Amazon’s New Ophthalmic OTC Product Policy

Under the policy, Amazon requires that ophthalmic products comply with all applicable laws, regulations, standards, and Amazon policies, including current Good Manufacturing Practices (cGMP) in manufacturing, packaging, labeling, or holding operations.

Amazon’s policy requires verifying ophthalmic OTC products through a third-party testing, inspection, and certification (TIC) organization. This move aims to enhance safety and quality assurance by requesting testing data and certificates of analysis directly from the lab to Amazon. Compliance with the new policy is crucial for sellers to ensure their listings remain on the platform.

Products already certified to NSF/ANSI 455-4 GMP certification for OTC products meet the GMP requirements for this policy. Label images, test results, and packaging requirement verification are also required. NSF can complete these verifications regardless of whether the product is certified by NSF to NSF/ANSI 455-4.

Third-party verification plays a pivotal role in the new policy on ophthalmic OTC products.

NSF provides compliance verification services against Amazon’s Policy, ensuring appropriate requirements are met based on the product type.

Get started on your compliance journey by speaking to NSF today.

• Call us now on +1 313 456 8832
• Email us: [email protected]
• Visit Seller Central and select NSF as your testing partner.

In addition to verification services that meet Amazon requirements, NSF offers an additional level of quality management with OTC GMP certification through NSF/ANSI 455 – OTC GMP Certification. Manufacturers who comply with NSF/ANSI 455 demonstrate their commitment to quality, industry best practices, and regulatory requirements outlined by the FDA. This certification helps sellers differentiate their brands from competitors, reduce supply chain risks, and increase consumer transparency.

NSF can assist sellers in meeting the new ophthalmic OTC product policy standards through verification and, if desired, GMP certification. As a global leader in testing and certification, NSF provides expertise in compliance verification, ensuring products align with Amazon’s requirements.

By selecting NSF as their testing partner through the Amazon Seller Central page, sellers can take advantage of NSF’s cutting-edge Seller Portal. This AI-powered proprietary system streamlines testing and certification, providing on-demand quotes for testing costs, a dashboard to track product testing and dedicated customer support.

Sellers who wish to comply with Amazon’s policy can initiate the compliance verification process through NSF.

To get started, sellers should contact NSF’s dedicated Amazon Seller support center via email or phone. NSF’s customer support staff is available from 7:30 am to 8:30 pm EST, Monday through Friday.

During the compliance verification process, sellers must provide essential information such as:

• Amazon Standard Identification Number (ASIN)
• Global Trade Item Number (GTIN)
• National Drug Code Number (NDC)
• Product brand name, product description
• Manufacturing facility details
• Label (and carton, if applicable) images for the product
• Documentation of a current Good Manufacturing Practices (GMP) certification is also required.

Amazon’s updated ophthalmic OTC product policy underscores the company’s commitment to safety and quality in the marketplace. By requiring third-party verification and GMP validation, Amazon aims to provide consumers with trustworthy and reliable products.

Sellers can navigate these policy changes by partnering with NSF for verification and/or certification, benefiting from our expertise and support throughout the compliance process. Embracing these new standards will ensure compliance with Amazon’s policy, enhance consumer trust, differentiate brands, and increase market opportunities.