FDA WARNING_LETTER - Fancy Drops Beauty LLC - July 31, 2024

On October 24, 2024, the FDA issued a Warning Letter to Fancy Drops Beauty LLC after reviewing their website, fancydropsbeauty.com, in July 2024. The letter addresses the sale of "Fancy Drops Color Changing Solutions Eye Drops" in various colors.

The FDA determined that Fancy Drops products are unapproved new drugs, violating sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)). Ophthalmic products pose a higher risk due to their administration route. The products are classified as drugs under section 201(g)(1) of the FD&C Act (21 U.S.C. 321(g)(1)) because website claims indicate intended use for disease diagnosis, cure, mitigation, treatment, prevention, and/or affecting body structure or function.

Fancy Drops products are not generally recognized as safe and effective (GRASE) for their claimed uses, making them "new drugs" under section 201(p) of the FD&C Act (21 U.S.C. 321(p)). No FDA-approved application exists for these products, rendering their introduction into interstate commerce illegal.

Fancy Drops Beauty LLC must respond in writing within fifteen working days, detailing corrective actions, steps