Approval to sell Dietary Supplements


#25

Amazon has completely changed the approval to sell supplements. Regardless of whether you’ve been approved in the past, you will need to provide the info below, exactly as written. CoA’s / GMP certs / Invoice from the supplier are no longer acceptable.

There doesn’t seem to be any notification of these new requirements, you just need to stumble upon them by finding locked out listings.

The new requirements go above and beyond current federal GMP guidelines so it’s going to be hard for many sellers to comply. Notably, most CM’s do their own testing and of course compile multiple lab tests for their CoA QC release. That document, which is in line with US regulations will not work with the new approval requirements.

Additionally, non standardized herbals will be a significant challenge. New requirements are to validate SFP (supplement facts panel not seller fulfilled prime) with ISO 17025 testing. Those of us in the know are aware that bulk herbs do not have markers to test and are always listed as “by input” referencing the formulation spec.

We welcome these new changes to remove the bad actors however because they differ from the law it will be a challenge for those selling herbs and for other reasons. The further difficult issue we all face is there is nobody to discuss this with at Amazon to have meaningful detailed conversations. What that means is some sellers, who are following the letter of the law / policies will be undoubtedly shut down without recourse.

Certificate of Analysis

  1. Must Contain lot number and manufacture date
  2. Expiration Date must not be in the past
  3. Includes the name and address of the manufacturer or distributor
  4. Must be issued by an ISO 17025 certified laboratory
  5. COA issued within the last 6 months
  6. COA must contain quantitative analysis to support the active ingredient concentration as claimed on the supplement facts panel.
  7. Must include item name.

**Here’s the info they need the seller to enter into the screen for the lab / COA

  • Name of ISO Certified Lab
  • Lab Address
  • Lab Contact Number
  • Lab Email Address
  • Report Date

Letter of Guarantee from Manufacturer (LoG)

  1. Must be printed on your company letterhead.
  2. LoG must contain complete product name as listed on label.
  3. LoG must contain an assurance that the product is manufactured under current Good Manufacturing Practices.
  4. LoG must contain an assurance that only lawful and safe, as defined in section 402 (f) of the FD&C Act, ingredients are utilized.
  5. LoG must contain an assurance that concentration of active ingredient(s) as stated on the label and labeling is safe for consumption.

#26

First of all, great answer. My experience so far, having been through one of these notifications, matches what you say.

Regarding the non-standardized herbals, my understanding is that Amazon will at some point require identity tests for those. Pretty much any herbal ingredient can be confirmed using an identity test.

However, phase 1 of this process is definitely focusing on testable active ingredients (e.g. gingerols or curcumin). As far as I know, supplements that only contain non-standardized ingredients have not been subject to this notification yet.

Would love to hear your thoughts too.


#27

Not true. We have a product that contains a vitamin, a mineral, and a bulk herb (Ginger Root).

It’s this item out of all of our listings that’s having its data requested.

This stupid blizzard, coupled with some internal Covid issues is delaying us in preparing everything needed for submission.

We anticipate submitting our documents for this product late next week or early the next.

Will follow up on the various threads with an update.

Identity testing would be nice and easy for us as we already require that data from our RM suppliers prior to production.


#28

That was selected because you have a specified, testable amount of the vitamin and mineral.

If you have any supplements that contain only bulk herbs (or herbal extracts without standardizations) on the label, my understanding is they won’t be tested during this initial phase. If the bulk herb is combined with other, testable items, then you may have to do the identity test.

Alkemist does all the identity testing and they are ISO 17052 certified. It’s really expensive though.

Good luck!


#29

No problem here. Have it all already. They can take a look at the 5000+ documents we have for roughly 25 products or our 44 page SOP manual and we aren’t even the manufacturer. Stability data too. YES - Testing is very expensive. Let’s see how many listings vanish from those that don’t do what they are supposed to. :face_with_raised_eyebrow:

All Buttoned Up


#30

Hi @ASV_Vites, thanks for sharing your insight as well. We sell dietary supplements as well and recently one of our listings was locked out due to the new requirements. We submitted the 3 main documents: LoG, PPP and CoA. But we keep getting a response that " One or more active ingredient name on the supplement fact is not present on the CoA", which I don’t understand and Amazon does not respond to my inquiries to be more specific on what’s missing. They accepted all the other documentation.

