Dear Amazon Team,

We are reaching out to seek urgent guidance and support regarding the recent compliance issues raised for our dietary supplement products. Specifically, 60 of our products have been flagged for not meeting FDA labeling requirements, as determined by Amazon. The primary concern appears to be related to the accuracy and presentation of the botanical extract per serving on our product labels.

We understand that labeling for botanical extracts must adhere to the criteria outlined in 21 CFR 101.36 and/or USP <565>. However, despite our best efforts to comply with these regulations, we are facing significant challenges in addressing the concerns raised.

Here’s a summary of the steps we have taken so far:

1. We initially provided images of our product labels as requested by Amazon Seller Support.

2. We subsequently submitted documentation, including our NSF Certificate of Analysis (COA) and other materials, to validate the accuracy of our supplement facts.

3. We were then informed that the weight of the capsule must be included on the front label, even though both the extract and weight are clearly described in the supplement facts section.

While we are willing to update our labels to include the capsule weight on the front, it has become clear that modifying the labels alone will not resolve the complaint or lead to reinstatement of our products. Additionally, there appears to be no clear path for appeal or resolution after making such updates. This lack of clarity and guidance has left us in a precarious position, with no actionable steps to move forward.

We have consulted with an FDA labeling expert who reviewed all our labels and confirmed that they meet regulatory requirements. Despite this, we are unable to find a resolution within Amazon’s framework, and the enforcement of this rule without prior warning has had a severe impact on our business operations.

We kindly request:

1. Clarification on how we can resolve this issue and reinstate our products.

2. Confirmation of whether updating the front label with the capsule weight will address the compliance concerns. Can we display both the total weight and extract weight on the front label, or only the capsule weight? Does the Amazon team prefer excluding the weight on the front label like the Amazon Brand Gaia? Additionally, does the Amazon team prefer formulation details per serving or per capsule?

3. Assistance in identifying a clear path for appeal or resolution if further actions are required on our part.

4. Why do major dietary supplement brands seem unaffected despite having similar labeling?

This situation has placed immense strain on our business, and without a viable solution, it could lead to devastating financial consequences for our company. We sincerely hope the Amazon Team can provide guidance and support to help us navigate this process effectively.

Thank you for your attention to this matter. We look forward to your prompt response.