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Inconsistent ultramarines stance from the FDA?

Hi everyone! I'm hoping I can get some insight into a really odd experience I had with the FDA a few months ago. I noticed a lipstick brand that blew up on Instagram was listing ultramarines in their lipstick ingredients. I sent a complaint to the FDA about it because the brand was based in the US and the FDA indicates ultramarines are not approved for use on the lips. The first response I received from the FDA was an email confirming ultramarines are not approved for use on the lips and asking me to resubmit my complaint to a different department. After I resubmitted my complaint as directed, I received a phone call from an FDA rep who said, effectively, "I don't understand the science behind it but I checked with my science team and they said it was fine."

Can anyone explain what happened here? I'm still puzzling about it months later. And for the record the brand in question has since switched to a blue dye, so the original issue is gone.


  • I'm looking into this but it would be helpful to have a link to the product that you mentioned which "blew up Instagram." I'd like to take a look at the ingredient list if you can provide a link. Thanks. 
  • Much obliged, RandyS. The brand is Melt Cosmetics. Until a few months ago they only made lipsticks and had a single ingredients page for all the lipstick shades. The Wayback Machine has a snapshot of the ingredients page here, dated Nov. 5 2014:

    The current ingredients page, showing they've switched to blue dye, is here:

    Let me know if you need any more info!

  • Ok, here's what I found out. It MAY explain the inconsistent response you saw from the FDA. 

    The first question is: how can ultramarines legally be used in cosmetics? 

    “The ultramarine pigments may be safely used for coloring externally applied cosmetics, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practice.”

    Ok, next question. What does "externally applied" mean when it comes to cosmetics? 

    According to CFR 70.3 part V
    The terms externally applied drugs and externally applied cosmetics mean drugs or cosmetics applied only to external parts of the body and not to the lips or any body surface covered by mucous membrane.
    Ok, so ultramarines can't be used on the lips. Right? Well, here's where the confusion comes in. A footnote (note 6) on this section says the following:

    “Some color additives that are permitted for external application also may be permitted in mouthwashes, dentifrices, or lipsticks in limited amounts specified in the color additive listing regulations.”

    That sounds like MAY leave the door open to using ultramarines on the lips if it's "specified in the color additive listing regulations." Of which I could find no reference. 

    So, maybe the person you talked to at the FDA saw this same foot note and got confused. 

    We may never know for sure... 
  • I'm glad someone else is looking at the FDA, and going wait, what the hell. It wasn't just me.
  • Iiinteresting. Thank you so much for looking into it, RandyS!
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