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This article applies to selling in: United States

Personal lubricants

If you list products on our store, you must comply with all federal, state, and local laws and our policies applicable to those products and product listings, including this policy.

Personal lubricants covered by this policy

Personal lubricants used for penile or vaginal application are intended to moisturize, lubricate, and enhance the comfort of intimate sexual activity

Our policy for personal lubricants

Amazon requires that all personal lubricants comply with the specific regulation or standard requirements listed below:

Product Regulation/Standard requirements
Personal lubricants
  • 21 CFR Part 807 (FDA Establishment Registration and Device Listing); and
  • 21 CFR Part 807 Subpart E (FDA 510(k) Premarket Notification); and
  • 21 CFR Part 801 (Medical Device Labeling)

Required information

  • Your company name (if applicable) and seller ID
  • Your contact information: email address and phone number
  • A list of all personal lubricants that you list
  • Images of the product and product packaging, as applicable, for all personal lubricants that you list. Images must include all sides of the product and product packaging for our review
  • Product images must demonstrate compliance with FDA Labeling Requirement (21 CFR Part 801)
  • Product images and detail page content must comply with Amazon’s labeling for medical devices. For more information on this specific policy and our requirements, go to Amazon’s policy on medical devices and accessories..
  • All of the following documentation:
    • Screenshots from FDA Listing Portal (FURLS) as evidence of compliance with FDA Establishment Registration Requirements (21 CFR Part 807)
    • Screenshots from FDA Listing Portal (FURLS) as evidence of compliance with FDA Device Listing Requirements (21 CFR Part 807)
    • FDA Approval Letter as evidence of compliance with FDA 510(k) Premarket Notification (21 CFR Part 807 Subpart E)

Some labs provide special Amazon rates for testing. To find more information about these providers, visit the Service Provider Network.

How to submit information

If we contact you for compliance documents, complete the following steps to submit the requested information:

  1. In Seller Central, select the Performance tab, and choose Account health.
  2. Under Product compliance requests in the bottom right corner of the page, click Documentation requests.
  3. Click Provide documentation or appeal next to the product.
  4. Select No to upload documents.
  5. Follow the steps in the Submit required documents section.

Note: Test reports must contain images of the tested products that are sufficient to demonstrate that the product tested is the same as the product listed on the detail page.

Policy violations

If you do not provide the required information by the applicable deadline, we may take the following actions:

  • Remove the relevant product listings
  • Suspend your ability to add new products, listing privileges, or both
  • Withhold any payments due to you

We reserve the right to take any further actions that may be necessary in our sole discretion.

Additional resources

Disclaimer: The information provided on this page does not, and is not intended to, constitute legal advice. All information, content, and materials available on this site are for general informational purposes only.

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