Home Cosmetic Science Talk Formulating Cosmetic Industry FDA Regulation Question

  • FDA Regulation Question

    Posted by Ron_93 on July 15, 2023 at 11:17 am

    Hey everyone! Do R&D-only labs need to be registered or adhere to specific requirements when formulating OTCs (specifically sunscreen)? I know contract manufacturers have to register with the FDA, conduct SPF testing, and follow strict guidelines, but I am curious if there are regulations put in place for actual R&D labs that do not conduct manufacturing. I formulated a men’s facial moisturizer and want to include some SPF, but I would like to contract a chemist to add that component to the formulation. The companies that I’ve contacted only do custom formulations. So, I’d have to outsource a contract manufacturer upon completion of the formula revision. I just want to make sure things are done right. Thanks in advance.

    PhilGeis replied 6 months, 1 week ago 6 Members · 10 Replies
  • 10 Replies
  • PhilGeis

    Member
    July 15, 2023 at 12:55 pm

    Will the R&D lab be making product for human use/application?

    • Ron_93

      Member
      July 15, 2023 at 6:16 pm

      Yes, it will be for human use. They will only be adding the SPF component to the formula, but not actually mass producing it. I would have to source a CM for production.

  • PhilGeis

    Member
    July 16, 2023 at 8:20 am

    CM as an FDA reg facility in GMP control and product within monograph??

    • Ron_93

      Member
      July 16, 2023 at 9:59 am

      Yes

  • microformulation

    Member
    July 16, 2023 at 11:55 am

    Your Formulator doesn’t have to be FDA Registered. They should however have experience with OTC products, the monographs, OTC documentation standards, and other specific tasks. Sunscreens are deceptively easy. There is far more to it than simply adding SPF to a product.

    • Ron_93

      Member
      July 16, 2023 at 1:12 pm

      Roger that. Thank you for the info.

  • DRBOB@VERDIENT.BIZ

    Member
    August 18, 2023 at 2:35 pm

    Supply lab with base formula under NDA and let them know desired SPF and specify zno and tio2 as sunscreens to use

  • Adamnfineman

    Member
    August 22, 2023 at 2:26 pm

    Hi @Ron_93,

    If you’re in the market for a CM with an R&D lab to help develop this formula you can PM me and I’ll see if our company can be a good fit for you. We’re located in southern Florida and have experience formulating and manufacturing SPF products and other OTCs.

  • mikethair

    Member
    August 22, 2023 at 9:00 pm

    The proposed MoCRA will change all of this.

    • PhilGeis

      Member
      August 23, 2023 at 6:37 am

      No - this is a drug question. MoCRA only addresses cosmetics and does not impact development labs

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