Label or Packaging Issue Regarding FDA Compliance?

We are selling Japanese-made supplements with supplement facts labels in English. However, our products were identified as unapproved items that do not meet FDA label requirements. Initially, we believed the issue was with the way we wrote the English labels, so we attempted to make corrections, but the revised version was also rejected by Amazon.

At that time, Amazon support proposed the following changes:

Recommended changes to be done:

• Upload all sides product images labeled in the English Language.

• Upload all "side images" of the product packaging/label showing the ingredient list on the product detail page.

• Upload all side images of the Product Label, where the Ingredient List is clearly visible on the product label itself, on the Details page for further review.

However, all our products have Japanese packaging, and we do not have all sides product images with English labels to provide. Instead, we uploaded images with English labels placed over the Japanese nutrition facts, similar to how we deliver them with FBA, but this was also rejected.

When we inquired about this issue on the seller forum, we received the following response from an Amazon Community Manager:

• For the product images, you will want to take pictures of the packaging as it is when you receive it. Our team is going to be looking to confirm that your product meets all of the requirements set forth. This includes confirming the ingredients that are listed on the product packaging.

• Are the ingredients for the product listed in English on the packaging? Have you verified that the product meets the listing requirements as seen on our dietary supplements page? Given the type of product being dealt with, if the packaging and ingredients are unable to be verified under our requirements, then it will get rejected. In some cases, there are restrictions on the packaging due to the marketplace the product is being listed in. If your packaging does not have any detail in the language that the product is being marketed in, then you may not be able to sell that product in that market.

• To avoid any confusion on the product, it is recommended for the US market to ship in packaging that can be easily understood by the consumer. With your situation, you do run the risk of a violation due to the packaging arriving in a foreign language. To resolve this, the packaging will need to be in English if provided to the US market. It will not be enough to just have the information on a labeling slip.

According to this response, even if there is an English label, selling supplements in foreign language packaging that cannot be read by US consumers poses a risk of violation on Amazon USA, and such products may become restricted items.

The question remains: Did the English label not conform to FDA standards and thus become a restricted item? Or did it become a restricted item because it is a supplement with foreign language packaging that cannot be read by US consumers, even if there is an English label?

Does anyone have any insights?

Thank you in advance.