FDA Sends Warning Letter to Maker of Eye Drops

Fancy Drops Beauty LLC, Boulder, CO, has received a Warning Letter from the US Food & Drug Administration following a July 2024 review of its website where it sells Fancy Drops Color Changing Solutions Eye Drops. According to FDA, the products are unapproved new drugs in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA flagged the following claim on the on the website: “Lighten & Brighten Dark Your Eye Color, Speed Up the Eye Color Changing Process.”

FDA also pointed to reviews of the product, such as: “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.”

Other statements noted in the FDA Warning Letter included:

• “Our Eye Color treatments harness the natural properties of plants that work in tandem with proven science to promote clean and gentle color changing process.”

• “Our Fancy Drops products work by inhibiting the production of Melanin, other pigmentation, and Tyrosinase. But that’s not all, our products go beyond this, working at cellular level to Inhibit the enzymes and underlying mechanisms responsible for producing and stimulating pigment-producing cells, [g]iving you a new eye color based on new lower levels of pigmentation.”

• “By inhibiting the expression of Melanin and other pigmentation, you increase the color expression of lighter tones, (such as blues, greens, hazels, and light honey shades) and the overall lightness of your eyes.”

The letter was dated Oct. 24, 2024.