Walgreens Boots Alliance, Inc. Warning Letter Details

Summary

Walgreens Boots Alliance was cited for selling three unapproved ophthalmic drug products—Walgreens Allergy Eye Drops, Walgreens Stye Eye Drops, and Walgreens Pink Eye Drops—in violation of sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act. The products were marketed with disease claims (such as relief of itching, burning, watering, and redness of eyes) on the company's website without FDA approval as new drugs. The FDA emphasized that ophthalmic products present heightened public health risk due to direct eye administration, which bypasses the body's natural defenses.