Warning Letter Issued for Eye Color Changing Drops

Do you ever see products and think to yourself, "This can't be safe" or "What regulatory category does that fall into?" After reading this recent warning letter that was issued to a company making ophthalmic (eyedrop) products designed to change people's eye color, I thought to myself, "Is this actually a product that people are putting in their eyes?"

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According to FDA, making claims such as "Lighten & Brighten Dark Your Eye Color, Speed Up the Eye Color Changing Process" are unapproved drug claims. This is the 13th ophthalmic-related warning letter this year, which shows that if you make a product that goes into the eyes, use extreme caution in product marketing and cleanliness. Also, there's been a group of ophthalmic letters that involve MSM and other ingredients that generally should not be placed in the eyes. I write about this here.  Also explore other homeopathic-related ophthalmic warning letters here.

Product reviews are cited in this warning letter. This is a reminder that when reviews are curated on a "Reviews" page, FDA looks at them as being showcased, which means they are marketing and fair game for enforcement. There seems to be a fine line between third-party, non-curated reviews on a website and "marketing" reviews curated on a reviews page. I rarely call out companies by name on Warning Letter Wednesday, but looking at how the company formatted their reviews page is an example of what not to do, and avoiding this can help keep you out of trouble. 

• From FDA letter. "On the webpage https://lnkd.in/gemFTh54. Customer review from 05/17/2024: "I've had brown eyes for years, and they were blue when I was born! Now, after 5 months, I bought it hoping for green eyes, and it works well. It has changed my eyes, and now having green eyes is what I'm most excited about."

This company appears to continue to sell the product, which means we can likely expect more decisive FDA action soon. What do you think?

Read the full letter here.

DATE ORIGINALLY POSTED: 11/13/24

Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.