The American Academy of Ophthalmology (AAO), the American Optometric Association (AOA), and the FDA have released warnings^1-3 about color-changing eyedrops that have appeared on social media. The drops — produced by LightEyez Ltd, Fancy Drops, and dupes on Amazon —are advertised as changing users’ iris color by altering the levels of melanin, other pigmentation, and tyrosinase in the iris, according to their respective websites.

The AAO released a statement that the drops have not been tested for safety and are not FDA-approved. “There is no evidence that the formula can target the iris pigment, and if the drops did destroy the pigmented cells in the iris, they could potentially harm the eye, causing light sensitivity, eye inflammation, and eventually vision loss," reveals the statement. "It’s also unclear how other parts of the eye that rely on melanin to function properly, such as the retina, would react to this ingredient.”¹

The AOA stated “There are no FDA-tested or approved color-changing eye drops on the market today. The AOA does not recommend the use of these products.”² 

The FDA’s warning letters to LightEyez and Fancy Drops note that these companies' product lines are in violation of several Food, Drug, and Cosmetic Act sections, which cover interstate commerce, drug claims on their respective sites, and more.³ Find overviews of each product below.

Drug Claims- LightEyez Products
The LightEyez website describes its drops as changing the color of the iris and an additional ability to possibly “combat the side effects of glaucoma medication, that cause the iris and sclera to become darker” or improve whitening of the eye overall.^3,4

The description of the company's Sensitive Eye Lightening Drop: “ideally suited to individuals with medical conditions, such as glaucoma and cataracts, those with dry or sensitive eyes or individuals prone to allergies” because of the extra hyaluronic acid and cucumber extract included in the formula.^3,5

While hyaluronic acid is being used in other formulations of eye care therapeutics, says Mark Schaeffer, OD, clinical excellence captain at MyEyeDr, in Birmingham, Ala, “each of these uses has been studied in live patient trials with reporting to ensure patient safety. The problem with any drop [including those mentioned] that does not go through any rigorous testing is that we won't be able to ascertain any interactions or adverse events," he explains. "[Additionally], patients who take [non FDA-approved] drops won't have the reporting mechanism to provide valuable feedback on how the drop works and how it is tolerated.”

According to the company's website, LightEyez formulations "are completely sterile, [and] balanced to the PH of the eye. With the added benefit of sterile water and saline, [the] drops work in equilibrium with your body."⁵

The FDA notes concerns with the sterility of the drops. Specifically, LightEyez “instruct[s] consumers to insert a foreign object into the dropper tip nozzle and/or remove the dropper tip to clear a blockage, which risks contamination of [the] ophthalmic drug products with foreign particulate matter and/or microorganisms.”³ Also, the FDA cites the containers’ tendency to leak during shipment as a potential sterility problem.³ 

LightEyez formulations also include a “patent-pending eye color-changing solution…to assist in overall lightening and melanin removal.”^3,6 Ingredients for this solution specifically are not listed on its website.

Conexiant has reached out to LightEyez for more information on these ingredients, but has not received a response as of the posting of this news item on Dec. 18, 2024.

The LightEyez website advertises certifications including USDA organic, gluten-free, preservative-free, paraben-free, cruelty-free, and compatibility with contact lenses and LASIK.⁴ The company describes a 347-participant trial in which “98% of participants found significant lightening over six months” and “94% found that the eye drops did not irritate the eyes."⁴ The study reported no adverse events, such as difficulties with vision, headaches, or infections.⁴ 

Additionally, the company recommends that its products be used in conjunction with its MSM (methylsulfonylmethane) drops, if the formulation of a particular product doesn’t already include it as a vehicle.⁴

The FDA has issued warnings against eye drops that contain MSM as an active ingredient, particularly with regard to the contaminated eye drops in 2023. Specifically, EzriCare Artificial Tears, Delsam Pharma’s Artificial Tears, and Delsam Pharma’s Artificial Eye Ointment were recalled.^3,7 

More than 80 cases of highly drug-resistant bacterial infections were already uncovered by the time these companies recalled their respective drops. Fourteen people were blinded, four had their eyes surgically removed, and four died from infections that became fatal when they entered the bloodstream.⁸

The products in question that contain MSM are, according to the FDA’s statement, “unapproved drugs and illegally marketed in the U.S.”⁷

The drops from LightEyez specifically were found to contain “gross microbial contamination” of the microorganisms Pseudomonas spp., Mycobacterium spp., Mycolicibacterium spp., and Methylorubrum spp., according to FDA testing.³ 

“Under the Federal Food, Drug and Cosmetic Act, eye drops must be sterile to be safe for use,” the FDA wrote.⁷

LightEyez has not responded to FDA or taken action to protect consumers, the FDA further stated. ⁷

LightEyez also says its MSM drops “soften eye tissues; equalise the pressure of eyes, repair damage to membranes, and help eye tissues to be able to more effectively absorb nutrients.”^3,9

According to the FDA, these statements could have implications for users who have clinical eye conditions: “Ophthalmic drug products, which are intended for administration into the eyes in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.”³

Drug Claims- Fancy Drops Products
Fancy Drops is another a brand circulating on social media platforms, including TikTok, Facebook, and Instagram.¹⁰

The FDA issued the company a warning letter similar to that of LightEyez regarding violations of the same Food, Drug, and Cosmetic Act sections.¹¹ 

Fancy Drops' formulation differs from LightEyez and includes ganoderma, which may have anti-melanogenic effects.¹²

Similar to LightEyez, ingredients in Fancy Drops’ Fancy Complex solution are not listed on its website, and, as of Dec. 18, 2024, its FAQ pages and ingredient lists are no longer available.¹³

Conexiant has reached out to the company to confirm the formulation’s ingredients, but it has not responded as of the posting of this news item (Dec. 18, 2024).

