FDA Regulation of Personal Lubricants

April 6, 2015 / Marc Sanchez /
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Marc Sanchez

Marc Sanchez

Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

4 Comments

  1. Radbert on May 5, 2017 at 6:31 am

    i want to do a personal lubricant FDA!can you tell me how to do the personal lubricant FDA?

    • Marc Sanchez on May 5, 2017 at 8:18 am

      It is likely that you would need to file a 510(k) application. At a minimum you would need to register.
      Much of this may depend on claims and classification.
      You can send me an e-mail at msanchez@fdaatty.com if you would like more information.

  2. Mary on April 8, 2015 at 8:04 pm

    How can I see which are? What are some that are approved? What are some that are not? In particular of the Natural Lubricants…thanks

    • Marc Sanchez on April 10, 2015 at 10:30 am

      You will need to visit the FDA’s medical device 510(k) database and search using the product code NUC.

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