Anyone else receive the new Oral OTC Medication testing email?
I received the attached Amazon notice stating that my oral OTC medication listings will be deactivated unless I submit the following:
- $1M commercial liability insurance
- third-party product testing through an Amazon-authorized TIC provider
- a surveillance testing agreement
- a penalty acknowledgment
I understand why Amazon has tightened compliance for dietary supplements.
What I am more curious about is why Amazon is now applying this framework to oral OTC drug products, including established OTC drug products that already exist within an FDA drug/regulatory framework, rather than just higher-risk supplement-type products.
I am curious if there is any differentiation or seperation out between USP Monograph products vs NDA/ANDA products – or if Amazon even understands this difference.
What I am trying to find out is:
- Has anyone else received this same notice?
- Has anyone already completed this process?
- What did Amazon actually require in practice?
- What exactly did the surveillance testing agreement turn out to mean?
- Is Amazon doing actual random post-listing lab pulls/testing?
- Has anyone successfully appealed products that were incorrectly classified into this requirement?
I’m especially interested in hearing from sellers dealing with actual OTC drug listings, not just supplements.
submitted by /u/robertmrome
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