FDA WARNING_LETTER - Walgreens Boots Alliance, Inc. - September 11, 2023

The FDA issued a Warning Letter to Walgreens on September 11, 2023, following an August 2023 review of their website, www.walgreens.com. The FDA identified that "Walgreens Allergy Eye Drops," "Walgreens Stye Eye Drops," and "Walgreens Pink Eye Drops" are offered for sale and are considered unapproved new drugs.

These ophthalmic products are deemed drugs under section 201(g)(1) of the FD&C Act due to claims on their labeling and website, such as "For relief of itching, burning, watering & redness of eyes" for Allergy Eye Drops, "Multi-symptom relief of redness, burning & tearing" for Stye Eye Drops, and "Relieves redness, burning, watery discharge & sensation of grittiness" for Pink Eye Drops. The FDA states these products are not generally recognized as safe and effective (GRASE) for their intended uses, making them "new drugs" under section 201(p) of the FD&C Act. Introducing or delivering these products into interstate commerce without an FDA-approved application violates sections 301(d) and 505(a) of the FD&C Act.

Furthermore, the letter notes that these homeopathic drugs are produced by a contract manufacturer, (b)(4), which has documented significant Current Good Manufacturing Practice (CGMP)