FAQ: Compliance Verification for Amazon’s Over-The-Counter Ophthalmic Products Program Policy

Amazon’s Over-The-Counter Ophthalmic Products Program Policy includes a testing policy and product review to verify quality and safety of OTC Ophthalmic products sold on the Amazon store. Eurofins will partner with you to ensure that the appropriate tests are conducted to align to this Policy based on your product type.

The product review includes gathering Good Manufacturing Practice (GMP) certificates from your manufacturer, images of the products label, and testing results to review against Amazon’s Over-The-Counter (OTC) Ophthalmic Products Program Policy standards. Once the testing and product review is completed, a pass or fail status will be reported to the seller and to Amazon directly.

If your product is eligible under this Policy, you will receive a notification from Amazon.

As a Selling Partner on Amazon, you will be notified by Amazon of the requirement that your product requires compliance verification. Follow the Amazon process for requesting testing services, which will allow a Selling Partner to select the laboratory for verification. Should you choose Eurofins, you will be contacted by a Eurofins representative and the path to verification begins.

Based on Amazon’s Over-The-Counter (OTC) Ophthalmic Products Program Policy, product compliance is valid for 1-year (12-months) from an acceptable verification and will be required to be renewed annually. If an ASIN’s product compliance status becomes expired, the ASIN may be suppressed by Amazon until a valid product compliance status is completed through the third party.

Eurofins asks that for each ASIN, the Selling Partner provide a minimum of 3 unopened retail packages plus any additional bottles / packages that may be needed to meet minimum sample weight requirements. Sample amounts needed will be finalized at the time of quoting. Samples shall be unopened and sealed as they would be sold.

The process from when the product arrives, and all the terms have been agreed upon will take about 3 to 5 weeks from sample submission to verification against Amazon’s Over-The-Counter Ophthalmic Products Program Policy. Things that may delay the process will be Out-of-Specification (OOS) investigations, communication delays, incomplete documents from manufacturers, etc. Eurofins will do our best to provide accurate and timely results and investigations to all products submitted.

There is not a one-fee service for each ASIN. Costs can vary greatly depending on the extent of the ingredients in the product. Costs are broken down by fees associated with contaminants, adulterants, label claim verification and product verification. For an exact price please request a quotation.

Each product that falls within one of the high-risk categories (sexual enhancement, weight management, sports nutrition/bodybuilding, and joint health) submitted under this Policy will be required to test for microbiological contaminants, heavy metals, pharmaceutical adulterants, and various label claim ingredients. There may also be some other mandatory requirements based on product specific situations.

Any test result that does not meet the declared label claims or fails the acceptance criteria that Amazon’s OTC Ophthalmic Products Program Policy has set for contaminants and adulterants will fail the verification. Out of Specification test results will have gone through the retest policy prior to issuance of a failure. Amazon will be notified of the failure and independently take whatever appropriate action is necessary.

If a Selling Partner disagrees with the testing results that culminate in a failed verification and are at an impasse, the Policy states that you should file an appeal with Amazon directly.

If your product is eligible for failure resolution, a Corrective and Preventive Action (CAPA) document must be issued to Eurofins by the Selling Partner which has a sound justification that implementation of the CAPA is expected to yield a different result. Upon successful resolution, which may require re-verification, Eurofins may change the overall status to PASS in these cases. Testing fees may apply. Cases which do not have a pathway to resolution include detection of pharmaceutical adulterants and/or a positive result for pathogenic organisms (Salmonella spp Staphylococcus aureus, pathogenic Escherichia coli).

Eurofins requires direct access to all required documents through the manufacturer or laboratory used in the product being evaluated. We will not accept any documents (i.e., COAs, GMP certificates, ISO accreditation certificates, etc.) from the Selling Partner as this introduces high risk for falsified documents and fake COAs. Please work with your providers (labs, manufacturers) to allow Eurofins a direct conduit to these items so there are no delays in meeting the requirements.