What Does The FDA Regulate When It Comes To Soap, Bath Bombs and More?
Overview
There has been a lot of confusion and misinformation regarding what the FDA does and does not regulate, what the FDA-permitted uses actually mean, and how that affects the cosmetic, soap and bath product industries. For better or worse, though, it's actually pretty straightforward.
What Does The FDA Regulate?
Let's start with this: "All color additives used in cosmetics (or any other FDA-regulated product) must be approved by FDA."1
However, there is an exemption for soap: "Products that meet the definition of "soap" are exempt from the provisions of the FD&C Act because—even though Section 201(i)(1) of the act includes "articles...for cleansing" in the definition of a cosmetic—Section 201(i)(2) excludes soap from the definition of a cosmetic."2 (Emphasis ours)
Got it - they regulate cosmetics, but not soaps. That seems pretty clear, but there's an obvious follow-up question: "when is a cosmetic a soap, and vice versa?" Well, here's the official FDA word on that:
"FDA interprets the term "soap" to apply only when:
- the bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product's detergent properties are due to the alkali-fatty acid compounds, and
- the product is labeled, sold, and represented solely as soap"3
In short, if it's not soap as defined by the FDA, they regulate it. And it's important to note that they do regulate "articles...for cleansing." This means that just because it cleans you it's not considered soap by the FDA.
Things like bath bombs, bubble bars, sugar and salt scrubs, lip scrubs, and the like, even if they contain some soap, are not considered soap by the FDA and are thus regulated and must comply with their guidelines.
To keep it simple: if it's not specifically soap, they regulate it.
And That Means?
Basically it means this: if you make anything that the FDA regulates, you must use colors only in ways the FDA has approved. How do you know if your color is allowed for your use? Well, every Mad Micas product has that information on the product page as well as the jars, but here's the broader explanation.
The FDA breaks down approved usage into three categories4 (you might recognize them from our labels):
- External Use
- Generally (Includes Lipsticks) - note that this is listed as "General (Including Lips)" on our site and labels.
- Eye Area
One important thing to note here: the Generally (Includes Lipsticks) category includes any mucus membranes. We got that information direct from our contact at the FDA. So if it's not allowed in this category, you cannot use it in bath bombs, fizzies, bubble bath, etc.
If you want to make eye shadow with one of our colors, you need to make sure that it's approved for "eye area" use. Nail polish? External Use (pretty much everything is approved for external, though some have restrictions)
So. Any color you want to use for whatever you're making needs to be allowed in that area according to the FDA regulations.
Unless it's soap. Because soap is not regulated.
And Glitters?
Well, there's a grey area with glitters. Although glitter is NOT on the permitted list, the FDA has enacted a grace period during which time enforcement of the regulations will be discretionary. We have seen this discretionary enforcement information dating back as far as 2012, and there has been no mention of any changes to the grace period that we've been able to find.
For more flexibility, we do carry quite a few glitter-like micas (our Sparkle Me Series is lovely and made entirely of bath-bomb safe components).
In the end, all we can do is provide the information we've been able to obtain; it is up to end users to decide what they are comfortable with.
And remember, they're ok in soap!
For use outside of the United States, please check the laws in your area.
So Now What?
Well, to make it all a bit easier, we do have a "Color By Use" category in the pulldown menu, so if you're looking for eye safe, or lip safe products, that's going to be your jumping off point.
And, if and when things change, we'll do our best to keep on top of it and let you know promptly.
As always, if you have any questions at all, contact us. We love to chat!