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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 All of the following:
  • 21 CFR Part 807 (FDA Establishment Registration and Device Listing); and
  • 21 CFR Part 807 Subpart E (FDA 510(k) Premarket Notification)

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 offer on our store
  • Images of the product and product packaging, as applicable, for all personal lubricants that you offer on our store. Images must include all sides of the product and product packaging.
  • 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)

Compliance services

If you need help getting compliance certifications, testing, and audits, use our service provider network.

How to submit information

If you receive a request from us 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 Manage your compliance in the bottom right corner, click Product Compliance Requests.
  3. To add compliance or appeal for a single product, click Add/Appeal Compliance. To add compliance or appeal for multiple products, select each product on the left hand side of the product and click Action Selected Products at the top of the product requirement table to make a selection about how you would like to submit documents and information.
  4. Provide compliance documents and information in the Provide Documents section, or provide appeal information and documents in the Appeal Request section.
  5. Click Submit for Approval to send your submission for review by Amazon.

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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