Quite some time ago, I stumbled across this article on TKB Trading’s site, regarding glitter and cosmetics.

The page states:
The FDA has determined that glitter is a color additive which is not listed on their list of approved color additives.  This means that a glitter product is not allowed for use in any cosmetic in the USA.   Consumers have expressed confusion over this, as it is obvious that there is glitter in all kinds of cosmetics sold currently in the USA and there are no known reports of harm caused by glitter.

The FDA has not explained itself to our company, but it has advised us that it recognizes that the cosmetics industry has been largely unaware of this determination and it is essentially providing the cosmetic industry a grace period during which FDA enforcement is “discretionary”.  This grace period allows the cosmetics industry to “respond”. The FDA has not provided us with any information on how long this grace period has been in effect, nor how long it will be in effect.  They simply state the issue is “active”.

You can check out TKB’s ingredients page here, which is a helpful resource.

 

Pictured are some of my bright, safe cosmetics.

 

I was shocked by this information (regarding glitter), so I started to research this issue. Please note, this issue is USA-centric, because it deals with the USA laws, which are different from European or elsewhere when it comes to Cosmetic Ingredients.

I ended up mailing the FDA, thinking that would clear things up. What transpired was nothing more than a confusing series of emails that left me with more questions.

I emailed:
Is it safe to buy products with glitter in them from MAC or other large cosmetics companies? Is it safe to use nail polish that contains glitter? Is it safe to use eye shadow with glitter? What about eye liner with glitter? Blush or lipstick with glitter? So many of the products I own have glitter in them and I have not had an issue, but I would like to know more.

I did read your page:
Color Additives in Specific Products
but I did not find the information there to be clear enough.

The response I received:

You have asked about the use of glitter in cosmetics. Here is some information that you may find helpful:

Color additives used to achieve variable effects, such as those found in pearlescent cosmetic products, are subject to the same regulations as all other color additives. Glitter usually consists of aluminum, an approved color additive, bonded to an etched plastic film composed of polyethylene terephthalate. FDA considers glitter and mica-based composite pigments to be non-permitted color additives when used in FDA-regulated products, including cosmetics. However, we are exercising enforcement discretion for a period of time. During this time, we will allow glitter and mica-based composite pigments to be released with comment when presented for importation into the US. Once the enforcement discretion period is over, FDA will resume our enforcement of these non-permitted colors.

A list of color additives permitted for use in cosmetics is available on FDA’s website at Color Additives Permitted for Use in Cosmetics.

FDA evaluates the safety of color additives as part of the color additive petition process.  So far we have not received a petition for listing glitter in our regulations. To learn about the petition process for color additive approval, please go to ColorAdditivePetitions. Petitions are usually submitted to FDA by color additive manufacturers or trade associations. We encourage petitioners to meet with FDA staff early in the petition process in order to discuss whether additional safety studies will be needed and to obtain other helpful information.

I emailed again, asking for further clarification. I listed specific examples and product ingredients.

The response I received was:
Under U.S. law, cosmetics are not subject to premarket approval by FDA, with the exception of color additives. Cosmetics must not be adulterated or misbranded; that is, they must be safe for consumers under labeled or customary conditions of use, and they must be properly labeled. With the exception of color additives and several ingredients that are prohibited or restricted by regulation (see Restricted/Prohibited, cosmetic firms may use any ingredient, provided it is safe and does not cause the product to be adulterated or misbranded in any other way. Companies and individuals who manufacture or market cosmetics have a legal responsibility for the safety and labeling of their products. FDA can and does take action against products that do not comply with the law, and against firms and individuals who market them.  

A cosmetic that is harmful under labeled or customary conditions of use would be considered adulterated—and thus prohibited in interstate commerce—under the Federal Food, Drug, and Cosmetic Act, whether or not it contains a prohibited or restricted ingredient. FDA’s general approach to investigations of the safety of cosmetics includes consideration of such factors as routes of exposure, vulnerable populations, and amounts expected to be absorbed or ingested under conditions of use.  

