Wondering how to get approved to sell Supplements on Amazon? Here’s all you need to know about selling under this gated category.

Amazon’s Terms of Service in the Dietary Supplements Category has dramatically changed over the past few months as per Amazon Agency. Much to the jarring reactions from various sellers, it is to be expected that there will be even more changes in the coming months. If you are planning to sell under this category and you want to avoid any future hiccups in your dietary supplement listings, it is essential to keep your seller account up to date with Amazon’s ever-changing policy.

Before anything else, make sure that you meet the following requirements:

1. A professional seller account
2. Your account must have a  clean track record – meaning no high number of late deliveries or canceled orders

Got those covered? Great! Here’s all you need to know about Selling Dietary Supplements on Amazon:

Step 1: Submit a qualified invoice from a supplement manufacturer or distributor.

Amazon wants to make sure you’re getting your supplies from reputable sources. The invoice copy you submit must include the following components:

a. Your name and address are an exact match with what’s listed on your Amazon seller account.

b. The invoice is dated within 180 days from the date you applied to Amazon to sell in the gated dietary supplement category.

c. 10 or more product units were purchased.

d. The name and address of the manufacturer or distributor are included.

TIP:

If you are purchasing your supplements from a wholesaler, you may simply use your invoices to get ungated on Virtual bundles Amazon.

But if you are doing retail arbitrage or private label vitamins and supplements, then you will need to make a wholesale purchase. It sure is an additional expense from you but it’s undoubtedly worth the extra cost since this will allow you to get ungated to sell in this category. 

When applying for a gated product category, you only need to submit a request to sell one product in order to gain access. The product you’ve selected should be the one on the wholesale or distributor’s invoice mentioned above.

Step 2: Send photos of the product.

You’ll need to submit photos of all six sides of the dietary supplement container. The photos need to be live and actual photos taken by you and not product photos you grabbed from the internet. Make sure that the images clearly show both the name of the manufacturer and the product name, model number, or trademark.

Product images MUST meet the following requirements:

• Must be legible
• Must clearly show the entire product label (all sides), including the applicable facts panel, ingredients list, certification logos, identity statement, instructions for use, and any product warnings
• Must contain the product name
• Must contain the name and contact information of the brand owner or manufacturer
• Must be a direct image of the product or its packaging. A computer-generated image or mock-up will not be accepted.
• These images must appear on the detail page of your product.

Step 3: Submit required documentation.

Lastly, Amazon also requires the submission of the following documents (dietary supplements) for reapproval to sell on the platform:

1. 21 CFR 101.36 – Nutritional Labeling of Dietary Supplements

2. 21 CFR 111 – Current Good Manufacturing Practice (cGMP) in manufacturing, packaging, labeling, or holding operations for dietary supplements

3. 21 CFR 117 – Current Good Manufacturing Practice (cGMP), Hazard Analysis, and Risk Based Preventative Controls (HARPC) for Human Food

UPDATED: Supplement Approval Requirements

On November 2, 2021, Amazon made the latest changes in the required documentation, and on Nov. 3, they sent the first documentation requests to sellers. 

Sellers who have been using their old CoAs most probably won’t be able to use them moving forward so it is imperative that they order new ones. Take note that you will need certificates of all single ingredients of the proprietary blends and everything that is certified as “by input”. 

New Requirements for the Certificate of Analysis (CoA)

With the new changes in the requirements for approval, it can be estimated at least 90% of herbal supplement products will most likely need to change their labels to meet the new requirements. Moreover, sexual enhancement products, weight loss, and weight management products will need additional CoAs for several controlled substances. The deadline for submission is on Jan. 5, 2022.

For your reference, here’s the COMPLETE list of all Required Documentation:

I. All dietary supplements

For each dietary supplement product or ASIN, you must submit the following documents:

1. A valid good manufacturing practice (GMP) certificate issued by an accredited third-party certification body in compliance with 21 CFR 111 and 21 CFR 117. Amazon accepts GMP certificates from the following third-party programs: NSF/ANSI 455-2, NSF/ANSI 173 Section 8, GRMA 455-2, UL GMP, USP GMP, Eurofins, SAI Global, SGS, Intertek, TGA, and SSCI.

AND

2. A finished product Certificate of Analysis (COA) of declared dietary ingredients issued by an ISO/IEC 17025 accredited laboratory or in-house laboratory located in the above facility that is compliant with current GMPs per 21 CFR 111 and 117. The valid COA must have the ISO accreditation number listed on the certificate being submitted. 

OR

Evidence of product enrollment or participation in one of the following third-party quality certification programs: NSF/ANSI 173 Product Certification, NSF Certified for Sport®, BSCG Certified Drug Free®, Informed-Choice/Informed-Sport Program, USP Dietary Supplement Verification Program, or UL Brand Certification Program.

AND

3. Product images – refer to the requirements listed above.

II. Supplements intended for sexual enhancement or weight loss and weight management

In addition to the above requirements, each dietary supplement product that is intended for sexual enhancement or weight loss and weight management must also submit the following documentation:

1. A finished product Certificate of Analysis (COA) for the compounds listed in Appendix 1, issued by an ISO/IEC 17025 accredited laboratory. 

Note: Amazon will not accept COAs from in-house labs for the compounds listed in Appendix 1. A valid COA must include the ISO accreditation number for the issuing lab or labs. Please note that not all labs have the capabilities to test for these specific compounds. Depending on whether you sell sexual enhancement or weight loss and weight management supplements or both, you may need to use more than one lab. 

Also, be mindful of the frequency of submission of testing results for Sexual Enhancement and Weight Loss & Weight Management Products for the substances listed above.

For more details, you can check out Amazon’s updated Terms of Services for Dietary Supplements here.

Make sure that you read and follow Amazon’s COMPLIANCE CHECKLIST for Dietary Supplements.

How to submit requirements:

If you have been contacted by Amazon to submit compliance documents as told by Amazon Advertising Agency, complete the following steps ASAP to start the application process.

1. In Seller Central, select the Performance tab, and choose Account health.
2. Under Product compliance requests in the bottom right corner of the page, click Documentation requests.
3. Click Provide documentation or appeal next to the product.
4. Select “No” to upload documents.
5. Follow the steps in the Submit required documents section.

FREQUENTLY ASKED QUESTIONS:

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