We are providing a CoA from an ISO certified lab that contains:
Product Name
Lot/Batch
Sample packaging
List of ingredients
Micro testing analysis
Identity test using HP/TLC

The product in question is a herbal supplement, only 1 ingredient (non standardized), so we felt the identify test would be sufficient.
I’m clueless as to what can Amazon possibly mean by the statement " One or more active ingredient name on the supplement fact is not present on the CoA"
BTW we are a registered brand as well.

I’ll continue to follow your updates and see if your COA worked, maybe then you can advise us on what to do :(:confused:


#31

Thanks for this info. Appreciate it.

The product we have the doc request on has a vitamin, mineral, and a bulk herb in it. The bulk herb (ginger) does not have a marker to be tested and is by input. We are working with our lab today to see if they will validate the formula and list it on the COA as confirmed by GMP regs. I won’t know more for several days once the COA is ready. Our supplier has the test method in house for the vitamin C that’s in it so they tested the vitamin C and the ISO lab tested the mineral originally. The complete COA was issued by our supplier but as you know that’s not acceptable even though that’s perfectly fine under GMP. Therefore, we are having it re-tested in totality by our ISO lab.

Question for you on the LOG - requirements say “your letterhead”. In our view the LOG should be coming from the GMP certified manufacturer guaranteeing the product was produced under GMP. What letterhead was yours under that was accepted? Supplier or Seller (you).

I’ll keep everyone updated on our progress.

ASV


#32

We already went through this process with one of our supplements. Our contract manufacturer issued the LOG on their letterhead and that worked for us.


#33

Official Notice From Amazon:

Dietary Supplements

If you list products on Amazon, you must comply with all federal, state, local laws, and Amazon policies applicable to those products and product listings.

Dietary Supplements covered by this policy

In the United States, the Food and Drug Administration (FDA) regulates the manufacturing, packaging, holding and labeling of dietary supplements under the Federal Food, Drug, and Cosmetic Act (FD&C Act), and its subsequent amending statutes including the Dietary Supplement Health and Education Act (DSHEA). All manufacturers and distributors of dietary supplements are responsible for ensuring that their products meet all regulatory standards before they go to market. The dietary supplements come in many forms such as powders, pills, liquid drops, and oral sprays. The FDA defines a dietary ingredient as a vitamin, mineral, herb or other botanical, amino acid, dietary substance for use to supplement the diet by increasing the total dietary intake or a concentrate, metabolite, constituent, extract, or combination of the preceding substances.

Our policy for Dietary Supplements

Amazon requires that Dietary Supplements meet applicable regulations or standard requirements, including but not limited to the below:

Product Regulation/Standard Requirements
Dietary Supplements 21 CFR 101.36 Nutritional Labeling of Dietary Supplements

21 CFR Part 111 Current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements.|

Please also see the Restricted Products help page on Dietary Supplement for additional product restrictions.

Required information

For Dietary Supplements, you must submit:

  1. Certificate of Analysis (CoA) from an ISO/IEC 17025 accredited laboratory (in-house or third party) for each dietary supplement you are applying to list OR product enrollment in an Independent Quality Certification Program (See FAQ #5).

  2. A CoA must contain the following information:

  3. Product name.

  4. Batch/lot number or date code of the finished product sample tested.

  5. Name and address of the accredited laboratory.

  6. Results from laboratory assay to support the dietary ingredient concentration as claimed on supplement facts panel.

  7. The laboratory method used must accompany each reported result.

  8. The ingredient name(s) on supplement facts panel should match the ingredient name(s) on the CoA.

  9. The unit of measure for each ingredient on the supplement facts panel (i.e. mcg/mg) should match the unit of measure on CoA.

  10. Additional CoA requirements:

  11. CoA submitted to Amazon must have been issued within the past nine months.

  12. Laboratory test results of expired product will not be accepted.

  13. CoA documents must be in Portable Document Format (.pdf).

  14. CoA documents must be accompanied by legible product images as referenced below in Item 2 (“Product Images”).

  15. Product Images must meet the following requirements:

  16. Have all sides of the product label visible.

  17. Have a clear image of the supplemental fact panel, and ingredient list.

  18. Contain name and address of the brand owner.

  19. Contain product name.

  20. Letter of Guarantee - A letter of guarantee from the brand owner of the product that meets the following requirements:

  21. Is on official brand owner letterhead.

  22. Contains complete product name as listed on label, or list of products manufactured under the brand or by facility.

  23. Assurance that the product is manufactured under current Good Manufacturing Practices as listed in 21 CFR Part 111.

  24. Assurance that only lawful and safe, as defined in section 402 (f) of the FD&C Act , ingredients are utilized.

  25. Assurance that concentration of active ingredient(s) as stated on the label and labeling is safe for consumption.

If you believe that your product is not a dietary supplement, please submit product images of all side of the product packaging and a brief explanation in the comments section.