The regulatory status and safety of glitter, mica-based pearlescent pigments, and other composite pigments used in cosmetics are currently under discussion while we are exercising enforcement discretion for these color additives.

So I emailed again, asking for more clarification. The response I received was:
We review this (products) on a case-by-case basis when products are presented for importation into the US. We cannot comment on the safety and/or regulatory status of particular products/ingredients to a third party due to protections granted under the Freedom of Information and Privacy Acts.

Enforcement discretion means that we will allow products into the US that contain certain non-permitted color additives, like glitter, while we continue to review data submitted through the petition process and gathered by other means. Once we have completed our review and made a determination, the enforcement discretion period will end.
I was shocked that they ‘couldn’t comment due to the Freedom of Information and Privacy Acts.

What I took away from my emails (and this is from reading between the lines and the ‘case-by-case basis’ comment) is that larger companies, such as MAC, will not have these rules surrounding glitter enforced. Smaller companies may be subject to enforcement of these laws.

So what sort of ingredients are safe for glitter?
Calcium aluminum borosilicate, mica, synthetic mica, or cosmetic safe glass-based borosilicates. Companies still have options for adding glitter and shimmer effects to their products while following the guidelines laid out by the FDA

Ingredients to look for that are not approved for cosmetics: (i.e. be wary)

  • Yellow 7, CI 45350:1, CAS 2321-07-5 (External cosmetic uses, not Lip and not Eye.)
  • Yellow 10, CI 47005, CAS 8004-92-0; 38615-46-2; 94891-32-4
    (General cosmetic uses, not Eye.)
  • Yellow 11, CI 47000, CAS 8003-22-3 (Cosmetic uses, not Lip and not Eye.)
  • Violet 2, CI 60725, CAS 81-48-1 (External and rinse off, not Lip, not Eye. )
  • *Orange 5, CI 45370:1, CAS 596-03-2 (approved for up to 5% of a lip formula.)
  • *Red 7 (not approved for the eyes, approved for blush and lipstick),
  • *Red 28, CI 45410, CAS 18472-87-2 (not approved for the eyes, approved for lipstick)
  • *Red 34  (not approved for lips)

* Ingredients approved in limited capacity

As such, if I were an independent company owner I would discontinue using any of the ingredients listed above, except for their intended use, such as Red 7 being perfectly safe for blush and lips. It would not be worth it to me to make products from those ingredients and run the risk of being held liable. However, I would also submit a petition to the FDA and get as many people as possible to petition about the glitter additives to enact a change in the law. The only way to enact a change is to have enough people contact the FDA over it.

If you come across a company selling products that list these ingredients that may not approved, you can always ask them about their certification. It should be called a batch certification. If the owner doesn’t have that certification, then the ingredient is likely not FDA approved and may not be safe to use around the eyes.

Additionally, even if a company says ‘this isn’t FDA approved for use around the eyes yet, but it’s approved in other countries’ I would be very cautious with the product. There could still be legal ramifications from the FDA for that company. Or you could end up with permanent damage to your eyes! Many, many people ended up with permanent scarring and damage from Glittersniffer products.

To boil this down a bit:

  • There is a lot of vagueness on the part of the FDA with glitter. There are certain ingredients that are definitely not safe and you should avoid them.
  • The FDA has not called cosmetic-grade PET microfine glitter, a staple in cosmetics manufacturing, unsafe.
  • If you have a reaction to an ingredient, immediately seek medical attention. You do not want to mess around with eye injuries. You can also contact the FDA.
  • Always be sure to read the ingredients listing for a product. If it doesn’t have a listing, be very wary.
  • You can always check the Color Additives Permitted for Use in Cosmetics list.

This post has been in the making since May. I’ve been thinking and researching on this issue for 2 months and I wanted to share what I’ve learned. I welcome discussion on this hot topic.

Edit: I added a chart from the Color Additives Permitted for Use in Cosmetics FDA  page for easy reference for the ingredients I listed above.

This post is accurate to the best of my knowledge. Please contact me if you feel there is more information that should be added or if anything is inaccurate.