Skip to content

Laws Around Decorative Contact Lenses Can Be Eye-opening

In early fall, it's prime season for merchants selling Halloween costumes, theatrical makeup, and, increasingly, decorative contact lenses. Since these contact lenses typically have no vision-correction purposes, consumers and payment facilitators alike may not realize they are products regulated by the Food and Drug Administration (FDA) that pose real risks if used improperly. 

Also called theatrical or fashion lenses, decorative contact lenses change the look of a user's eyes - such as snake eyes or "zombie eyes" - but typically do not correct vision. These types of lenses are especially popular around Halloween, but with an increase in costume-oriented activities such as Comic-Con and cosplay (costume play) events, decorative contact lenses are becoming increasingly popular year-round.

The FDA designates most of these lenses as Class II medical devices because they pose a moderate risk to patient health when used without appropriate physician oversight. Improper use and maintenance of contact lenses can lead to severe eye problems such as corneal abrasion, allergic reaction, infection, decreased vision, and even blindness. Many consumers and payment facilitators alike may not realize they are products regulated by the FDA and require a prescription.

Website selling contact lenses

This website selling decorative contact lenses allows users to check out without asking for a prescription.

Many brands of decorative contact lenses are sold online, but not all have received FDA approval or clearance. Before medical devices (including contact lenses) can be sold in the US, the FDA reviews the marketing application or premarket notification from medical device companies to determine whether the companies can release the device into the marketplace.  

Payment facilitators can search the FDA's medical device databases to get information about FDA-approved contact lens brands and manufacturers. They can also search the FDA's warning letters and import alerts to see if a brand or manufacturer has been identified as unauthorized or problematic. 


What to Watch Out For


    • Merchants selling decorative contact lenses without requiring a prescription

    • Merchants selling decorative contact lenses to the US from overseas

    • Websites that accept payment and process orders prior to prescription validation


Want to learn more? Download our Decorative Contact Lenses FAQ.

Man dressed as a skeleton on cover of guide


Recent Blog Articles

Levels of risk.

What You Need to Know About the Different Levels of Merchant Risk

Many risk mitigation approaches focus on high-risk merchants, but what about medium-risk merchants? Being aware of the various levels of risk and which category your merchant falls into is a critical step in quantifying risk. Let's delve into what low-, medium-, and high-risk merchants are and the v...
Northern Colorado Hemp Exposition (NOCO)

Navigating Compliance: LegitScript’s Insights from NOCO

Join LegitScript on a journey to the 10th annual Northern Colorado Hemp Exposition (NOCO), where we immersed ourselves in the heart of the CBD industry. LegitScript shared critical compliance knowledge, exchanged insights with industry peers, and absorbed vital regulatory updates from the FDA and US...

What’s Hiding on Your Marketplace? A Look at How Risk Infiltrates Your Platform

You monitor seller listings on your e-commerce marketplace, but do you know what's going on behind the scenes - or, rather, behind the screens? Illegal and brand-damaging activity isn't always easy to spot, and the risk only compounds as your platform scales. In this post, we explore violative activ...
Addiction Treatment Advisory Committee

Harnessing Collaboration: Highlights from LegitScript’s First Advisory Committee Meeting of the Year

Last year, LegitScript set out to relaunch its Addiction Treatment Certification Advisory Committee in order to strengthen avenues of communication and ensure the continued improvement of its Certification solutions. On March 27, 2024, the revitalized committee convened for the first time. Keep read...