FDA Regulations - What Colors Are Allowed In Bath Bombs May 12 2017

There has been a lot of conflicting information regarding what colors are legal to use in the making of Bath Bombs. I have been directly in touch with one of the Directors at the FDA who cleared up some grey areas around this topic. There is a lot of confusion whether the use of neons in bath bombs is within the FDA regulations, or if using micas in bath bombs are regulated.  The following is what information I have collected directly from the FDA.

According the the FDA, bath bombs, bath truffles, bubble bars, bath salts and nail polish are regulated as cosmetics.  They should, according to the FDA, only contain FDA approved color additives.  Bath bombs and nail polish are FDA regulated products.  

If the color additive is not on this list it is not permitted in the U.S.

(List of ingredients, uses and restrictions for each approved color additive which are listed on the FDA site: https://www.fda.gov/Cosmetics/Labeling/IngredientNames/ucm109084.htm

If the color additive is only allowed for external use (general use), then it is not allowed in lip products or bath salts/bombs.  Please see the definition of external use in the Code of Federal Regulations Title 21 Part 70.3(v):

  • 70.3   Definitions.……(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.

Regulations around neon pigments or other pigment blends:

If the dye or lake, such as Yellow 5, Red 28, Red 40, etc. is not from a certified lot, then the pigment blend is not permitted in FDA regulated products.  It may be okay in countries other than the United States, but in the USA they are not allowed.

If you use an approved color additive in your bath bomb, it must be batch certified by the supplier you purchased it from.   Neons are not permitted at all unless the Pigment Mixture contains Batch Certified dyes or Batch Certified lakes by the FDA.  If you use a supplier that sells a neon color and they claim it is safe for nail polish, lips or bath bombs,than demand lot numbers for those D&C or FD&C dyes or lakes within the Pigment Mixture.

Micas, on the other hand, are not regulated by the FDA even if they are cosmetic grade and can be used in bath products.  Micas can be used in cosmetics depending on their ingredients.  Buy only from reputable companies that can provide documentation regarding whether or not they are lip safe, eye safe, or safe for general use.

Again, if you are making bath bombs or nail polish and selling them to the public, make sure you are not breaching the regulations set forth by the FDA. 

 In short:  

  • Micas are allowed since they are not regulated by the FDA, however can't contain the ingredients such as chromium oxide green or ultramarine blue which are not approved.
  • Neon pigments are not allowed unless they are a mixture which contain FD&C or D&C batch certified dyes (these mixtures are then exempt from certification).
  • A straight color additive, such as a dye or Aluminum Lake must be Batch Certified

I hope some of the misinformation that is out there has been made more clear.  We do sell Batch Certified Aluminum Lakes and micas.

Feel free to contact us if you have any questions:  info@madoils.com