Reviewed and Approved by Joanne Starkey, CMQ/OE, VP of Quality, Certified Group; Jennifer Sawkins, VP of Operations, Certified Group
1-Minute Summary
- New Amazon policies enforce verified testing, GMP certification, and labeling compliance for skin-lightening and ophthalmic products.
- Skin-lightening products must undergo heavy metals, microbiological, and adulterant testing.
- Ophthalmic products require sterility testing and tamper-evident packaging.
- Certified Laboratories, as an Amazon-approved TIC, offers all required testing for these products.
- EAS Consulting Group, part of Certified Group, provides label reviews to meet Amazon’s FDA-aligned labeling requirements.
Amazon Introduces New Requirements for Skin-Lightening & Ophthalmic Products
First dietary supplements, now skin-lightening and ophthalmic products.
Amazon recently introduced new compliance standards for skin-lightening and ophthalmic products sold on its platform. These updates mandate rigorous testing, Good Manufacturing Practice (GMP) certification, and detailed labeling requirements, among other regulations, to meet safety, efficacy, and quality standards.
In this post, we outline Amazon’s new standards for these products and how Certified Laboratories, an Amazon-approved TIC, can help you meet these requirements.
What Types of Products Are Affected?
Amazon’s updated policies target products in two categories:
Skin-Lightening Products: According to Amazon’s Skin-Lightening Policy, these include, but are not limited to…
- Bleaching creams
- Whiteners
- Skin brighteners
- Fading creams
They are typically marketed to lighten skin tone, reduce age spots, freckles, blemishes, and wrinkles.
Ophthalmic Products: As stated in Amazon’s Ophthalmic Drug Products Policy, this category includes any over-the-counter drug product intended for use in or on the eye, such as…
- Solutions
- Eye drops
- Suspensions
- Gels
- Ointments
- Creams
Why is Amazon Implementing These Policies?
Amazon’s goal is clear: to prioritize consumer safety, transparency, and trust. These enhanced requirements minimize the risk of harmful ingredients and unverified claims.
Some skin-lightening products, for example, have been found to contain banned substances like mercury, posing significant health risks. Likewise, ophthalmic products used directly on the eyes require high standards of sterility and tamper-proof packaging.
What Testing is Required for Each Product Type?
The policies mandate specific testing protocols for both skin-lightening and ophthalmic products to ensure safety, efficacy, and quality.
Skin-lightening products must undergo the following lab tests:
Heavy Metals Testing: Amazon requires testing for mercury, lead, arsenic, and cadmium using AOAC methods 2011.19, 993.14, and 2015.01.
Microbiological Testing: Products must be tested for…
- Total aerobic mesophilic microorganisms
- E. coli
- Pseudomonas aeruginosa
- Staphylococcus aureus
- Candida albicans
- Burkholderia cepacia complex
Adulterant Testing: Amazon requires testing for specific banned chemicals, including…
- Hydroquinone
- Betamethasone dipropionate
- Beclometasone 17-valerate
- Clobetasol propionate
- Clotrimazole
- Halobetasol propionate
- Fluocinonide
- Fluocinolone acetonide
Ophthalmic products require:
- Sterility Testing: Testing to verify that products are free from microbial contamination must be conducted by an ISO 17025-accredited lab.
- Tamper-Evident Packaging Compliance: Packaging must meet FDA’s tamper-evident packaging standards under 21 CFR 211.132.
Why Do I Need an Amazon-Approved TIC for Verification?
Amazon mandates that all Testing, Inspection, and Certification be performed by Amazon-approved TIC providers, such as Certified Laboratories.
Only Amazon-approved TICs can verify your products against Amazon’s policies. However, it’s important to note that any ISO 17025-accredited lab (including in-house labs) can perform the required testing, but the COA must be verified by the TIC of your choice to meet Amazon’s requirements.
What Label Reviews Are Required?
In addition to testing, Amazon requires that labels comply with FDA regulations and be clear and accurate:
- Skin-Lightening Products: Must follow FDA regulations 21 CFR 701 and 21 CFR 740, which mandate clear ingredient listings, including both active and inactive ingredients, along with directions and any required warnings.
- Ophthalmic Products: Labels must be verified to ensure clarity, accuracy, and legality according to 21 CFR 201 subpart C and 21 CFR 349.
Is Good Manufacturing Practices (GMP) Certification Required?
Yes, Amazon requires manufacturers to possess a valid GMP certificate.
For skin-lightening products, verification of Good Manufacturing Practices compliance in accordance with ISO 22716:2007 or equivalent is required.
The GMP requirements for ophthalmic products are more complex.
GMP compliance for ophthalmic products must be verified through an accredited third-party audit, such as cGMP 210/211 or NSF 455-4. Only third-party audits are accepted; private or first-party audits will not fulfill this requirement.
Validation involves thorough checks by an Amazon-approved TIC provider, who may confirm GMP status via public listings, direct contact with the facility, or the issuing body. FDA inspections do not replace GMP certification.
How Do I Ensure My Products are Compliant?
Navigating Amazon’s requirements can be complex, but you don’t have to do it alone. Here’s how Certified Laboratories can support you:
- We provide validated heavy metals, microbiological, sterility, and adulterant testing, covering all Amazon requirements for both skin-lightening and ophthalmic products.
- Non-viable particulate monitoring of sterile product may also be performed.
- Certified Laboratories is an Amazon-approved TIC for ophthalmic and skin-lightening products. We can conduct your required testing and we can verify your COA against Amazon’s policy so you can confidently list your products on the platform.
- If you need guidance understanding the regulations for label development, EAS Consulting Group, a Certified Group company, can help you ensure compliance.
Working with Certified Laboratories means choosing an Amazon-approved TIC provider that understands the intricacies of these compliance updates.