FDA WARNING_LETTER - CVS Health - September 12, 2023

The FDA issued a Warning Letter to CVS on September 11, 2023, following a July 2023 review of their website, www.cvs.com. The letter identifies "CVS Health Pink Eye Relief Drops" as an unapproved new drug, violating sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)). The product is deemed a "new drug" under section 201(p) (21 U.S.C. 321(p)) because it is not generally recognized as safe and effective (GRASE) for its intended uses, and no FDA-approved application is in effect.

The FDA expressed significant public health concerns due to the ophthalmic route of administration, which bypasses natural defenses. The product's labeling, including claims on the website, provides evidence of its intended use as a drug. Although labeled as homeopathic, the FDA states that homeopathic drugs are subject to the same statutory requirements, including FDA approval.

Furthermore, the product is considered adulterated under section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)) because it was manufactured by a contract manufacturer, (b)(4), which