How to submit information

If you would like to seek approval to sell the affected products, complete the following steps to start the application process:

  1. In Seller Central, click the Inventory menu, and then select Add a Product .
  2. Search for the ASIN you want to sell.
  3. In the search results, click the Listing limitations apply link next to the ASIN.
  4. Click Request Approval to start the application process.

FAQ

1. Does the scope of the laboratory’s ISO/IEC 17025 accreditation need to include each test method listed on the CoA?

We only require that the laboratory (in-house or third party) currently holds an ISO/IEC 17025 accreditation. Although we do not require accreditation specific to a certain test, the fact that the laboratory holds any ISO/IEC 17025 accreditation demonstrates general competence of preforming tests and calibrations.

2. May I use “by input” method on a CoA (also knowns as a quantitative amount by weight)?

Industry recognized laboratory assays of finished product should be accomplished whenever possible. If that is not possible due to the unavailability of a scientifically valid test method, then you must provide either a CoA for the raw materials or additional information (such as ingredient identity testing) that can verify that the ingredients meet their specifications for identity, purity, strength, or composition as claimed on the label without testing, as permitted by 21 CFR 111.75©.

3. Do I have to provide a test that ensures that the total amount of active ingredients in a proprietary blend is accurately represented on the label, or do I need to show a test for each individual ingredient?

The proprietary blend must be listed on the product label in accordance with 21 CFR 101.36 ©. The CoA may contain the quantitative amount for all the ingredients listed in the proprietary blend; however, if this is not possible due to the unavailability of a scientifically valid test method for one or more ingredients, you may list the ingredient “by input” subject to the conditions set forth in question #2 above.

4. My product is an herbal supplement, does it need to have a CoA?

You must have a CoA with a laboratory assay(s) for each ingredient if the supplement facts panel declares:

  1. A primary plant constituent (such as common sugars, amino acid, or proteins).
  2. A secondary plant constituent (such as alkaloids, terpenoids, saponins, phenolic compounds, flavonoids, or tannins).
  3. A whole plant ingredient, plant part(s) such as roots or leaves, in a dried state (such as a powder), must have a CoA containing confirmation of plant identity.

5. My product is part of a quality certification program. Can I submit the certificate instead of a CoA?

Yes, Amazon accepts certifications for review from the following independent organizations: NSF International Sport, Banned Substances Control Group (BSCG), Informed-Choice/Informed-Sport, or active participants of USP Dietary Supplement Verification Program. These certifications are an acceptable alternative to a CoA and LoG. Images are still required.

Policy violations

If you do not provide the required information by the applicable deadline, we may:

  • Remove the relevant product listings
  • Suspend your ability to add new products and/or listing privileges
  • Withhold any payments due to you
  • Pursue legal action

We reserve the right to take any further actions that may be necessary in our sole discretion.


Amazon's Dietary Supplement selling policy
#34

Thanks! That’s some much-needed clarity about identity testing for herbs.


#35

Hi,
We submitted the LoG on our letterhead (Brand Owner). We added verbiage to our letter describing the contract manufacturing company we use and we attached their FDA registration and their cGMP certificate.
Thanks for sharing the additional FAQs from Amazon, I did not see them before.
Let me know if you need more details around the LoG we did and I’ll be happy to help.


#36

Yes it is. Would have been helpful prior to being locked out of our listings.

We are breathing a sigh of relief because we already have all of this and test every single batch.

Wondering if this will be required for every single product or just the one currently flagged. Not sure how amazon is going to manually review a few million sets of docs by 5-31.

Previously, you got ungated with 1 product and good to go on all the rest. Time will tell.


#37

Thanks. Got mixed messages on the LOG. Seems it’s being accepted from the manufacturer or the brand but we were planning on following the exact path you took so thanks again for confirming.


#38

We just got our first request for documents too.

My question is: how do we get out in front of this on other products? They are giving themselves 7 days to approve current documents - that is an eternity for some of our products that sell very well.

