Records · criterion S8

FDA warning letters named in this ledger

Recorded September 2026 · Standard v1.1

A warning letter alleges violations and asks for a written response. It does not halt a business, and it does not remove a seller from this ledger. 12 letters name 11 of the 47 companies recorded here, and all 11 still trade.

Each letter below has its own page, carrying the number, the addressee and address as the Food and Drug Administration files them, the website the agency states it reviewed, the statutory sections cited, what the letter alleges, the test that ties it to a ledger record, and what has happened since. Every letter was fetched from fda.gov and read in full. Criterion S8, enforcement status, records a letter on the seller record and fails a seller only where an action halted the business.

The count, with its denominator

Of the 47 records in the ledger, 11 disclose at least one letter and 36 disclose none. 1 of the 11 carries more than one letter: Hims & Hers with 2. The count of companies is therefore 11 and the count of letters is 12, and the two numbers are not interchangeable. S8 records 0 failures across the 47 records, because no action recorded here has halted a business.

Every letter, by number

Grouped by the date the letter was issued, oldest group first. The subject is the one the FDA index files each letter under.

Two kinds of allegation

The index files the 12 letters under 3 subjects: 5 under “Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)”; 5 under “False & Misleading Claims/Misbranded (Telehealth)”; 2 under “Unapproved New Drugs/Misbranded”. The subject line matters because two different statutes sit behind it. A telehealth letter cites sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act, which concern labeling and the advertising of a compounded drug. A research-vendor letter cites sections 505(a) and 301(d), which concern an unapproved new drug introduced into interstate commerce. A labeling citation and an unapproved-drug citation are different allegations against different conduct.

Two patterns recur in the telehealth letters. The first is a claim of sameness, that a compounded product carries the same active ingredient as an approved brand drug, which the agency reads as implying equivalence to an approved product. The second is a claim of authorship, that a pictured label names the seller as the compounder when a pharmacy the seller does not name did the compounding. Those letters close by asking the company to identify the entities that produce the products its website offers, which is the question criterion S3, pharmacy identification, asks of every record in the ledger.

What a letter does, and does not, do

Each letter requests a written response within fifteen working days and states that failure to address the violations may result in legal action, including seizure and injunction. Seizure and injunction are the actions S8 fails on. A letter is the notice that precedes them and it is not one of them. This site therefore records a letter in full on the seller record, links the seller exactly as it links a record with no letter, and reserves failure for an injunction, a consent decree, a seizure, or a closure.

5 of the letters above were issued on one day, in a wave the index records as 69 letters carrying that single issue date. The wave includes letters to Eli Lilly and Company and Novo Nordisk Inc., the manufacturers of the approved brand drugs those telehealth letters compare against.

The agency publishes a close-out letter where it has evaluated a company's corrective actions and found them adequate. When the index was read in September 2026 it held 3,677 letters and 417 of them carried a close-out letter in that column, so an empty cell is a reading rather than a gap. 0 of the 12 letters recorded here carry one.

How the screen is run

The screen is run against the operating entity and the address, never against the brand name on the storefront. A letter is filed under the company, and a company may trade under names that appear nowhere in the letter, so a brand-name search returning nothing is not a clean result. Every attribution on these pages states its test, and a name resemblance is never the test.

Absence is reported only from a run that proved it could find something. When these letters were re-read in September 2026, every one of the 12 returned a document and a fabricated letter address returned nothing, in the same run and by the same method, so the instrument was shown to discriminate before any absence was recorded. The control is re-run whenever a letter is added, because a control that covered eight rows says nothing about the ninth.

The findings piece that censuses these letters across the whole ledger →

Sources

• FDA warning letter 695663 to Swisschems
• FDA warning letter 715218 to PureRawz
• FDA warning letter 716567 to Hims & Hers Health, Inc. dba Hims
• FDA warning letter 716825 to Hims & Hers Health, Inc. dba Hers
• FDA warning letter 716822 to directmeds.com, Inc. dba DirectMeds
• FDA warning letter 716501 to FitRX, LLC dba Zealthy
• FDA warning letter 716830 to Remedy Meds
• FDA warning letter 721448 to Strut Health, LLC dba Strut
• FDA warning letter 721816 to Ivim Services LLC dba Ivim
• FDA warning letter 728279 to Eden Health International Inc. dba Eden
• FDA warning letter 728236 to Trinity HealthCare Supply, LLC dba altRx
• FDA warning letter 728291 to OrderlyMeds LLC dba OrderlyMeds
• FDA, About Warning and Close-Out Letters
• FDA warning letter index

Counts are generated from the ledger at build time, against Standard v1.1, so this page cannot drift from the records it summarizes. It ranks nothing, recommends nothing, and carries no partner link.