDA registration in the voluntary cosmetics registry might work.
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I’m approved to sell topicals on Amazon. I just want to say your post is very inaccurate as I didn’t need any of these:
2. Packaging design with manufacturer name.
3. GMP certificates OR proof of FDA registration for each product.to get approved.
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Hi Problemod89.
It’s verbatim from the Amazon requirements, so it’s not or at least was not inaccurate when I posted it.
Also you might be approved, but then be hit with these requirements.
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@ZinkYou are correct. I have had several clients who have been approved for years to sell on Amazon just get a notice from them out of the blue. If they haven’t gotten one yet, it is likely coming.
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What’s the issue with listing the CMO on the product label?
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@zink still trying. Got denied about 10 times and they don’t really explain why. Possibly going to use 3rd party to get approved. Worth the cost at this point
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We got approved with a one page COA from a 3rd party analytics lab, photos of the product from all angles and manufacturer invoice for said product.
The CMO name did NOT need to be on the packaging.
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@Zink Can you share what the COA included? I assume microbial and chemical. Although, I don’t know what type of chemical analysis would be enough to satisfy Amazon’s requirements. Thank you
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