Glitter In Bath Bombs - FDA Regulations

Bath bombs are considered a cosmetic and there are rules and regulations imposed by the FDA for coloring bath bombs.  This has been a challenging time for people who make soap who have recently added bath bombs to their catalog.  Soaps are a rinse off product, whereas bath bombs are used in bathwater and are in contact with mucous membranes (genitals) for extended periods of time.

Glitter has been mostly ignored in the community as a color additive.  Suppliers who offer these glitters often have untrue statements or misinformation on their website about their approved applications.

Many cosmetic glitters contain aluminum. If you don't know if your does, look at the ingredient list on the label or on the website of your supplier.  If it contains aluminum, you may not use these safely in bath bombs (or bath products made for the tub).

The Director of Color Certification at the FDA confirmed that if a color additive contains aluminum or aluminum powder, it is approved for the following for cosmetics

• Eyes:  YES
• Generally (includes lipstick) NO
• External: YES  This means it should not come in contact with mucous membranes for extended periods of time. 

From the CFR:

 73.2645   Aluminum powder. (a) Identity and specifications. The color additive aluminum powder shall conform in identity and specifications to the requirements of §73.1645 (a)(1) and (b). (b) Uses and restrictions. Aluminum powder may be safely used in coloring externally applied cosmetics, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practice.

So in layman's terms, ALUMINUM is:

1. Not permitted on lips
2. Not permitted in bath bombs, bath salts, bath bubble bars, etc.

It is hard to keep track of all the rules.  We understand.  We try hard to keep up on all of the color additive rules and regulations,keep you informed so you can comply with the FDA regulations.  The FDA list all color additives that are approved for cosmetics and their safety applications.  If you are having trouble deciphering what all of it means, feel free to email me at info(at)madoils(dot)com or contact the FDA.

To read more on FDA Regulations, see my other FDA blog post here:  http://thesoapbar.blogspot.com/2017/04/fda-regulations-regarding-color.html

Keep your peeps safe and your reputation intact.

Please feel free to try our Sparkle Plenty at Mad Micas for a sparkle that is absolutely permitted by the FDA and deemed safe. 

FDA Regulations Regarding Color Additives In Cosmetics

I have been corresponding with the Director of Color Certification & Technology Division at the FDA regarding exactly what is legal to use in Bath Bombs specifically. We (at Mad Micas) carry Batch Certified Lakes and we carry neon pigments. There seems to be some confusion regarding whether the use of neons in bath bombs is within the FDA regulations. 

These are my findings:

Bath bombs, bath salts and nail polish are regulated as cosmetics so they should only contain FDA approved color additives.  You must check the uses and restrictions for each approved color additive.  Refer to the list of approved color additives. If you don’t see the color on this list it is not permitted in the U.S.:

https://www.fda.gov/Cosmetics/Labeling/IngredientNames/ucm109084.htm

If the color additive is only allowed for external 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.

Regarding 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 Europe or Asia, but in the U.S. it is not allowed.

In layman's terms, if you use an approved color additive in your bath bomb, it must be batch certified.  Period.  Neons are not permitted at all unless the blend uses FDA batch certified dyes or lakes.

Micas, on the other hand, are not regulated by the FDA even if they are cosmetic grade and can be used in any bath products unless they contain ultramarines or chromium green oxide.  Cosmetic micas can be used in cosmetics depending on their ingredients (depending on if they are lip and eye safe, etc.)

I hope this has cleared up some fuzzy areas when making bath bombs or nail polish for sale and staying within the FDA regulations regarding these products.  

Please see an updated (and more bath bomb specific) blog post here.

What's in YOUR red colorant?

I know this is my soap blog and I try not to include too much stuff about Mad Oils, my wholesale supply company, but I thought this was just too important not to post here:

Mad Oils carries only vegan ingredients.  We believe in using and selling only cruelty free products.  We are an animal loving team here with a vast array of rescued pets between us.

Carmine is an ingredient very often used in red and pink micas.  You may not be aware of what it is or where it comes from, but it might be in the micas and other colorants you use in your products.  

photo courtesy of http://safewithdrsandraelhajj.com

“Carmine” is an ingredient used often in the food and cosmetic industry.  It is often found in micas and other colorants to produce red, pink, purple and brown colors.  What is carmine?  Cochineal bugs that are dried and crushed to produce a red dye, are called cochineal, carmine, or carminic acid.  The dye comes specifically from the female insect called Dactylopius coccus. These bugs are killed, dried and crushed to create the color.

It takes about 70,000 insects to make one pound of cochineal.

 

photo courtesy of http://www.hottopixnow.com

 

Carmine is generally safe, but manufacturers of products need to know that in a small number of people, carmine can cause swelling, skin rashes and even respiratory problems.  The red powdered pigment is used as a natural alternative to artificial coloring, but it is not vegan.  It is important to be aware of ingredients we choose when making our products so that customers can choose for themselves what they want to use on their body.  

We share this information with you, not to gross you out, but to ensure that when choosing Mad Oils, you know exactly what you’re getting.  We stand by our claim that Mad Oils will carry only 100% vegan micas.  In fact, all of our products are 100% vegan, even our fragrance oils.  (Yes, fragrances often contain animal products).  We know this is important to many of you, as it is to us.

It’s important to make an educated choice when purchasing reds, pinks, browns and purples. It is up to you whether to use products containing carmine or not. Remember that knowing what is in your products and providing full disclosure about their ingredients is empowering to you, as well as your customer.  Knowledge is power.

Xoxo - All of us at Mad Oils

Note: Please refer to the FDA website for color additive regulations to find out what label requirements are in effect.

 http://www.fda.gov/ForIndustry/ColorAdditives/GuidanceComplianceRegulatoryInformation