Additionally, like LightEyez, Fancy Drops say its products are cruelty-free and sustainable with clean ingredients. The company's website also says the drops are “approved by Federal Cosmetics Regulation.”¹³ The FDA says these drops are not approved.¹¹

Drug Claims- Amazon
Product descriptions of the Amazon dupes contain no more than a legal disclaimer: “Statements regarding dietary supplements have not been evaluated by the FDA and are not intended to diagnose, treat, cure, or prevent any disease or health condition.”¹⁴ No ingredient lists are included in the listings.^14,15

Effects of Social Media and Consumer Recommendations
Many eye care professionals have taken to TikTok to warn consumers away from Fancy Drops, but the products are still being promoted across the platform, and will appear as a sponsored ad when users go to a new platform to scroll, as the author of this news item discovered. 

Consumer reviews regarding LightEyez and Fancy Drops discuss the lack of side effects experienced and the effectiveness of the products over time. At the time of the posting of this news item (Dec. 18, 2024), Fancy Drops reviews are no longer available.¹⁶ 

Some reviews mention conditions such as dry eye, and suggest that fellow consumers who have the condition could benefit from the drops.^3,5,16 

Most of the consumer reviews on Amazon say that the drops did not work, and some consumers say they experienced stinging upon instillation.^14,15

“We have patients who ‘self-medicate' with various OTC drops, especially those that get the red out,” Dr. Schaeffer says in response to Conexiant’s questions regarding the color-changing drops. “We [ODs] spend a good amount of time discussing [with patients] the long-term side effects — such as dryness, grittiness, burning and redness — that can occur from using drops without guidance or recommendation from their eye care provider.”

The AAO’s advice: The best way to change eye color is colored contact lenses fit and dispensed by eye care providers.¹

References

1. American Academy of Ophthalmology. What ophthalmologists want you to know about eye color-changing drops. August 27, 2024. Accessed December 18, 2024. https://www.aao.org/newsroom/news-releases/detail/what-ophthalmologists-want-you-to-know-about-eye-c
2. American Optometric Association. Consumer alert: eye color changing eye drops. August 12, 2024. Accessed December 18, 2024. https://www.aoa.org/about-the-aoa/press-room/statements/consumer-alert-eye-color-changing-eye-drops?sso=y
3. U.S. Food and Drug Administration. Warning letter: LightEyez Limited. February 15, 2024. Updated February 27, 2024. Accessed December 18, 2024.  https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lighteyez-limited-665450-02152024
4. LightEyez. Color changing & eye lightening. Accessed December 18, 2024. https://www.lighteyez.com/changeeyecolor.html
5. LightEyez. The sensitive eye lightening drop. Accessed December 18, 2024. https://www.lighteyez.com/store/p6/Color_changing_Eye_Drop_for_Sensitive_Eyes.html
6. LightEyez. Premium high strength eye colour changer jarrah honey drops. Accessed December 18, 2024. https://www.lighteyez.com/store/p22/Premium_High_Strength_Eye_Colour_Changer_
   Jarrah_Honey_Drops.html
7. U.S. Food and Drug Administration. FDA warns consumers not to purchase or use certain methylsulfonylmethane (MSM) eye drops due to contamination. August 22, 2023. Updated August 30, 2023. Accessed December 18, 2024. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-certain-methylsulfonylmethane-msm-eye-drops-due
8. NBC News. CDC reports another death linked to recalled eyedrops. May 19, 2023. Accessed December 18, 2024. https://www.nbcnews.com/health/health-news/cdc-recalled-eyedrops-deaths-cases-rise-rcna85116
9. LightEyez. MSM eye repair drops. Accessed December 18, 2024. https://www.lighteyez.com/msmeyedrop.html
10. FancyNuro. Fancy Drops homepage. Accessed December 18, 2024. https://fancydropsbeauty.com/
11. U.S. Food and Drug Administration. Warning letter: Fancy Drops Beauty LLC. October 24, 2024. Updated November 5, 2024. Accessed December 18, 2024. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fancy-drops-beauty-llc-688469-10242024
12. Lai Y-J, Hsu K-D, Huang T-J, Hsieh C-W, Chan Y-H, Cheng K-C. Anti-melanogenic effect from submerged mycelial cultures of ganoderma weberianum. Mycobiology. 2019 Feb;47(1):112-119. doi:10.1080/12298093.2019.1568680
13. FancyNuro. Fancy Drops FAQ. Accessed December 18, 2024. https://fancydropsbeauty.com/pages/faqs
14. Amazon. Spectraeye Color Changing Drops, Fancy Eye Drops Change Eye Color, Color Changing Eye Drop, Vihue Color Eye Drops, Color Changing Eye Drops, Drops Change Your Eye Color (C). Accessed December 18, 2024. https://amzn.to/3VKeSVY
15. Amazon. 2Pcs Eye Color Changing Drops, Fancy Drops Change Your Eye Color, IrisInk Eye Drops, Color Changing Eye Drops, Change Eye Color Drops(Light Green). Accessed December 18, 2024. https://amzn.to/4fnzj1V
16. FancyNuro. Fancy Drops Reviews. Accessed December 18, 2024. https://fancydropsbeauty.com/pages/reviews