Is there anything we can do to submit our documents in advance and avoid this situation entirely in the future? Or do we just need to be ready for when it happens.


#39

Does anybody understand if sellers will be able to continue to sell items via FBA that they are currently allowed to sell? Or after May 3, 2021, will all products require new approval (COA, LoG, etc) from scratch?

As of now, I have hundreds of items in this category that I’m approved to sell, and none have yet to be pulled. For items I’m already approved to sell, no “request approval” buttons are present in “add a product”, I’m still able to sell them.

However, as of today, I noticed that I cannot create sell under existing dietary supplement listings without providing COA and LoG.

I wonder if come May 3rd, If I will have to provide COA and LoG for all of my existing dietary supplement listings, or if they will be grandfathered in?


#40

The email they sent around today (copied below) suggests that after May 3, you will only be able to change the price or quantity on a listing. Any other change will automatically trigger the document approval requirement. What is unclear is if this period extends past May 31. What is also very unclear is if only one seller will be required to submit compliance documents for a particular ASIN or each seller. If the latter, then the big supplement companies have finally found a way to kick 3rd party sellers out of the category.

Hello,

We are contacting you because you have listed dietary supplement product(s) that have updated compliance requirements. Effective May 3, 2021, you will need to submit documents to obtain approval to list the affected products. If you do not obtain approval to sell these products prior to May 31, 2021, we may remove these listings.

How will this affect my existing products?

Your listings of dietary supplement products will not be affected until May 3, 2021. After May 3, 2021, you may only change the price and/or quantity of your listing. ANY OTHER CHANGES WILL MAKE YOUR LISTING UNAVAILABLE, AND YOU WILL BE REQUIRED TO SUBMIT COMPLIANCE DOCUMENTS TO REINSTATE YOUR OFFER.

Why is this happening?

This updated requirement helps ensure current and future Dietary Supplements meet applicable regulations or standard requirements listed in this help page. To find more information about compliance requirements, check here:

https://sellercentral.amazon.com/gp/help/GUCMGZBFXQ97P2SU

How do I seek approval to sell the affected products?

Post May 3, 2021, if you would like to seek approval to sell the affected products, complete the following steps to begin the application process:

  1. In Seller Central, click the ‘Inventory’ menu, and then select ‘Add a Product.’

  2. Search for the ASIN you want to sell.

  3. In the search results, click the ‘Listing limitations apply’ link next to the ASIN.

  4. Click the ‘Request Approval’ button to start the application process.


#41

No grandfathering. Tried that already.

It’s unknown if it’s every listing or just one like it used to be. The notification seems to suggest that it’s all but I don’t know how Amazon will be able to manually verify a million sets of documents by May.

My assumption is it’s 1 for now. Try editing all your DS listings and see if one is blocked requesting the approval. That’s seems to be the MO for everyone I have interacted with today.

My assumption is after the 1 it will be everything new. Again assumptions. Not sure. Won’t know for a about a week until we are ready to submit. Need to have something retested bc our CM has the method in house for 1 ingredient and sent out the other to the ISO. GMP manufacturer’s with labs that aren’t ISO but GMP certified are not acceptable anymore like they were. So redoing everything. Oddly enough, that’s the only listing that we didn’t have ISO for bc it was tested in house.


#42

What’s wrong with that?

Now Foods bought a whole bunch of products from PL Amz sellers last year and tested them. Guess what - most of them had nothing in them. They reported this to Amazon and made a splash in the industry.

The time has come to rid this platform of garbage. Sellers selling products for less than they cost to make legit.

This is a welcome change. We are all buttoned up and ready to gain more market share and we are not big, not yet, working on it but we have always operated under the law, testing every single batch and never releasing anything that wasn’t 100% even though 95% is acceptable due to testing variation.

We applaud this move.


#43

I’m not talking about dishonest private label sellers. I’m talking about 3rd party sellers who purchase big name brand supplement products from authorized US distributors and list them. They will have a very hard time getting the docs, the brands will control the listings and prices will increase.


#44

We didn’t receive this email. We’re a small dietary supplement manufacturer and we’ve successfully gone through the LOG/COG process with one of our listings.

I still think that we will have to submit all these documents for our other products. I’m not sure why we didn’t receive this email.

Did the email actually specify a list of ASINs that would be affected on May 3rd?