Appeal Denial for Ephedrine Cases 17808081691, 17808074851 & 17808149451

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Seller_Lu3bFSNnS57zM

Appeal Denial for Ephedrine Cases 17808081691, 17808074851 & 17808149451

These products are marketed and sold as Traditional Chinese Medicine and not Vitamin supplements as required by the FDA on top of that NIH already shows FDA incorrect by testing of 100s of samples to find no ephedrine alkaloids

I’m frankly appalled by Amazon’s willful denial of my ephedrine‐related appeals (Case IDs 17808081691, 17808074851, 17808149451). Their response ignores every piece of evidence I submitted:

Misapplication of FDA Scope

• The FDA’s Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated clearly limits its ban to products marketed as dietary supplements (FederalRegister.gov Document/search ID 04-2912, ¶ 107).

• Paragraph V.B.5 of that same rule states traditional‐medicine preparations are “beyond the scope of this rule because they are not marketed as dietary supplements.” (Document/search ID 04-2912, ¶ 219).

Zero Ephedrine in Pinellia

• A 2021 NIH-indexed LC-TOF/MS study (Yahagi T. et al., “Quality evaluation of Pinellia tuber by LC-TOF/MS targeted to ephedrine,” PubMed PMID 33517509) analyzed 55 commercial samples and found no detectable ephedrine (LOD 0.5 ppb).

Proper Product Categorization

• I have re-categorized each ASIN under “Alternative Medicine”/“Chinese Medicine” in Seller Central and uploaded complete label photos showing they are not sold as dietary supplements.

Amazon’s blanket refusal to look up these authoritative sources is blatant ignorance. Moderators, please intervene and require a policy‐accurate review with these citations on hand.

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Tags:Product compliance, Product safety
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Michelle_Amazon

Hello @Seller_Lu3bFSNnS57zM,

Thanks for reaching out regarding your listings that are restricted from Amazon. I have reviewed the images of your products that have been uploaded by multiple sellers and it states on the product labels that these are dietary supplements, therefore, these must be compliant with our dietary supplements requirements and get the required testing. If you do not provide the required testing to prove that your products do not contain ephedrine, your listings will not be reinstated.

If you have a current case open where you have provided the required testing documents and you need it to be reviewed again, please provide me with that case ID and I will be happy to have it reviewed again.

Regards,

Michelle

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