Amazon’s Ophthalmic OTC Product Policy

Amazon has recently updated it’s Over the Counter (OTC) Ophthalmic Products Program Policy . The new requirements mandate third-party verification based on specific parameters outlined on the Amazon Seller page.

Under Amazon's New Policy, Sellers must work with an approved third-party organization to test, inspect, and certify their products. Third party verification validates that products meet regulatory standards, including proper manufacturing and labeling.

Third party verification is essential for Sellers to keep their listings active, as the updated policy aims to improve the safety and quality of these products on the platform.

Partnering with SGS for Verification Services

In addition to making your Amazon Verification as seamless as possible, SGS provides full service regulatory for OTC, Pharmaceuticals, Dietary Supplements and Food.  This includes labeling, registration and claim substantiation for FDA, Health Canada and many other global locations.   SGS also provides full service clinical trials in both humans and companion animals.

GRAS Associates, a subsidary  of SGS Nutrasource, provides services to verify compliance with Amazon's Over the Counter (OTC) Ophthalmic Products Program Policy. To get started with your testing, simply visit your Amazon Seller Central page and choose SGS as your testing provider

Dedicated Customer Support: SGS offers personalized experience by providing you with a dedicated Client Service Specialist. The specialist will be your point of contact throughout the entire process, ensuring you receive tailored assistance every step of the way.

Expertise in OTC Ophthalmic Product Testing: Our expertise in OTC Ophthalmic product testing is built on years of scientific support, ensuring that your product testing aligns with Amazon's quality and safety standards.

GMP Accredited Laboratory: Our state-of-the-art GMP accredited laboratory uses scientifically valid methods to conduct the testing of your over-the-counter Ophthalmic product. You can be confident that testing methods fully comply with Amazon's OTC Ophthalmic Program Policy, ensuring safety and quality standards are met.

Start your compliance journey by connecting with SGS today

  • Please visit Amazon Seller Central and select SGS as your testing partner.
  • Once you have selected SGS as your laboratory and submitted your Testing Request Form (TRF) through Seller Central, here is what you can expect next:
    • Keep an eye on your inbox for an e-mail from your dedicated Customer Support Specialist. This e-mail will guide you through the next steps in the process and will be sent to the primary e-mail address associated with your Amazon Seller account.
    • Please respond to your welcome e-mail with the below information. This will help ensure smooth communication and processing of your request.
      • Legal Company Name
      • Legal Company Address
      • First and Last Name of Your Company Contact
    • Receive a quote: After all the required information from Step 2 is received, your Customer Support Specialist will prepare a quote for your product. You will receive this quote via e-mail for your review and acceptance.

FAQ 

1. What is the process for Amazon's Over the Counter (OTC) Ophthalmic Products Program Policy?

Amazon's Over the Counter (OTC) Ophthalmic Products Program Policy outlines requirements to ensure the safety and quality of Ophthalmic products sold on its platform. The process involves:

  1. Product testing and review: Sellers partner with SGS, a third-party testing and certification company, to conduct necessary testing based on the specific Ophthalmic product type. This testing helps verify that the product aligns with Amazon's safety and quality standards.

  2. Good Manufacturing Practice (GMP) Certificates: The Seller must provide GMP certificates from their manufacturer, verifying compliance with recognized quality manufacturing standards.

  3. Label Verification and Product Testing: The product’s label images, and testing results are reviewed to ensure they meet Amazon's OTC Ophthalmic product standards.

    • Phase 1 Label Verification

      • Verification of labels to ensure clarity, accuracy, and legality according to 21 CFR 201 subpart C and 21 CFR 349.
      • Verification of Good Manufacturing Practices compliance in accordance with cGMP 210/211, NSF 455-4, or equivalent.
    • Objective: Ensure that the product's label meets regulatory standards and guidelines.
    • Why It Matters: Label verification is critical as any errors or non-compliance with labeling regulations can prevent the product from reaching the market.
    • Outcome of Phase 1:
      • If Approved: We proceed to Phase 2, where we focus on product sterility.
      • If Not Approved: No further testing is needed, as label compliance is a prerequisite for product acceptance. This avoids unnecessary cost of additional testing if the product cannot move forward due to labeling issues.

    • Phase 2: Product Sterility Testing

    • Phase 2 includes Sterility Testing under cGMP and Tamper Evident Packaging Verification

    • Objective: Assess the product’s sterility, ensuring it meets the safety and quality standards required for customer use.
    • Cost Consideration: Since Phase 2 is a more resource intensive and costly process, we only proceed if Phase 1 verification is successful. This phased approach helps minimize costs and avoid redundant testing on products that may not be marketable due to labeling issues.

    • Why This Two-Phase Approach Benefits You:

    • By invoicing each phase separately, we help you control expenses, paying only for the testing your product is prepared to complete. You will not incur the full cost up front, which could otherwise mean paying for both label verification and sterility testing even if the label does not pass.

  4. Outcome notification: Once the review is completed, SGS reports a “Pass” or “Fail” status to both the Seller and Amazon.

    • Once a product passes, it is authorized by Amazon for sale on its platform.

 

2. How do I request service to get compliance verification against Amazon's Over the Counter (OTC) Ophthalmic Products Program Policy?

As an Amazon Selling Partner, Amazon will notify you if your product requires compliance verification. Follow the Amazon process for requesting testing services, typically through your Seller Central Portal, which will allow a Selling Partner to select a laboratory for verification. Should you choose SGS, you will be contacted by a SGS representative and the path to verification begins.

3. How often will my Over the Counter (OTC) Ophthalmic Products be required to be verified?

Per Amazon's Over the Counter (OTC) Ophthalmic Products Program Policy, product compliance is valid for 12 months from the date of acceptable verification. After this period, you must renew compliance annually to continue selling your product on Amazon. If the compliance status of a product expires, Amazon may suppress the ASIN (product listing), meaning the product will no longer be available for purchase on the Amazon platform until compliance is renewed and verified. To renew compliance, you will need to repeat the verification process through a third-party laboratory (such as SGS) to ensure the product still meets Amazon safety and quality standards.

4. How many product samples do I need to provide?

Sample amounts needed will be finalized at the time of quoting. Samples shall be unopened and sealed as they would be sold.

5. What is the turnaround time after submitting my product for verification under Amazon's Over the Counter (OTC) Ophthalmic Products Program Policy?

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.

6. What are the costs associated with this program?

 For an exact price please request a quotation. 

7. What options do I have for remediation if I disagree with a failed verification from SGS under Amazon's Over the Counter (OTC) Ophthalmic Products Program Policy?

If a Selling Partner disagrees with testing outcomes that result in a failed verification and reach an impasse, the Amazon Policy states that an appeal should be filed directly with Amazon.

8. Is there a pathway to have my product reinstated after a failed verification by SGS under Amazon's Over the Counter (OTC) Ophthalmic Products Program Policy?

If your product qualifies for failure resolution, the selling partner must submit a Corrective and Preventative Action (CAPPA) document to SGS, providing a strong justification that implementing the CAPPA is likely to yield a different result. Upon successful resolution, which may require product re-verification, SGS may change the product status to “Pass.”  Testing fees may apply.

9. Why does SGS require documents from my manufacturer or laboratory directly?

According to Amazon's Over the Counter (OTC) Ophthalmic Products Program Policy, SGS must obtain 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 an elevated risk for falsified documents. Please work with your providers (labs, manufacturers) to allow SGS direct access to these items so there are no delays in meeting the requirements.