Warning letter · Center for Drug Evaluation and Research (CDER)
FDA warning letter 663246 to CVS Health
Issued September 11, 2023. The letter alleges that homeopathic pink eye relief drops sold under the CVS Health name on CVS MinuteClinic's website are unapproved new drugs, and are adulterated because a contract manufacturer made them outside current good manufacturing practice. It asks for a written response and it did not halt the business. The ledger record for CVS MinuteClinic passes S8.
The letter, as filed
Every line below is copied from the letter itself. The addressee and the address are the ones the agency prints in the header, which is the pair an attribution rests on.
| Number | MARCS-CMS 663246 |
|---|---|
| Issued | September 11, 2023 |
| Addressee | CVS Health |
| Address | One CVS Drive, Woonsocket, RI 02895 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Subject | Unapproved New Drugs/Misbranded |
| Website reviewed | CVS MinuteClinic's website, reviewed in July 2023 |
| Sections cited | 505(a), 301(d), 501(a)(2)(B), 301(a), 301(c) of the Federal Food, Drug, and Cosmetic Act |
| Close-out letter | None on the index when the close-out column was last read. |
What it alleges
Homeopathic pink eye relief drops sold under the CVS Health name on CVS MinuteClinic's website are unapproved new drugs, and are adulterated because a contract manufacturer made them outside current good manufacturing practice.
The letter quotes 2 claims from the website it reviewed, reproduced here exactly as the letter prints them, including the agency's own elisions.
“[T]emporarily relieve minor eye symptoms: •excessive watery (clear) discharge •sensation of grittiness •redness and burning”
“CVS Health Pink Eye Drops is a homeopathic formula that stimulates the body’s ability to relieve redness, burning, watery discharge, and sensations of grittiness.”
A quoted claim is evidence of what a page said when the agency read it. It is not evidence of what the page says today, and this site records the seller's current pages separately, on the seller record, with their own date.
The sections cited are 505(a), 301(d), 501(a)(2)(B), 301(a), 301(c). Section 505(a) prohibits introducing an unapproved new drug into interstate commerce and section 301(d) makes doing so a prohibited act. That is an unapproved-drug allegation rather than a labeling one.
How it was attributed
The letter names CVS MinuteClinic's website as the website it reviewed, the domain the MinuteClinic program pages sit on, and is addressed to CVS Health at One CVS Drive, Woonsocket, the street address the privacy policy prints for CVS Pharmacy, Inc. A letter is filed under an operating entity, and a company may trade under names that appear nowhere in it, so the screen is run against the entity and the address rather than against the brand on the storefront. A name resemblance is never the test, because attaching one company's enforcement record to another is a worse error than missing a disclosure.
What the ledger records since
CVS MinuteClinic is recorded against criterion S8, enforcement status as PASS. The basis reads: FDA warning letter 663246, September 2023, names CVS Health at its Woonsocket, Rhode Island headquarters and the seller's own website, and alleges that homeopathic pink eye relief drops sold under the CVS Health name are unapproved new drugs. It does not concern weight loss medication. No FDA action has halted the business, and the company continues to operate. The storefront was trading as of the date on its record.
The index carries no close-out letter for it. As of September 2026 the index held 3,677 letters and 417 of them carried a close-out letter, so the column is populated and an empty cell is a reading rather than a gap. A letter that has been neither closed out nor followed by an action is the ordinary state of a warning letter.
Why this is not a disqualification
A warning letter identifies a concern, requests a response, and states that failure to address the violations may result in legal action, including seizure and injunction. Those actions are what criterion S8 fails on. The letter is the notice that precedes them and it is not one of them, so this ledger records it in full, dates it, links it, and leaves the seller listed and linked exactly as a seller with no letter.
1 other letter in this ledger carries the same issue date: 663404, to Walgreens Boots Alliance, Inc..
Sources
- FDA warning letter 663246 to CVS Health, read in full
- FDA, About Warning and Close-Out Letters
- FDA warning letter index, and its close-out column
- The seller record this letter is disclosed on
The letter is quoted from its own page on fda.gov, as it stood on the date in the meta line above. This page ranks nothing, recommends nothing, and carries no partner link.