The New Regulations and Requirements For Selling Supplements On Amazon - BellaVix

The New Regulations and Requirements For Selling Supplements On Amazon

At the end of 2021, Amazon updated its policy regarding selling supplements on the marketplace, and implemented new requirements for selling dietary supplements. 

While the new requirements may look pretty straightforward (it’s only three new requirements), many sellers on Amazon Marketplace are finding these requirements very challenging. 

What are the new requirements? 

Let’s first briefly mention what the newly implemented requirements are. Along with all requirements stated in their policy mentioned above, Amazon has added new requirements for so-called “documentation requests.” After the due date for submission and review of documentation requests, sellers with an unsuccessful submission were faced with their products being suspended, their inventory going under stranded inventory, and the product being marked as “qualification required.”

The documentation requests consist of the following elements that the sellers were supposed to submit: 

  1. A Certificate of Analysis (CoA) from an ISO/IEC 17025 accredited laboratory.
  2. Product images that must show all sides of the product label.
  3. Good Manufacturing Practices Certificate. 

The Certificate of Analysis (CoA) should not be older than six months, and it must be related to the product it is requested for. It should also contain the product name, batch, lot number, manufacturer name, and the name of each ingredient noted on the Supplement Facts Panel. In the end, your CoA must contain an analysis that will prove the ingredients noted in the previously mentioned panel are listed correctly. 

Product Images: Sounds very straightforward, right? Yes, but if you don’t have these product images on your product detail pages, Amazon will respond by declining your submission. 

Good Manufacturing Practices Certificate: This certificate must be valid, which means not expired. 

Possible Challenges

If you haven’t worked with these submissions of documentation requests by Amazon, be aware that you could experience many challenges and hidden requirements, which are not mentioned in the initial announcement posted by Amazon. This can cause a headache and a lot of back-and-forth messaging with updates between Amazon and the seller/manufacturer of supplements. 

The first challenge is related to the Certificate of Analysis (CoA) from an ISO/IEC 17025 accredited laboratory. Documentation submitted to them can contain everything initially mentioned in Amazon’s new requirements, but their response can be surprising. 

For example, Amazon may follow up with, “We have determined that your product could also be related to weight loss, so we require an updated COA.” Amazon may request a new COA which needs to prove that the product does not contain Sibutramine, Desmethyl sibutramine, Phenolphthalein, and Fluoxetine. 

Additionally, if Amazon does not recognize your laboratory, Amazon will ask you to provide them with Laboratory ISO/IEC 17025 accreditation number or certificate. 

Secondly, Amazon did not mention that the product name on the CoA must be EXACTLY the same product name from the Amazon product detail page, and it literally means the same name. Have small letters in your CoA or any minor difference, and, once more, Amazon will reject your submission. 

Additional challenges are lot numbers and the list of ingredients. If any of the ingredients mentioned on the CoA were missed from the SFP on your product detail page or product image, your submission is not valid. 

The last challenge we will mention is a huge dependence on the Amazon employee reviewing your submission. 

You could experience an absurd situation where, for example, one pack listing was approved, and a multi-pack variation of entirely the same product was rejected. The CoA, GMP Certificate, and product images contain accurate information, but two different people reviewed your submissions, with differing results. 

Advice for the successful submission

For successful submission, we would recommend detailed research on all requirements needed before submitting the documentation requested by Amazon. Submitting documents with any missing detail will create back-and-forth problems with Amazon and you will not be sure your product will be approved. To prevent these issues, check how Amazon determines your product, what claims your product listing contains, and what details Amazon is requesting for each type of supplement. 

Do not try to provide false documentation because that can lead to account termination and legal problems. 

These new requirements apply to any new brand or product on Amazon.

Conclusion

It is great to see that Amazon is requesting a high level of safety and quality for these products, and generally, many are happy with the new approach, especially customers. 

However, after some research and checking various supplements, it seems that Amazon did not consider any different testing methods, labeling requirements, or different categories of supplements. Also, some claims included in these documentation requests are odd, like mentioning active ingredients, which is generally a claim related to drugs. 

In the end, many sellers decided to quit the Amazon Marketplace after January 2022, and some of them decided to leave when they could not satisfy Amazon’s additional challenges and requirements.

If you are a supplements manufacturer or seller and are interested in more advice, you can contact the Bellavix team.

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